CASRAI Dictionary
Open, citable controlled vocabulary for research administration.
CASRAI — Standards for Research Administration
Generative AI use and disclosure
Vocabulary for human–AI collaboration on research outputs and the disclosure required.
CRediT extensions and adjacent contribution vocabularies
Extending CRediT to acknowledged contributors, peer reviewers, technical staff.
Mentorship, training, and career stages
Career-stage terms underpinning narrative CVs and mentorship recognition.
Research outputs (expanded)
Modern outputs taxonomy beyond articles — preprints, datasets, models, protocols, more.
Scholarly publishing
Vocabulary bridging dictionary entries to the scholarly-literature and editorial ecosystem.
The persistent identifier ecosystem
ORCID, ROR, RAiD, IGSN, PIDINST, DOIs — the PID landscape.
Research-information systems and integration
CRIS, RIM, CERIF, OpenAIRE, JATS — vendor-neutral terms.
Research data infrastructure
Trusted repositories, EOSC, biobanks, data trusts, federated infrastructure.
Machine-actionable data management plans
RDA DMP Common Standard and the ecosystem of maDMP tools.
Reproducibility and computational research
Workflows, containers, FAIR4RS, Software Heritage, computational reproducibility.
AI and ML research outputs
Model cards, system cards, datasheets, benchmarks, evaluation suites.
Research integrity and misconduct
FFP, paper mills, retractions, COPE / ORI / UKRIO frameworks.
Compliance and regulatory
IRB/REC, IACUC, GDPR, MTAs, EAR/ITAR — the compliance lattice.
Research security
NSPM-33, foreign component, DURC, dual-use research.
Indigenous data governance — CARE principles
CARE alongside FAIR; TK labels, FPIC, GIDA.
Clinical research and clinical trials
Clinical trial protocols, IND/IDE filings, case report forms, and HIPAA research-disclosure rules.
Consent, privacy, and regulatory disclosure
GDPR/data-protection sections, the EU AI Act, informed-consent waivers, financial-interest and covered-species disclosure rules.
Responsible research assessment
DORA, COARA, R4RI, narrative CVs.
Knowledge equity, diversity, global-south inclusion
Diamond OA, APC waivers, Plan S, bibliodiversity.
Engagement, impact, and SDG alignment
REF Impact, PPI, citizen science, SDGs.
Sustainable research and laboratory operations
LEAF, My Green Lab, carbon footprint of research.
Funding lifecycle and financial vocabulary
Calls, NCE, indirect costs, biosketch, current & pending.
Grants management and sponsor compliance
Award administration vocabulary — supplements, FFATA reporting, warranties and covenants, funder-specific terms.
Research lifecycle stages and project metadata
RAiD-anchored project lifecycle, phases, milestones.
Technology transfer and commercialization
Patents, licensing agreements, IP disclosures, and university–industry deal terms.
Life sciences and biology
Vocabulary anchored in biological and life-sciences research disciplines.
Earth, environmental, and marine sciences
Vocabulary anchored in earth, environmental, and marine-science research disciplines.
Space and planetary sciences
Vocabulary anchored in space and planetary-science research disciplines.
Physical sciences and materials
Vocabulary anchored in physical-science and materials-research disciplines.
Conceptualization
Ideas; formulation or evolution of overarching research goals and aims.
Methodology
Development or design of methodology; creation of models.
Software
Programming, software development; designing computer programs; implementation of the computer code and supporting algorithms; testing of existing code components.
Validation
Verification, whether as a part of the activity or separate, of the overall replication/reproducibility of results/experiments and other research outputs.
Formal analysis
Application of statistical, mathematical, computational, or other formal techniques to analyse or synthesise study data.
Investigation
Conducting a research and investigation process, specifically performing the experiments, or data/evidence collection.
Resources
Provision of study materials, reagents, materials, patients, laboratory samples, animals, instrumentation, computing resources, or other analysis tools.
Data curation
Management activities to annotate (produce metadata), scrub data and maintain research data (including software code, where it is necessary for interpreting the data itself) for initial use and later re-use.
Writing — original draft
Preparation, creation and/or presentation of the published work, specifically writing the initial draft (including substantive translation).
Writing — review & editing
Preparation, creation and/or presentation of the published work by those from the original research group, specifically critical review, commentary or revision — including pre- or post-publication stages.
Visualization
Preparation, creation and/or presentation of the published work, specifically visualization / data presentation.
Supervision
Oversight and leadership responsibility for the research activity planning and execution, including mentorship external to the core team.
Project administration
Management and coordination responsibility for the research activity planning and execution.
Funding acquisition
Acquisition of the financial support for the project leading to this publication.
CONSORT Flow Diagram for Randomised Trials
Human Cell Atlas (HCA)
An international, open-science consortium, founded in 2016 and convened by the Broad Institute, the Wellcome Sanger Institute, and Wellcome, that aims to create comprehensive reference maps of every cell type in the human body using single-cell and spatial genomics. The HCA is a distributed research collaboration organized into national/regional networks and topic-specific Biological Networks (not a repository, funder, or formal legal entity), coordinated by an Organizing Committee and Working Groups, publishing data and analysis tools through the HCA Data Portal for free public reuse under its own network-level standards.
Reverse Causality
Reverse causality (also called reverse causation) is the error of assuming a relationship between two variables, X and Y, runs from X to Y when the true causal arrow runs the opposite way -- from Y to X -- or, in the general case, runs both ways at once as a feedback loop. It requires no third variable: the mistake is not that some lurking factor is driving both X and Y (that is confounding), it is that the direction assigned to a real relationship between X and Y is simply backwards. Observing that X and Y are correlated, or even that X was measured before Y, does not establish that X causes Y -- it is equally consistent with Y's own prior trajectory having produced X, which is common whenever both variables are stable traits or slow-moving processes capable of influencing each other over time.
Vivli (concept)
A non-profit, independent clinical-trial data-sharing platform that hosts a searchable catalogue of individual participant-level data (IPD) from completed clinical trials and mediates researcher access to it through a structured, multi-stage request-and-review process rather than open download. Approved researchers analyze the data inside a browser-based secure research environment; the underlying files are never downloaded to the researcher's own machine. Vivli grew out of a project at the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women's Hospital and Harvard, and launched publicly in July 2018.
PharmGKB (Now ClinPGx): The Pharmacogenomics Knowledgebase
ClinPGx (the renamed, relaunched successor to PharmGKB, the Pharmacogenomics Knowledgebase) is the NIH-funded, Stanford-hosted resource that curates the evidence linking specific genetic variants to drug response -- clinical annotations, dosing guidelines, and drug-label pharmacogenomic annotations -- and now brings PharmGKB's original knowledgebase together with CPIC's dosing guidelines and PharmCAT's genotype-to-phenotype annotation tool under one platform at clinpgx.org (pharmgkb.org now redirects there). What makes a gene-drug relationship a PharmGKB/ClinPGx entry specifically is that the resource's own curation team has reviewed the evidence and published a structured clinical annotation with an assigned level of evidence under a stable, citable identifier -- not merely that a primary study reported the association.
Authorised Prescriber (AP) Scheme (TGA, Australia)
The Authorised Prescriber (AP) Scheme is one of two pathways under Australia's Therapeutic Goods Act 1989 (Cth) letting a medical practitioner lawfully supply an unapproved therapeutic good (one not on the Australian Register of Therapeutic Goods for the intended use) outside a formal clinical trial. It applies when a single named practitioner needs standing authority to prescribe that good to an entire class of patients with a defined medical condition under their ongoing care -- as opposed to the Special Access Scheme (SAS), which covers a single patient or a specific small group per request. Becoming an Authorised Prescriber requires endorsement from a Human Research Ethics Committee or relevant specialist college (or, for products with an established history of use, direct TGA application), and carries an ongoing obligation to report patient numbers to the TGA roughly every six months.
Office of the Gene Technology Regulator (OGTR)
The Office of the Gene Technology Regulator (OGTR) is the Australian Government statutory regulator, established under the Gene Technology Act 2000 (Cth), whose approval is required before any dealing with a genetically modified organism (GMO) can lawfully proceed in Australia. A dealing falls under OGTR's jurisdiction whenever it involves developing, producing, propagating, or releasing an organism whose genetic material has been modified using gene technology; OGTR (directly, or via an OGTR-accredited Institutional Biosafety Committee) then classifies that dealing as exempt, a Notifiable Low Risk Dealing (NLRD), a licensed Dealing Not involving Intentional Release (DNIR), or a licensed Dealing Involving Intentional Release (DIR) -- with DIR, covering field trials and environmental release, subject to the most stringent review and mandatory public consultation.
Composite Endpoint
A composite endpoint is a single clinical trial outcome built by combining two or more distinct individual outcome events into one measure, counted as a single event at the time of whichever qualifying component occurs first (time-to-first-event analysis). Trials use composites mainly to raise the total event rate, which increases statistical power and can shorten follow-up or reduce required sample size compared with powering each component outcome separately. A defensible composite requires components of similar clinical importance, a treatment effect that is directionally consistent across components, and individual component results reported alongside the combined figure -- not just the top-line composite result.
Health Canada Special Access Program (SAP)
Health Canada's Special Access Program (SAP) is the federal mechanism that lets a licensed health, dental, or veterinary practitioner request an unauthorized drug, biologic, or medical device for a named patient with a serious or life-threatening condition when conventional therapies have failed, are unsuitable, or are unavailable in Canada. It runs as two administratively separate streams -- drugs/biologics and medical devices -- each with its own request form. SAP is explicitly not a research pathway: Health Canada's own guidance states it cannot be used to bypass a Clinical Trial Application, run a research study, or promote early product adoption. The practitioner (not the patient) sources the product and submits the request; time-sensitive, life-threatening cases are typically resolved within hours, while cost is set by the manufacturer and may fall to the hospital, an insurer, or the patient.
Negative Predictive Value (NPV)
Negative predictive value (NPV) is the proportion of all negative test results that are true negatives: NPV = TN / (TN + FN), calculated within the test-negative row of a diagnostic accuracy 2x2 table. It answers 'given that a patient tested negative, how likely is it the condition is genuinely absent' -- the mirror statistic to positive predictive value (PPV), which is calculated within the test-positive row of the same table. Like PPV, NPV depends on the prevalence of the condition in the population tested, but moves in the opposite direction: NPV rises as prevalence falls, while PPV falls.
Number Needed to Harm (NNH)
Number needed to harm (NNH) is the average number of patients who must receive a specific treatment, or be exposed to a specific risk factor, over a defined time period, for one additional patient to experience a specified harmful outcome compared with a control condition. It is the reciprocal of the absolute risk increase (ARI): NNH = 1 / ARI, where ARI is the harmful-event rate in the exposed or treated group minus the harmful-event rate in the unexposed or control group. NNH is the arithmetic mirror of number needed to treat (NNT) applied to an adverse rather than a beneficial outcome, and the two are only meaningfully compared for the same intervention, the same outcome definitions, and the same follow-up duration — an NNH computed for one adverse event at one time horizon cannot be validly compared against an NNT for a different outcome measured over a different period. A calculated NNH is only interpretable as evidence of harm when the underlying absolute risk increase is statistically significant; when a trial's confidence interval for the risk difference crosses zero, the resulting NNH is not a meaningful single number (its reciprocal passes through infinity at zero difference) and should be reported as a non-significant risk difference instead.
Ensembl (Genome Browser)
A genome browser and annotation resource, maintained by EMBL-EBI, that automatically annotates reference genomes -- gene models, transcripts, regulatory features, comparative-genomics alignments -- and integrates that annotation with other biological data (variation, expression, disease association) into one browsable, queryable interface. As of 2022, Ensembl supports 271 registered vertebrate and other model-organism species directly; a sister project, Ensembl Genomes (launched 2009), extends equivalent coverage to invertebrates, plants, fungi, bacteria and protists, together spanning over 50,000 genomes by 2020. Data and software are released under a Creative Commons Attribution 4.0 license, accessible via the website, REST and Perl APIs, BioMart, FTP, and public MySQL databases, with mirror sites at the Sanger Institute (UK) and on AWS (US, Asia).
Odds Ratio (OR)
An odds ratio (OR) is the ratio of the odds of an outcome occurring in one group to the odds of it occurring in another group, where odds is the probability of the event divided by the probability of the event not occurring (p / (1−p)), not the probability itself. OR = 1 indicates no association; OR > 1 indicates higher odds in the first (numerator) group; OR < 1 indicates lower odds. What makes a ratio genuinely an odds ratio, rather than a relative risk described loosely as 'odds,' is that it is built from odds (a ratio of two probabilities) rather than from a risk (a single probability of the event among everyone at risk) — the calculation OR = (A×D)/(B×C) from a 2×2 table is mathematically identical whether the underlying study is a cohort, a cross-sectional survey, or a case-control study, which is precisely why OR (unlike relative risk) is calculable from a case-control design that samples on outcome status rather than on exposure and follows no defined population forward in time.
STRING (Protein-Protein Interaction Networks)
A biological database of known and predicted protein-protein interactions, maintained by an academic consortium including the Novo Nordisk Foundation Center for Protein Research, EMBL, the University of Copenhagen, the Swiss Institute of Bioinformatics, Dresden Technical University, and the University of Zurich. Every interaction carries a weighted confidence score, computed by combining multiple independent evidence channels -- experimentally observed interactions and curated databases (imported from sources like BioGRID, HPRD, and MINT), automated text mining of the literature for statistically significant gene co-occurrence, and computational predictions from genomic context (gene neighborhood, gene fusion events, phylogenetic co-occurrence) and coexpression patterns. Version 12.0 (2023) covers roughly 59 million proteins across more than 12,000 organisms; free web access, bulk download, and a programmatic API.
Reactome
A free, open-access, manually curated database of human biological pathways, built on a reaction-based data model: the core unit is a single reaction, and entities (proteins, complexes, nucleic acids, small molecules) participating in that reaction connect into a network of reactions that together form a pathway. Content is authored by PhD-level biologists and passes a structured peer-review process before publication -- a pathway is not 'in Reactome' merely because a contributor drafted it, but only once it has cleared that editorial review. Maintained collaboratively by teams at OICR, OHSU, EMBL-EBI, and NYULMC; equivalent pathways in other species are generated computationally by orthology projection from the curated human data rather than curated independently for each organism; updated quarterly; exportable in BioPAX, SBML, Neo4j graph, and other standard formats.
Relative Risk (RR)
Relative risk (RR), also called risk ratio, is the ratio of the cumulative incidence (absolute risk) of an outcome in an exposed or treated group to the cumulative incidence of that same outcome in an unexposed or control group over a defined follow-up period: RR = Risk(exposed) / Risk(unexposed). Something counts as a genuine relative risk, rather than an odds ratio wearing the same name, only when both risks in the ratio are true incidence proportions computed from a population followed forward in time — a prospective or retrospective cohort study, a randomized trial, or a cross-sectional prevalence survey — because only those designs let you count everyone who was 'at risk' at the start and observe what fraction actually had the event. A study that instead samples on outcome status (a case-control design, which fixes the number of cases and controls by researcher choice rather than by observing a population's true incidence) cannot validly produce a relative risk at all; the corresponding statistic there is an odds ratio, which approximates RR only when the outcome is rare.
KEGG (Kyoto Encyclopedia of Genes and Genomes)
A manually curated, integrated database resource -- initiated in 1995 by Minoru Kanehisa at Kyoto University's Institute for Chemical Research and maintained by the Kanehisa Laboratories -- that represents biological systems as a computable network linking genes, proteins, small molecules and reactions to the higher-level pathways and functions they participate in. Organized into linked component databases: PATHWAY (manually drawn pathway maps), MODULE (functional gene-set units), BRITE (hierarchical functional classifications), GENES/ORTHOLOGY (gene and ortholog annotation across sequenced genomes), and COMPOUND/REACTION/ENZYME (chemical and enzymatic data). Free to browse via the website; bulk FTP downloads have required a paid subscription since July 2011, a funding-driven access split worth noting explicitly in a data management plan rather than assuming KEGG data is unconditionally free to redistribute.
UK Stem Cell Bank (UKSCB)
The single national repository, hosted by NIBSC (part of the MHRA) since 2003, that banks and distributes quality-controlled UK-derived human embryonic stem cell (hESC) lines for research and clinical use. Deposit and access decisions are reviewed by the independent UK Stem Cell Bank Steering Committee against the Bank's Code of Practice, operating downstream of and in addition to the HFEA research licence that authorised deriving the line in the first place -- distinct from a private cord-blood or dental stem-cell storage company despite the similar generic name.
ChEMBL
A manually curated database, maintained by EMBL-EBI, of bioactive small molecules with drug-like properties -- recording measured bioactivity values (Ki, Kd, IC50, EC50) against specific molecular targets, extracted from medicinal-chemistry literature and deposited screening data, not merely a registered chemical structure. Released under a Creative Commons Attribution-ShareAlike license and accessible via web interface, bulk FTP/SQLite download, REST web services, and a SPARQL endpoint. Originated as StARlite (Inpharmatica Ltd.), acquired and reorganized by EMBL-EBI with Wellcome Trust funding in 2008, first released as ChEMBL in 2009.
Health Technology Assessment (HTA)
Health technology assessment (HTA) is the systematic, multidisciplinary process by which a national or regional body evaluates a health technology -- a drug, medical device, diagnostic test, or procedure -- across its clinical effectiveness, cost-effectiveness, safety, and broader organisational, social and ethical impact, to inform a coverage, pricing, or reimbursement decision. HTA is the international family of institutions and methods that a specific national process, such as NICE's technology appraisal in the UK, is one member of; the term names the general discipline and its bodies (NICE, IQWiG, HAS, CADTH, PBAC, and others), not any single country's procedure.
Cost-Utility Analysis (CUA)
Cost-utility analysis (CUA) is the specific form of cost-effectiveness analysis that always measures health outcomes in quality-adjusted life years (QALYs), combining survival and health-related quality of life into one utility-weighted unit, rather than in a natural clinical unit specific to one condition. Because every CUA uses the same QALY denominator, its results are directly comparable across otherwise unrelated disease areas -- which is why NICE and most other national health technology assessment (HTA) bodies designate CUA, not cost-effectiveness analysis generally, as their required reference-case method for a technology appraisal.
Cost-Effectiveness Analysis (CEA)
Cost-effectiveness analysis (CEA) is a method of economic evaluation that compares two or more health interventions by dividing the difference in their cost by the difference in their health outcome, where that outcome is measured in a single natural clinical unit -- a life-year gained, a case of disease averted, a point of blood pressure reduced -- rather than a generic utility measure. The result is an incremental cost-effectiveness ratio (ICER) expressed as cost per unit of that outcome achieved, which a health technology assessment (HTA) body then weighs against a cost-effectiveness threshold to judge value for money.
BioSample
An NCBI database that stores structured, standardized metadata describing the physical biological source material -- a tissue biopsy, cell line, environmental isolate, or strain -- behind a sequencing or experimental dataset, distinct from the sequence data itself. Each record gets a SAMN-prefixed accession, is described using a defined 'package' of controlled attributes appropriate to its sample type (including the MIGS/MIMS/MIMARKS standards for environmental and genomic samples), and links out to the BioProject umbrella it belongs to and the downstream data (SRA reads, GenBank sequences) generated from it. A dataset is 'in BioSample' only once its source-material metadata has actually been registered through this system -- raw sequence data without a linked BioSample accession lacks the standardized provenance record other repositories and downstream analyses depend on.
ENCODE (Encyclopedia of DNA Elements)
An NHGRI-funded international research consortium, launched in September 2003, that systematically catalogs the functional and regulatory elements of the human genome (and, since ENCODE3, the mouse genome) using standardized assays -- ChIP-seq for transcription-factor binding and histone marks, RNA-seq for transcription, DNase-seq/ATAC-seq for chromatin accessibility, and Hi-C for 3D genome contacts -- run across a wide panel of cell types and tissues. Data is released through the ENCODE Portal under standardized accessions (ENCSR for experiments, ENCFF for files), validated and harmonized by a central Data Coordination Center, and no dataset is 'ENCODE data' unless it was actually submitted to and processed through that pipeline.
Human Fertilisation and Embryology Authority (HFEA)
The UK's statutory regulator for fertility treatment and embryo research, created by the Human Fertilisation and Embryology Act 1990 and operational since 1991. The HFEA licenses and inspects three categories of activity -- treatment, storage, and research -- through its Licence Committee, and publishes the Code of Practice (currently 9th edition, version 9.4) and General Directions that translate the Act's requirements into day-to-day licence conditions for licensed centres.
Human Fertilisation and Embryology Act (HFE Act)
The UK statute (1990, as amended by the 2008 Act) making it an offence to create, keep, or use a human embryo outside the body -- or to provide licensable fertility treatment -- except under a licence granted by the Human Fertilisation and Embryology Authority (HFEA). It defines the three licence categories (treatment, storage, research), restricts research licensing to a closed list of purposes in Schedule 2, and fixes the 14-day statutory limit on keeping or using a licensed embryo.
ICER (Incremental Cost-Effectiveness Ratio)
The ICER (incremental cost-effectiveness ratio) is the additional cost of one health intervention compared with a next-best alternative, divided by the additional health benefit (usually measured in QALYs) that intervention produces: ICER = (Cost A - Cost B) / (QALYs A - QALYs B). It is the primary quantitative output a health technology assessment body compares against a cost-effectiveness threshold when deciding whether a new technology represents good value relative to current practice.
QALY (Quality-Adjusted Life Year)
A QALY (quality-adjusted life year) is a health-outcome unit equal to one year of life lived in full health (utility = 1.0), calculated by multiplying the number of years spent in a given health state by a utility weight for that state (0 = death, 1.0 = full health, with negative values possible for states considered worse than death) and summing across every health state a person passes through. Health technology assessment bodies, most prominently NICE in the UK, use QALYs as the common outcome unit in cost-utility analysis so that interventions across unrelated disease areas can be compared for cost-effectiveness on a single scale.
Pending IRG Review
Pending IRG Review is the eRA Commons application status (status code 17) shown for an NIH grant application that has not yet been assigned to a later phase of NIH's review process — in practice, it signals the application is waiting for evaluation by its assigned Initial Review Group (IRG), the panel of scientific peer reviewers, also called a study section when it refers to a chartered (standing) group, that scores the application for scientific and technical merit. It is one of a series of numbered phase/status codes eRA Commons uses to track an application's progress from receipt through award or decline, and it displays on an application's own status screen and on the Pending Review portfolio view used by NIH program and review staff. Per NIH's own eRA Commons help documentation, applications carry this status when they have "not been assigned to another phase" for the relevant fiscal year window — it is a default/waiting state rather than a milestone the application actively reaches. Seeing this status does not mean an application has been approved, rejected, or even fully scheduled for a specific review meeting yet — it means no decision has been recorded and the application is somewhere in the pipeline between receipt and its Initial Review Group's evaluation, which could mean rosters and meeting logistics are still being finalized. Once the IRG actually meets and evaluates the application, NIH's next-level outputs are a priority (impact) score and a written summary statement; CASRAI's NIH Study Section entry covers how that scoring and the subsequent Institute/Center advisory-council review fit into NIH's overall two-tier review structure. Examples A PI checks their eRA Commons Status screen two months after their R01 application's receipt deadline and sees "Pending IRG Review" — this tells them the application has not yet gone through its scheduled study section meeting, but not the specific meeting date, which is typically confirmed separately through the assigned Scientific Review Officer or the study section roster listing. A sponsored programs office monitoring a portfolio of submitted applications for annual reporting purposes uses this status, alongside other eRA Commons phase codes, to distinguish applications still awaiting initial scientific review from those that have already been scored and are awaiting Institute/Center council-level funding decisions. Counter-examples "Pending IRG Review" is not the same as "Council Review Pending." The former means the application has not yet had its Initial Review Group (study section) merit review; the latter means merit review is already complete and the application is instead awaiting the second-tier Institute/Center advisory council's programmatic review — a materially later stage in NIH's dual review structure. The status is not a rejection or a hold placed on the application for cause. It is the routine default state for any application that has not yet progressed past initial review, and the large majority of on-time applications pass through it as a matter of course. A study section itself is not the same thing as this status code. "IRG" here refers to the reviewing body (see CASRAI's NIH Study Section entry for what that body is and how applications are assigned to one); "Pending IRG Review" is the tracking label eRA Commons applies to an application while it waits on that body's action. References National Institutes of Health, eRA Commons Program and Portfolio Management help documentation, "Pending Review" (era.nih.gov/erahelp/PMM/Content/Phases/Pending_Review.htm) — defines application status code 17. National Institute of Mental Health, "Step 3 – Application Assignment and Review Process" — describes Integrated Review Groups/Initial Review Groups as clusters of related standing Review Committees. See also CASRAI's NIH Study Section entry for the full peer-review and dual-review-tier structure this status sits within.
Hierarchy of Controls (NIOSH)
The hierarchy of controls is a five-level framework, developed and maintained by NIOSH (the National Institute for Occupational Safety and Health), for selecting and ranking measures to reduce or eliminate a workplace hazard, ordered from most to least reliably effective: (1) elimination -- physically removing the hazard entirely; (2) substitution -- replacing the hazard with a less hazardous alternative; (3) engineering controls -- isolating people from the hazard through the design of equipment or the workspace, without depending on a worker's behavior; (4) administrative controls -- changing how people work through policies, training, signage, or scheduling; and (5) personal protective equipment (PPE) -- protecting the individual worker as a last line of defense. A control measure's position in the hierarchy reflects reliability, not preference: the top levels remove or reduce the hazard at its source and do not depend on correct human behavior to work, while the lower levels (administrative controls and PPE) depend on people consistently following a procedure or wearing equipment correctly, and therefore fail more often in practice even when correctly specified on paper.
Person-Time
Person-time is a denominator that combines the number of subjects under observation with the actual length of time each subject was observed while at risk for the outcome under study, expressed in units such as person-days, person-months, or person-years. It is used specifically as the denominator of an incidence rate (also called a person-time rate) when the length of follow-up differs across subjects -- because they entered the study at different times, left early, were lost to follow-up, died of an unrelated cause, or (once they experience the outcome) stop contributing further person-time for that outcome. A measure qualifies as using person-time, rather than a simple head-count denominator, specifically when subjects contribute unequal amounts of observed at-risk time and that variation is summed rather than ignored: ten subjects each followed for one year contribute the same 10 person-years as one subject followed for ten years, even though the two scenarios describe very different studies.
Case Fatality Rate (CFR)
The case fatality rate (CFR) is the proportion of confirmed cases of a specified disease or condition that die from it within a defined period, calculated as the number of deaths attributed to the disease divided by the total number of confirmed (or diagnosed) cases of that disease, multiplied by 100. Despite the name, it is a proportion, not a true rate, because both numerator and denominator are counts of people, not person-time. A measure qualifies as a CFR specifically when its denominator is confirmed cases of the disease -- as opposed to the total population (which yields a mortality rate) or the total number of exposed or at-risk individuals regardless of whether they became cases (which yields an attack rate restricted to fatal outcomes). CFR is a measure of disease severity among the already-affected, conditioned on someone having already met the case definition, not a measure of population-level risk.
Attack Rate
The attack rate is the proportion of an at-risk population that develops a defined outcome (illness, injury, or death) during a specified observation period bounded by a discrete exposure event -- such as a foodborne outbreak, a point-source chemical release, or a single gathering -- calculated as new cases divided by the population at risk at the start of that period, multiplied by 100. Despite the name, it is a cumulative incidence proportion, not a true rate: it carries no explicit time dimension in the denominator. A measure qualifies as an attack rate rather than a general incidence proportion specifically because the population and time window are bounded by an identifiable exposure episode, not an open-ended surveillance period. Two named variants extend the same logic: the food-specific attack rate restricts both numerator and denominator to people exposed to one candidate vehicle (a specific dish, water source, or lot), used to identify which exposure caused an outbreak; the secondary attack rate restricts both to susceptible close contacts of a known primary case, used to measure person-to-person transmissibility within a household, ward, or classroom.
CCRC (Certified Clinical Research Coordinator)
The Certified Clinical Research Coordinator (CCRC) credential is an individual professional certification administered by the Association of Clinical Research Professionals (ACRP) that recognizes a Clinical Research Coordinator (CRC) who has demonstrated proficiency in the specific knowledge and job-related skills the coordinator role requires. It is one of four role-specific credentials in ACRP's certification family (alongside CCRA for associates/monitors, CPI for principal investigators, and the general ACRP-CP), distinguishing it from SOCRA's single, role-agnostic CCRP credential. Eligibility generally requires attesting to roughly 3,000 hours of verifiable, paid clinical-research work experience (a waiver of up to 1,500 hours is available to applicants who already hold an active ACRP certification or completed an accredited clinical-research education program aligned with the exam content outline); candidates then sit a 125-question, 180-minute exam referenced to ICH guidelines, and must renew the credential every two years.
CCRP (Certified Clinical Research Professional)
The Certified Clinical Research Professional (CCRP) credential is an individual professional certification administered by the Society of Clinical Research Associates (SOCRA) that validates a candidate's knowledge, ethics, and ability to conduct regulated clinical trials against U.S. Code of Federal Regulations, ICH guidelines, and Good Clinical Practice. Unlike ACRP's role-specific certification family (CCRC for coordinators, CCRA for associates/monitors, CPI for principal investigators, ACRP-CP as a general credential), SOCRA offers a single comprehensive CCRP designation open to coordinators, monitors, investigators, and other clinical-research roles alike -- the credential attaches to demonstrated clinical-research competence generally, not to one specific job title. Eligibility runs through one of three paths built around full-time clinical-research experience (with or without a supporting degree), and the credential must be renewed every three years with 45 continuing-education hours.
CIP (Certified IRB Professional)
The Certified IRB Professional (CIP) credential is an individual professional certification, awarded by the Council for Certification of IRB Professionals (CCIP) under PRIM&R (Public Responsibility in Medicine and Research), that formally recognizes a person's broad working knowledge of Institutional Review Board (IRB) functions and Human Research Protection Program (HRPP) administration. It attaches to the individual who holds it, not to an institution or an IRB itself -- an institution cannot be 'CIP-certified,' only the staff who administer or oversee its IRB/HRPP can be. Eligibility requires either a bachelor's degree plus two years of relevant HRPP experience, or three years of relevant HRPP experience without a degree, accumulated within the past seven years; candidates sit a 130-question, three-hour, closed-book exam covering human-subjects-protection regulations and IRB operations, and must recertify every three years.
dbSNP
dbSNP is NCBI's public archive that assigns a persistent Reference SNP (rs) identifier to every distinct short genetic variant reported to it -- single nucleotide polymorphisms, small insertions/deletions, and other short variants -- regardless of clinical significance or population frequency. It catalogues where a variant occurs and gives it a stable, shareable identifier; a variant only needs to be submitted and assigned an rs number to be in dbSNP, it does not need a clinical interpretation (ClinVar's role) or population-frequency data (gnomAD's role) to qualify.
Sequence Read Archive (SRA)
The Sequence Read Archive (SRA) is NCBI's repository for raw or minimally processed high-throughput DNA and RNA sequencing reads, submitted in FASTQ, BAM, or CRAM format, and operated as the US node of the International Nucleotide Sequence Database Collaboration (INSDC) alongside Europe's ENA and Japan's DDBJ, which mirror the same submissions. SRA does not accept assembled genomes, contigs, or already-processed variant calls -- those belong in GenBank/RefSeq or a variant database -- and every SRA submission must be linked to a BioProject (the study) and at least one BioSample (the biological source material) record.
1000 Genomes Project
The 1000 Genomes Project was a completed (2008-2015) international research consortium that sequenced the genomes of 2,504 individuals across 26 populations worldwide, specifically to catalogue common human genetic variation (variants at roughly 1% or greater population frequency), and discovered more than 88 million variants in doing so. It is not an ongoing project -- its data and reference resources are now maintained and updated by the International Genome Sample Resource (IGSR) -- and it did not attempt to catalogue rare, individually clinically actionable variants the way a targeted clinical sequencing effort would.
All of Us Research Program
The All of Us Research Program is an ongoing NIH longitudinal precision-medicine cohort study, launched for enrollment in 2018, that recruits a target of at least one million U.S. volunteers -- deliberately oversampling communities historically underrepresented in biomedical research -- and links each participant's genomic data, electronic health records, physical measurements, and survey responses into a single dataset. Researchers access that linked data through a secure cloud analysis environment (the Researcher Workbench) rather than as downloadable raw files; a dataset lacking that individual-level genomic-to-clinical-to-survey linkage is not what distinguishes All of Us from other large biobanks.
The Cancer Genome Atlas (TCGA)
The Cancer Genome Atlas (TCGA) was a completed (2006-2018), joint National Cancer Institute (NCI) and National Human Genome Research Institute (NHGRI) program that molecularly characterized more than 11,000 primary cancer cases across 33 cancer types, generating matched genomic, epigenomic, transcriptomic, and proteomic data for each case. TCGA is not an active, growing repository -- no new cases have been added since the program concluded -- and its full, fixed dataset now lives inside the Genomic Data Commons (GDC) alongside other harmonized NCI cancer datasets.
gnomAD (Genome Aggregation Database)
gnomAD is a population-scale reference database of aggregated human exome and genome sequencing data, developed by an international coalition of investigators at the Broad Institute of MIT and Harvard, that reports allele frequencies and quality metrics for genetic variants across major ancestry groups so researchers can distinguish common polymorphisms from likely disease-causing rare variants. It is a frequency reference, not a clinical diagnostic tool or a repository of raw individual-level sequencing reads -- gnomAD releases jointly-called, harmonized summary statistics, not per-participant genomes.
Positive Predictive Value (PPV)
A test result's positive predictive value (PPV) is the proportion of all positive results that are true positives — TP / (TP + FP) — calculated within the test-positive row of a 2×2 diagnostic accuracy table, not within the disease-present column the way sensitivity is. Because it conditions on the test result rather than the true disease state, PPV moves with the prevalence of the condition in the population tested: the same test, at the same sensitivity and specificity, produces a different PPV in a specialist referral population than in an unselected screening population, so a manuscript reporting PPV must state the prevalence (or pretest probability) it was calculated at for the number to be interpretable elsewhere.
StarLIMS
StarLIMS is a commercial, enterprise-grade laboratory information management system (LIMS) originally developed in Israel and now owned by private-equity firm Turn/River Capital, after previous ownership by Francisco Partners (2021-2026) and, before that, Abbott Laboratories (2010-2021, which branded the product line "Abbott Informatics" for most of that period). What makes a deployment "StarLIMS" rather than a generic LIMS is its sample-lifecycle-state model -- a sample moves through configurable status states from registration to disposition -- paired with a largely graphical, state-driven workflow-configuration environment, in contrast to competitors such as LabWare LIMS that lean more heavily on custom scripting for the same configurability. It has a long-standing base in regulated pharmaceutical quality-control labs and public-health/clinical laboratories, ships with 21 CFR Part 11 audit-trail and electronic-signature support, and is available both as a traditional on-premises/vendor-hosted enterprise deployment and, for smaller batch-manufacturing quality labs, as a cloud-hosted product marketed as QM Essentials.
jamovi
jamovi is a free, open-source statistical software application that provides a spreadsheet-style graphical interface to analyses executed by R packages underneath it (the jmv R package for its core menu), distributed under the AGPL-3.0 licence (select components GPL-2.0-or-later) for Windows, macOS, and Linux, plus a browser-based cloud version, with no licence fee, seat count, or activation step required.
Labguru
Labguru is a cloud-based ELN and LIMS platform from BioData Inc. that combines experiment documentation, sample and inventory tracking, and equipment management in one linked system: an experiment record can reference the exact inventory lot and instrument used, rather than those records living in separate tools.
Citavi
Citavi is a commercial reference-management application, originally from Swiss Academic Software and now owned by QSR International (distributed under the Lumivero brand since the 2021 acquisition), that combines three tools inside one project file: a Reference Editor for citation capture and bibliography formatting, a Knowledge Organizer for PDF annotation and note-filing by topic, and a Task Planner for tracking source-linked to-dos. The full Citavi Desktop application is Windows-only; a lighter, separately licensed Citavi Web product runs in a browser on any OS. Citavi Free, the no-cost tier, was discontinued after the 2021 acquisition -- current access is trial-then-paid only.
Limited IRB Review
Limited IRB review is a narrow, privacy-focused form of IRB review that the 2018 Revised Common Rule requires as a condition of exemption for four specific exempt-research categories -- 45 CFR 46.104(d)(2)(iii), (d)(3)(i)(C), (d)(7), and (d)(8) -- each involving identifiable private information or identifiable biospecimens. Rather than the full risk-benefit determination a convened board makes under 46.111(a)(1)-(2), a limited reviewer (commonly the IRB Chair or a designated experienced member) applies only the privacy/confidentiality safeguard criteria at 46.111(a)(7)-(a)(8): whether there are adequate provisions to protect subjects' privacy and to maintain confidentiality of data. Once satisfied, the research proceeds as exempt. Per 45 CFR 46.109(f)(1)(ii), research reviewed under limited IRB review is not subject to the ongoing continuing-review requirement that applies to convened-board research.
IRB Administrator
The IRB Administrator is the staff role responsible for the day-to-day operational management of an Institutional Review Board (IRB) program -- drafting and maintaining written IRB policies and procedures, managing OHRP registration and Federalwide Assurance (FWA) recordkeeping, supervising IRB coordinator/analyst staff, and serving as the office's primary liaison to federal oversight agencies (OHRP, and FDA where applicable). In most institutional hierarchies it sits above IRB Coordinator (submission-level, day-to-day processing) and below IRB Manager/Director in scope and reporting line. It is distinct from the IRB Chair, who is a voting board member presiding over convened meetings and making expedited-review determinations rather than institutional office staff.
Comparative Effectiveness Research (CER)
Comparative effectiveness research (CER) is a category of clinical and health-services research that directly compares two or more existing, already-in-use healthcare interventions -- drugs, devices, procedures, or care-delivery models -- against each other, rather than against placebo, to determine which works better, for which patients, and under real-world practice conditions. CER differs from a standard efficacy trial in comparator (active treatment vs. active treatment, not treatment vs. placebo) and often in study population (broad, pragmatic real-world eligibility criteria rather than a narrow explanatory-trial population). Methods used to conduct CER include pragmatic randomized trials, head-to-head RCTs, observational and registry-based studies, and systematic reviews/meta-analyses synthesizing existing comparative evidence. In the US, the Patient-Centered Outcomes Research Institute (PCORI) -- a nonprofit authorized and funded under the Patient Protection and Affordable Care Act of 2010 -- is the principal funder of CER and the related patient-centered outcomes research (PCOR).
CPIA (Certified Professional in IACUC Administration)
CPIA (Certified Professional in IACUC Administration) is the individual professional credential PRIM&R (Public Responsibility in Medicine and Research), through its CPIA Certification Council, awards to staff who administer, coordinate, or manage an Institutional Animal Care and Use Committee (IACUC) and its animal-research-oversight program. Established in 2007, it certifies broad working knowledge of IACUC functions -- protocol review procedures, semiannual program review and facility inspection requirements, and the federal framework governing animal research (the Animal Welfare Act, PHS Policy administered by OLAW, and institutional AAALAC accreditation practice). Eligibility requires substantive, qualifying IACUC-administration work experience within a recent multi-year window; candidates sit a 135-question multiple-choice exam (120 scored plus 15 unscored pretest items) and must recertify every five years. CPIA is a sibling credential to CIP (Certified IRB Professional) -- both administered under PRIM&R's certification program -- but CPIA governs the animal-subjects/IACUC side of research oversight, not human-subjects IRB work.
GISAID
A public-private data-sharing initiative (founded 2008, from a 2006 avian-influenza data-sharing dispute) hosting genetic sequence data for priority viral pathogens across pathogen-specific databases (EpiFlu for influenza, EpiCoV for SARS-CoV-2, EpiPox for mpox, EpiRSV) -- free to access but gated by a Database Access Agreement barring redistribution, requiring lab acknowledgment, and prohibiting patent filing, distinct from an open-access repository despite the word "sharing" in its name.
ClinVar
NCBI's free, public archive of submitted claims relating human genetic variants to phenotypes (disease, drug response), aggregated at three levels -- SCV (one submitter's assertion), RCV (all assertions for one variant-condition pair), VCV (all conditions reported for one variant) -- using ACMG/AMP five-tier clinical-significance terms (Pathogenic through Benign) and displaying, rather than resolving, conflicting submitter classifications.
Genomic Data Commons (GDC)
NCI's harmonized repository for cancer genomic and clinical data (TCGA, TARGET, and directly-submitted projects) -- every dataset is reprocessed through a common bioinformatics pipeline against a shared reference genome, split into open- and controlled-access tiers (the latter gated through dbGaP's Data Access Request system), and served via the GDC Data Portal, API, and Data Transfer Tool.
Mental Capacity Act 2005: The Consultee Model for Research
The Mental Capacity Act 2005 (MCA) consultee model is the mechanism England and Wales use to allow research involving adults who lack the mental capacity to consent for themselves, where that research is not a clinical trial of an investigational medicinal product (CTIMP). Sections 30–33 of the Act set out when such research can lawfully proceed and who must be consulted before a person is enrolled. Why this is a separate regime from CTIMP consent England and Wales run two distinct legal frameworks for research involving adults who lack capacity, and CASRAI's Simplified Consent Arrangements for Adults Lacking Capacity entry covers the CTIMP side of that split — the legal representative pathway under Schedule 1 of the Medicines for Human Use (Clinical Trials) Regulations 2004. CTIMPs are explicitly carved out of the MCA's own research provisions. This entry covers the other half: non-CTIMP intrusive research, which stays inside the MCA and uses a consultee, not a legal representative, as its safeguard. What counts as "intrusive" research Research is intrusive under the Act if it would otherwise require the participant's own informed consent — interventional studies, but also non-interventional work involving personal data processing, questionnaires, interviews, or direct observation of the person. Research that uses only non-identifiable data, or that is separately authorised under Section 251 of the NHS Act 2006 via the Confidentiality Advisory Group, is not intrusive in this sense and does not trigger the MCA consultee requirement. The consultee model Instead of a substitute decision-maker who consents on the participant's behalf, the MCA uses an advisory role: Personal consultee — someone connected with the participant in a personal capacity (typically a family member or close friend), not paid to care for them, who is willing to be consulted. Nominated consultee — used only when no personal consultee is available; an independent person appointed under Department of Health and Social Care guidance, often a clinician not involved in the research. The distinction that trips up first-time applicants: a consultee does not consent on the participant's behalf. They advise the researcher on what the participant's own wishes and feelings would likely be, and on whether the participant should take part. The decision to enrol — and the responsibility for it — sits with the researcher, informed by that advice, not transferred to the consultee. This is the structural difference from the CTIMP legal representative, who does give consent standing in the participant's place. The best-interests requirement Every enrolment decision must satisfy the Act's core principles: it must be in the participant's best interests, it must be the least restrictive option available, and — specific to research — the interests of the participant must always be assumed to outweigh those of science and society. A Research Ethics Committee (an "appropriate body" under Section 30) must also be satisfied that the study meets the Section 31 conditions before approval: The research is connected with an impairing condition affecting the participant, or its treatment. Comparable results could not be obtained by research involving only participants who retain capacity. The research either has the potential to benefit the participant directly without disproportionate burden, or carries only negligible risk while contributing knowledge relevant to their condition. The consultation and safeguard arrangements set out in Sections 32–33 are followed. The urgent-situation exception Section 32(8) allows enrolment without prior consultee consultation in genuinely time-critical circumstances — where urgent treatment is being provided and it is not practicable to identify and consult a consultee before that treatment (and, by extension, research participation) must begin. Consultation must still happen as soon as practicable afterwards, and the participant or their consultee can withdraw them from the study at that point. This is a narrower, differently-triggered exception from the emergency provisions built into the CTIMP legal-representative regime, and the two should not be conflated when writing a protocol that might need both. Geographic scope The MCA 2005 applies to England and Wales only. Scotland uses the Adults with Incapacity (Scotland) Act 2000; Northern Ireland uses the Mental Capacity Act (Northern Ireland) 2016. A mutual recognition arrangement lets a single Research Ethics Committee opinion cover a multi-jurisdictional UK study, but the underlying legal basis for enrolling an incapacitated adult still differs by jurisdiction, and protocols and participant information sheets should reflect the framework that actually applies at each site. Worked example A study recruiting stroke patients within 24 hours of admission to compare two rehabilitation protocols is non-CTIMP intrusive research. Patients unable to consent because of the stroke itself are approached through a personal consultee (usually a spouse or adult child present at the bedside) or, if none is available in time, a nominated consultee such as an independent clinician. The consultee is asked what the patient would likely have wanted, not asked to consent on the patient's behalf; the research team makes the enrolment decision informed by that advice, subject to the REC-approved protocol's Section 31 justification. Counter-example A Phase II trial of a new anticoagulant in patients with acute ischaemic stroke who cannot consent is a CTIMP. Even though the clinical scenario looks identical to the worked example above, this study falls under the Medicines for Human Use (Clinical Trials) Regulations 2004, not the MCA's consultee provisions — it requires a personal or professional legal representative who can give consent on the participant's behalf, not a consultee offering advice. Applying the wrong regime is one of the more common protocol-design errors in UK dementia and stroke trials that mix drug and non-drug interventions. Related terms See also Simplified Consent Arrangements for Adults Lacking Capacity for the CTIMP legal-representative pathway, Confidentiality Advisory Group (CAG) / Section 251 for non-intrusive confidential-data research, and Favourable Opinion (NHS REC) for how a Research Ethics Committee records its Section 30 approval.
Strategy for Patient-Oriented Research (SPOR)
SPOR is the Canadian Institutes of Health Research's (CIHR) national strategy, launched in 2011, for embedding patients and caregivers as active partners across the research cycle -- funded and coordinated through eleven provincial/territorial SPOR SUPPORT Units, pan-Canadian SPOR Networks, the SPOR Evidence Alliance, and a 1:1 matched-funding structure with non-federal partners, rather than through a single grant program a researcher applies to directly.
ResearchNet (CIHR)
ResearchNet is the Canadian Institutes of Health Research's (CIHR) self-registered, web-based grants portal: the system where CIHR funding applicants and Peer Review Committee members complete every task-based step of an application and its review -- account creation, on-screen application tasks, signature-page upload, and submission -- distinct from, but used alongside, a separately-registered CIHR PIN and Canada's Tri-Agency Common CV.
Special Access Scheme (SAS)
The Special Access Scheme (SAS) is the Therapeutic Goods Administration (TGA) pathway that lets a registered health practitioner in Australia lawfully access and supply an 'unapproved' therapeutic good -- a medicine, medical device, or biological not entered on the Australian Register of Therapeutic Goods (ARTG) for the intended use -- for a specific patient or a defined group of patients, outside a formal clinical trial. It operates under the Therapeutic Goods Act 1989 (Cth) and runs through three categories: Category A (notification-only, for patients who are seriously ill, product used immediately, TGA notified within 28 days), Category B (application-based, requires TGA approval before use, typically 2-5 working days), and Category C (notification-only for products on a pre-approved TGA list with an established history of safe use). SAS is distinct from the Authorised Prescriber (AP) scheme, which is limited to medical practitioners prescribing to a class of patients on an ongoing basis rather than the SAS's individual/defined-group, per-request model.
Cincinnati Radiation Experiments
The Cincinnati Radiation Experiments were a series of total- and partial-body irradiation tests performed on at least 90 patients with advanced cancer at Cincinnati General Hospital between 1960 and 1971, led by radiologist Dr. Eugene L. Saenger and funded in part by the Department of Defense's Defense Atomic Support Agency to study how radiation exposure would incapacitate military personnel in a nuclear-war scenario. Patients, disproportionately low-income and Black, believed they were receiving cancer treatment and were not clearly informed of the study's military research purpose; at least 21 died within a month of high-dose exposure. University of Cincinnati English professor Martha Stephens's investigation brought the program to public attention, Senator Edward Kennedy's pressure contributed to the Department of Defense ending its funding around 1971-72, and the case was later examined by the federal Advisory Committee on Human Radiation Experiments (1994-95). A 1994 class-action lawsuit, In re Cincinnati Radiation Litigation, settled in 1999 for $3.6 million.
Nuremberg Doctors’ Trial
The Nuremberg Doctors' Trial (United States of America v. Karl Brandt, et al.) was the first of the twelve "Subsequent Nuremberg Proceedings," an American military tribunal held in Nuremberg, Germany from December 1946 to August 1947, which tried 23 defendants -- 20 physicians and 3 administrators, led by Karl Brandt, Hitler's personal physician -- for conspiracy, war crimes, and crimes against humanity arising from the Aktion T4 involuntary-euthanasia program and non-consensual, frequently fatal medical experiments (including high-altitude, hypothermia, malaria, mustard gas, and seawater studies) on concentration-camp prisoners. The tribunal's August 1947 judgment convicted 16 defendants, sentenced 7 to death, and acquitted 7; its section on permissible human experimentation became known separately as the Nuremberg Code, whose first point establishes voluntary informed consent as absolutely essential. The trial itself -- the defendants, charges, evidence, and verdict -- is a genuinely distinct reference point from the Code's normative text, which the tribunal's judgment produced but which is cited on its own terms.
Jesse Gelsinger Case
The Jesse Gelsinger case refers to the September 17, 1999 death of an 18-year-old research subject four days after receiving an experimental adenoviral-vector gene therapy at the University of Pennsylvania's Institute for Human Gene Therapy, in a Phase I trial for ornithine transcarbamylase (OTC) deficiency led by Dr. James Wilson. Gelsinger had a mild, drug-controlled form of OTC deficiency rather than the severe infant form the therapy was ultimately intended to treat, and died of a massive systemic inflammatory response and multi-organ failure after infusion. A subsequent FDA investigation found the trial had deviated from its approved protocol (Gelsinger's blood ammonia level was above the enrollment threshold at the time he was dosed), that prior serious adverse events in animal studies and other participants had not been adequately reported, and that Wilson and the University of Pennsylvania held undisclosed financial interests -- equity in Genovo, Inc., the biotechnology company that had licensed the vector technology -- not clearly disclosed to Gelsinger. The case is the standard reference point for financial conflict-of-interest disclosure and protocol/safety-reporting failures in human-subjects research, distinct from Willowbrook's and Guatemala's consent-and-vulnerable-populations failures.
Genome Canada
Genome Canada is a federally funded, not-for-profit organisation, established in 2000, that funds large-scale, mission-driven genomics research in Canada through a network of six regional Genome Centres (Genome British Columbia, Genome Alberta, Genome Prairie, Ontario Genomics, Genome Quebec, and Genome Atlantic) and competitions such as the Large-Scale Applied Research Project (LSARP) Competition and the Genomic Applications Partnership Program (GAPP). Funding is structurally co-funded, typically requiring at least a 1:1 match in cash or in-kind support from outside partners, distinguishing it from a direct-to-investigator Tri-Agency (CIHR/NSERC/SSHRC) grant.
Declaration of Geneva
The Declaration of Geneva is a physician's ethical pledge adopted by the World Medical Association's (WMA) 2nd General Assembly in Geneva, Switzerland, in September 1948, drafted as a modern restatement of the Hippocratic Oath in the aftermath of medical crimes committed by physicians in Nazi-occupied Europe. Framed as a pledge rather than an oath, it commits a physician to dedicate their life to the service of humanity, place a patient's health and well-being above all other considerations, respect patient autonomy and dignity, maintain confidentiality even after a patient's death, and not permit considerations of age, disease, disability, religion, nationality, race, sex, or similar factors to interfere with care. The WMA has revised the text repeatedly since 1948 -- in 1968, 1983, 1994, with minor amendments in 2005 and 2006, and a substantive 2017 revision that added explicit commitments to respect patient autonomy, attend to a physician's own health and well-being, and share medical knowledge respectfully with teachers, colleagues, and students. It is a general statement of physician ethics governing clinical practice, distinct from the WMA's separate Declaration of Helsinki, which specifically governs the ethics of medical research involving human subjects.
Therapeutic Misconception
Therapeutic misconception is the failure of a research participant to understand that the procedures, interventions, and decisions in a clinical study are driven by a fixed research protocol designed to answer a generalizable scientific question -- not by an individualized clinical judgment about what is best for that particular participant -- leading the participant to believe study assignment and procedures were chosen for their personal medical benefit in the same way a treating physician's recommendations would be. The term was coined by Paul S. Appelbaum, Loren H. Roth, and Charles W. Lidz in a 1982 article in the International Journal of Law and Psychiatry, and introduced more widely to the bioethics community in a 1987 Hastings Center Report article, 'False Hopes and Best Data: Consent to Research and the Therapeutic Misconception.' It is distinguished from therapeutic misestimation, in which a participant correctly understands that they are in a research study but still over- or under-estimates its specific risks and benefits, and from therapeutic optimism, in which a participant realistically understands the research process yet reasonably hopes for a good outcome -- only the first of the three is considered to compromise the validity of informed consent, since it involves a fundamental misunderstanding of what the study is rather than a miscalculation within an accurate understanding of it.
Guatemala Syphilis Experiments
The Guatemala syphilis experiments were a series of nontherapeutic human-subjects experiments conducted from 1946 to 1948 by the U.S. Public Health Service (PHS), led by physician John Charles Cutler, in which researchers deliberately exposed Guatemalan soldiers, prisoners, psychiatric patients, and orphaned children -- populations unable to give free informed consent -- to syphilis, gonorrhea, and chancroid, initially through infected commercial sex workers and later through direct inoculation by skin abrasion, injection, and spinal puncture, in order to test whether penicillin could prevent infection after exposure. Roughly 5,500 people were enrolled across the study's diagnostic and experimental arms; at least 1,308 were intentionally exposed to an infection, and only about 700 of those received any treatment. The experiments ran under the same PHS research program that later conducted the Tuskegee Syphilis Study, were kept from public knowledge for more than sixty years, and were rediscovered in 2010 by Wellesley College historian Susan M. Reverby while she was researching Cutler's role in Tuskegee. The United States formally apologized to Guatemala in October 2010, and a Presidential Commission for the Study of Bioethical Issues concluded in its 2011 report that U.S. officials at the time understood the research would have been 'ethically impossible' to conduct on U.S. soil.
Cooperative Research Centres (CRC) Program
The Cooperative Research Centres (CRC) Program is an Australian Government scheme, established in 1990 and administered by the Department of Industry, Science and Resources, that funds industry-led collaborative research between industry, universities, and research organisations. It runs two streams: long-term CRCs (up to 10 years, typically $30-75 million in Commonwealth funding, requiring at least matching industry co-investment) and shorter CRC-P Grants (up to 3 years, $100,000-$3 million, also requiring matched funding). Unlike ARC schemes such as Discovery Projects or Centres of Excellence, which are university-led and administered by the Australian Research Council, a CRC's research agenda originates from an industry-identified problem and requires industry co-investment as a structural condition of funding.
ARC LIEF (Linkage Infrastructure, Equipment and Facilities)
LIEF (Linkage Infrastructure, Equipment and Facilities) is an Australian Research Council scheme, within the Linkage Program, that funds the acquisition, construction, or installation of shared research equipment, infrastructure, or facilities for use by a consortium of researchers and institutions rather than a single investigator or lab. The ARC contributes a minimum of $150,000 per year and up to 75% of the eligible direct costs, with participating organisations required to provide at least 25% of the total direct cost in cash co-contribution plus additional in-kind support, distinguishing it from research-activity schemes like Discovery Projects or Linkage Projects that fund the conduct of research itself rather than the underlying tools and facilities.
National Clinical Trials Governance Framework (NCTGF)
The National Clinical Trials Governance Framework (NCTGF) is an Australian hospital-accreditation standard, developed and managed by the Australian Commission on Safety and Quality in Health Care (ACSQHC), that assesses whether a health service's own clinical-governance systems are mature enough to safely host and oversee clinical trials as part of routine care. It is built on 27 specific actions drawn from two National Safety and Quality Health Service (NSQHS) Standards -- the Clinical Governance Standard and the Partnering with Consumers Standard -- organised around five core areas: governance/leadership/culture, patient safety and quality improvement, clinical performance and effectiveness, a safe environment for care, and partnering with consumers. An approved accrediting agency assesses a health service against these actions during its routine accreditation survey and rates it on a maturity scale. The operational distinction that matters: the NCTGF is an institution-level check on whether a hospital's governance systems are adequate to run trials at all, entirely separate from trial-level steps like ANZCTR registration or a TGA Clinical Trial Notification/Approval, which concern one specific study rather than the hosting institution's standing capability.
NHMRC Partnership Project
An NHMRC Partnership Project is a competitively awarded grant from Australia's National Health and Medical Research Council that funds collaborative research between an investigator team and a genuine, co-funding health policy-maker, health-service manager or clinical-practice partner, with the explicit goal of translating research evidence into health policy or practice. Two features distinguish it from NHMRC's other major schemes: a named partner organisation must be part of the application from the outset, and that partner must co-contribute cash or substantial in-kind support -- NHMRC funding-round data has shown partner contributions exceeding NHMRC's own contribution in a given round. Grants have run up to $1.5 million over terms as long as five years, administered through NHMRC's Sapphire platform. This is the operational distinction from NHMRC's Ideas Grants (investigator-driven research judged on scientific merit alone, no partner requirement) and Investigator Grants (career-stage salary support): a Partnership Project's eligibility and assessment hinge on the strength of the researcher-partner relationship and the policy/practice translation pathway, not the research question in isolation.
Ethics Review Manager (ERM)
The Ethics Review Manager (ERM) is the cloud-based ethics- and research-governance workflow platform, built on Infonetica software, used by most Australian universities, hospitals and health services to submit, route and track human research ethics and governance paperwork electronically. Each institution operates its own separately branded ERM instance (Monash, University of Melbourne, QUT, Swinburne, Queensland Health, and others each run their own portal on the shared platform), and New Zealand's Ministry of Health runs a related instance. ERM is the system through which a researcher submits a Human Research Ethics Application (HREA) for HREC review and, separately, a Site-Specific Assessment (SSA) for each additional site that needs local governance authorisation to host an already-approved study. It is the platform, not the reviewing body (that is the HREC) and not the application itself (that is the HREA) -- the operational distinction that matters when a research office is trying to work out which document to draft versus which system to submit it through.
NCRIS (National Collaborative Research Infrastructure Strategy)
NCRIS (the National Collaborative Research Infrastructure Strategy) is the Australian Government program, administered by the Department of Education, that funds and coordinates shared national research infrastructure -- major equipment, digital platforms, data collections and specialist facilities -- rather than individual research projects. Established in 2006 and delivered against a periodically updated National Research Infrastructure Roadmap, it has received over $5.5 billion in cumulative Australian Government support, backing 26 major funded projects delivered through more than 400 partnerships as of its 20th anniversary in 2026. Researchers do not apply to NCRIS directly for project funding; instead, NCRIS funds lead agents (universities, public research agencies, dedicated not-for-profits) who operate national facilities, and researchers apply separately for merit-based access to that shared infrastructure -- commonly through the Research Infrastructure Connected discovery portal or a facility's own access process. This is the key operational distinction from ARC and NHMRC grant schemes: NCRIS funds the standing capability a research project draws on, not the project itself.
Willowbrook Hepatitis Study
The Willowbrook hepatitis studies were a series of nontherapeutic human-subjects experiments conducted from 1956 to 1971 at the Willowbrook State School, a New York state institution for children with intellectual disabilities on Staten Island, in which researchers led by Dr. Saul Krugman (New York University) and Dr. Robert W. McCollum (Yale University) deliberately infected healthy, newly admitted children with live hepatitis virus -- by feeding them extracts prepared from infected stool or by injection -- to study the natural history of infectious and serum hepatitis and to test gamma globulin as a preventive treatment. In practice, admission to the chronically overcrowded institution was effectively conditioned on parental agreement to enroll a child in the study, and researchers justified the design by arguing that hepatitis was already endemic at the school and that children would likely be infected regardless. The studies were among the 22 examples of ethically dubious research Henry Beecher cited in his catalytic 1966 New England Journal of Medicine article 'Ethics and Clinical Research,' and the case is invoked today specifically for the consent and coercion issues raised by research on children and institutionalized, cognitively impaired subjects -- distinct from the later, separate 1975 Willowbrook Consent Decree, which addressed the institution's living conditions generally rather than the hepatitis research itself.
Research Councils UK (RCUK)
Research Councils UK (RCUK) was the strategic partnership body that coordinated the UK's seven publicly funded research councils from 2002 until 2018, when it was replaced by UK Research and Innovation (UKRI) alongside Innovate UK and Research England. A funding reference, grant terms and conditions, or a compliance citation qualifies as "RCUK" rather than "UKRI" when it predates the 2018 reorganisation — RCUK never held its own grant-funding budget or made funding decisions directly; it was a coordinating secretariat that set shared cross-council policy (open access, data, and the original funding Concordats) while each of the seven councils kept its own budget, remit, and award decisions throughout RCUK's existence.
National Mutual Acceptance (NMA) Scheme
The National Mutual Acceptance (NMA) scheme is the Australian mechanism that allows a single scientific and ethical review of a multi-centre human research project, conducted by one certified Human Research Ethics Committee (HREC), to be recognised across participating public health organisations in every Australian state and territory, instead of each site's own HREC independently re-reviewing the same protocol. A study accepted under NMA still requires a separate, per-site Site-Specific Assessment (SSA) -- confirming local feasibility, resourcing, and governance authorisation to conduct the research at that particular site -- because SSA covers matters the single ethics review does not (institutional capacity, local risk, indemnity and insurance arrangements). NMA applies mainly to research conducted in publicly funded health services, and specific categories are commonly carved out of the single-review pathway, including research involving Aboriginal and Torres Strait Islander health and wellbeing, people in custody, and studies requiring separate statewide data or coronial-material access, each of which retains its own distinct jurisdictional review requirement.
ARC Centres of Excellence
An ARC Centre of Excellence (CoE) is a large-scale, multi-year collaborative research hub funded by the Australian Research Council under its Linkage Program, bringing together researchers from multiple Australian universities -- and often international and industry partners -- around a single major research theme, rather than funding one team's discrete project. Centres are funded over an extended term (recent rounds have run seven years) at a scale of many millions of dollars per centre, covering researcher salaries, postgraduate and postdoctoral training positions, and operating costs, and are led by an administering university that hosts the centre while partner investigators and institutions contribute across the collaboration. Unlike a Discovery Project or a personnel fellowship, a Centre of Excellence funds an entire program of coordinated activity -- research, capacity-building, and national/international collaboration -- built around a named centre rather than a single proposal-bound piece of work.
HREA (Human Research Ethics Application)
The Human Research Ethics Application (HREA) is the standard, NHMRC-developed application form Australian researchers complete to seek ethics approval for research involving human participants. It replaced the National Ethics Application Form (NEAF) in January 2017 and is structured around the risk- and content-based principles of the National Statement on Ethical Conduct in Human Research, adapting its questions to the specific research design a project describes rather than presenting one fixed question set for every study type. The HREA itself is jurisdiction- and institution-neutral -- it is the same form nationally -- but researchers typically complete and submit it through a specific online system, most commonly Ethical Review Manager (ERM), which routes the completed application to the relevant institutional Human Research Ethics Committee (HREC) or, for multi-centre studies, the single reviewing HREC under the National Mutual Acceptance scheme.
ARC DECRA (Discovery Early Career Researcher Award)
The Discovery Early Career Researcher Award (DECRA) is a competitively awarded, individually held three-year fellowship from the Australian Research Council's Discovery Program that funds an early-career researcher's salary plus a fixed pool of project funding, administered through an eligible Australian university or research institution as the formal applicant. Eligibility turns on a PhD-conferral window measured from the closing date of the round -- currently a PhD awarded on or after 1 March in the relevant reference year, adjusted for allowable career interruptions such as parental leave or medical conditions -- not on job title, so a person can hold a teaching-and-research or a research-only position and still qualify. This is the ARC's dedicated early-career personnel award: it funds a person at a defined career stage, not a specific piece of research chosen independently of who is applying, which is the operational line separating it from a Discovery Project.
PHIPA (Personal Health Information Protection Act)
PHIPA (Personal Health Information Protection Act, 2004, S.O. 2004, c. 3, Sched. A) is Ontario's health-sector-specific privacy statute. It governs how "health information custodians" -- hospitals, physicians, other regulated health professionals, and similar bodies that have custody or control of personal health information in the course of providing health care -- may collect, use, and disclose that information, and it is administered by Ontario's Information and Privacy Commissioner (IPC). For a use or disclosure to be described as falling "under PHIPA" rather than under Canada's general federal privacy law, it must involve personal health information held by a custodian carrying out a health care function in Ontario specifically; PHIPA is a provincial statute and does not apply outside Ontario. PHIPA's research provision -- generally cited as section 44 -- lets a custodian disclose personal health information to a researcher without the individual's consent, but only where the researcher has submitted a written application and a research plan describing the research's objectives and the personal health information needed, that plan has been approved by a research ethics board (REB), and the researcher and custodian have entered into a written research agreement governing how the data will be safeguarded, used, and eventually destroyed or returned. A use or disclosure that skips REB approval, or that is not governed by a research agreement meeting PHIPA's requirements, is not a valid PHIPA research disclosure, whatever else it may be.
Best Evidence Synthesis (BES)
Best evidence synthesis (BES) is a review method, originated by Robert Slavin as an explicit alternative to both traditional narrative reviews and formal meta-analysis, that combines a systematic, exhaustive literature search with a narrative interpretation focused specifically on the studies with the strongest internal AND external validity -- rather than either pooling every study statistically (as meta-analysis does) or summarizing the literature without explicit selection criteria (as a narrative review does). A study qualifies as 'best evidence' under this method when its design minimizes bias (internal validity) and its sample and setting generalize to the population the review is meant to inform (external validity); studies that are rigorous but narrow, or broad but methodologically weak, are treated as lower-quality evidence and weighted accordingly in the narrative synthesis rather than excluded outright or averaged in on equal footing.
Meta-Synthesis
Meta-synthesis is the systematic integration of findings across multiple primary qualitative studies to produce a new, higher-level interpretation that none of the individual studies contains on its own -- as distinct from meta-analysis, which statistically pools numerical results from quantitative studies. A meta-synthesis follows an explicit protocol (formulate a question, search and select studies against defined criteria, appraise their quality, then translate and synthesize concepts across them), and the output is genuinely interpretive: new themes, a conceptual model, or 'lines-of-argument' that reframe the underlying findings, not a summary that restates them.
Health Data Research UK (HDR UK)
Health Data Research UK (HDR UK) is the UK's national institute for health data science -- an independent registered charity (charity number 1194431), not a government body, whose mission is to accelerate trustworthy use of health data to enable discoveries that improve people's lives. HDR UK is backed by nine funders, including the Medical Research Council, the National Institute for Health and Care Research, the British Heart Foundation, Cancer Research UK, and Health and Care Research Wales, and it works across academia, the NHS, industry, charities, and the public rather than running a single physical institute. Its work is organised around a small number of concrete pieces of shared national infrastructure: the UK Health Data Research Alliance, the Health Data Research Gateway, and a network of Health Data Research Hubs.
Health and Care Research Wales (HCRW)
Health and Care Research Wales (HCRW) is the Welsh Government-funded national body responsible for promoting, funding, and coordinating health and social care research in Wales. Established in 2015, HCRW sits within the Population Healthcare Directorate of Welsh Government's Research and Development Division and reports through it to the Minister for Health and Social Services. In practice, research administrators encounter HCRW in three roles: as a national funder (fellowships, studentships, and infrastructure funding schemes), as the body that funds Wales's research delivery infrastructure (research nurses, delivery staff, and support units embedded across NHS Wales), and as the Wales-side counterpart in the UK's devolved research-permissions arrangements alongside England's Health Research Authority (HRA).
CCAC (Canadian Council on Animal Care)
The Canadian Council on Animal Care (CCAC) is Canada's national, non-profit, volunteer-governed body for setting standards and certifying institutional programs that use animals in research, teaching and testing. Something falls under CCAC's role specifically when it concerns institution-level program assessment and certification (the Certificate of GAP) against CCAC's own guidelines -- not individual protocol approval (which belongs to the institution's own Animal Care Committee, the Canadian counterpart to a US IACUC), not human-subjects research ethics (governed instead by TCPS 2 / Research Ethics Boards), and not research funding itself (CCAC is funded by CIHR and NSERC, but is not a Tri-Agency funding body).
Health Research Authority (HRA)
The Health Research Authority (HRA) is an executive non-departmental public body sponsored by the Department of Health and Social Care, established on 1 January 2015 under Part 3, Chapter 2 of the Care Act 2014. It protects and promotes the interests of patients and the public in health and social care research across England, principally by overseeing the Research Ethics Service (the network of NHS Research Ethics Committees, or RECs) and by granting HRA Approval -- the combined ethical-review-plus-NHS-permissions decision required before most NHS-related research can start recruiting. A body is operating under HRA remit when its function is defined by this statutory framework -- REC review coordinated by the HRA, or an HRA Approval / Combined Review decision -- not merely because it reviews research generally; a university's own institutional ethics committee, or a company's internal governance sign-off, is not an HRA function even when the underlying study also needs HRA Approval separately.
ANZCCART (Australian & New Zealand Council for the Care of Animals in Research and Teaching)
ANZCCART (the Australian and New Zealand Council for the Care of Animals in Research and Teaching) is the advisory body that supports institutional Animal Ethics Committees (AECs) and researchers in applying the Australian code for the care and use of animals for scientific purposes and its New Zealand counterpart, distinguished from that Code and from AECs themselves by having no regulatory or protocol-approval authority of its own — ANZCCART trains, advises and publishes guidance (including the ComPass online training course and the ANZCCART Openness Agreement), while the Code sets the binding standard and each institution's own AEC actually reviews and approves individual research and teaching protocols.
Omitted Variable Bias
Omitted variable bias (OVB) is the bias in a regression coefficient that occurs when a variable is left out of the model that (1) has its own effect on the dependent variable, independent of the variable(s) included, and (2) is correlated with an included independent variable. Because the omitted variable's influence does not disappear, it is absorbed into the error term; since that error term is now correlated with the regressor, the coefficient on the included variable no longer isolates that variable's own effect on the outcome -- part of what it measures is really the omitted variable's effect, passed through the correlation between the two. Both conditions must hold: a variable correlated with the regressor but with no independent effect on the outcome produces no bias, and a variable that affects the outcome but is uncorrelated with the regressor (for example, because the regressor was randomly assigned) produces no bias either, no matter how important that variable otherwise is.
ICH Q8 (Pharmaceutical Development)
ICH Q8(R2) (Pharmaceutical Development) is the ICH Quality-series guideline covering the pharmaceutical-development section of a marketing application: how a sponsor defines the Quality Target Product Profile (QTPP), identifies Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs), and, under the enhanced (Quality by Design) approach, establishes a design space and control strategy. A development report follows Q8(R2) when it (1) states the QTPP the product is designed to meet, (2) links each CQA to the material attributes and process parameters shown to affect it, and (3) -- for an enhanced-approach filing -- defines the design space's boundaries with data, not a single fixed set-point, and states the control strategy that keeps production inside them.
Amendment Clauses: Why Verbal Changes to a Vendor Contract Usually Don’t Count
An amendment clause (also called a written-amendment clause or a 'no oral modification' / NOM clause) is the boilerplate provision stating that a vendor contract can be changed -- amended, modified, supplemented, or waived -- only by a document that is (1) in writing and (2) signed by an authorized representative of both parties. What makes a proposed change qualify as a valid amendment under this clause, rather than just something a vendor employee said or agreed to, is that it satisfies both elements together: an unsigned email discussing a change, a verbal agreement over the phone, or a handshake understanding at a site visit does not amend the contract -- no matter how clearly both sides intended it -- unless it is captured in a writing signed by someone with actual authority to bind each party.
Entire Agreement (Integration) Clauses in Vendor Contracts
An entire agreement clause (also called an integration clause or merger clause) is a contract provision stating that the signed written document constitutes the complete and final agreement between the parties on its subject matter, superseding all prior drafts, emails, verbal statements, and negotiations that preceded signature. What makes a provision an entire agreement clause specifically, rather than just a signed contract, is that it invokes the parol evidence rule to exclude outside evidence -- a sales rep's verbal promise or an earlier email -- from being used to add to or contradict the written terms once a court finds the contract fully integrated.
Waiver Clause: Why Excusing One Breach Doesn’t Waive Future Enforcement Rights
A waiver clause (also called a No Waiver or Non-Waiver clause) is a vendor-contract provision stating that a party's failure or delay in enforcing any contract right, or its acceptance of a late or non-conforming performance on one occasion, does not waive that right and does not excuse the other party's future compliance -- unless a waiver is made expressly, in a signed writing that identifies the specific right or provision. Three elements distinguish a waiver clause from a general courtesy or informal accommodation: (1) it addresses conduct-based (implied) waiver specifically, not an express written waiver, which remains fully effective if one is actually signed; (2) it confines any excused breach to that single instance -- excusing one late delivery does not excuse the next one, and does not waive the right to enforce the underlying deadline term going forward; and (3) it is a defensive backstop against a party's own leniency being read as a course-of-dealing modification of the contract, distinct from the cure-period mechanic (which governs notice-and-fix timing for a specific breach) and from termination rights (which the waiver clause preserves rather than creates).
Non-Solicitation Clauses in Vendor Contracts
A non-solicitation clause in a vendor contract is a mutual provision under which each party agrees not to directly recruit, hire, or induce away the other party's employees who worked on the engagement, typically for the contract term plus a defined tail period afterward (commonly 12-24 months) -- distinct from a non-compete clause, which restricts competing in the marketplace rather than recruiting specific staff. What makes it a non-solicitation clause specifically is that it targets active, directed recruitment of identified individuals, not an employee's own initiative to leave, and not the parties' general ability to compete for the same business.
Notice Requirements in Vendor Contracts: How and Where Notice Must Be Delivered
A vendor contract's notice clause (also called a notices provision) governs how a party must formally communicate certain events under the agreement -- most consequentially termination, default, and cure notices -- as distinct from ordinary day-to-day communication. What makes a communication qualify as 'notice' under this clause, rather than just an email or phone call someone happened to receive, is that it satisfies three things the clause itself specifies: it uses one of the clause's designated delivery methods (commonly certified or registered mail, hand delivery, a nationally recognized overnight courier with tracking, or email only if the clause explicitly lists email, often paired with a delivery or read-receipt requirement); it is sent to the exact address and named contact or title the clause designates, which is frequently not the buyer's or vendor's day-to-day account representative; and it is treated as received on whatever date the clause's own deemed-receipt rule sets -- actual delivery date, a fixed number of days after mailing, or the next business day for email -- rather than the date it was sent or the date someone actually opened it.
Severability Clauses in Vendor Contracts
A severability clause (also called a savings clause) is a contract provision stating that if a court or arbitrator finds any single provision of the agreement illegal, invalid, or unenforceable, that finding does not void the rest of the contract -- the remaining provisions stay in force, and the unenforceable clause is either deleted or narrowed ('blue-penciled') to the extent the law allows. What makes it a severability clause specifically, rather than a passing legal formality, is that it converts uncertain common-law severability doctrine -- which many but not all courts apply by default -- into an explicit, negotiated statement of the parties' intent: keep the rest of the deal alive around one bad provision, rather than leave a court to decide from scratch whether the whole agreement is inseverable and void.
Cure Period: How Long a Vendor Gets to Fix a Breach Before Termination
A cure period is the specific, contractually defined window of time -- starting when the non-breaching party delivers written notice identifying a particular breach -- during which the breaching party may fix that breach before the non-breaching party's right to terminate the contract for cause becomes exercisable. Three elements make something a cure period rather than a general grace period or informal courtesy: (1) it is triggered by written notice that identifies a specific breach, not a vague complaint; (2) the contract sets a defined length for the window (commonly 30 days for a general material breach, though payment defaults often run shorter and some breach categories -- insolvency, loss of a required license, confidentiality or IP breaches -- are carved out with no cure right at all); and (3) curing the identified breach within the window defeats the termination-for-cause right for that specific breach, while failing to cure it makes that right exercisable. It is the procedural mechanic underneath the "for cause" side of a termination-for-convenience-vs-cause clause, not a separate standalone right.
MFN (Most-Favored-Nation) Pricing Clauses in Vendor Contracts
A Most-Favored-Nation (MFN) pricing clause is a promise a vendor makes in a contract that if it later offers a better price or better terms to another buyer for a comparable purchase, the original buyer becomes entitled to that better price or terms too. What makes a clause an MFN clause specifically, rather than a general price-fairness assurance, is that entitlement is conditioned on comparability: the triggering deal has to match the original buyer's own volume commitment, contract term length, payment terms, and scope of covered products closely enough to count as the 'same deal' under the clause's own definition of comparable. That comparability requirement is doing almost all of the work in an MFN clause, and it is also the source of the most common misunderstanding buyers bring to one: an MFN clause is a promise to match the vendor's best price among comparable customers, not a guarantee of the single lowest price the vendor charges anyone, anywhere, under any terms.
Consignment Inventory Pricing: How a Consignment Fee Structure Actually Works
A consignment fee structure is the pricing mechanism inside a consignment inventory arrangement: the facility is billed for a unit only when it is used or otherwise triggers a sale, at a per-unit price the two parties agreed to before any stock shipped — not at delivery, and not on a schedule tied to when the order was placed. What makes a price genuinely a consignment fee structure, rather than an ordinary purchase discount, is that the agreed price already has the vendor's carrying cost built into it: because the vendor retains title to — and financial risk on — every unit sitting unbilled on the facility's shelf, the pre-agreed consignment unit price for a given SKU commonly runs somewhat higher than that same vendor's direct-purchase price for the identical item and quantity tier bought outright at delivery. A facility that pays a discounted price for the full order quantity at time of delivery, regardless of how quickly it uses the stock, is not running a consignment fee structure even if the headline unit price is lower — that's an ordinary volume-discounted purchase, not consignment.
Minimum Advertised Price (MAP) Policy in Medical Distribution
A Minimum Advertised Price (MAP) policy is a rule a manufacturer sets that puts a floor on the price a reseller may publicly advertise for that manufacturer's product — in a catalog, on a website, or in a mass email — enforced by the manufacturer declining to keep supplying resellers who advertise below it. What makes a restriction a MAP policy specifically, rather than a price-fixing agreement, is that it only ever governs what is publicly displayed: the actual price a reseller privately quotes, negotiates, or invoices to a specific buyer sits entirely outside MAP's scope. That is why an institutional buyer can be quoted a genuine contract price below the advertised MAP figure without either the distributor or the manufacturer doing anything improper.
Supplier Diversity Certifications: MBE, WBE, VOSB and What They Mean for Institutional Buyers
A supplier diversity certification -- MBE (Minority Business Enterprise), WBE (Woman-Owned Business Enterprise), or VOSB/SDVOSB (Veteran-Owned/Service-Disabled Veteran-Owned Small Business) -- is a third-party-verified status confirming a business is at least 51% owned, operated, and controlled by a member of the certifying category, established through a documented review (ownership records, tax filings, sometimes a site visit) rather than a vendor's own claim. MBE and WBE are typically certified by private nonprofit bodies (NMSDC and WBENC affiliate councils) for use in corporate and institutional supplier-diversity programs. VOSB/SDVOSB status for federal contracting purposes is certified by the SBA through its VetCert program, a distinction that determines whether a certification counts toward a federal prime contractor's small-business subcontracting-plan credit or only toward a private buyer's internal diversity-spend tracking.
BBB Rating Scale: What A+ Actually Means
The BBB rating scale is the letter-grade system (A+ through F, in thirteen notches: A+, A, A-, B+, B, B-, C+, C, C-, D+, D, D-, F) that the Better Business Bureau assigns to a business it profiles, computed from a set of business-conduct factors -- not from product quality, technical compliance, or a regulatory inspection. A score counts as a BBB rating, in the operational sense, only when it reflects BBB's own weighted evaluation of factors it discloses in category (complaint volume relative to the business's size and time in business, how responsively and completely the business resolves complaints filed through BBB's process, the transparency of its advertising and business practices, licensing status, and any government actions on record) without disclosing the exact point value BBB assigns to each factor. A star average, a review-site badge, or a vendor's own self-reported "A-rated" claim that isn't a live grade pulled from a business's actual BBB profile is not a BBB rating in this sense, whatever it's labeled as.
DSCSA Compliance: What It Requires of a Distributor
DSCSA (Drug Supply Chain Security Act) compliance, at the distributor level, means a wholesale distributor passes complete Transaction History, Transaction Information, and Transaction Statement (collectively 'T3') with every change of ownership of a human prescription drug product; verifies that every trading partner it buys from and sells to is an FDA-authorized trading partner; and quarantines, investigates, and (when confirmed) reports suspect or illegitimate product rather than reselling it. As of the law's full implementation, that exchange must happen electronically, in an interoperable format, down to the individual saleable unit -- not on paper, and not only at the lot level. A distributor is DSCSA-compliant only when all of these run together on every transaction: an incomplete T3 record, a trading-partner-verification step that is skipped or informal, or a suspect-product investigation that never happens are each, on their own, enough to break compliance even if the other pieces are in place.
FDA Registered Establishment: What It Means and Doesn’t Mean
An FDA Registered Establishment is a facility that has completed FDA’s annual device establishment registration under 21 CFR Part 807, Subpart B — an administrative disclosure that the facility exists and what device-related activity (manufacturing, repackaging, relabeling, sterilizing, or similar) it performs there. Registration is assigned an FEI (FDA Establishment Identifier) number and must be renewed each year between October 1 and December 31. Critically, under 21 CFR 807.39, registration “does not in any way denote approval of the establishment or its products,” and any representation implying otherwise is misbranding. Registration is separate from, and does not substitute for, device listing, 510(k) clearance or PMA approval of a specific product, or third-party quality-system certification such as ISO 13485.
Backhaul Freight
A shipment counts as backhaul freight -- rather than a standard (headhaul/dedicated) movement -- when it is booked onto a truck's already-committed return leg after that truck has delivered an unrelated outbound load, priced at the marginal cost of that return leg rather than a full round-trip rate, and scheduled opportunistically around the return leg's timing rather than against a firm, buyer-driven delivery commitment. If a carrier builds a dedicated schedule around the order from the outset -- rather than fitting the order into a schedule built for something else -- it is standard freight, not backhaul, regardless of the rate charged.
Contract Price vs. List Price on a Distributor Price List
On a medical/lab distributor's price list or invoice, the list price is the distributor's standard, undiscounted catalog price for an item -- the number every buyer without a qualifying contract pays. The contract price (also shown as a contract tier, contract number, or GPO tier) is a lower, pre-negotiated price that applies only to a buyer covered by a specific purchasing agreement -- most often a GPO (Group Purchasing Organization) contract the buyer has signed a Letter of Participation for, but sometimes a direct facility-to-manufacturer agreement or a distributor's own volume-tier program. A price sheet or invoice line is genuinely showing a contract price, not just a discount, when it cites a specific contract number/tier and an effective date range, and when that price traces back to a real underlying agreement the buyer's facility is a party to -- not a one-off negotiated discount the sales rep offered informally, which is a different thing (an off-contract concession) even though it can look identical on the page.
Cross-Docking
A shipment is cross-docked, rather than warehoused-and-picked, when it moves from an inbound trailer directly to an outbound trailer via a staging/sortation area -- with no put-away step into rack, shelf, or bin storage -- and the outbound movement it's loaded onto is a scheduled route or trailer that already exists, not one created on demand once the item is requested.
Chargeback in Medical Distribution Pricing
A chargeback is the reimbursement a distributor claims from a manufacturer after selling product to a GPO-contract (or other manufacturer-contracted) buyer at a negotiated contract price lower than the distributor's own acquisition cost. It requires all of: an active manufacturer contract price covering the buyer, the distributor invoicing the buyer at that contract price rather than its own cost, a claim filed by the distributor identifying the pricing gap, and reimbursement or credit from the manufacturer once the claim is validated. It is a distributor-to-manufacturer reconciliation happening behind the buyer's invoice, not a transaction the buying institution is directly party to.
Electronic Data Interchange (EDI) in Medical Supply Procurement
Electronic Data Interchange (EDI) is the direct, computer-to-computer exchange of standardized business documents — purchase orders, invoices, advance ship notices — between a buying facility's procurement/AP system and a distributor's order-management system, using a structured transaction format (ANSI ASC X12 in the US) rather than a person re-keying the same data from a fax, email, or PDF. What makes an exchange EDI rather than merely "electronic": (1) the document is generated and consumed directly by each side's own business system, not typed by a human into the other party's web portal; (2) it follows a standardized transaction-set format (e.g., an 850 for a purchase order) both systems are configured to parse identically; and (3) no manual re-entry step sits between the buyer's order and the seller's fulfillment system. A facility's AP/purchasing system needs EDI capability — native ERP support, a VAN connection, or a direct integration — to work efficiently with a high-volume distributor at order volumes where manual entry on either side no longer scales.
Net-30 Payment Terms and Vendor Account Verification
Net-30 payment terms allow a buyer to receive goods or services now and pay the full invoice within 30 days of the invoice date, but a vendor only grants this to a verified account: an institution that has submitted a credit application, supplied trade references confirming an on-time payment history, and been formally approved for invoice billing rather than required to prepay or pay by card at the time of order. An arrangement only counts as "Net-30" for planning purposes once the vendor's credit review has actually approved it — a buyer assuming Net-30 terms apply by default to a brand-new supplier relationship, without having gone through that verification, is describing a hope, not an actual account status.
Backorder vs. Discontinued: Reading Medical Supply Vendor Status Codes
A backorder is a temporary vendor status: the item remains in the vendor's active catalog and a specific shipment or lot is delayed, with an expected restock date (an ETA) that the buyer can plan a reorder timeline around. A discontinued status is permanent: the vendor has stopped producing or carrying the item entirely, there is no restock date because none is coming, and the correct response is to identify and validate a substitute item rather than wait. A status only counts as "discontinued" for planning purposes once the vendor confirms it directly (or the item is formally removed from the vendor's catalog) — an unexplained delay or an ambiguous "unavailable" label is neither one until confirmed.
Par Level (Inventory) in Clinical Supply Management
A stocking quantity is a par level (rather than an arbitrary reorder habit) when it is calculated as (Average daily usage x Lead time in days) + Safety stock, and is used as the target quantity a stocking location -- a supply cart, a lab bench, a central stores shelf -- is restocked up to at each periodic review, so that the reorder amount at any count is simply par level minus on-hand quantity.
Group Purchasing Organization (GPO)
A group purchasing organization (GPO) is an entity that aggregates the purchasing volume of multiple, separately owned member facilities and uses that combined volume to negotiate supply and equipment contracts with vendors on members' behalf. What makes something a GPO rather than a related arrangement: (1) it aggregates volume across multiple independent legal entities, not just departments within one organization; (2) it negotiates and publishes vendor contracts members can buy against directly, without members running their own competitive solicitation for that item; and (3) it is typically funded by an administrative fee the awarded vendor pays the GPO on completed sales, not by membership dues charged to the facility. Contracts are commonly structured in pricing tiers tied to how much of a facility's category spend it commits to routing through the awarded vendor, and facilities remain free to buy specific items off-contract when no suitable GPO contract exists or a documented exception applies.
Minimum Order Quantity (MOQ) in Medical Supply Procurement
The smallest quantity of a single SKU a supplier will accept in one order, set by the supplier as a mandatory floor for the sale to happen at all -- distinct from a price-break quantity, which is an optional volume tier for a lower per-unit price.
Vendor-Managed Inventory (VMI)
Vendor-managed inventory (VMI) is a supply-chain arrangement in which the vendor, not the purchasing facility, monitors on-hand stock levels for a defined set of items and decides when and how much to reorder, replenishing against par levels (or min/max thresholds) the two parties agreed to in advance. What makes an arrangement VMI specifically is that the reorder decision itself sits with the vendor, exercised against pre-agreed rules and some visibility into actual consumption — not merely that the vendor delivers supplies, and not necessarily that the vendor owns the stock until it's used (that's a separate, sometimes-combined arrangement called consignment inventory). The facility placing every order itself, tracking its own shelves and submitting its own purchase orders item by item, is the traditional alternative VMI replaces for the items it covers.
Total Cost of Ownership (TCO) in Medical Equipment Purchasing
Total cost of ownership (TCO) in medical equipment purchasing is the sum of every cost a unit generates over a defined ownership horizon -- typically its expected useful life -- minus any residual or resale value at the end of that horizon, evaluated on the same basis as a competing option. A cost belongs in the calculation if it is a direct consequence of owning and operating that specific unit: purchase price, installation, service/maintenance contracts, consumables and reagents, calibration and compliance testing, staff training, downtime, financing costs, and disposal or decommissioning. Comparing two options on purchase price alone, or over mismatched time horizons, is not a TCO comparison even if it is labeled one.
Newcastle-Ottawa Scale (NOS)
The Newcastle-Ottawa Scale (NOS) is a star-rating quality-assessment tool used to appraise non-randomized studies -- cohort studies and case-control studies -- for inclusion in systematic reviews and meta-analyses. Developed by Wells, Shea, O'Connell, Peterson, Welch, Losos and Tugwell through a University of Newcastle (Australia) / University of Ottawa (Canada) collaboration and maintained by the Ottawa Hospital Research Institute, it scores studies across three domains -- Selection (max 4 stars), Comparability (max 2 stars), and Outcome/Exposure (max 3 stars) -- for a maximum of 9 stars. It is commonly paired with the MOOSE reporting guideline for meta-analyses of observational studies, and is distinct from ROBINS-I (Cochrane's preferred non-randomized-study risk-of-bias tool) and GRADE (which rates the overall evidence base rather than individual studies).
Digital Curation Centre (DCC)
The Digital Curation Centre (DCC) is a UK centre of expertise in research data management and digital curation, established in 2005 by a consortium led by the University of Edinburgh following a competitive bid process run by Jisc. It is best known for DMPonline, the UK's most widely used data management planning tool, but also provides training, guidance, consultancy, and the widely-cited Curation Lifecycle Model. Jisc funding ended in 2016; the DCC's ongoing core partnership is with the Universities of Edinburgh and Glasgow.
STTR (Small Business Technology Transfer)
STTR (Small Business Technology Transfer) is a U.S. federal award program created by the Small Business Technology Transfer Act of 1992 (Public Law 102-564) that funds early-stage small-business R&D on the condition that the small business formally partners with a U.S. nonprofit research institution, with the small business performing at least 40% of the work and the research institution at least 30%. Like the earlier SBIR program it is modeled on, STTR funding is non-dilutive (no equity taken, no government IP ownership) and runs through the same three-phase structure, but unlike SBIR the Principal Investigator may be employed by either the small business or the partnering research institution rather than being required to work primarily for the small business.
SNIP (Source Normalized Impact per Paper)
Source Normalized Impact per Paper (SNIP) is a journal-level citation metric calculated from Scopus data by the Centre for Science and Technology Studies (CWTS) at Leiden University -- not by Elsevier, despite appearing alongside Elsevier's own CiteScore on Scopus source pages. SNIP measures citations received in a given year to a journal's publications from the preceding three years, divided by the number of those publications, then normalizes that ratio by the citation potential of the journal's subject field, correcting for the fact that citation practices (typical reference-list length, citation density) vary sharply across disciplines.
ChiCTR (Chinese Clinical Trial Registry)
The Chinese Clinical Trial Registry (ChiCTR) is China's national clinical trial registry, established in 2005 by the Chinese Cochrane Centre/Chinese Evidence-Based Medicine Centre team at West China Hospital, Sichuan University, and accepted in 2007 as the fourth WHO International Clinical Trials Registry Platform (ICTRP) Primary Registry, with the Ministry of Health of China (now the National Health Commission) designating it as China's official representative to that network. ChiCTR accepts registration of both interventional and observational studies, from China and internationally, and publishes the full WHO Trial Registration Data Set for each registered study.
CTRI (Clinical Trials Registry – India)
The Clinical Trials Registry - India (CTRI) is India's national clinical trial registry, established on July 20, 2007 and operated by the Indian Council of Medical Research (ICMR), currently hosted at ICMR's National Institute for Research in Digital Health and Data Science (formerly NIMS), and recognized as a WHO International Clinical Trials Registry Platform (ICTRP) primary registry. Registration is mandatory and must occur prospectively, before enrollment of the first participant; the requirement, initially a 2009 order from India's Drugs Controller General, was subsequently placed on a statutory footing by the New Drugs and Clinical Trials Rules, 2019.
FDA De Novo Classification
De Novo classification is an FDA pathway, provided for at Section 513(f)(2) of the FD&C Act (21 U.S.C. 360c(f)(2)), that creates a new device classification -- Class I or Class II, with general controls alone or general and special controls -- for a novel, low-to-moderate-risk device that has no legally marketed predicate device to compare it against for 510(k) substantial-equivalence review. Since 2012, a sponsor can request De Novo classification directly, without first submitting and receiving a Not Substantially Equivalent (NSE) determination on a 510(k).
FDA Breakthrough Device Designation
Breakthrough Device Designation is a voluntary FDA status, created by Section 3051 of the 21st Century Cures Act (2016) and codified at Section 515B of the FD&C Act (21 U.S.C. 360e-3), granted to a medical device or device-led combination product that provides more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition and meets at least one of several additional statutory criteria. It grants the sponsor prioritized FDA review, a dedicated review team, senior-manager engagement, and more frequent, interactive communication throughout development -- it does not change the substantive evidentiary standard the device must ultimately meet for 510(k) clearance, De Novo classification, or PMA approval.
U01 (NIH Research Project Cooperative Agreement)
U01 (Research Project Cooperative Agreement) is NIH's cooperative-agreement counterpart to the R01 grant: it funds a discrete, specified project performed by a named investigator, using the same purpose language as R01, but with a different funding instrument. Under a cooperative agreement, NIH expects to be substantially involved in carrying out the project after award -- for example, participating in study design, data collection, and data analysis and interpretation; approving a stage of a clinical trial or other collaborative project before the next stage starts; or coordinating overall project efforts across multiple sites. The Principal Investigator retains primary responsibility and the dominant role for planning, directing, and executing the project, with NIH staff substantially involved as a partner rather than in the standard oversight role NIH plays on a grant. U01s generally do not result from investigator-initiated applications the way R01s do -- they are typically issued in response to a specific NIH funding opportunity built around a defined, often multi-site or multi-institutional, research need such as a coordinated clinical trial network.
K99/R00 (Pathway to Independence Award)
The K99/R00 (Pathway to Independence Award) is a two-phase NIH career-development mechanism that supports a promising postdoctoral researcher through a mentored phase (K99) and then a subsequent independent phase (R00) as they transition into a tenure-track or equivalent faculty position. Applicants must have no more than 4 years of postdoctoral research experience at the time of the initial or resubmission application (limited exceptions apply for events like childbirth or qualifying medical/parental leave). The K99 phase runs 1-2 years with NIH mentored-research-award terms (annual cost capped around $125,000, PI salary capped near $75,000 plus fringe); the R00 phase runs up to 3 years once the awardee has secured an independent faculty position and received Institute approval to transition, with a higher annual budget cap (around $249,000) and no mentor requirement. Unlike R01, R21 and R03, K99/R00 is restricted to a specific career stage rather than open to any qualified investigator.
Phase 4 Trial
A Phase 4 trial is a clinical study conducted after a drug has received FDA marketing approval, commonly called a post-marketing or post-approval study. It is not one of the phases 21 CFR 312.21 formally defines — that regulation covers only pre-approval testing under an active IND. Phase 4's regulatory basis instead comes from the FDA Amendments Act of 2007, which added 21 U.S.C. section 355(o) to the FD&C Act, authorizing FDA to require postmarketing requirements (PMRs, mandatory and enforceable) as distinct from postmarketing commitments (PMCs, voluntary but reported annually under section 506B) and from studies required under a Risk Evaluation and Mitigation Strategy (REMS) at section 355-1. Phase 4 studies typically enroll thousands of participants and can run indefinitely to detect rare, long-term, or subpopulation-specific effects.
Phase 3 Trial
A Phase 3 trial is the large-scale, confirmatory ("pivotal") stage of drug development conducted under 21 CFR 312.21(c), run after preliminary evidence of effectiveness to gather the additional effectiveness and safety data needed to evaluate a drug's overall benefit-risk relationship and support physician labeling. Phase 3 studies are expanded controlled or uncontrolled trials typically enrolling 300 to several thousand participants over one to four years — larger and longer than Phase 2, which makes them more likely to surface uncommon adverse reactions. Most marketing applications rely on two positive, independently conducted, pre-specified pivotal Phase 3 trials as their substantial evidence of effectiveness, though FDA can occasionally accept a single sufficiently robust trial.
Phase 2 Trial
A Phase 2 trial is the controlled efficacy-testing stage of drug development conducted under 21 CFR 312.21(b), enrolling patients who have the target disease or condition to evaluate whether the drug is effective for a particular indication and to characterize its common short-term side effects and risks. Phase 2 studies are well controlled, closely monitored, and relatively small, usually involving no more than several hundred subjects, and typically run from several months to about two years. Sponsors often distinguish Phase 2a (a smaller proof-of-concept/dose-finding study) from Phase 2b (a larger, dose-confirming efficacy study) as an informal industry convention layered on top of the single regulatory Phase 2 category.
Phase 0 Trial
A Phase 0 trial (exploratory IND study) is a very small, short human study conducted before traditional Phase 1 dose-escalation testing, using microdoses below any expected pharmacologic threshold to gather early pharmacokinetic or receptor-binding data on a candidate compound. It is not one of the phases 21 CFR 312.21 defines; under FDA's 2006 Exploratory IND Studies guidance, any study meeting exploratory-IND criteria legally qualifies as a Phase 1 trial under 312.21(a) and is filed under the same IND. Designs typically enroll under 15-30 participants for seven days or less, using doses under 1/100th the pharmacologically active dose (capped at 100 micrograms), qualifying sponsors for a reduced nonclinical toxicology package relative to a standard first-in-human study.
R01 (NIH Research Project Grant)
R01 (Research Project Grant) is NIH's most commonly used grant mechanism for an independent, investigator-initiated research project, funded through the standard grant instrument rather than a cooperative agreement. Awards generally run 1-5 budget periods of about 12 months each, carry no statutory budget cap, and can be renewed by competing for an additional project period. Unlike R21 (Exploratory/Developmental, capped at $275,000 direct costs over 2 years) and R03 (Small Grant, capped at $50,000/year), both of which are non-renewable, the R01 has no such restriction and no career-stage eligibility limit.
FDA Fast Track Designation
Fast Track designation is an FDA status, created by the FDA Modernization Act of 1997 and codified at Section 506(b) of the FD&C Act, granted to a drug intended to treat a serious or life-threatening condition when nonclinical or clinical data demonstrate its potential to address an unmet medical need. It gives a sponsor more frequent FDA meetings and written communication during development, eligibility for Accelerated Approval and Priority Review if the drug separately meets those programs' criteria, and eligibility for Rolling Review of a future marketing application. It is the baseline of FDA's four expedited programs for serious conditions -- Breakthrough Therapy, Accelerated Approval, and Priority Review each require a higher or different bar on top of it.
NSF CAREER Award (Faculty Early Career Development Program)
The NSF CAREER Award is a five-year National Science Foundation grant for untenured, tenure-track faculty (or equivalent) that funds a single integrated plan of research and education; it totals a minimum of $400,000 ($500,000 for BIO, ENG, or OPP proposals), and an eligible PI may submit only one proposal per annual competition and no more than three over a career.
Plant Patent
A plant patent is a U.S. patent, granted under 35 U.S.C. § 161, that protects a distinct and new variety of plant that has been asexually reproduced (e.g., by grafting or cuttings) rather than grown from seed or propagated from tubers. It runs 20 years from the U.S. filing date, the same term as a utility patent, but carries no maintenance fees. It is distinct from both a utility patent claiming plant subject matter and from a Plant Variety Protection Act (PVPA) certificate issued by USDA.
Defined Daily Dose (DDD)
The Defined Daily Dose (DDD) is a WHO-assigned statistical unit defined as the assumed average maintenance dose per day for a drug used for its main indication in adults. DDDs are assigned only to drugs with an ATC (Anatomical Therapeutic Chemical) classification code, one per code and route of administration, by the WHO Collaborating Centre for Drug Statistics Methodology in Oslo. DDD is a fixed technical unit for measuring and comparing aggregate drug consumption across populations, institutions, and countries -- commonly expressed as DDD per 1,000 inhabitants per day -- and does not necessarily correspond to the Prescribed Daily Dose (PDD) an individual patient actually receives.
New Chemical Entity (NCE)
A New Chemical Entity (NCE) is FDA's classification for a small-molecule drug substance whose active moiety has not been previously approved by FDA in any application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act. NCE is the small-molecule subset of the broader New Molecular Entity (NME) classification, and the specific subset that 21 CFR 314.108 grants five years of marketing exclusivity to on approval, running independently of any patent protection the sponsor separately holds. Not to be confused with No-Cost Extension, an unrelated grants-management term abbreviated the same way.
New Molecular Entity (NME)
A New Molecular Entity (NME) is FDA's classification for a drug application whose active ingredient contains no active moiety previously approved by FDA in any prior application, whether the product is a small-molecule chemical drug or a biologic. NME is the broader category; New Chemical Entity (NCE) is the small-molecule subset of NME that qualifies for a distinct five-year regulatory exclusivity period under 21 CFR 314.108, and New Biological Entity (NBE) is the biologic subset. FDA tracks NME approvals (small molecules plus new biologics) as its headline annual measure of genuinely novel drug innovation, separate from generics, reformulations, and new uses of already-approved active ingredients.
Observer Bias
Observer bias is a systematic distortion introduced by the person doing the observing, recording or interpreting, rather than by the participants or the sampling. The Catalogue of Bias defines it as a 'systematic difference between a true value and the value actually observed due to observer variation'. It arises wherever measurement requires judgement - reading an image, scoring a scale, coding an interview transcript, grading a lesion, deciding whether an adverse event is related - and it is strongest where the observer knows which group a participant belongs to and has an expectation about what they should find. It is a form of detection or measurement bias and belongs to the recording end of a study, not the sampling end: it is distinct from selection bias, which distorts who enters the study, and from confounding, which distorts the comparison itself. It is also distinct from the observer effect, where the participant changes behaviour because they know they are being watched; in observer bias the participant behaves normally and it is the observer's record of that behaviour that is wrong. Observer bias is controlled at the design and procedure level - by blinding outcome assessors, separating the people who know exposure status from the people who record outcomes, pre-specifying operational definitions and coding rules, using independent duplicate coding, and quantifying agreement between observers - rather than by any statistical adjustment after the fact.
Regression to the Mean
Regression to the mean is the tendency for an extreme measurement to be followed by one closer to the average, purely because the extreme value was partly the product of chance. It is a property of repeated measurement rather than a real change in the thing being measured, and it operates whenever a group is selected on the basis of an extreme score. A before-after comparison that selects on an extreme baseline and lacks a control group cannot distinguish regression to the mean from a treatment effect.
Standardized Infection Ratio (SIR)
The Standardized Infection Ratio (SIR) is an NHSN risk-adjusted summary measure calculated as the number of healthcare-associated infections observed at a facility or unit divided by the number statistically predicted for that same population, using a risk-adjustment model fit against a national NHSN baseline. SIR = 1.0 means observed infections matched the risk-adjusted prediction; SIR > 1.0 means more infections were observed than predicted; SIR < 1.0 means fewer were observed than predicted. NHSN reports a 95% confidence interval alongside the point estimate because small device-day or procedure denominators make the SIR statistically unstable at the unit level.
Beyond-Use Date (BUD)
A beyond-use date (BUD) is the date, or date and hour, established by a compounding pharmacist after which a compounded preparation must not be used, stored, or transported. It is set at the time of compounding and is distinct from a manufacturer's expiration date, which applies only to the original, unopened, commercially manufactured product. Under USP General Chapter 797 (sterile preparations, current since November 1, 2023), the BUD is determined primarily by the CSP Category the preparation was compounded under (Category 1, 2, or 3, reflecting the degree of verified environmental control), together with the storage condition (controlled room temperature, refrigerated, or frozen), the dosage form, and any supporting sterility or stability testing or applicable stability data. Under USP General Chapter 795 (nonsterile preparations, also current since November 1, 2023), the BUD is determined primarily by whether the formulation is aqueous or nonaqueous, the dosage form and packaging, the storage condition, and whether supporting stability data exists — the chapter provides conservative default periods to use when no such data is available. In both chapters, the current chapter text and the USP Compounding Compendium contain the exact, category-specific and formulation-specific tables a compounder should use to assign a BUD to a given preparation; a value copied from a pre-2023 reference will not reflect the current framework.
EU AI Act
Regulation (EU) 2024/1689, the European Union's law regulating AI systems and general-purpose AI (GPAI) models placed on or used in the EU market. It classifies AI systems into four risk tiers (unacceptable, high, limited, minimal) with obligations scaling to risk, applies a separate GPAI-model regime, and phases in on a multi-year timeline set by Article 113 and later revised by the 2026 'Digital Omnibus' amendment.
CSE (Council of Science Editors)
CSE (the Council of Science Editors) is an international individual-membership society for editorial professionals across the sciences, founded in 1957 as the Conference of Biology Editors, incorporated in 1965 as the Council of Biology Editors and renamed Council of Science Editors on 1 January 2000. It publishes The CSE Manual (titled Scientific Style and Format through its eighth edition, 2014; ninth edition, University of Chicago Press, 2024), the source of the three CSE documentation systems -- citation-sequence, citation-name and name-year -- and the Recommendations for Promoting Integrity in Scientific Journal Publications, first issued in 2006 and updated on a rolling basis since May 2018.
Research Support Services
Research support services are the institutional functions -- sponsored-programs (pre- and post-award) administration, core research facilities and shared instrumentation, research data management and IT infrastructure, regulatory and compliance support (IRB, IACUC, biosafety), research development and grant-writing assistance, and technology transfer -- that a university, hospital, or research institute provides centrally or departmentally so individual researchers do not have to build each capability themselves. The term is used both internally (an institution's own research-support-services office or division) and externally, in procurement, where an institution contracts a third-party vendor to provide one of these functions.
Request for Proposal (RFP)
In research administration, a Request for Proposal (RFP) is a formal solicitation document a research office, core facility, or sponsored institution issues to invite competing vendors or service providers to propose an approach for performing a defined scope of work -- for example, a clinical trial CRO, a survey or data-collection vendor, a specialized instrumentation service contract, or a research-data platform -- along with pricing, so the institution can evaluate approach and cost on a comparable basis before making an award. This is distinct from a Request for Quote (RFQ), where the work is already fully defined and only price is being compared, and a Request for Information (RFI), which scopes the market without an intent to award.
Jussieu Call for Open Science and Bibliodiversity
The Jussieu Call for Open Science and Bibliodiversity is an open-access policy declaration launched on 10 October 2017 by a French collective of researchers and scholarly-publishing professionals, organized through the Bibliotheque Scientifique Numerique's open-access working group. It sets out principles for the open-access transition that explicitly reject reliance on a single dominant publishing or business model in favor of supporting a diversity of models, actors, and languages -- what the declaration terms 'bibliodiversity' -- and calls for redirecting subscription spending toward researcher-controlled, non-APC publishing infrastructure.
Helsinki Initiative on Multilingualism in Scholarly Communication
The Helsinki Initiative on Multilingualism in Scholarly Communication is a 2019 open-science policy declaration -- jointly issued by the Federation of Finnish Learned Societies, the Committee for Public Information, the Finnish Association for Scholarly Publishing, Universities Norway, and the COST Action European Network for Research Evaluation in the Social Sciences and Humanities (ENRESSH) -- that calls on universities, funders, and research-evaluation bodies to protect and reward publication in languages other than English alongside international publication, on the grounds that locally and nationally relevant research often needs to reach non-English-speaking audiences to achieve its full societal impact.
DuraSpace
DuraSpace was a US 501(c)(3) nonprofit organization, formed in 2009 through the merger of the DSpace Foundation and Fedora Commons, that stewarded the open-source DSpace and Fedora repository platforms -- and later VIVO -- on behalf of their user communities. DuraSpace merged into LYRASIS (announced 24 January 2019, completed 1 July 2019) and its software programs now continue as the DuraSpace Community Supported Programs division within LYRASIS; DuraSpace no longer exists as an independent organization.
ORCID Peer Review Record
An ORCID peer review record is an entry in the Peer Review section of a researcher's ORCID record documenting that they reviewed for a named journal, publisher, funder, or other convening organization -- carrying a group tag identifying that organization, a review type, a completion date, and, optionally, external identifiers. Unlike Works, Employment, or Education entries, a researcher cannot type a peer review record into their own ORCID profile directly: it can only be added via the ORCID Member API by a trusted organization, and only after the researcher signs in to ORCID and explicitly authorizes that organization to write to their record.
GRADE (Evidence Certainty Rating)
GRADE (Grading of Recommendations Assessment, Development and Evaluation) is a structured, transparent methodology, developed by the international GRADE Working Group beginning in 2000, for rating the certainty of a body of evidence -- typically from a systematic review -- as High, Moderate, Low, or Very Low, and for connecting that certainty rating to the strength of a resulting clinical or policy recommendation. Certainty starts from study design (randomized evidence starts High, observational evidence starts Low) and is then downgraded for risk of bias, inconsistency, indirectness, imprecision, or publication bias, or upgraded for a large effect, dose-response gradient, or plausible confounding working against the observed effect.
Crossref REST API
The Crossref REST API (api.crossref.org) is Crossref's free, public web API for programmatically querying its registered scholarly-metadata database. It exposes routes for works, journals, members, funders, licenses, prefixes, and types, returning structured JSON that can be filtered and queried -- including free-text bibliographic matching via the query.bibliographic parameter on the /works route -- without requiring authentication, though including a mailto contact parameter or identifying User-Agent header routes requests to Crossref's faster 'polite pool.'
AI Literacy (EU AI Act Article 4)
Under Article 4 of the EU AI Act, AI literacy is the obligation on providers and deployers of AI systems to take measures ensuring, to their best extent, a sufficient level of AI literacy among staff and other persons who operate or use AI systems on their behalf -- accounting for those individuals' technical knowledge, experience, education, and training, and the context and population the AI system is used on or for. The obligation entered into force on 2 February 2025 under Article 113(a), ahead of the Act's later staged compliance deadlines for high-risk and GPAI provisions.
Fundamental Rights Impact Assessment (FRIA)
A Fundamental Rights Impact Assessment (FRIA) is the pre-deployment assessment that Article 27 of the EU AI Act requires certain deployers of high-risk AI systems -- public bodies, private entities providing public services, and deployers of the Annex III(5)(b)/(c) credit-scoring and life/health-insurance risk-assessment use cases -- to complete before first use. It must describe the intended deployment process, the categories of people likely affected, the specific risks of harm to their fundamental rights, the human-oversight arrangements, and the mitigation measures in place, using a template the European AI Office is required to provide.
European AI Office
The European AI Office is the body established within the European Commission -- by Commission Decision of 24 January 2024, effective 21 February 2024 -- to oversee implementation and enforcement of the EU AI Act. It has exclusive enforcement authority over the general-purpose AI (GPAI) model obligations in Chapter V, develops codes of practice and evaluation methodologies for GPAI, coordinates enforcement with Member States' national market surveillance authorities, monitors AI market and technology developments, and publishes standard templates -- including the Fundamental Rights Impact Assessment template.
WAME (World Association of Medical Editors)
WAME (World Association of Medical Editors) is a nonprofit professional association of editors of peer-reviewed medical journals, founded in 1995 at Bellagio, Italy, that develops and publishes consensus policy statements and recommendations on editorial ethics -- authorship, peer review, conflicts of interest, plagiarism, and correction/retraction practice among them. WAME is one of the four co-authoring bodies, alongside COPE, DOAJ, and OASPA, of the Principles of Transparency and Best Practice in Scholarly Publishing.
Guarantor of a Paper
The guarantor of a paper is the author (occasionally more than one, as co-guarantors) who takes explicit responsibility for the integrity of the work as a whole -- from study conception through the accuracy and reporting of every result -- even for portions led by other co-authors. Several journals, including BMJ and PNAS, require submissions to name a guarantor explicitly; the role is distinct from authorship generally and from the corresponding-author role specifically.
STAR Methods
STAR Methods (Structured, Transparent, Accessible Reporting) is Cell Press's standardized methods-section format for life-science papers. It is organized around a Key Resources Table that lists every reagent, model organism, cell line, software tool, and dataset used in a study alongside a source and, wherever one exists, a unique catalog number or Research Resource Identifier (RRID), so materials can be independently sourced and the reported experiments reproduced.
Grant DOI
A grant DOI is a Digital Object Identifier minted for an individual research grant or award record — rather than for a publication, dataset, or person — through Crossref's Grant Linking System (GLS), launched in 2019. Where a conventional DOI resolves to a journal article or dataset landing page, a grant DOI resolves to a metadata record describing the award itself: funder, award title, award/grant number, dates, and, where supplied, participants. When a funder or grantee includes a grant_doi attribute in Crossref metadata for a research output, Crossref automatically inserts an isFinancedBy relationship linking that output back to the grant record, making the funding-to-output relationship machine-traceable across the scholarly record rather than relying on a free-text funding-acknowledgment sentence alone.
RDA FAIR Data Maturity Model
The RDA FAIR Data Maturity Model is a common, community-endorsed set of indicators for assessing how well a specific dataset — not a repository or an organization — implements the FAIR Data Principles, published by the Research Data Alliance's FAIR Data Maturity Model Working Group. Rather than leaving "FAIR compliance" as a vague aspiration, the model breaks each of the four FAIR principles (Findable, Accessible, Interoperable, Reusable) down into specific, individually checkable indicators, each evaluable against a given dataset, producing a structured maturity picture rather than a single pass/fail score. It was explicitly designed to harmonise the many divergent FAIR-assessment approaches that had proliferated by the late 2010s into one shared reference set other tools and projects could build on. FAIRsFAIR formally adopted the RDA model's specification and guidelines as the basis for its own assessment work, and DANS's FAIR-Aware self-assessment tool draws its metrics substantially from these same indicators.
FAIR-Aware
FAIR-Aware is a free, self-guided online self-assessment questionnaire developed by DANS (Data Archiving and Networked Services, the Netherlands) to help researchers and data stewards gauge their own understanding of, and their dataset's likely alignment with, the FAIR Data Principles before depositing data in a repository. It was developed and refined through the FAIRsFAIR EU project, and its assessment metrics are built substantially on the indicators separately developed by the RDA FAIR Data Maturity Model Working Group — so a FAIR-Aware score gives a rough, self-reported proxy for how a dataset would likely perform against that more granular indicator set, without requiring the technical setup an automated tool needs.
C2PA Content Provenance
C2PA content provenance refers to the tamper-evident metadata record — called a Content Credential — attached to a piece of digital media (image, video, audio, or document) under the technical specification published by the Coalition for Content Provenance and Authenticity (C2PA). C2PA is a standards initiative founded by Adobe, Microsoft, Intel, the BBC, and Truepic, since joined by a large roster of member organizations including Google, Meta, OpenAI, Amazon, and Sony. Its specification (versioned; C2PA 2.x as of 2026) defines a cryptographically signed, chained record of who or what created a piece of media, what tools or AI models touched it, and what edits were subsequently made — designed so a viewer can inspect that chain without having to trust a single central authority.
AI Output Verification
AI output verification is the practice of checking generative-AI-produced content — text, code, data analysis, citations, or images — for accuracy, validity, and fabricated material before it is used, published, or relied upon in a research context. It is the necessary corollary to disclosure: telling a reader that an AI tool was used does not, on its own, discharge a researcher's responsibility for whether what the tool produced is actually correct. ICMJE's recommendations state that authors are responsible for all aspects of their work, including any content produced with the assistance of an AI tool, and must vouch for its accuracy and for the absence of plagiarism; COPE's position statement on AI tools similarly places responsibility for verifying AI-generated content on the human author rather than the tool, and does not permit an AI tool to be listed as an author precisely because it cannot take on that accountability.
AI Transparency Marker
An AI transparency marker is a visible label, watermark, or embedded machine-readable metadata tag attached to a piece of content — text, image, audio, or video — to disclose that it was generated or substantially modified by an artificial intelligence system. The concept spans two related but distinct mechanisms: human-readable disclosure (a statement in a manuscript, caption, or figure legend that AI assistance was used) and technical marking embedded directly in the file itself (for example, a C2PA Content Credential or an invisible watermark) that software can detect even if the disclosure text is stripped or ignored.
Contributor Role Ontology (CRO)
The Contributor Role Ontology (CRO) is a formal OWL ontology, developed by the data2health consortium and published via the OBO Foundry and NCBO BioPortal, that extends CASRAI's CRediT (Contributor Roles Taxonomy) into a machine-reasonable class hierarchy. Where CRediT defines a flat, non-hierarchical list of 14 contribution roles (Conceptualization, Data curation, Writing — original draft, and so on) intended for a human to pick from a fixed list on a manuscript submission form, CRO represents each role — plus additional roles beyond CRediT's 14 — as a formally defined ontology class with a unique persistent identifier in the form CRO:NNNNNNN, explicit parent/child relationships, and logical axioms suitable for automated reasoning and integration into knowledge graphs and biocuration systems.
FAIR Implementation Profile (FIP)
A FAIR Implementation Profile (FIP) is a structured, machine-actionable declaration of the specific technology choices — repositories, metadata standards, identifier schemes, vocabularies, and access protocols — that a research community selects in order to implement the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable) in practice. Each declared technology choice is called a FAIR Enabling Resource (FER). A FIP is normally produced through a structured question-and-answer process — historically in facilitated FIP Wizard workshops run by the GO FAIR Foundation, now increasingly self-service via the FIP Wizard 4.0 tool — and is published as an openly reusable dataset (in nanopublication-compatible, machine-actionable form, alongside human-readable PDF/Word/Excel/CSV exports) rather than kept as an internal policy document.
NSF Common Forms
NSF Common Forms refers to the pair of standardized, NSPM-33-driven disclosure documents the US National Science Foundation requires on proposals -- the Biographical Sketch and the Current and Pending (Other) Support statement -- built to a shared structure across federal funders and generated through SciENcv rather than agency-specific templates. The 'common' in the name refers to the underlying form structure being shared across federal agencies implementing NSPM-33, not to NSF and other agencies sharing a single deadline: NSF's Common Forms mandate took effect in 2023, well before NIH's equivalent mandate, which did not take effect until proposals or reports due on or after January 25, 2026.
Scholarly Communication Librarian
A scholarly communication librarian is an academic or research library position focused on an institution's engagement with the scholarly publishing and communication system, as distinct from traditional collection development and reference work. Typical responsibilities include interpreting and supporting compliance with open access policies (institutional and funder mandates), managing and populating the institutional repository, advising researchers on copyright and author rights in publisher agreements, administering article processing charge (APC) funds and transformative or read-and-publish agreements, and, at many institutions, supporting research data management and researcher identifier (ORCID) adoption.
WHO International Clinical Trials Registry Platform (ICTRP)
The WHO International Clinical Trials Registry Platform (ICTRP), initiated in 2000 and operated by the World Health Organization, is a search portal and aggregation platform over a network of independently operated national and regional 'primary registries' -- it is not itself a registry that a trial registers with directly. Each primary registry (ClinicalTrials.gov, the EU's CTIS, ISRCTN, ANZCTR, CTRI, ChiCTR, DRKS, JPRN, and others) independently meets WHO's registry-quality criteria and sends regular data feeds to ICTRP, which pools records into a single global, searchable database. A trial is registered once, with one primary registry, and becomes automatically discoverable through ICTRP's search portal.
eduGAIN
eduGAIN is an interfederation service, operated by GÉANT, that interconnects independently operated national and regional research-and-education identity federations (such as InCommon in the United States, the UK federation, and their counterparts in dozens of other countries) under a common technical and policy framework. It does not issue identities or authenticate users directly -- it lets a service provider that trusts its own national federation extend that trust to users from any other eduGAIN-connected federation, and vice versa, without negotiating bilateral trust agreements one federation at a time.
Publons
Publons was a researcher-facing web platform, launched in 2012, that let researchers log, verify, and get credit for peer review and editorial work performed for academic journals, building a portable reviewer history and profile. Clarivate acquired Publons in 2017 and progressively integrated it with Web of Science; Clarivate retired Publons as a separate destination in 2022, migrating existing profiles and their verified review history into the native Web of Science Researcher Profile. Publons is a retired, absorbed product, not a currently operating independent service -- content and guidance referring to 'signing up for Publons' or maintaining a separate Publons profile describes a discontinued workflow.
Funnel Plot
A funnel plot is a scatter plot used in meta-analysis in which each included study's effect estimate (x-axis) is plotted against a measure of its precision -- typically standard error, with precision increasing up the y-axis, or sometimes sample size directly. Under no bias and no meaningful heterogeneity, the plot should form a roughly symmetric, inverted funnel: small, low-precision studies scatter widely near the bottom, while large, high-precision studies cluster narrowly near the top, close to the pooled effect. Funnel plots are a diagnostic tool for so-called 'small-study effects' -- the tendency for smaller studies in a meta-analysis to report systematically different (usually larger) effects than larger studies -- not a direct measurement of publication bias itself.
JOSS (Journal of Open Source Software)
JOSS is a peer-reviewed, diamond open-access academic journal, founded in 2016 under the Open Journals umbrella, that publishes short papers (roughly 750-1750 words) about research software rather than the software itself. Acceptance requires an OSI-approved open-source licence, substantial and feature-complete engineering work, adequate documentation and tests, and a version-specific DOI from an archiving service (e.g. Zenodo or figshare) obtained after review; accepted papers receive their own Crossref DOI.
ORCID Member API
The ORCID Member API is the paid, OAuth-scoped tier of ORCID's API, available only to organizations holding ORCID membership, which lets a trusted party (an institution, publisher, funder, or recognition service the researcher has authorized) read and write specific sections of a researcher's ORCID record on the researcher's behalf. It is distinguished from the free Public API by write access and by the trusted-party permission model: the researcher grants scoped authorization and the member organization acts only within that scope. An integration that merely reads public ORCID data does not require the Member API.
Problematic Paper Screener (PPS)
A free, public automated screening website, built and maintained by Guillaume Cabanac with Cyril Labbé and Alexander Magazinov, that flags candidate papers exhibiting tortured phrases, computer-generated text (SCIgen/Mathgen), or heavy reliance on retracted references ('Feet of Clay'), posting the results to PubPeer for human review rather than issuing findings itself.
Citation File Format (CITATION.cff)
A CITATION.cff file is a plain-text, YAML-formatted metadata file, conforming to the Citation File Format schema, placed in the root of a code (or dataset) repository to record machine- and human-readable citation information -- authors (ideally with ORCID iDs), title, version, release date, identifiers such as a DOI, and licence -- so tools and humans can produce a correct, consistent citation without guesswork.
NIH AI Policy
NIH AI policy is not one document but three separate NIH Guide notices, each governing a different actor at a different stage of the grant lifecycle: NOT-OD-23-149 (June 2023) prohibits NIH scientific peer reviewers from using generative AI tools to analyze applications or draft critiques, on confidentiality grounds; NOT-OD-25-132 (July 2025) tells applicants that NIH will not treat an application substantially developed by AI as an original idea, and caps any PI to six new/renewal/resubmission/revision applications per calendar year; and a May 2026 Extramural Nexus notice extends the standard federal research-misconduct definition (fabrication, falsification, plagiarism) to AI-related lapses in the conduct and reporting of already-funded research. Which rule applies to a given situation depends on which lifecycle stage - review, application, or funded-research conduct - it falls into.
Sale-Leaseback (Equipment)
An equipment sale-leaseback is a two-part transaction, executed together, in which an institution that already owns a piece of equipment (1) sells it to a buyer-lessor at fair market value and (2) immediately leases the same equipment back for continued operational use. It qualifies as a distinct instance of this concept only when both legs occur as part of the same arrangement and the seller retains uninterrupted physical use of the asset; a disposal followed by acquiring different, replacement equipment is not a sale-leaseback, and a loan collateralized by owned equipment (with no transfer of title) is not a sale-leaseback either.
Ancillary Materials in Cell Therapy Manufacturing
A raw material used during the manufacture of a cell, gene, or tissue-engineered product that contacts the cells or construct during processing but is not intended to remain in the final product administered to the patient (e.g., growth factors, cytokines, enzymes, selection reagents, culture media additives) -- as distinct from a 'component,' which is a raw material deliberately carried through into the finished product. Qualification rigor is risk-tiered per USP General Chapter <1043>, based on the material's existing quality pedigree (cGMP manufacturing history, prior regulatory approval) versus weaker documentation such as research-use-only labeling.
Temperature Monitoring Alarm
A temperature monitoring alarm is the notification component of a temperature monitoring system: the function that detects a monitored storage condition moving outside its defined safe range and actively alerts a responsible person, rather than simply recording the excursion for later review. A monitoring setup only has a functioning alarm -- as distinct from a data logger that merely stores readings -- when three things are true together: (1) a defined threshold (high, low, or both, and often a duration threshold to filter brief door-opening events from real excursions) triggers the notification automatically, without a person having to check a screen or download a log; (2) the notification reaches a specific accountable person or on-call rotation through a channel independent of a single point of failure, typically an escalation sequence -- local audible/visual alarm, then app push or email, then SMS or automated phone call, then a secondary contact or central monitoring station if the first contact does not acknowledge within a defined window; and (3) the alarm's own function (power supply, connectivity, and trigger logic) is itself periodically tested and that testing is documented, since an alarm that has never been verified to actually fire is not meaningfully different from having no alarm.
21 CFR Part 11 Temperature Monitoring
A temperature-monitoring system (freezer, refrigerator, incubator, or cold-room monitor) is accurately called "21 CFR Part 11 compliant" only when its electronic records -- and any electronic signatures applied to them -- meet 21 CFR Part 11 Subpart B/C requirements as actually configured, validated, and used at a specific site: a secure audit trail, unique attributable user accounts, documented system validation (IQ/OQ/PQ), retrievable retention, access controls, and (if used) compliant electronic signatures. It is a property of site-level configuration and validation, not a certificate a vendor sells.
Thermal Cycler Specifications
Thermal cycler specifications are the documented set of performance parameters — block format and sample capacity, ramp rate, temperature accuracy and uniformity, gradient range, lid control, and connectivity/data-logging features — that a manufacturer publishes for a PCR instrument and that a buyer uses to compare models against a specific assay's requirements. In a procurement context, a spec sheet is not a marketing document to skim; it is the primary evidence a lab manager or procurement officer can hold a vendor to, and it is what should be cross-checked against method validation records, accreditation requirements, and service contracts before an order is placed. A thermal cycler that is technically capable of amplifying DNA does not necessarily meet the documented performance a regulated or accredited lab needs for a specific application — that gap is exactly what a specifications comparison is meant to close.
Scientific Data Management System (SDMS)
A scientific data management system (SDMS) is laboratory software that automatically captures, indexes, and archives electronic data files generated by lab instruments (chromatography, spectroscopy, balances, plate readers, raw instrument logs) in their original native format, and makes that archive centrally searchable, version-controlled, and audit-trail-protected. It is distinguished operationally from a shared drive or manual file store by automated unattended capture direct from the instrument, metadata extraction that makes files findable without opening each one, and a tamper-evident audit trail logging every access, export, or modification attempt. An SDMS is the raw-data archive layer beneath a LIMS (sample/workflow/results management) and an ELN (experimental narrative record), and typically integrates with one or both rather than replacing either.
True Lease vs. Finance Lease
A true lease (an operating lease under ASC 842) is an equipment lease where the lessor retains ownership for tax purposes, claims depreciation, and bears residual-value risk; the lessee simply expenses rental payments and, if there is a purchase option, it is priced at genuine fair market value. A finance lease (formerly called a capital lease under ASC 840) transfers substantially all the economic risks and benefits of ownership to the lessee -- via a bargain purchase option, a lease term covering most of the asset's useful life, payments approximating the asset's fair value, or a specialized asset with no alternative use -- so the lessee is treated as the owner for accounting and typically tax purposes, capitalizing the asset and recording depreciation and interest expense instead of rent.
Veterinary Cytology
Veterinary cytology is the diagnostic technique of collecting, preparing, staining, and microscopically examining individual cells (rather than intact tissue architecture, as in histopathology) obtained from an animal by fine-needle aspiration, impression smear, scraping, swab, or body-fluid sampling, in order to characterize a lesion, mass, effusion, or organ as inflammatory, infectious, hyperplastic, or neoplastic — and, for neoplastic samples, to assess features consistent with malignancy. A sample or workflow counts as veterinary cytology, in the operational sense used here, when it involves: (1) a minimally invasive collection method that disaggregates or exfoliates cells rather than removing an intact tissue block; (2) a rapid stain (commonly a Romanowsky-type stain such as Diff-Quik, Wright-Giemsa, or new methylene blue for fluids) applied to an air-dried or fixed smear; and (3) microscopic interpretation — performed in-house by a trained veterinarian or veterinary technician, or referred to a board-certified veterinary clinical pathologist (Diplomate, American College of Veterinary Pathologists, ACVP-Clinical Pathology) — that produces a cytologic diagnosis or descriptive report distinct from a surgical histopathology report. Procurement and lab-management decisions in this category generally split into two connected questions: what in-house capability (microscope, stains, slide-prep supplies, staff training) a practice or diagnostic lab maintains for first-pass or triage interpretation, and which reference laboratory or telecytology service it uses for definitive, board-certified review — most practices use both, routing straightforward or urgent cases in-house and referring diagnostically challenging, potentially malignant, or medicolegally significant samples out.
ELAP Certification (Environmental Laboratory Accreditation Program)
A laboratory holds ELAP certification when California's State Water Resources Control Board (Division of Drinking Water) has accredited it for specific matrix/analyte/method combinations, called "fields of accreditation," allowing it to perform environmental testing whose results can be used to satisfy California regulatory compliance reporting. Certification is field-specific rather than a single blanket credential, and it requires ongoing proficiency testing participation plus a documented quality management system consistent with the TNI Standard.
What Is A2LA? American Association for Laboratory Accreditation Explained
A2LA (American Association for Laboratory Accreditation) is a US-based, nonprofit, third-party accreditation body, founded in 1978, that formally recognizes a testing/calibration laboratory, medical laboratory, inspection body, biobank, or certification body meets the requirements of a specific ISO/IEC conformity-assessment standard (e.g. ISO/IEC 17025 for testing and calibration labs, ISO 15189 for medical labs, ISO 20387 for biobanks). A2LA does not itself test or certify products; it audits and accredits the bodies that do, and is a signatory to the international mutual-recognition arrangements consolidated under Global Accreditation Cooperation Incorporated (Global ACI), which brought ILAC and IAF together on 1 January 2026; accreditations issued under the former ILAC MRA and IAF MLA remain recognised.
Tier II Reporting Software
Tier II reporting software is compliance software purpose-built to compile a facility's hazardous chemical inventory into the data fields, threshold calculations, and submission format required under EPCRA Section 312 (40 CFR Part 370), and to generate or submit the annual Emergency and Hazardous Chemical Inventory ("Tier II") report to the State Emergency Response Commission (SERC), Local Emergency Planning Committee (LEPC), and local fire department. To qualify, a tool must apply EPCRA's threshold-planning-quantity logic (not just list inventory) and output in a format the recipient agency accepts, such as EPA's Tier2 Submit schema or a state's electronic portal.
Colilert
Colilert is a defined-substrate technology (DST) reagent, manufactured by IDEXX Laboratories, used to simultaneously detect and enumerate total coliform bacteria and Escherichia coli (E. coli) in a single water sample. A test is correctly described as 'Colilert' only when it uses IDEXX's proprietary ONPG/MUG nutrient-indicator reagent, incubated per the manufacturer's protocol (24 hours for Colilert, 18 hours for the Colilert-18 variant) and read for color change (yellow indicates total coliform presence) and fluorescence under 365 nm UV light (indicates E. coli presence). Quantification requires pairing the reagent with IDEXX's Quanti-Tray or Quanti-Tray/2000 sealing system to produce a Most Probable Number (MPN) result per 100 mL. The method is standardized as Standard Methods 9223B (Enzyme Substrate Coliform Test) and is included on the U.S. EPA's list of approved analytical methods for Safe Drinking Water Act compliance monitoring under 40 CFR Part 141.
Types of Equipment Leases
An equipment lease type is defined by two independent things: (1) the commercial end-of-term structure the vendor or leasing company offers -- fair market value (FMV), $1 buyout, 10% option, or Terminal Rental Adjustment Clause (TRAC) -- which determines whether and how the lessee can own the equipment when the term ends and how monthly payments are set; and (2) the ASC 842 accounting classification of that lease as a finance lease or an operating lease, which determines balance-sheet and income-statement treatment rather than end-of-term ownership. A lease is not fully specified by the word "lease" alone -- comparing two lease offers requires knowing both of these dimensions.
TRAC Lease (Terminal Rental Adjustment Clause)
A TRAC lease is a motor-vehicle lease governed by IRC Section 7701(h)'s terminal rental adjustment clause exception: the lessee guarantees the vehicle's end-of-term residual value and pays (or is credited) the difference between that guaranteed figure and the vehicle's actual value when the lease ends, while the lease still qualifies as a true lease for tax purposes rather than being recharacterized as a financed purchase. It applies specifically to motor vehicles and trailers, not general lab or clinical equipment, and sits alongside fair market value (FMV) leases and dollar buyout leases as one of the standard vehicle-lease structures procurement and fleet teams compare.
Scale vs Balance
A scale is a general-purpose weighing instrument (commonly strain-gauge based) optimized for capacity and ruggedness with coarser readability, while a balance is a precision weighing instrument (traditionally comparative, now typically electromagnetic force restoration) optimized for fine resolution -- down to 0.1 mg or better -- under controlled, draft-free conditions; procurement should be driven by the required readability/minimum sample weight, applicable regulatory framework (NTEP/Handbook 44 for legal-for-trade, OIML R76 accuracy class, USP <41> for pharmacopeial work), and calibration traceability, not by marketing language alone.
What Is ANAB? ANSI National Accreditation Board Explained
ANAB (the ANSI National Accreditation Board) is a US laboratory and certification-body accreditation organization, operated as a subsidiary of ANSI, that formally recognizes a testing/calibration laboratory, medical laboratory, inspection body, biobank, or certification body meets the requirements of a specific ISO/IEC conformity-assessment standard (e.g. ISO/IEC 17025 for testing and calibration labs, ISO 15189 for medical labs, ISO 20387 for biobanks). ANAB does not itself test or certify products; it audits and accredits the bodies that do, and is a signatory to the international mutual-recognition arrangements consolidated under Global Accreditation Cooperation Incorporated (Global ACI), which brought ILAC and IAF together on 1 January 2026; accreditations issued under the former ILAC MRA and IAF MLA remain recognised.
Xeno-Free Media
Xeno-free (XF) media is cell-culture medium formulated to contain no components derived from a species other than the one being cultured, used to eliminate the risk of xenogeneic contamination (viral, prion, and immunogenic non-human antigens) that comes with animal-derived supplements like fetal bovine serum. A product qualifies as xeno-free specifically when every raw material's species of origin has been checked against the cell type being grown -- human-derived components (e.g., human platelet lysate, human serum albumin) are permitted in xeno-free media intended for human cell culture, which is what distinguishes it from the stricter 'animal-component-free' (ACF) or 'animal-origin-free' (AOF) designation, where no animal-derived material of any species, including human, is used at all.
Unique Molecular Identifiers (UMIs)
Short, random or semi-random nucleotide sequences (typically 6-12 base pairs) added to individual DNA or RNA fragments during next-generation sequencing (NGS) library preparation, before PCR amplification, so that reads descended from the same original molecule can be identified and collapsed into a single consensus read.
Cryo-EM Microscope
A cryo-EM microscope is a transmission electron microscope purpose-built or fitted with an integrated cryogenic specimen workflow -- a cryo-transfer/autoloader system, a stable cryo-stage held below devitrification temperature, a field emission electron source, and (for modern structural-biology use) a direct electron detector and usually an energy filter -- so vitrified biological specimens can be imaged in a near-native, non-crystalline-ice state at near-atomic to atomic resolution. It depends on, but does not itself perform, upstream vitrification (plunge-freezing) of the specimen.
SEFA 8 (Laboratory Fume Hoods Recommended Practice)
SEFA 8 is the Laboratory Fume Hoods Recommended Practice published by the Scientific Equipment and Furniture Association (SEFA), setting construction requirements and tracer-gas containment/face-velocity test protocols (As-Manufactured, As-Installed, As-Used) that laboratory fume hood procurement specifications cite to verify vendor performance claims.
PhiX Control
PhiX control (PhiX Control v3) is an adapter-ligated sequencing library derived from the bacteriophage PhiX174 genome, spiked into Illumina NGS runs at a defined percentage to calibrate base-calling and error-rate metrics, and, at higher spike-in levels, to supply base-composition diversity that low-diversity libraries (e.g., amplicon panels, ChIP-seq, bisulfite sequencing) lack for reliable cluster calling and index demultiplexing.
Single-Use Assemblies (SUAs)
A single-use assembly (SUA) is a pre-fabricated, pre-sterilized fluid-path component -- typically some combination of flexible tubing, bags, connectors, filters, and sensors -- manufactured, irradiated, and supplied ready to install into a bioprocess for exactly one production run before being discarded rather than cleaned and reused. What separates an SUA from ordinary disposable plasticware is that it is qualified as a controlled process component: it comes with sterilization-validation and, for GMP or GMP-adjacent use, extractables-and-leachables documentation, rather than being purchased as a generic consumable on a certificate of conformance alone.
Chemically Defined Media (CDM)
Chemically defined media (CDM) is a cell-culture growth medium in which every component -- salts, amino acids, vitamins, lipids, and any protein supplements -- is a known, individually specified chemical entity added at a documented concentration, with no undefined biological components such as serum, hydrolysates, or tissue extracts. A formulation qualifies as CDM only when its full composition is disclosed and quantified, protein supplements (if present) are purified/recombinant and identified by expression source, and no ingredient is an undefined animal- or plant-derived mixture -- a medium that is merely 'serum-free' does not automatically meet this bar if it still contains an undefined hydrolysate or extract.
Chemical Safety Software
Chemical safety software is a category of purchased or subscribed platforms that help a lab, facility, or manufacturer manage the compliance obligations that come with owning, using, or producing hazardous chemicals. In procurement terms, a product qualifies as chemical safety software if it automates at least one of these core workflows: safety data sheet (SDS) management (collecting, indexing, and making supplier SDSs searchable at the point of use), GHS-compliant labeling (generating secondary-container and workplace labels with the correct pictograms, signal words, and hazard statements under 29 CFR 1910.1200 or the EU CLP Regulation), chemical inventory tracking (quantities, locations, and container-level data tied to a chemical's CAS number), exposure and risk assessment (flagging incompatible storage, threshold quantities, or reactive combinations), and regulatory reporting (EPA EPCRA Tier II / Form R, state fire-code chemical inventories, or waste manifests). A single-purpose spreadsheet or a manual paper SDS binder does not meet this definition even though it stores some of the same information — the defining feature of the category is automated compliance workflow, not just data storage. Buyers evaluating this category should distinguish it from two narrower, adjacent purchases it often gets bundled or confused with: a chemical inventory management system, which focuses specifically on tracking what chemicals exist, in what quantity, and where; and SDS authoring software, which generates new, regulator-compliant SDSs for chemicals an organization manufactures or reformulates under its own label, rather than managing SDSs received from suppliers. Many commercial chemical safety platforms bundle inventory tracking, SDS management, and labeling into one subscription; others are sold as separate modules. Neither is inherently the correct scope — the right purchase depends on which specific compliance obligations (OSHA HazCom, EPCRA reporting, fire-code inventory limits, internal EHS audit requirements) a facility actually has to meet.
Glove Compatibility Chart
A glove compatibility chart is a reference table, published by a glove manufacturer, distributor, or standards body, rating a specific glove product's resistance to specific named chemicals, typically as a breakthrough-time-based class (ANSI/ISEA 105's 0-6 scale, or an EN ISO 374 Type A/B/C letter code) derived from ASTM F739 or EN 16523-1 permeation testing. A table only qualifies as compatibility-grade data if it ties a named test method to a specific product, a specific chemical (not a category), and a time-based rating rather than a plain yes/no label; procurement and EHS teams use it, alongside Section 8 of the relevant Safety Data Sheet, as the documented basis for specifying which glove is fit for a given task.
NELAC (National Environmental Laboratory Accreditation Conference)
NELAC (National Environmental Laboratory Accreditation Conference) was the multi-state, EPA-supported effort that created the original national standard for accrediting environmental testing laboratories, replacing separate state-by-state certification schemes. The standard is now governed by The NELAC Institute (TNI) and implemented through the National Environmental Laboratory Accreditation Program (NELAP), under which recognized state and other Accreditation Bodies grant scoped accreditation -- specific to matrix, analyte, and test method -- to individual labs. In field usage, 'NELAC accreditation' commonly means current NELAP accreditation to the TNI Standard.
Fetal Bovine Serum (FBS)
Fetal bovine serum (FBS), also called fetal calf serum (FCS), is the liquid fraction of blood collected from bovine fetuses at slaughter, clarified and filtered for use as a growth-supporting supplement added to basal cell-culture media (typically 5-10% of final volume). It qualifies as FBS specifically when the source animal is a bovine fetus, distinguishing it from newborn calf serum (collected postnatally) and adult bovine serum (collected from mature cattle) -- both related but compositionally and functionally distinct products.
Eyewash Station
An eyewash station is emergency safety equipment that delivers a controlled, hands-free stream of flushing fluid to a person's eyes (or eyes and face) to remove a hazardous substance following an accidental exposure. In U.S. laboratory and facility procurement, "eyewash station" means specifically equipment designed and installed to meet ANSI/ISEA Z358.1, the voluntary consensus standard OSHA cites as the benchmark for the general duty created by 29 CFR 1910.151(c) to provide "suitable facilities for quick drenching or flushing of the eyes and body." A device only counts as an eyewash station in this operational sense if it can deliver flushing fluid to both eyes simultaneously, hands-free, for a continuous 15-minute minimum, at a minimum flow rate of 0.4 gallons per minute (eyewash-only) or 3.0 gpm (eye/face wash) in the tepid 60-100°F (16-38°C) range Z358.1 specifies — a first-aid-kit eye-flush bottle or a sink does not meet this definition even though it can rinse an eye.
Nitrile Glove Sizing: Chart, Fit, and Facility Size-Mix
Nitrile glove sizing is the mapping between a glove's dimensional designation (XS through XXL) and hand-circumference measurements, used both to fit an individual wearer and, for institutional buyers, to translate a facility's hand-size distribution into a purchase-order size split. Because ASTM D6319 and its counterpart exam-glove standards set performance requirements rather than a mandatory dimensional band per size label, the same size letter can differ measurably between manufacturers.
Nitrile Glove Thickness (Mil)
Nitrile glove thickness in mils measures the gauge of the glove material -- one mil equals 0.001 inch (0.0254 mm) -- and is reported per point on the glove (fingertip, palm, cuff) because dipped-glove manufacturing, the standard nitrile exam-glove process under ASTM D6319, produces uneven thickness across a single glove. Within a given material, higher mil thickness generally increases puncture resistance and permeation breakthrough time, and decreases tactile sensitivity and increases hand fatigue. It is a secondary variable within a material choice, not a stand-alone chemical-protection rating: material compatibility with the specific chemical in use governs whether a glove protects against it at all.
Procurement Card (P-Card)
A procurement card (P-card, used interchangeably with 'purchasing card') is a commercial charge or credit card an institution issues to a named individual for direct, point-of-sale purchases within defined transaction and monthly limits, reconciled centrally against the institution's own accounts after the fact rather than approved through a purchase order beforehand. To qualify: the card must be tied to the institution's own commercial card program (not personal credit used for later reimbursement); the purchase must occur directly at point of sale, not via a purchase order or punchout catalog; and institutional limits plus post-purchase reconciliation, not pre-purchase approval, are the control mechanism.
Central Stores
A centralized institutional department -- part of a university's or hospital's supply chain, procurement, or facilities organization -- that receives, inspects, warehouses, and internally distributes commonly used supplies, chemicals, and equipment to the labs and departments it serves, instead of each unit receiving and stocking its own shipments independently. Central stores sits downstream of purchasing: it governs how an already-ordered item physically arrives and gets stocked/distributed, not which vendor or price it was bought at.
Simplified Acquisition Threshold (SAT)
The simplified acquisition threshold (SAT) is the dollar ceiling, set in FAR 2.101 and cross-referenced by 2 CFR 200.1 for federal grant recipients, up to which a buyer may use streamlined, informal purchasing procedures instead of formal sealed bidding or a competitive request-for-proposals process. A purchase counts as falling under the SAT when its total anticipated value -- not a single invoice or line item, but the full requirement, since the FAR and 2 CFR 200 both prohibit splitting a purchase into smaller pieces to stay under a threshold -- is above the micro-purchase threshold but at or below the current SAT figure. Cross the SAT and the buyer must switch to formal procurement methods (sealed bidding under FAR Part 14, or competitive proposals under FAR Part 15 for direct federal contracts; sealed bids or competitive proposals under 2 CFR 200.320(b) for non-federal entities spending federal award funds), plus additional documentation obligations such as an independent cost estimate and, for construction, bonding.
GPO Administrative Fee
A GPO administrative fee is the percentage-based payment a vendor makes to a group purchasing organization (GPO), tied to the volume of purchases its member institutions make under that vendor's GPO contract, which the GPO retains to fund its own contracting and member-services operations rather than billing members a direct fee. The payment runs vendor-to-GPO, not buyer-to-GPO, and is what distinguishes this arrangement, for Anti-Kickback Statute purposes, from a direct vendor discount to a buyer.
What Is a DICOM Conformance Statement?
A DICOM conformance statement is a vendor-published document, structured per DICOM PS3.2 (Conformance), that specifies exactly which SOP (Service-Object Pair) classes a medical-imaging device or software supports and in which network role (SCU or SCP), which transfer syntaxes it can send or receive, which network and media-storage services it offers, and any vendor-specific extensions or restrictions. A document counts as a real conformance statement only if it specifies this level of protocol detail; a marketing claim of 'DICOM compliant' with no published SOP-class/transfer-syntax detail does not meet the bar, because it gives a buyer no way to verify whether two specific devices will actually interoperate.
ECCN (Export Control Classification Number)
An Export Control Classification Number (ECCN) is a five-character alphanumeric code assigned to an item, software package, or technology when it matches a specific entry on the US Commerce Control List (CCL) under the Export Administration Regulations (EAR, 15 CFR Parts 730-774), administered by the Department of Commerce Bureau of Industry and Security (BIS). The code format is: one digit (0-9) for product category, one letter (A-E) for product group, and three digits identifying the specific CCL entry and reason(s) for control. Items subject to the EAR that match no CCL entry are not assigned an ECCN; they are designated EAR99 instead.
CGA Pamphlet P-1
CGA Pamphlet P-1 (Safe Handling of Compressed Gases in Containers) is the Compressed Gas Association's industry consensus standard covering the in-plant handling, storage, and use of compressed gas cylinders, portable tanks, and similar containers. It is incorporated by reference into US federal law at 29 CFR 1910.101(b), OSHA's general industry rule for compressed gases, which states that 'the in-plant handling, storage, and utilization of all compressed gases in cylinders, portable tanks, rail tankcars, or motor vehicle cargo tanks shall be in accordance with Compressed Gas Association Pamphlet P-1-1965.' A lab, hospital, or industrial site is operating 'under CGA P-1' whenever its cylinder-securing, storage-segregation, and handling practices trace back to this pamphlet's requirements, whether an EHS policy cites the pamphlet by name or simply cites the OSHA regulation that incorporates it. Because OSHA's text still names the 1965 edition specifically, facilities should treat that citation as the enforceable floor and CGA's more recent revisions (the association updates its pamphlets periodically, as it does across its full P-, C-, V-, and S-series) as current good-practice guidance layered on top.
CGA Fittings
A CGA fitting is the standardized valve outlet/regulator inlet connection, identified by a CGA (Compressed Gas Association) three-digit number under CGA V-1 / ANSI B57.1, that is matched to a specific gas or group of compatible gases so that a regulator built for one gas cannot readily be connected to an incompatible one. It answers 'will this regulator connect to this cylinder,' a separate question from the gas identity or the cylinder size.
USP Class VI Certification
USP Class VI certification is a designation that a specific plastic material or component has passed the most stringent tier of biological reactivity testing under United States Pharmacopeia (USP) General Chapter <88>, "Biological Reactivity Tests, In Vivo." Chapter <88> defines six plastic classes (I through VI) based on which combination of three in-vivo bioassays -- systemic (acute) toxicity injection, intracutaneous reactivity, and implantation -- a material passes, and at what extraction rigor. A material reaches Class VI, the highest of the six classes, only when it passes all three bioassays using extracts prepared at the most demanding temperature/duration condition the material can withstand without degrading. Certification is specific to a tested formulation and manufacturing process, not a general property of a polymer family: it is not automatically inherited by variants, colorants, regrind blends, or downstream-sterilized versions of the same base resin, and passing Class VI does not by itself satisfy the broader ISO 10993 biocompatibility program most finished medical devices require.
Type I Borosilicate Glass
Type I borosilicate glass is a pharmaceutical primary-packaging glass classified under USP General Chapter <660>, Containers—Glass, as meeting the highest hydrolytic-resistance category through borosilicate composition and a passing result on the chapter's powdered glass test. A glass lot or container qualifies for the 'USP Type I' designation only once tested and documented under this method — borosilicate composition is necessary but not sufficient on its own; the designation follows from a specific tested result, not from raw material alone. It is distinct from the general-purpose term 'borosilicate glass' used for laboratory apparatus under ASTM E438, a different standard that covers non-pharmaceutical labware such as beakers and flasks.
Biospecimen
A biospecimen is a biological material — such as blood, tissue, urine, saliva, or a derived product like extracted DNA/RNA, plasma, or a cell line — that has been collected from a human or other living source and preserved under a documented chain of custody for use in research, clinical testing, or long-term storage in a biorepository or biobank. What distinguishes a biospecimen from a routine clinical sample is retention beyond the point of care: it is collected, labeled, and stored specifically so that it (or data derived from it) can be used again, often by someone other than the original collector, under a defined protocol and consent framework.
EAR99 Classification
EAR99 is the residual classification for an item, software, or technology that is subject to the US Export Administration Regulations (EAR, 15 CFR 730-774) but matches no specific Export Control Classification Number (ECCN) entry on the Commerce Control List (CCL). It is reached by elimination -- comparing an item's technical parameters against the CCL's Order of Review (15 CFR 774, Supplement No. 4) and finding no match -- not selected directly. Most EAR99 items may be exported to most destinations and end users without an individual license (No License Required, NLR status), but the EAR's General Prohibitions still apply: restricted-party screening (Denied Persons List, Entity List, Unverified List, OFAC SDN list), comprehensively embargoed/sanctioned destinations, and prohibited end-uses or end-users under 15 CFR Part 744 (including the Military End-User rule) can all still require a license for an EAR99 item.
Vendor Neutral Archive (VNA)
A vendor neutral archive (VNA) is a medical-imaging storage architecture that ingests, indexes and stores diagnostic images and related clinical content in standard formats (typically DICOM for images, non-DICOM objects via XDS-style wrapping) with vendor-agnostic access interfaces, so the archive is decoupled from any single PACS (Picture Archiving and Communication System) vendor's proprietary database. A storage system counts as a true VNA only if a hospital or health system could, in principle, replace its front-end PACS/viewer without a forced, costly data-migration project — normalization of incoming studies to a consistent format, standards-based query/retrieve (DICOM Query/Retrieve, IHE XDS-I.b, HL7/FHIR for metadata), and no lock-in to a single vendor's schema are the defining tests, not simply 'a central image store.'
What Is a Radiology Information System (RIS)?
A radiology information system (RIS) is the software that manages a radiology or imaging department's operational workflow around an exam — patient scheduling and registration, order/accession tracking from request through signed report, radiologist reporting and dictation, results distribution, procedure-based billing/coding, and departmental resource management — as distinct from a PACS, which stores and displays the diagnostic images themselves, and from a hospital's general EHR/HIS, which holds the full patient record across every department, not just imaging.
cGMP Facility
A cGMP facility is a drug, biologic, device, or API manufacturing site that meets FDA's current Good Manufacturing Practice regulations (21 CFR Parts 210/211 for drugs; Part 600-series provisions for biologics; Part 820/QMSR for devices; ICH Q7 for APIs) through qualified facilities and equipment (IQ/OQ/PQ), an independent quality unit, documented and followed procedures, trained personnel, and demonstrated process validation. cGMP status is verified through FDA registration, listing, and inspection — FDA does not issue a one-time 'cGMP certificate.'
ANSI/AIHA Z9.5 (Laboratory Ventilation)
ANSI/AIHA Z9.5 ("Laboratory Ventilation") is the American National Standards Institute-approved consensus standard, developed and maintained by AIHA (the American Industrial Hygiene Association), that specifies engineering and performance criteria for laboratory ventilation systems, including general room air-change rates, fume hood design and containment performance, and the recurring testing needed to verify a hood or ventilation system still performs as designed. It is periodically revised by an AIHA-accredited standards committee, with the most recent edition dated 2022; the core testing benchmarks below have held stable across recent revisions. A laboratory or ventilation system is operating "to Z9.5" when it meets both the initial design/commissioning criteria in the standard and the ongoing routine-testing schedule it sets out.
GMP Facility
A GMP facility is a manufacturing, packaging, testing, storage, or distribution site that is designed, qualified, and operated to meet Good Manufacturing Practice requirements applicable to its product type (21 CFR Part 211 for finished drugs, ICH Q7 for APIs, 21 CFR Part 820/QMSR for devices, or equivalent EU/international GMP regulation) -- demonstrated through a documented quality system (qualified premises via IQ/OQ/PQ, environmental controls, batch records, CAPA, calibrated equipment, trained personnel) that a regulatory authority can inspect and hold the site to, rather than a self-declared or purely physical description of the space.
Compressed Gas Cylinder Sizes
A compressed gas cylinder size designation is the alphanumeric code (for example lecture bottle, size 150, size 200, size 300, or letter codes such as D, K, Q, and T) that gas suppliers use to describe a cylinder's physical dimensions (diameter and height), water capacity, and the resulting volume of gas it delivers at a given fill pressure. Labs use the designation, not the raw dimensions, to specify what to order because it determines storage footprint, how it fits in a gas cabinet or cylinder rack, how often it needs to be swapped or refilled at a given consumption rate, and which regulator and CGA fitting it takes.
CLIA-Waived Test
A CLIA-waived test is a laboratory test the FDA has determined is simple and accurate enough to perform under a CLIA Certificate of Waiver -- 42 CFR 493.15's criteria are that the methodology is "so simple and accurate as to render the likelihood of erroneous results negligible" and poses no reasonable risk of harm if performed incorrectly. Waived status attaches to a specific FDA-cleared test system, not to a facility or a general category of testing; a facility can hold waived and non-waived tests side by side depending on which certificate(s) it holds.
ACT Label (ACT Ecolabel)
The ACT Label (ACT Ecolabel) is a product-level sustainability rating for laboratory equipment and consumables, administered by My Green Lab and independently validated by its third-party partner Verico. A product carries a genuine ACT Label only when it has a listed, verified entry in My Green Lab's ACT database with a weighted score out of 100 across categories such as energy use, materials, chemical hazards, and end-of-life impact — a manufacturer's own 'eco-friendly' marketing claim, without that database listing, does not qualify.
Purchasing Cooperative
A purchasing cooperative is a membership-based arrangement in which two or more independent organizations — typically public entities such as states, municipalities, school districts, public universities, or hospital systems — pool their buying volume and jointly use a single, competitively solicited contract, so that any member can purchase against it directly instead of running its own bid or RFP for the same goods or services. Membership is usually formal (a signed participation or membership agreement) and the lead contract is awarded through one member's or one cooperative's own competitive solicitation process, which is what lets other members 'piggyback' on it and still satisfy their own competitive-procurement requirements.
Specific Pathogen-Free (SPF) Mice
A colony or shipment of mice qualifies as specific pathogen-free (SPF) when it is bred and housed in a barrier facility and is documented, through a formal, periodic health-monitoring program, to be free of a defined list of excluded microorganisms and parasites (the 'exclusion list' or 'agent panel'). SPF is a relative, list-bound status, not a claim of total sterility: two colonies can both be validly called SPF while being screened against different panels, so the operative question for procurement and research use is always 'SPF with respect to which agent list, tested how recently, and by whom' rather than a single universal standard.
Gnotobiotic Mice
A mouse (or other laboratory animal) is gnotobiotic when its microbial status is completely known and controlled, rather than merely reduced or partially defined. This is a stricter standard than "clean": a gnotobiotic mouse is either (a) germ-free (axenic) — free of all detectable bacteria, fungi, viruses, and parasites — or (b) deliberately colonized with a specific, fully characterized set of microorganisms (the animal's defined "gnotobiote" community), with no other organisms present. The term comes from the Greek gnotos (known) plus bios (life) — literally "known life." Operationally, an animal only qualifies as gnotobiotic if all three of the following hold: it was derived by a method that excludes environmental microbial contamination (aseptic hysterectomy/hysterotomy or embryo transfer into a germ-free foster dam, followed by hand-rearing in isolation); it is housed for its entire life in a gnotobiotic isolator — a sealed, HEPA-filtered, positive- or negative-pressure enclosure with sterilized food, water, bedding, and air supply, entered only through a sterilizable transfer port or dunk tank; and its microbial status is periodically verified by culture-based and molecular (e.g., 16S rRNA sequencing, PCR) monitoring to confirm no unintended organisms have been introduced.
Emergency Unblinding
Emergency unblinding (an emergency code-break) is the procedure by which a blinded clinical trial participant's individual treatment assignment is disclosed to their treating investigator or a qualified sub-investigator during an acute medical event, so clinical management is not compromised by not knowing whether the participant received active study drug, an active comparator, or placebo. It is authorized in advance by the protocol and, typically, an IRT (Interactive Response Technology) system's standard operating procedure -- the treating clinician does not need real-time sponsor approval to act, consistent with ICH E6(R2)'s principle that participant safety takes precedence over maintaining the blind. It is a single-participant, investigator-level safety procedure, distinct from the aggregate, by-arm unblinding a Data Safety Monitoring Board (DSMB) performs for a scheduled interim trial-level review.
Shut the Sash
A behavioral/energy-conservation practice and campaign name instructing fume hood users to lower the sash to its closed or minimum-opening position whenever the hood is not in active use, reducing the volume of conditioned air a variable-air-volume (VAV) hood exhausts and, in turn, the lab's ventilation energy cost. Distinct from keeping the sash at its certified working height while actively using the hood, which is a separate safety practice.
Biosafety Cabinet (BSC)
A biosafety cabinet (BSC) is a ventilated enclosure that uses HEPA filtration (removing at least 99.97% of particles 0.3 microns in diameter) combined with directional, certified airflow to contain biological aerosols generated during laboratory procedures. A device only counts as a biosafety cabinet, in the operational sense used across biosafety programs, if it (1) HEPA-filters air before it reaches the work surface, the exhaust, or both; (2) maintains inward airflow at its front opening (Class I and most Class II) or is fully gas-tight and glove-operated (Class III), so aerosols generated inside cannot reach the operator uncontrolled; and (3) has been performance-tested and field-certified — typically against NSF/ANSI 49 in the U.S. — rather than simply having a fan and a filter installed. Class I protects the worker and environment only; Class II protects the worker, product, and environment together and is the most common type in research and clinical microbiology labs; Class III is a gas-tight glovebox providing the highest level of containment, used for BSL-4 work. A biosafety cabinet is not a chemical fume hood (no certified chemical vapor containment unless specifically a Class II Type B cabinet) and is not a laminar flow "clean bench" (which protects only the sample and provides no worker protection at all).
Sustainable Purchasing Leadership Council (SPLC)
The Sustainable Purchasing Leadership Council (SPLC) is a US-based membership nonprofit that develops purchasing guidance, criteria, and training to help institutional buyers embed sustainability considerations into procurement decisions. Members include research universities, hospital systems, government agencies, and corporations. SPLC organizes its guidance by purchasing category rather than by institution type; one of these categories, Laboratory Supplies and Services, sets out sustainability-related purchasing considerations specific to research-lab consumables, reagents, and equipment — including the energy use of cold storage and analytical instruments, packaging and take-back programs, hazardous-material substitution, and supplier sustainability disclosure. An institution is 'using SPLC guidance' when its procurement office cites SPLC category resources or criteria in an RFP, supplier scorecard, or purchasing policy, or when staff complete SPLC training and certificate programs, or when the institution holds SPLC membership to access peer benchmarking data. SPLC itself does not certify individual products, suppliers, or laboratories — it is a guidance, standards-development, and training body, not an accreditation or certification scheme. That distinction matters for procurement officers evaluating standards bodies: a supplier or lab can point to SPLC-informed purchasing criteria in a policy document, but cannot hold an 'SPLC certification,' because SPLC does not issue one.
Capital Equipment Depreciation Schedule
A capital equipment depreciation schedule is the itemized calculation, specific to one capitalized asset, that spreads its depreciable cost (acquisition cost minus salvage value) across its useful life using a defined method (typically straight-line) and shows the resulting depreciation charge for each accounting period. It is the auditable record behind depreciation figures used in indirect cost rate proposals and core-facility rate-setting, distinct from simply noting that an asset depreciates.
Universal waste disposal requirements
A waste item is subject to universal waste disposal requirements — rather than full hazardous-waste rules — only if it falls into one of the categories EPA designates under 40 CFR Part 273 (batteries, pesticides, mercury-containing equipment, lamps, and, since 2019, aerosol cans, plus any categories a state adds) and the generator meets that rule's labeling, containment, and one-year accumulation-time-limit conditions. Items outside those designated categories remain fully regulated hazardous waste regardless of volume or apparent low risk.
Fume Hood
A fume hood (also called a chemical fume hood) is a ventilated enclosure that captures, contains, and exhausts airborne hazardous vapors, gases, dust, and fumes generated by chemical work, drawing room air in through an open front (the sash) and expelling it — usually after passing through ductwork, and sometimes through filtration — outside the building or to a treatment system. It protects the worker, not the material inside it: contaminated room air is pulled away from the user's breathing zone rather than the hood creating a sterile or particle-free zone around the work. A device only counts as a fume hood, in the operational sense used across lab-safety programs, if it (1) has continuous mechanical exhaust ventilation drawing air inward through a face opening, (2) is tested and certified to maintain a minimum face velocity (commonly cited around 80–120 feet per minute under ANSI/AIHA Z9.5, the U.S. consensus standard for laboratory ventilation) rather than simply having a fan running, and (3) is used specifically to control chemical exposure — not biological aerosols and not sample contamination, which are the jobs of a biosafety cabinet and a laminar flow hood respectively.
ANSI/AAMI ST79
ANSI/AAMI ST79 is the ANSI-approved consensus standard, developed by AAMI (Association for the Advancement of Medical Instrumentation), titled "Comprehensive guide to steam sterilization and sterility assurance in health care facilities." A sterile processing program is operating to ST79 when it documents, for every steam sterilizer and load type: (1) installation, operational, and performance qualification (IQ/OQ/PQ) testing at commissioning and after major repair or relocation; (2) routine physical monitoring (time, temperature, pressure) on every cycle; (3) a chemical indicator inside every package and a Bowie-Dick air-removal test on each dynamic-air-removal (pre-vacuum) sterilizer, run daily before the first processed load; (4) a biological indicator (BI) in at least one load per sterilizer per day and in every load containing an implantable device, with the implant load held until a negative BI result returns; and (5) written procedures for immediate-use steam sterilization (IUSS), wet-pack investigation, and load recall when a monitoring result fails. The current edition is ST79:2017, the consolidated base text plus amendments issued through 2020; AAMI has not published a full replacement edition since 2017, so "ANSI/AAMI ST79 2020" and "ANSI/AAMI ST79 latest version" both refer to this same amended 2017 text rather than a separate edition. ST79 is a voluntary consensus standard rather than a federal regulation in its own right, but it is the document nearly universally treated as the baseline standard of care for hospital-based steam sterilization in the United States, and many state health department licensing rules and hospital accreditation surveys reference it directly.
LIMS vs LIS: What’s the Difference?
A system is a LIMS (Laboratory Information Management System) when its central unit of record is the sample: it registers specimens and aliquots, tracks them through testing, quality control and disposition or storage, manages instrument interfaces and inventory, and is built for research, industrial, environmental, quality-control and reference laboratories. A system is an LIS (Laboratory Information System, sometimes called a Laboratory Information Systems platform) when its central unit of record is the patient encounter: it receives test orders from an electronic health record (EHR), routes the associated specimen through a clinical diagnostic workflow, and returns a coded, clinician-facing result (commonly mapped to LOINC codes) back into the patient's chart, typically operating under CLIA and CAP oversight in the United States. The dividing line is audience and unit of record, not the feature list — both categories commonly include barcoding, instrument connectivity, chain-of-custody tracking and audit trails, so those features alone do not tell you which category a given system belongs to.
Second-Party Audit
A second-party audit is an audit an organization conducts, or commissions, against one of its own suppliers, contractors, or external providers — using the customer's own criteria (a contract, quality agreement, or specification) — to decide whether to qualify, continue, or remove that supplier, as distinct from a first-party (internal self-audit) or a third-party (independent certification/regulatory) audit.
HS Code for Chemicals
An HS code for chemicals is the numeric classification assigned to a chemical substance or product under the World Customs Organization's (WCO) Harmonized System (HS) nomenclature, used by customs authorities to determine import duty rates, admissibility requirements, and statistical reporting for a shipment. It is not the same as the chemical's CAS Registry Number, its UN transport hazard number, or its Export Control Classification Number (ECCN) -- those identify what the substance is or how it must be shipped/exported, while the HS code determines how it is classified and taxed at the customs border. In the United States, HS codes are implemented as 10-digit Harmonized Tariff Schedule (HTSUS) codes for imports, maintained by the U.S. International Trade Commission (USITC) and enforced by U.S. Customs and Border Protection (CBP); exports use the related but separate Schedule B code maintained by the U.S. Census Bureau.
DEA Form 161
DEA Form 161, officially the 'Application for Permit to Export Controlled Substances,' is the permit application a DEA registrant with export authority must file with the DEA Diversion Control Division before shipping a Schedule I-V controlled substance out of the United States. It is transaction-specific -- filed for a defined substance and schedule, quantity, destination country, and consignee -- and it is not itself a registration: holding a DEA registration whose authorized business activity includes exporting is a precondition for filing Form 161, not a consequence of filing it. A DEA 'Researcher' registration, which authorizes possession and use of controlled substances for research, does not by itself authorize export.
DEA Form 357
DEA Form 357 ("Application for Permit to Import Controlled Substances") is the application a DEA registrant -- typically a research or analytical lab that is not registered as a DEA Importer -- files with DEA's Diversion Control Division to obtain a shipment-specific permit to bring a controlled substance into the United States for a scientific, research, or analytical purpose, under 21 CFR Part 1312.
Class 9 Dangerous Goods
Class 9 (Miscellaneous Dangerous Goods) is the transport hazard classification, under the UN Model Regulations, the IATA Dangerous Goods Regulations (DGR), the US DOT Hazardous Materials Regulations (49 CFR Parts 171-180), and the IMDG Code for ocean freight, that captures any substance or article presenting a hazard during transport that isn't already covered by Classes 1 through 8. It functions as a catch-all class. In a research lab, the two shipments that trigger Class 9 most often are dry ice (UN1845, solid carbon dioxide, used as a coolant for biological and temperature-sensitive materials) and lithium batteries (UN3480/UN3481 lithium-ion, UN3090/UN3091 lithium metal) packed in or with instruments, sensors, and data loggers.
IMDG Code Classes (Ocean Freight Dangerous Goods)
The IMDG Code (International Maritime Dangerous Goods Code) is the International Maritime Organization's (IMO) mandatory code for classifying, packing, marking, labeling, and documenting dangerous goods carried by sea in packaged form, given legal force under SOLAS Chapter VII. A material is governed by the IMDG Code's class system whenever it is offered for carriage on a vessel and meets one of the same nine UN hazard-class definitions used across every transport mode — the classes themselves come from the UN Recommendations on the Transport of Dangerous Goods (the 'Orange Book'), so a chemical's or biological substance's UN number, proper shipping name, hazard class, and packing group (I, II, or III) do not change between air, road, and sea. What changes for ocean freight is the layer of sea-specific requirements the IMDG Code adds on top of that shared classification: Emergency Schedules (EmS) codes for firefighting and spillage response, a separate 'Marine Pollutant' designation and marking driven by aquatic-toxicity criteria (which can apply on top of a substance's primary class), 18 segregation groups controlling which dangerous goods cannot be stowed near each other, and lettered stowage categories describing where on or below deck a package may be carried relative to accommodation and machinery spaces. The Code is amended on a two-year cycle by IMO's Maritime Safety Committee, drawing on the same biennial UN Model Regulations updates that also feed the IATA Dangerous Goods Regulations and (in the US) 49 CFR.
Packing Group I, II & III (Hazmat)
A packing group is the DOT/UN three-tier severity classification (I = great danger, II = medium danger, III = minor danger) assigned to a hazardous material within its hazard class, using class-specific criteria under 49 CFR 173.121-173.137, that determines the required UN-specification packaging performance level, maximum shipping quantities, and eligibility for limited/excepted quantity provisions.
Cold Chain
A cold chain is an unbroken sequence of temperature-controlled storage, handling, and transport steps that keeps a temperature-sensitive product inside its defined safe range from the point of manufacture or collection to the point of use. A given movement of goods qualifies as a cold chain only when all of the following hold together: (1) the product itself has a defined temperature specification (e.g., 2-8C for most vaccines and many biologics, or a validated frozen/ultra-cold range) set by the manufacturer or a pharmacopeial standard; (2) every storage and transport step in the sequence -- warehouse, courier, transit hub, receiving site -- uses equipment qualified to hold that range; (3) temperature is continuously monitored and logged, not just checked at the start and end points; and (4) there is a documented procedure for what happens when a monitored excursion occurs (assessing whether the product is still usable, commonly via a Mean Kinetic Temperature calculation per USP <1079.2>, and disposing of or quarantining product that fails). A single unmonitored or unqualified segment -- even if brief -- breaks the chain and invalidates the temperature assurance for everything downstream of it, regardless of how well-controlled the rest of the movement was.
Mean Kinetic Temperature (MKT)
A calculation counts as mean kinetic temperature (MKT), in the USP <1079> sense, if it meets both of the following: (1) it is an Arrhenius-weighted average of a time series of temperature readings, using an assumed activation energy constant, so each reading's contribution scales exponentially rather than linearly with its temperature; and (2) it is expressed as a single equivalent isothermal temperature -- the constant storage temperature that would produce the same overall thermal degradation effect as the actual, fluctuating record over the same period. A plain arithmetic average of the same readings is not MKT, and because degradation reactions generally accelerate exponentially with temperature, MKT is always equal to or slightly above the simple arithmetic mean -- never below it.
Punchout Catalog
A punchout catalog is a live link between a buyer's e-procurement system (such as SAP Ariba, Coupa, or Jaggaer) and a supplier's own hosted online catalog. Instead of storing a static price list inside the buyer's system, the requester clicks a supplier tile inside the procurement portal, is redirected ("punched out") to that supplier's real-time storefront to browse and select items at negotiated contract pricing, then returns the completed shopping cart ("punched in") to the buyer's system as a structured requisition -- typically transmitted using the cXML or OCI protocol -- where it re-enters the institution's normal approval, budget-check, and purchase-order workflow.
Capital Equipment
A tangible, non-consumable asset with a useful life of more than one year and a per-unit acquisition cost that meets or exceeds an institution's capitalization threshold, recorded on the fixed-asset register and depreciated over its useful life rather than expensed in the year of purchase.
IQ/OQ/PQ (Installation, Operational, and Performance Qualification)
IQ/OQ/PQ is the three-stage documented qualification sequence used to prove equipment, instruments, utilities, or systems were installed correctly (Installation Qualification), operate correctly across their full specified range (Operational Qualification), and perform consistently under actual conditions of use (Performance Qualification). An activity counts as IQ/OQ/PQ only when it produces signed, documented evidence tied to pre-defined acceptance criteria for that specific stage and that specific unit as installed — vendor factory testing, calibration, and routine preventive maintenance are related but distinct activities that do not by themselves satisfy any of the three stages.
JAMA Network Impact Factor: Why There’s No Single Figure
JAMA Network's Impact Factor is not a single figure: JAMA Network is the American Medical Association's family of 13 peer-reviewed journals (including flagship JAMA and the open-access JAMA Network Open), and Clarivate assigns a Journal Citation Reports (JCR) Journal Impact Factor separately to each individual title, not to the family as a whole. Neither the AMA nor Clarivate publishes a blended or family-wide figure; any source quoting one number for 'JAMA Network' has either mislabelled a single member journal's figure or invented the number. A searcher wanting a specific figure must specify which of the 13 journals -- JAMA, JAMA Network Open, JAMA Cardiology, JAMA Dermatology, JAMA Health Forum, JAMA Internal Medicine, JAMA Neurology, JAMA Oncology, JAMA Ophthalmology, JAMA Otolaryngology-Head & Neck Surgery, JAMA Pediatrics, JAMA Psychiatry, or JAMA Surgery -- they mean, then look that title up directly at jamanetwork.com or in the JCR (jcr.clarivate.com).
Kerndatensatz Forschung (KDSF)
The Kerndatensatz Forschung (KDSF) is Germany's national standard defining how universities and non-university research institutions structure and report information about research activity -- projects, personnel, publications, funding, and infrastructure -- using a shared base data model (Basisdatenmodell), topic-scoped modules, and standardised reference queries (Referenzabfragen). Voluntary adoption was recommended by the German Council of Science and Humanities (Wissenschaftsrat) in January 2016; ongoing governance now sits with the Kommission fur Forschungsinformationen in Deutschland (KFiD).
SocArXiv
SocArXiv is a free, open-access preprint repository for the social sciences. It was founded in 2016 by sociologist Philip N. Cohen in partnership with the nonprofit Center for Open Science (COS) and runs on the Open Science Framework (OSF) — the same underlying infrastructure that hosts OSF Preprints and sibling branded servers such as PsyArXiv (psychology) and engrXiv (engineering). SocArXiv launched alongside those two services on December 5, 2016, as part of COS's branded-server model, in which a scholarly community operates its own named, separately moderated preprint service on shared OSF backend infrastructure rather than building hosting from scratch. SocArXiv is not a COS-run editorial operation in the way a journal is. It is governed by a volunteer steering committee of scholars and library professionals under the banner "SocOpen," and since 2021 its institutional home has been the University of Maryland Libraries, which provides the administrative and legal footing for the service as an ongoing academic unit rather than a standalone nonprofit. Operational definition A deposit is properly identified as a "SocArXiv preprint" if it meets all of the following: It was submitted through the SocArXiv service on OSF (osf.io/preprints/socarxiv), not simply cross-listed or mirrored from another repository such as arXiv or SSRN. It falls within sociology or a closely related social-science field — SocArXiv accepts working papers, preprints, published-paper copies, data, and code across the social sciences broadly, not sociology alone. It has passed SocOpen's moderation screen, which is a scope-and-completeness check, not peer review: moderators confirm the item is scholarly, falls within a supported research area, is plausibly categorized, is correctly attributed to its stated authors, is in a moderated language, and is submitted in a text-searchable format (PDF or DOCX, not a scanned image). It has received an automatically assigned, persistent DOI on upload, making it citable independent of eventual journal publication; a prior DOI issued by another publisher can also be linked to the same record. It carries one of SocArXiv's permitted reuse terms — CC BY 4.0, CC0 (public-domain dedication), or no license — selected by the author at deposit. What SocArXiv is not Posting to SocArXiv is explicitly not peer review, and a SocArXiv record is not, by itself, evidence that a manuscript has been formally accepted anywhere. Moderation checks scope and completeness, not scientific merit, methodology, or novelty. SocArXiv is also free to authors and readers — there is no submission fee or paywall, which distinguishes it from many venues that require an article processing charge (APC) at the journal stage. Examples A sociologist deposits a working paper analyzing survey data on labor-market outcomes to SocArXiv ahead of submitting it to a peer-reviewed journal, receiving a citable DOI immediately and using that DOI in grant reports and CVs while the manuscript is still under review elsewhere. A research team posts the accepted-but-not-yet-typeset version of a political-science article to SocArXiv under a publisher-permitted embargo, satisfying a funder's open-access mandate without waiting for the journal's own publication date. Counter-example A working paper in economics or sociology posted only to SSRN, a university's own institutional repository, or a personal website is not a "SocArXiv preprint," even though it may cover an identical topic and serve a similar function — the term refers specifically to material submitted through and moderated by the SocArXiv service on OSF, not to social-science preprints in general (for that broader category, see preprint). Related terms Preprint OSF Preprints PsyArXiv Open Science Framework (OSF) DOI How to Choose a Preprint Server Preprint Servers Explained
TGA CTN and CTA (formerly CTX) Schemes
The CTN (Clinical Trial Notification) and CTA (Clinical Trial Approval, formerly called CTX -- Clinical Trial Exemption) schemes are the two regulatory pathways Australia's Therapeutic Goods Administration (TGA) uses to permit the lawful supply of an 'unapproved' therapeutic good -- one not yet entered on the Australian Register of Therapeutic Goods (ARTG) -- for use in a clinical trial. A trial is a CTN trial if the sponsor self-assesses the product and trial as suitable to proceed on notification alone: the sponsor lodges a CTN with the TGA (via the TGA Business Services online CTN form) after the trial protocol has HREC (Human Research Ethics Committee) approval, pays the CTN fee, and the trial may then start -- the TGA does not review the scientific data before the trial begins. A trial is a CTA trial if the sponsor instead applies for the TGA's formal evaluation and approval of the unapproved good before the trial can start; the TGA reviews the supporting data (quality, safety, and available efficacy information) and must approve the application before recruitment begins. Both schemes sit alongside, not instead of, HREC ethical review and (for CTN trials) the relevant institution's own governance authorisation -- TGA approval or notification concerns lawful supply of the unapproved product, not the ethics of the study design.
TCET (Transitional Coverage for Emerging Technologies)
TCET (Transitional Coverage for Emerging Technologies) is a CMS coverage pathway, finalized August 2024 (final procedural notice CMS-3421-FN, effective August 12, 2024), that expedites Medicare national coverage for a limited set of FDA-designated Breakthrough Devices by running the device through CMS's existing National Coverage Determination (NCD) and Coverage with Evidence Development (CED) machinery on an accelerated, pre-planned timeline rather than creating a new coverage authority. A device becomes TCET-eligible only if it holds FDA Breakthrough Device designation, has received FDA market authorization, falls within an existing Medicare benefit category, and is not already the subject of an NCD; CMS finalized an exclusion for digital-only technologies and capped the pathway at five new candidates accepted per year, reviewed on a quarterly cycle. A manufacturer engages CMS well before authorization: a non-binding Letter of Intent roughly 18-24 months out, formal self-nomination roughly 12 months out, a CMS-contractor-generated evidence preview identifying gaps in the existing clinical evidence, and a manufacturer-authored Evidence Development Plan (EDP) mapping how those gaps will be closed. If accepted, CMS pursues an NCD conditioned on CED, giving the device national Medicare coverage for several years -- potentially up to roughly five -- while the manufacturer collects the additional outcomes data the evidence preview identified as missing.
PMDA Clinical Trial Notification (CTN)
A Clinical Trial Notification (CTN, chiken todokede) is the regulatory filing a sponsor must submit to Japan's Ministry of Health, Labour and Welfare (MHLW) -- reviewed on MHLW's behalf by the Pharmaceuticals and Medical Devices Agency (PMDA) -- before initiating a clinical trial of an unapproved drug, or a new indication/dosage of an approved drug, in Japan. It is Japan's functional counterpart to a U.S. FDA Investigational New Drug (IND) application, but operates as a notification-and-review-window system rather than an affirmative approval: for an initial CTN, PMDA has a 30-day review period after receipt in which it can raise questions or object; if PMDA raises no objection within that window, the sponsor may proceed to start the trial. A submission counts as a CTN when it is filed under Japan's PMD Act (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices) and includes the trial protocol, investigational product information, and details of the investigators and institutions where the trial will be conducted.
Patent Pool
A patent pool is an arrangement among two or more independent patent holders -- which can include a university technology transfer office -- to combine a defined set of patents into a single licensing package administered through one licensor or pool entity, so a licensee can obtain rights to every pooled patent in one transaction, with royalties divided among members by a pre-agreed allocation formula. Distinct from a standard bilateral exclusive or non-exclusive license, which involves a single licensor.
Reach-Through Royalty
A reach-through royalty is a licensing clause requiring the licensor of a research tool (an assay, screening platform, reagent, or similar upstream technology) to be paid a share of revenue from a future product the licensee later discovers or develops using that tool -- even though the tool's own patent claims do not cover, and are not incorporated into, that downstream product. It is distinguished from an ordinary running royalty by that gap: the royalty base is a product outside the scope of what was actually licensed.
QDR (Qualitative Data Repository)
The Qualitative Data Repository (QDR) is a domain repository dedicated to curating, preserving, and providing access to digital data generated through qualitative and multi-method social science research — interview transcripts, fieldnotes, focus-group recordings, participant-observation records, and other unstructured or semi-structured data types that do not fit the tabular, quantitative deposit model most general-purpose repositories are built around. It is hosted by the Center for Qualitative and Multi-Method Inquiry at Syracuse University's Maxwell School of Citizenship and Public Affairs. A dataset qualifies as a QDR deposit when it is submitted through QDR's own curation and review workflow, receives a persistent identifier (a DataCite DOI), and is described with QDR's qualitative-data-specific metadata and, where the depositing researcher chooses to use it, QDR's Annotation for Transparent Inquiry (ATI) format for linking published claims back to underlying data excerpts.
GBIF (Global Biodiversity Information Facility)
GBIF (the Global Biodiversity Information Facility) is an intergovernmental network and open-access data infrastructure -- coordinated by a Secretariat in Copenhagen and funded by its participating governments and organizations -- that aggregates, indexes, and republishes species-occurrence and specimen records contributed by data-holding institutions worldwide through a global network of national and thematic Participant Nodes. A dataset counts as GBIF-mediated when it has been registered through a GBIF Participant Node (or directly via GBIF.org) and is discoverable, searchable, and downloadable through the GBIF occurrence-search interface and API; the great majority of datasets reach GBIF as Darwin Core Archives (DwC-A), most commonly built and published using GBIF's own Integrated Publishing Toolkit (IPT). GBIF itself does not define a data standard -- it consumes Darwin Core, the pre-existing TDWG biodiversity-data standard -- and is best understood as the largest aggregating platform built on top of that standard, not the standard itself.
REMS (Risk Evaluation and Mitigation Strategy)
A REMS is a required FDA drug safety program, authorized under Section 505-1 of the Food, Drug, and Cosmetic Act (added by the 2007 FDAAA), imposed on a drug or biologic when FDA determines its serious risks require controls beyond standard professional labeling. It can combine a Medication Guide, a prescriber/provider communication plan, and Elements to Assure Safe Use (ETASU) such as prescriber or pharmacy certification, restricted dispensing settings, mandatory patient monitoring, or registry enrollment -- with an implementation system required whenever ETASU is used.
GA4GH (Global Alliance for Genomics and Health)
An international not-for-profit alliance, founded in 2013, that develops and maintains technical interoperability specifications and policy frameworks (such as the Data Use Ontology, GA4GH Passport, Beacon, htsget, Crypt4GH, and Phenopackets) enabling genomic and health-related data to be shared responsibly across research and clinical institutions worldwide; GA4GH does not host data itself but defines the standards that repositories, biobanks, and national genomic initiatives implement to interoperate.
Publish or Perish (Harzing’s citation-analysis software)
Publish or Perish is a free desktop program, created by Anne-Wil Harzing and first released in October 2006, that queries academic data sources (as of version 8: Google Scholar, Google Scholar Profile, Crossref, PubMed, OpenAlex, Lens.org, Scopus, Semantic Scholar, and Web of Science) for a given author, journal, or search term, then calculates citation-based metrics such as the h-index and g-index from whatever results are returned. It holds no citation data itself and is not a database, persistent identifier registry, or CRIS -- it is a query-and-calculate client for other providers' data, so results vary by which source was queried and change over time as underlying citation counts change.
Kudos (research-impact platform)
Kudos is a free platform on which an author or institution takes a Crossref-DOI-registered publication and (1) attaches a plain-language explanation of the work, (2) enriches it with supporting links, data, or media, and (3) shares that package through built-in social/email distribution tools, with usage, download, and attention-metric data reported back afterward. It does not register DOIs, host full text, or index the literature itself -- it is an outreach and measurement layer sitting on top of publications already registered elsewhere.
TechRxiv
A manuscript counts as a TechRxiv deposit if it has been submitted to, and cleared the appropriateness screening of, TechRxiv — the free, IEEE-operated preprint server for unpublished research in engineering, computer science, and related technology. TechRxiv's scope is bounded to IEEE's core subject areas (electrical and electronics engineering, computer science, telecommunications, and adjacent technology fields) rather than open to any discipline, and it exists to let authors post a manuscript publicly, with a citable identifier, before or during formal peer review at a journal or conference. The screening TechRxiv applies is editorial and scope-based only: a moderator confirms the submission is a genuine, appropriately-scoped, non-plagiarized research manuscript, not that its findings are accurate, complete, or novel — that judgment is reserved for peer review at whatever venue eventually considers the work for publication.
Professor’s Privilege
Professor's privilege is the legal default, historically common in continental European patent law, under which an individual academic inventor -- rather than the employing university -- automatically owns the patent rights to inventions arising from their own research, including the right to decide whether to patent, license, or exploit the result. It is the structural inverse of institutional-ownership regimes like the U.S. Bayh-Dole Act, and today survives in full among major European research systems primarily in Sweden (the lärarundantaget, or 'teacher's exemption'); Germany, Italy, Denmark, Finland, and Norway have each abolished it in favor of university ownership over the past two decades.
Bronze open access
An open access article that is free to read on the publisher's own website but carries no explicit open license (such as a Creative Commons license) and is not published in a DOAJ-indexed fully open-access journal — meaning the free-to-read status is not contractually guaranteed and can be withdrawn or altered by the publisher at any time.
Open Database License (ODbL)
The Open Database License (ODbL) is a copyleft license from Open Data Commons (a project of the Open Knowledge Foundation), version 1.0 published June 2009, that grants reuse rights to a database subject to attribution and share-alike conditions, drafted specifically around database rights and database structure/contents rather than adapted from a creative-works copyright license.
DMPTool
DMPTool is a free, web-based data management plan (DMP) authoring service operated by the California Digital Library (CDL), through its University of California Curation Center (UC3), on behalf of an international partner consortium. It runs on the open-source DMPRoadmap codebase -- the same platform underlying the Digital Curation Centre's UK-based DMPonline -- and is the DMPRoadmap deployment used predominantly by US institutions and funders. An instance qualifies as DMPTool (rather than a generic DMPRoadmap deployment or DMPonline) when it is accessed at dmptool.org, uses CDL/UC3-maintained funder templates (NSF, NIH, NEH, DOE, IMLS, and others), and is administered under an institution's DMPTool participation agreement rather than a DCC/DMPonline subscription.
Grounded Theory
Grounded theory is a qualitative research methodology in which a theory is generated inductively from data, rather than proposed in advance and tested against it. A study counts as grounded theory only when three things hold together: data collection and analysis proceed simultaneously and iteratively, not sequentially; codes and categories are developed and refined through the constant comparative method, systematically comparing each new piece of data against categories built from earlier data; and further data collection is directed by theoretical sampling -- deliberately seeking cases likely to test, extend, or challenge the emerging categories -- continuing until theoretical saturation, the point at which new data stops adding new properties to the core categories. The output is a substantive theory: interrelated concepts explaining a process or pattern of social action, grounded in and traceable back to the data itself.
Commerce Control List (CCL)
The Commerce Control List (CCL) is the master list of 'dual-use' items -- goods, software, and technology with both civilian and military, terrorism, or weapons-of-mass-destruction-related applications -- that are subject to the Export Administration Regulations (EAR, 15 CFR Parts 730-774) and administered by the Department of Commerce's Bureau of Industry and Security (BIS). The CCL is organized into ten numbered categories (0-9) and, within each category, five lettered product groups (A-E); an item that matches a specific CCL entry is assigned an Export Control Classification Number (ECCN), while an item that is subject to the EAR but matches no CCL entry falls into the residual EAR99 classification.
K01 (NIH Mentored Research Scientist Development Award)
A K01 is an NIH individual, mentored career-development activity code (Mentored Research Scientist Development Award) that funds a research-doctorate-holding investigator's three-to-five-year transition toward independent, NIH-fundable research through protected effort (at least 75% of full-time professional effort), a qualified mentor, and a formal career-development plan. What distinguishes a K01 from other individual mentored K mechanisms: it requires a research doctorate (PhD or equivalent) rather than a clinical doctorate, carries no fixed postdoctoral-experience ceiling the way K99/R00 does, and runs as a single mentored phase for its full duration with no automatic transition into a separate independent-phase award.
Research Collaboration Agreement (RCA)
A research collaboration agreement (RCA) is a contract between two or more independent institutions or organizations that jointly and actively perform research work toward a shared objective, allocating rights and obligations among genuine co-participants -- as distinct from a sponsored research agreement, where one party funds a single performing institution's defined scope of work, and a material transfer agreement, which governs only the transfer of a physical research material with no joint research performed. An RCA typically covers background vs. foreground IP ownership and licensing, publication-review timelines, data ownership and sharing, funding/cost-sharing across parties, and liability and termination terms.
Research Manuscript
A research manuscript is the complete, submission-ready written account of a study — background, methods, results, and discussion (or the equivalent structure for the field) — that an author submits to a journal, conference, or other venue for editorial and peer review, before it has been accepted, copyedited, or published. The term marks a stage in the publication lifecycle, not a content type: the same underlying work is a manuscript from first submission through any round of revision, and stops being called a manuscript once it is accepted and moves toward publication, at which point more specific terms apply — author accepted manuscript (AAM) for the peer-reviewed, accepted-but-not-yet-typeset version, and version of record (VoR) for the final published form. A document only counts as a research manuscript if it is (a) a structured, complete write-up of original research or scholarship, and (b) has been or is intended to be submitted somewhere for editorial evaluation. A rough draft circulated only among co-authors, or a preprint posted to a server outside any journal's review process, are related but distinct in most editorial and funder usage — see the counter-examples below.
Spencer Foundation
The Spencer Foundation is a private, non-federal U.S. foundation dedicated exclusively to funding research aimed at the understanding and improvement of education, broadly construed across disciplines, methodologies, and education levels. A project qualifies as Spencer-funded research if it is submitted under one of the Foundation's active grant mechanisms -- principally the Small Research Grants on Education program (budgets up to $50,000) or the Large Research Grants on Education program (budgets of $125,000 to $500,000) -- through an eligible non-profit or public administering institution, since the Foundation does not award grants directly to individuals. A related but separately administered mechanism, the NAEd/Spencer Dissertation Fellowship, supports individual doctoral candidates directly through the National Academy of Education rather than through Spencer's own research-grant portal.
FAIR Data Principles
The FAIR data principles are a set of four foundational goals — Findable, Accessible, Interoperable, and Reusable — for how research data and its metadata should be described, deposited, and structured so that both humans and machines can locate, retrieve, and reuse it with minimal manual effort. FAIR is a set of guiding goals for data stewardship, not a certification, a checklist with one correct implementation, or a data-sharing mandate in itself: a dataset is 'FAIR' to the degree its metadata and deposit environment satisfy the fifteen sub-principles across the four categories, and different repositories, disciplines, and data types satisfy them by different concrete means.
H-Index Inflation
H-index inflation is a rise in a researcher's h-index that is driven mainly by co-authorship on a small number of very-large-team papers, rather than by a broader pattern of individually-led, independently cited work. Because the h-index counts a paper toward every listed co-author identically regardless of team size or individual contribution, a researcher who appears as one name among several hundred or several thousand co-authors on a heavily-cited paper receives the same per-paper credit as a sole author of an equally-cited paper. An h-index is flagged as inflated, in bibliometric practice, when a meaningful share of the citing papers behind it trace back to a handful of hyperauthored publications rather than to a broad base of independent outputs -- a distinction visible on inspection of the underlying publication list, not from the index number alone.
Digitally Anonymised Data
Digitally anonymised data is an electronic dataset that has been processed with computational techniques so that no living individual can reasonably be re-identified from it, either on its own or by combination with other information a realistic adversary could plausibly obtain, and no key, lookup table, or other additional information exists anywhere that could reverse the process. It differs from data that is merely stored in digital form and stripped of obvious direct identifiers: to count as digitally anonymised, a dataset has to pass the same substantive test any anonymisation method must meet under frameworks such as GDPR Recital 26 (identifiability assessed against 'all the means reasonably likely to be used', accounting for cost, time, and available technology) -- the 'digitally' in the term describes how the anonymisation was performed (masking, generalisation, aggregation, noise addition, k-anonymity/differential-privacy methods, or synthetic-data generation applied by software to an electronic source dataset), not a lower or different bar than anonymisation achieved by any other means. If a re-identification key is retained anywhere, even encrypted or access-controlled, the output is pseudonymised data, not digitally anonymised data, and remains personal data under GDPR (Recital 26; Article 4(5)).
Textual Plagiarism
Textual plagiarism is unattributed copying of another person's written words — as distinct from plagiarism of ideas, where an author paraphrases someone else's argument or findings thoroughly enough that no wording matches but the underlying contribution still goes uncredited. The U.S. Office of Research Integrity (ORI) uses this exact two-way split — plagiarism of text vs. plagiarism of ideas — in its own research-integrity guidance. A passage counts as an instance of textual plagiarism when matching or near-matching wording appears without both a citation to the source AND quotation marks (or block-quote formatting) marking exactly which words are borrowed; a citation alone, without quotation marks around verbatim language, is not sufficient. Because it is defined by the words on the page rather than by intent, textual plagiarism is the category similarity-checking software (Turnitin, iThenticate, Crossref Similarity Check) is built to surface — these tools compare submitted text against a reference corpus and report string-level matches. They cannot detect plagiarism of ideas, since a thoroughly reworded passage produces no textual match at all.
NSF Regional Innovation Engines (NSF Engines)
The NSF Regional Innovation Engines program (branded "NSF Engines") is a large-scale National Science Foundation funding mechanism, authorized under Section 10388 of the CHIPS and Science Act of 2022 and administered by NSF's Directorate for Technology, Innovation and Partnerships (TIP). Rather than funding an individual investigator's research question, an NSF Engines award funds a multi-year, multi-institution coalition — typically spanning universities, industry, nonprofits, state/local government, and community organizations — that commits to building a self-sustaining, technology-driven innovation ecosystem around a defined regional focus area (a specific technology domain paired with a societal or economic challenge). A submission qualifies as an NSF Engine, operationally, when it names a lead institution accountable for a CEO-led governance structure, documents a coalition of partners across multiple sectors, defines a regional geography the ecosystem is meant to strengthen, and proposes a multi-phase plan (nascent, emergent, growth) for translating research into regional economic and workforce outcomes over up to a decade — not merely a shared research interest among co-PIs.
SURF (Summer Undergraduate Research Fellowship)
SURF (Summer Undergraduate Research Fellowship) is a category of institutionally administered summer research program that places undergraduates into a mentored, full-time research placement -- typically 8 to 11 weeks -- under a faculty or staff scientist, usually with a stipend and often modeled on the grant-seeking process: the student writes a short research proposal to be accepted, conducts the project over the summer, and closes the program with a written report and an oral or poster presentation at a culminating symposium. 'SURF' is not one single national program; it is a naming convention independently adopted by dozens of individual institutions for their own summer undergraduate research fellowship, most prominently the California Institute of Technology (Caltech), whose SURF program is the oldest and most widely cited namesake of the term. A program counts as a SURF in the operational sense used here if it (a) is undergraduate-only, (b) runs as a discrete summer term rather than during the academic year, (c) pairs each student with an individual faculty/research mentor rather than a classroom instructor, and (d) issues a stipend or fellowship award rather than treating the position as employment paid hourly.
Leverhulme Trust
An independent UK charitable foundation, endowed under the will of William Hesketh Lever (founder of Lever Brothers, now part of Unilever) and operating since 1925, that funds academic research and personal fellowships across all disciplines -- including arts, humanities, and social sciences -- without the thematic remit restrictions that apply to UKRI's discipline-specific research councils.
Pharmaceutical Company Research Grants (Investigator-Initiated Studies)
A pharmaceutical company research grant, in the investigator-initiated study (IIS/ISS) sense, is funding a pharmaceutical or biopharmaceutical company provides for a research project that a physician, scientist, or other qualified investigator conceives, designs, and directs -- distinguishing it from company-sponsored clinical trials, where the company itself designs the protocol and directs the study through a sponsor or sponsor-CRO relationship. A grant counts as an investigator-initiated study grant, and not ordinary trial sponsorship, only when the funding company has no control over hypothesis, design, endpoints, or data interpretation -- its role is limited to scientific review of the proposal, funding decision, and (for studies involving its product) supply of drug or device as specified in the grant agreement.
MRC (Medical Research Council, UK)
The MRC (Medical Research Council) is the UK statutory research council responsible for funding biomedical, clinical, and translational health research. It is one of the seven discipline-based research councils operating as constituent parts of UK Research and Innovation (UKRI) — a project or researcher qualifies as "MRC-funded" when the award is made under an MRC scheme (an applicant-led responsive-mode grant, an MRC-badged fellowship, or funding to one of MRC's own institutes/units) and its subject matter falls within MRC's biomedical/clinical remit, as distinct from awards made by UKRI's other councils (ESRC for social science, BBSRC for biosciences, EPSRC for engineering/physical sciences, and so on) or by the separately governed National Institute for Health and Care Research (NIHR).
EPSRC (Engineering and Physical Sciences Research Council)
The EPSRC (Engineering and Physical Sciences Research Council) is the UK statutory research council responsible for funding engineering, physical sciences, mathematics, and digital/AI research. It is one of the seven discipline-based research councils operating as constituent parts of UK Research and Innovation (UKRI) — an award qualifies as "EPSRC-funded" when it is made under an EPSRC scheme (responsive-mode grants, EPSRC-badged fellowships and studentships, or EPSRC-led cross-council calls) and its subject matter falls within EPSRC's remit (engineering, physical sciences, mathematical sciences, chemistry, materials, digital technologies and AI), as distinct from awards made by UKRI's other councils (STFC for particle physics, astronomy and space science; MRC for biomedical/clinical research; BBSRC for biosciences; and so on) or by non-statutory private funders.
NSF FastLane (Legacy Grants Portal)
NSF FastLane (fastlane.nsf.gov) was the National Science Foundation's original web-based electronic system for proposal preparation, submission, and award administration, launched in the 1990s. A document or workflow is properly described as "a FastLane submission" or "a FastLane-era award" if it was prepared, submitted, or administered through that platform prior to NSF's cutover to Research.gov. As of 2023, FastLane is decommissioned as a live proposal-submission channel: NSF's Proposal & Award Policies & Procedures Guide (PAPPG) NSF 23-1 removed FastLane as a submission option for all NSF funding opportunities effective January 30, 2023, and NSF phased out FastLane's remaining functions (award documents, organizational reports, Grants.gov integration) in the months that followed, including a further phase in November 2023. The fastlane.nsf.gov domain now 301-redirects to research.gov, confirming there is no live FastLane instance to submit to. Research administrators encountering the term today are almost always dealing with historical records, legacy award documentation, or institutional process guides that have not yet been updated to reflect the transition.
Statement of Work (SOW)
A Statement of Work (SOW) is the contractual document -- typically an exhibit or attachment incorporated by reference into a sponsored research contract, industry-funded research agreement, or subaward -- that specifies the concrete work a recipient is legally obligated to perform: the specific tasks, deliverables, timeline, and milestones the funded party must complete. It functions as a binding technical and performance specification, not as a scientific narrative. That distinguishes it from a grant proposal's Specific Aims (or Research Strategy) section, which argues the scientific rationale and hypotheses behind proposed work to persuade a funder or peer-review panel of merit, but does not itself create an enforceable task list. A SOW's tasks and deliverables are what the contracting parties monitor performance against and, in a true contract, what a breach or termination-for-default claim would be measured against; missed Specific Aims in a grant typically trigger a progress-report conversation, not a contractual remedy.
BBSRC (Biotechnology and Biological Sciences Research Council)
BBSRC is one of the seven discipline-based research councils inside UK Research and Innovation (UKRI), responsible for funding fundamental and applied bioscience research and postgraduate training in the UK -- from molecular and cellular biology through to agriculture, food security, engineering biology, and biotechnology. An award counts as BBSRC funding when it is made through a BBSRC-branded scheme (responsive-mode grants, fellowships, doctoral training partnerships, Institute Strategic Programme funding, or industry-partnered awards) rather than through one of UKRI's other six research councils, even though all UKRI councils share the same underlying application system, costing model, and outcome-reporting requirements.
Advarra IRB
Advarra is a commercial (independent) Institutional Review Board (IRB) provider based in Columbia, Maryland, formed in 2017 through the merger of Chesapeake IRB and Schulman IRB and expanded in 2019 through the acquisition of Quorum Review IRB. It is one of the largest commercial IRBs operating in the United States, reviewing human-subjects research on a fee-for-service basis for pharmaceutical, biotech, medical-device, and academic sponsors, and is frequently designated as the central IRB / single IRB of record (sIRB) for multi-site clinical trials. Advarra is registered with the Office for Human Research Protections (OHRP) under 45 CFR 46 and with FDA under 21 CFR Part 56, and holds full accreditation from AAHRPP. Sites and sponsors submit and track studies through Advarra's electronic platform, the Center for IRB Intelligence (CIRBI).
William T. Grant Foundation
The William T. Grant Foundation (WTGF) is a private, non-federal U.S. foundation, headquartered in New York City, that funds research in the social sciences. Since 1936 it has supported studies aimed at reducing inequality in the outcomes of young people (ages 5-25) in the United States and, more recently, at improving how research evidence is used by the policymakers, agency leaders, and other decision-makers who shape youth-serving systems. A project qualifies as WTGF-funded research if it is submitted under one of the Foundation's active funding mechanisms — principally the Research Grants on Reducing Inequality program and the Research Grants on Improving the Use of Research Evidence program — and is reviewed and awarded through the Foundation's own letter-of-inquiry and full-proposal process, which runs on its own cycle and criteria rather than a federal grants system such as Grants.gov or NIH's eRA Commons.
ESRC (Economic and Social Research Council)
The ESRC (Economic and Social Research Council) is the UK statutory research council responsible for funding economic, social, behavioural, and human data science research. It is one of the seven discipline-based research councils operating as constituent parts of UK Research and Innovation (UKRI) — a body qualifies as "ESRC-funded" when its award is made under an ESRC scheme (responsive-mode grants, ESRC-badged fellowships and studentships, or ESRC-led cross-council calls) and its subject matter falls within ESRC's social-science remit, as distinct from awards made by UKRI's other councils (EPSRC for engineering/physical sciences, MRC for biomedical/clinical research, BBSRC for biosciences, and so on) or by non-statutory private funders.
Network Meta-Analysis (NMA)
Network meta-analysis (NMA) is a statistical technique that estimates the comparative effectiveness of three or more interventions within a single unified model by combining two kinds of evidence: direct evidence, from trials that compared two of the interventions head-to-head, and indirect evidence, inferred through one or more common comparators (such as a shared placebo or standard-of-care arm) that connect trials which never compared those two interventions directly. A body of evidence qualifies as an NMA, rather than a standard pairwise meta-analysis, when it (1) includes three or more interventions across the included trials, (2) links those trials into a connected network via shared comparators, and (3) produces relative-effect estimates for treatment pairs even when no trial tested that pair directly. NMA rests on an assumption called transitivity — that trials contributing indirect evidence are similar enough in patient population, setting, and other effect modifiers that comparisons through a common comparator are valid — and its statistical counterpart, consistency, which checks that direct and indirect estimates for the same pair of interventions agree.
Research.gov
Research.gov is the U.S. National Science Foundation's primary electronic system for the full lifecycle of an NSF award: proposal preparation and submission, panel/merit review support, and post-award administration. Its post-award functions include submitting annual and final project reports, project outcomes reports, no-cost extension requests, and other award actions that an authorized organizational representative (AOR) or principal investigator (PI) performs after an award is made. Research.gov has progressively absorbed the functions of NSF's legacy FastLane system: since 2018 the two systems ran in parallel, but NSF has moved specific proposal types and modules to Research.gov-only submission over time (for example, SBIR/STTR proposals must now be submitted through Research.gov, and the Proposal Evaluation System (PES) replaced FastLane's Interactive Panel System (IPS) for NSF-wide merit review in FY2024). A submission counts as made through Research.gov, rather than FastLane or Grants.gov, when the specific funding opportunity's program solicitation or the current NSF Proposal & Award Policies & Procedures Guide (PAPPG) designates Research.gov as the required or available submission route for that proposal type.
ARPA-H (Advanced Research Projects Agency for Health)
A U.S. federal award qualifies as ARPA-H funding when it is issued under a Program Manager-defined program announced via an Innovative Solutions Opening (ISO), rather than through NIH's standard investigator-initiated peer-review process -- typically structured as an Other Transaction agreement, contract, or cooperative agreement with funding disbursed against pre-negotiated technical milestones, and subject to Program Manager oversight and go/no-go performance review rather than a fixed project period awarded purely on initial peer-review score.
Investigator’s Brochure (IB)
The Investigator's Brochure (IB) is the ICH E6(R2)-required compilation of physical, chemical, pharmaceutical, nonclinical, and available clinical data on an investigational product, supplied by the sponsor to investigators and the IRB/IEC before a trial begins and kept current through an ongoing review-and-update obligation for as long as the product remains investigational, so investigators can make an informed risk-benefit assessment and comply with protocol-specified dosing and safety monitoring.
Non-Patent Literature (NPL)
Non-patent literature (NPL) is any published material submitted or cited as prior art in a patent search or examination that is not itself a patent or published patent application. It covers journal articles, conference proceedings and papers, theses and dissertations, preprints, technical standards, product manuals and datasheets, trade publications, websites, and even oral presentations or public demonstrations with a documented date. A document counts as NPL for a given invention when two conditions are both met: it was publicly accessible before the invention's effective filing (or priority) date, and it discloses subject matter relevant to novelty or obviousness. NPL is functionally equivalent to patent prior art in legal weight — a single relevant journal article can invalidate a patent claim exactly as a prior patent can — but it is indexed far less consistently, which is what makes NPL search its own distinct skill within prior art search rather than a simple extension of a patent database query.
European Research Council (ERC)
The European Research Council (ERC) is the European Union's funding body for frontier basic research, established in 2007 and operating as part of the Horizon Europe programme (2021-2027). A funding instance qualifies as ERC-administered if it is awarded through one of the ERC's own investigator-driven grant schemes -- Starting, Consolidator, Advanced, or Synergy Grants, plus the smaller Proof of Concept top-up for existing grantees -- selected on scientific excellence alone via a bottom-up, discipline-blind peer review process, rather than through a thematic Horizon Europe call defined around a predetermined policy priority.
NIH ASSIST
ASSIST (Application Submission System & Interface for Submission Tracking) is NIH's own web-based system for preparing, submitting, and tracking electronic grant applications through Grants.gov to NIH. It is one of three ways an institution can get an application from the eRA Commons/Grants.gov ecosystem to NIH — the others being institutional system-to-system (S2S) software (e.g. Cayuse, InfoEd, ProposalCentral) or, less commonly today, Grants.gov Workspace used directly — and NIH designates it as required, rather than optional, for certain complex application types, most notably multi-project applications submitted under the Program Project/Center (PPG) forms family, where S2S vendor support is often incomplete.
eRA Commons: Accounts, Roles, ORCID Linking & Troubleshooting
eRA Commons (commons.era.nih.gov) is NIH's web-based portal for post-submission electronic Research Administration: the system where a Principal Investigator, institutional Signing Official, or other registered role accesses and manages an NIH application and award after it has been submitted through Grants.gov. Grants.gov is where an application package is transmitted to NIH; eRA Commons is where nearly everything that happens to it afterward -- assignment tracking, summary statements and scores, Just-in-Time (JIT) submissions, Research Performance Progress Reports (RPPR), ORCID linkage, no-cost extension requests, prior-approval requests, and final closeout -- takes place. A task counts as "in eRA Commons" if it requires an eRA Commons account and role-based login (era.nih.gov credential) to view or act on, as distinct from the one-time act of transmitting an application via Grants.gov.
NIH Activity Codes
An NIH activity code is the two-to-three-character alphanumeric code -- one or two letters followed by two digits, such as R01, K08, T32, F31, U01, or P01 -- that NIH assigns to classify a specific type of funding mechanism (grant, cooperative agreement, or fellowship) by the kind of support it provides, independent of the awarding Institute or Center, the scientific topic, or the specific Notice of Funding Opportunity (NOFO) issuing it. The activity code is the second element of a full NIH grant number (after the application-type digit and before the Institute/Center code and serial number), for example the 'R01' in '1 R01 CA123456-01.' A funding mechanism is correctly described as belonging to an activity code -- rather than being one -- when its scope, review criteria, budget structure, and duration are all defined NIH-wide (or Common-Fund-wide) by that code's own governing policy, rather than being invented ad hoc by a single NOFO.
Reporting Guidelines
Reporting guidelines are checklists, flow diagrams, or structured-text tools that specify the minimum set of information authors must include when writing up a specific type of study, so that readers, peer reviewers, and editors can judge what was done and trust that nothing material has been left out. The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network, an international initiative founded in 2006 and based at the University of Oxford's Centre for Statistics in Medicine (NDORMS), is the field's central clearinghouse: it defines a reporting guideline as a checklist, flow diagram, or structured text developed using an explicit, documented consensus methodology to guide authors in reporting a specific type of research, and it maintains a searchable library of several hundred such guidelines spanning study designs, specialties, and report sections. A reporting guideline is not a methodological standard. It does not tell an investigator how to design a trial, calculate a sample size, randomize participants, or run an assay -- that is the job of methodological/conduct standards such as ICH Good Clinical Practice, CIOMS guidance, or a funder's data-collection protocol. Nor is a reporting guideline a critical-appraisal or risk-of-bias tool -- it does not score how well a study was conducted (that is the role of instruments such as the Cochrane risk-of-bias tools). A reporting guideline answers a narrower, prior question: given that the study was conducted a particular way, has the write-up disclosed enough about it -- the eligibility criteria, the randomization method, the funding source, the flow of participants -- for a reader to evaluate and, ideally, reproduce the work? An author can follow a reporting guideline to the letter while having run a methodologically weak study, and a well-conducted study can still be reported so incompletely that a reader cannot tell.
Cochrane Handbook for Systematic Reviews of Interventions
The Cochrane Handbook for Systematic Reviews of Interventions is the methodological standard maintained by Cochrane (founded 1993, named after epidemiologist Archie Cochrane) that specifies how a systematic review of a health intervention must be planned, conducted, and reported to qualify as a Cochrane Review. It requires a registered protocol with a PICO-structured question, a comprehensive pre-specified search strategy across multiple databases, dual independent screening and data extraction, formal risk-of-bias assessment (the RoB 2 tool for randomized trials, ROBINS-I for non-randomized studies), GRADE-based certainty-of-evidence rating, and, where studies are sufficiently similar, meta-analysis. Reviews that follow the Handbook are published in the Cochrane Database of Systematic Reviews (CDSR) within the Cochrane Library and are maintained as living documents, updated as new evidence emerges.
Plain Language Summary (PLS)
A plain language summary (PLS) is a short, jargon-free account of a clinical trial's design and results, written so that a layperson — typically framed as a trial participant or member of the public — can understand what the study tested, what it found, and what that means, without needing scientific or medical training. In EU-regulated clinical trials it is a defined regulatory deliverable, not an optional courtesy: under Regulation (EU) No 536/2014 (the EU Clinical Trials Regulation, CTR), sponsors of trials authorised under the Regulation must submit a lay summary of the trial's results to the Clinical Trials Information System (CTIS) alongside the technical results summary, generally within 12 months of the trial's global end date. That deadline extends to up to 30 months for certain non-therapeutic Phase 1 trials, and shortens to 6 months for paediatric trials. Lay summaries must generally be provided in the official language(s) of the EU/EEA member state(s) where the trial was conducted, not only in English. An instance of a PLS is a written summary that (a) covers the trial's purpose, participant population, methods, and results including any relevant safety information, (b) is written for a non-specialist reading level (commonly targeted around a 12-14 year-old reading age in EMA/national guidance), and (c) is submitted as a distinct, identifiable document alongside — not merged into — the technical/scientific summary of results. A document that simply restates the scientific abstract in shorter form, or that omits the trial's actual findings in favour of only describing its design, does not meet the operational bar even if labelled a lay summary.
PICOTS Criteria
A research question is PICOTS-structured when it explicitly specifies all six elements — Population, Intervention, Comparator, Outcome, Timing, and Setting — rather than only the four PICO elements, typically to derive study-eligibility criteria for a systematic review, evidence synthesis, or health-technology assessment protocol.
Conference Travel Grant (Award)
A conference travel grant (also called a conference travel award) is a discrete funding mechanism -- distinct from a project's general travel budget line -- that pays some or all of the cost of a researcher attending and presenting at an academic or professional conference. It is an instance of this concept when: (1) the funds are awarded competitively or by defined eligibility criteria rather than simply drawn down from an existing project budget; (2) the covered costs are conference-specific (registration fee, travel, lodging, and sometimes per diem/subsistence) rather than general research expenses; and (3) eligibility and award size are set by a funder, professional society, or institution operating a named award program, not negotiated ad hoc. Three source types are common: (a) institutional travel funds administered by a graduate school, department, or office of research, typically capped per award ($300-$1,500 is a common range) and limited to one award per researcher per year; (b) professional-society travel awards tied to a specific annual meeting, frequently reserved for student, postdoctoral, or early-career members and conditioned on having an accepted abstract or paper; and (c) funder-level mechanisms built into a federal grant program, such as NIH's R13/U13 Support for Scientific Meetings and Conferences (Parent R13, e.g. PA-25-080) and comparable NSF conference/travel solicitations, which are typically awarded to the hosting institution or organization -- not to an individual researcher directly -- to subsidize the meeting itself and, within that award, the travel of students, trainees, and junior investigators attending it. This is a funding-mechanism concept, not a cost-allowability concept: whether a specific expense charged against any of these awards is allowable follows ordinary sponsor cost policy (2 CFR 200.475, the Fly America Act for federally funded international air travel, per diem rules) -- see Travel cost (grant) for that separate question.
Patient Consent for Case Report Publication
The written authorization a patient (or parent/guardian/legally authorized representative) gives before a clinical case report describing their presentation, treatment, images, or outcome is submitted to a journal -- required whenever the report contains identifiable information, per ICMJE's patient-privacy recommendations and CARE Guidelines checklist item 13, independent of any separate IRB determination about the underlying case.
NIH Director’s New Innovator Award (DP2)
The NIH Director's New Innovator Award (DP2) is a Common Fund High-Risk, High-Reward Research grant that funds early-career investigators (Early Stage Investigators, within 10 years of their terminal degree or clinical training) proposing exceptionally creative, high-risk research, without requiring the extensive preliminary data a standard R01 application expects. It provides a single award, historically up to $1.5 million and more recently up to $2.375 million in total direct costs, over a five-year project period.
NIH R03 (Small Grant Program)
An R03 is an NIH research-grant activity code — the Small Grant Program — that funds modest, short-term, self-contained research projects rather than the extended, larger-scale programs an R01 supports. R03 budgets are capped at up to $50,000 in direct costs per year, over a project period of up to two years (commonly cited as up to $100,000 in direct costs total across the period). No preliminary data are required to apply, though supporting evidence can strengthen an application. NIH designates the R03 mechanism for a defined set of uses: pilot or feasibility studies, secondary analysis of existing data, small self-contained research projects, development of new research methodology, and development of new research technology. The mechanism has no Type 2 competing-renewal option, and not every NIH Institute or Center (IC) participates in the Parent R03 Funding Opportunity Announcement (FOA) — applicants must confirm the specific IC's current participation and any IC-specific R03 announcement before applying.
Retrospective Study
A retrospective study is an observational research design in which investigators identify subjects, exposures, and outcomes that have already occurred and reconstruct the exposure-outcome relationship from data recorded before the study began -- most often clinical records, administrative/claims data, registries, or prior test results -- rather than measuring events as they unfold going forward. What makes a study retrospective is not its statistical method but the timing relationship between the start of the study and the events under analysis: if the outcome had already happened before subjects were identified and data collection began, the study is retrospective, regardless of whether it is framed as a cohort, case-control, or case-series design. Because the data were typically generated for clinical care, billing, or another purpose unrelated to the study's hypothesis, retrospective studies trade weaker control over data quality and measurement consistency for speed, lower cost, and the ability to study rare outcomes or long latency periods that a forward-looking design could not practically capture.
ANSI/NISO Z39.56 (SICI — Serial Item and Contribution Identifier)
A code counts as a SICI only if it assembles all three ANSI/NISO Z39.56-1996 [R2002] segments in sequence — an Item segment (ISSN + chronology + enumeration), a Contribution segment (starting page + title-code checksum for the specific article), and a Control segment (structure/version/check-character) — to identify one specific item within a serial. NISO withdrew the standard in 2012; new article-level identification now runs through the DOI.
ANSI/NISO Z39.14 (Guidelines for Abstracts)
ANSI/NISO Z39.14-1997 (R2015), Guidelines for Abstracts, is an American National Standard developed by the National Information Standards Organization (NISO) that gives authors and editors guidance on writing abstracts for research publications and other scholarly works -- specifically, texts reporting the results of experimental work or descriptive or discursive studies. It is a guideline, not a mandatory format: it does not set a single fixed word limit or template that every abstract must follow. Instead it covers where an abstract should be placed in a publication, the different types of abstracts and what content each type is expected to cover, document-type-specific abstracting recommendations, style guidance, and worked examples. A document's abstracting practice can be described as following Z39.14 when it applies this general guidance -- consistent placement, content coverage matched to abstract type, and a style suited to standalone use by abstracting and indexing services -- rather than any one publisher's or journal's own house-style abstract instructions.
NISO Z39.29 (Bibliographic References)
ANSI/NISO Z39.29-2005 (R2010), Bibliographic References, is the American National Standard that specifies the data elements and construction rules for citing print, audiovisual, and electronic materials, both published and unpublished. It does not mandate a single citation style (it does not compete with APA, MLA, Chicago, or Vancouver); instead it defines the underlying data elements a reference needs to uniquely identify a source (creator, title, date, publisher/source, locator, and medium-specific descriptors) and the construction rules for assembling them, organized across fifteen broad categories of material (books, articles, technical reports, audiovisual works, maps, patents, online/electronic resources, unpublished materials, and others). A document or metadata record operationally conforms to Z39.29 when it captures the standard's required data elements for its material category and assembles them per the standard's ordering/punctuation rules — the same underlying logic that named citation-style guides (APA, MLA, etc.) each format differently on the page. The standard was approved by ANSI in July 2005 and reaffirmed by NISO in May 2010 (hence the "R2010" suffix); as of this writing no newer published edition supersedes it, though NISO solicited volunteers for a possible revision in 2016.
IACUC Adverse Event and Unanticipated Outcome Plan
An IACUC adverse event and unanticipated outcome plan is the written contingency component of an approved animal-use protocol specifying: (1) trigger criteria for what counts as an adverse event or unanticipated outcome for that study (pain, distress, injury, illness, or a clinical sign exceeding the approved humane endpoints); (2) who is authorized to act immediately, in practice the Attending Veterinarian or delegated veterinary staff, who can order treatment, analgesia, or euthanasia without prior investigator consent when welfare requires it; (3) a defined internal reporting pathway and timeframe from the observer to veterinary staff to the IACUC office; and (4) a documented outcome record distinguishing an isolated clinical event from a pattern indicating the protocol itself needs IACUC-reviewed modification. Institutions holding a PHS Animal Welfare Assurance must additionally report specific categories of event -- serious or continuing noncompliance, serious deviation from the Guide for the Care and Use of Laboratory Animals, or an IACUC-ordered suspension -- to OLAW under PHS Policy IV.F.3.
SPRE (Strategy, People and Research Environment)
SPRE is the REF 2029 assessment element scoring the conditions an institution and its submitting units put in place to enable research, replacing REF 2021's Environment element (REF5a/REF5b). It is worth 20% of the overall REF 2029 quality profile, combining an Institution-Level Statement (ILS, 60% of the SPRE score) and a Unit-Level Statement (ULS, 40%), each covering context/mission/strategy, people, income/infrastructure/facilities, and collaboration/engagement/impact. Guidance is still being finalised through 2026.
TCPS 2 Chapter 7 (Conflicts of Interest)
TCPS 2 (the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans), Chapter 7, "Conflicts of Interest," is the chapter of Canada's tri-agency human-research ethics policy that governs how researchers, research ethics boards (REBs) and institutions identify, disclose and manage conflicts of interest arising in human-participant research. A conflict of interest under Chapter 7 exists whenever a person's or institution's duties toward research participants and the research record could be compromised, or could reasonably appear to be compromised, by a competing personal, financial, professional or institutional interest. The chapter treats real, potential and perceived conflicts as equally disclosable -- a conflict does not need to have actually influenced a decision to trigger Chapter 7's disclosure and management requirements, only to create a reasonable appearance that it might. Chapter 7 applies at three distinct levels: individual conflicts (a researcher's own competing interests), institutional conflicts (the institution's own financial or other stake in a study's outcome), and REB-member conflicts (a board member with a personal or professional stake in a protocol under that board's review).
Data Protection Act 2018, Section 19 (Research Safeguards)
DPA 2018 Section 19 was the UK domestic provision requiring that research/archiving/statistics processing under UK GDPR Article 89(1) not be likely to cause substantial damage or distress, and not be used for decisions about a particular individual unless for approved medical research. It was omitted from 5 February 2026 by the Data (Use and Access) Act 2025; the same safeguards now sit in UK GDPR Articles 84B and 84C.
ISO 18626 (Interlibrary Loan Transactions — Application Protocol)
ISO 18626, Information and documentation — Interlibrary loan transactions, is the international application-protocol standard for the messages that library systems exchange to request, supply, and track resource-sharing loans and copies between institutions. A transaction qualifies as ISO 18626-compliant when it is carried out as a defined sequence of XML messages — a Request from the borrowing (requesting) library, and Supplying Agency and Requesting Agency status/action messages exchanged between the two systems — rather than as free-text email, fax, or a proprietary, non-standard API. First published by ISO in 2014, revised in 2017, and further revised as ISO 18626:2021, the standard is maintained under ISO/TC 46, the technical committee for information and documentation.
NISO Z39.98 (Authoring and Interchange Framework for Adaptive XML Publishing)
ANSI/NISO Z39.98-2012, Authoring and Interchange Framework for Adaptive XML Publishing Specification (commonly called the A&I Framework, or by its DAISY-side identifier Z3998), is a joint NISO/DAISY Consortium standard, published in 2012, that defines a modular framework for building XML markup languages for accessible, adaptive publishing rather than a single fixed document format. A publication workflow is 'Z39.98-conformant' when its source XML is authored against a document model built on the A&I Framework's shared architecture (a common core vocabulary plus resource-type-specific modules for books, periodicals, and other content types), so that a single authored source can be transformed into multiple universally accessible output formats -- braille, large print, synthetic speech/DAISY talking book, and EPUB -- without re-authoring content per format. It supersedes ANSI/NISO Z39.86-2005(R2012), the original DAISY Digital Talking Book (DTB) specification, of which it is a substantial, non-backward-compatible redesign -- which is why NISO and the DAISY Consortium issued it under a new standard number rather than as a further DTB revision.
Participant Health Literacy
Participant health literacy is the degree to which a prospective or enrolled research participant can find, understand, and act on the information needed to make a voluntary decision about joining a study and to follow study procedures once enrolled. In practice, a research team is designing for participant health literacy whenever it (1) writes consent forms, recruitment materials, and result-summary/plain-language-summary documents at a reading level and format the target population can actually process (commonly benchmarked to roughly a 6th-8th grade level, though neither the Common Rule nor FDA regulations set a numeric threshold -- both simply require information 'understandable to the subject'), and (2) actively checks comprehension rather than assuming it, most often via the teach-back method: asking the participant to restate key study facts (purpose, main procedures, risks, voluntariness, right to withdraw) in their own words before consent is finalized. A document or process only counts as addressing health literacy if both elements -- accessible language AND a comprehension check -- are present; a well-simplified form that nobody ever asks the participant to explain back is a partial, not complete, application of the concept.
IRB Approval and Expiration of Recruitment Materials
IRB approval and expiration of recruitment materials refers to the fact that flyers, advertisements, social-media posts, phone/email scripts, screening questionnaires, and other materials used to identify and approach prospective participants are themselves reviewed and approved by the IRB as part of the informed-consent process -- not treated as separate marketing collateral -- and that approval carries its own expiration date, tied to the study's current approval period, independent of whether the underlying protocol itself continues. A recruitment or screening document is an approved recruitment material only for the interval the IRB has authorized; once that interval lapses, the material cannot be used to recruit or screen new participants even if the protocol has not been suspended or terminated and even if continuing review is only pending, not yet complete.
Research Security
Research security is the set of institutional and federal policies, disclosures, and safeguards designed to protect the U.S. federally funded research enterprise against foreign government interference, undisclosed foreign support, and the misappropriation of research and development. The controlling federal definition comes from National Security Presidential Memorandum 33 (NSPM-33) (issued January 2021) and its implementing guidance from the National Science and Technology Council (NSTC): research security means "safeguarding the research enterprise against the misappropriation of research and development to the detriment of national or economic security, related violations of research integrity, and foreign government interference." An activity, disclosure, or policy is an instance of research security -- as distinct from general information security, export control, or research integrity -- when it satisfies three conditions together: (1) it concerns federally funded or federally regulated research; (2) it addresses a risk tied to foreign government interference, undisclosed foreign talent recruitment, or misuse of research outputs for national/economic security ends; and (3) it maps to one of the concrete compliance mechanisms federal research agencies now require -- disclosure of foreign financial support and affiliations, foreign travel security, research security training, export control training, and cybersecurity controls for federally funded R&D. Under NSPM-33's implementation, research organizations that receive more than $50 million per year in federal research funding must certify they operate a research security program covering four elements: cybersecurity, foreign travel security, research security training, and export control training.
ICH E6(R2) Section 5 Sponsor Obligations
A duty ICH E6(R2) Section 5 (subsections 5.0 through 5.23) assigns by default to the trial sponsor -- spanning quality management, quality assurance/control, CRO oversight, trial management and recordkeeping, investigator selection, subject/investigator compensation, investigational-product supply, safety reporting and monitoring, audit, noncompliance handling, trial termination/suspension, and multicenter-trial coordination -- that the sponsor retains unless specifically transferred in writing to a CRO under Section 5.2.
DARPA Countering Foreign Influence Program (CFIP)
A DARPA-specific risk-review process, applied to proposed awards, in which senior/key personnel disclosures are screened against a qualitative risk rubric covering participation in foreign talent programs, affiliation with denied or restricted entities, funding or in-kind support from foreign government sources, and affiliation with designated high-risk foreign institutions, generally over the preceding four years, with results assigned a risk level from low to very high that informs (but does not automatically decide) award negotiation.
AAALAC Accreditation Requirements
The specific set of standards and recurring obligations an institution must satisfy to achieve and then keep AAALAC International accreditation: evaluating its animal care and use program against AAALAC's Three Primary Standards (principally the Guide for the Care and Use of Laboratory Animals), submitting a detailed Program Description and hosting an on-site peer review before initial accreditation, then filing an Annual Report every year and undergoing a full site visit roughly every three years to keep that status.
Program of Veterinary Care (PVC)
A Program of Veterinary Care (PVC) is the documented set of policies, procedures, and staffing arrangements through which an institution's Attending Veterinarian provides adequate veterinary care to animals used in research, teaching, and testing. It is a required component of an animal-care-and-use program under Animal Welfare Act regulations (9 CFR 2.33) and, in parallel, under PHS Policy for PHS-supported vertebrate-animal research. A program qualifies as an adequate PVC only if it addresses, at minimum: preventive medicine (quarantine, disease surveillance, herd/colony health monitoring, vaccination and parasite control where applicable); appropriate methods for preventing, controlling, diagnosing, and treating disease and injury; guidance and oversight of surgery (pre-, intra-, and post-operative care) and of anesthesia and analgesia use, including a mechanism for the Attending Veterinarian to require or adjust pain relief; a means of communication so personnel promptly report animal health concerns; and 24-hour availability of emergency veterinary care. Where the Attending Veterinarian serves in a part-time or consultant capacity rather than full-time employment, 9 CFR 2.33 requires the arrangement to be formalized through a written program of veterinary care and regularly scheduled site visits, not an informal or on-call-only relationship.
EU AI Act Annex III (High-Risk Use Cases)
A system falls under EU AI Act Annex III when it (1) is one of the eight listed use-case categories -- biometrics, critical infrastructure, education and vocational training, employment, essential services, law enforcement, migration, or administration of justice -- and (2) performs the specific function that category text describes (e.g., for education: admissions/access decisions, evaluating learning outcomes, assessing appropriate education level, or monitoring prohibited test behaviour). Matching both conditions triggers high-risk status under Article 6(2), subject to the narrow Article 6(3) exception, which itself never applies if the system profiles natural persons.
TCPS 2 Article 3.1 (Free and Informed Consent)
TCPS 2 (the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2022 edition) Article 3.1, in Chapter 3 ('The Consent Process'), sets out Canada's core requirement that participation in research involving human participants be based on free, informed, and ongoing consent. A consent process satisfies Article 3.1 when: (1) it is FREE -- given voluntarily, without manipulation, undue influence, or coercion; (2) it is INFORMED -- the prospective participant has enough understandable information about the research's purpose, procedures, reasonably foreseeable risks and potential benefits to make a genuine choice; and (3) it is ONGOING -- treated as a continuing process rather than a single signature, with researchers under a standing obligation to disclose material changes in risk or benefit as the study proceeds, and to reconfirm consent or offer withdrawal where warranted. Research Ethics Boards (REBs) are directed to apply particular scrutiny to trust or dependency relationships (for example, physician-patient or professor-student) where the relationship itself could create undue influence on a prospective participant's decision to take part.
GDPR Article 22 (Automated Decision-Making in Research)
GDPR Article 22(1) gives a data subject 'the right not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her.' A research activity triggers Article 22 only if all three elements hold at once: (1) the decision is made solely by an automated system, with no meaningful human involvement in reaching the specific outcome -- a human merely rubber-stamping an algorithmic output does not count as meaningful involvement, but a human who genuinely reviews the case and can depart from the system's recommendation does; (2) the processing includes profiling or another automated evaluation of the person, not just automated data collection or storage; and (3) the decision produces a legal effect or similarly significant effect on that individual -- something that meaningfully affects their circumstances, behaviour, or choices, not a trivial or cosmetic outcome. In a research context this most commonly arises where an AI/ML system automatically screens, ranks, or excludes real individuals as part of a study -- for example, a clinical-trial-eligibility screening tool that auto-rejects applicants, or an automated participant-selection or risk-stratification algorithm that determines who is invited, enrolled, or offered an intervention -- as opposed to a model that only analyses aggregate or already-anonymised data with no decision made about a specific identifiable person. Article 22(2) narrows this to a qualified right rather than an absolute prohibition: solely automated decisions with legal/significant effect are permitted where (a) necessary for entering into or performing a contract, (b) authorised by Union or Member State law that also lays down suitable safeguards, or (c) based on the data subject's explicit consent. Where (a) or (c) applies, Article 22(3) requires the controller to implement suitable safeguards -- at minimum the right to obtain human intervention, to express a point of view, and to contest the decision. Article 22(4) adds a further restriction: these decisions must not be based on special category data (Article 9(1) -- including data concerning health, which covers most clinical and biomedical research) unless a specific Article 9(2)(a) or (g) exemption applies and suitable safeguards are in place. For research controllers, this means an automated eligibility or selection tool operating on health or genetic data faces a materially higher bar than one operating on non-sensitive data, even where a general Article 6 lawful basis for the underlying processing is otherwise sound.
EU AI Act Article 53 (General-Purpose AI Model Obligations)
Article 53 of the EU AI Act (Regulation (EU) 2024/1689) sets the baseline obligations that apply to every provider of a general-purpose AI (GPAI) model placed on the EU market -- a model trained on large amounts of data using self-supervision at scale, showing significant generality, and capable of competently performing a wide range of distinct tasks (Article 3(63)). A GPAI provider must, at minimum: (1) draw up and keep current technical documentation of the model per Annex XI, available on request to the AI Office and national authorities; (2) draw up and make available to downstream AI-system providers the information and documentation set out in Annex XII needed to understand the model's capabilities and limitations; (3) put in place a policy to comply with EU copyright law, including respecting rightsholders' text-and-data-mining opt-outs reserved under Article 4(3) of Directive (EU) 2019/790; and (4) draw up and publish a sufficiently detailed summary of the content used to train the model, following a template the AI Office provides. These obligations became applicable on 2 August 2025 (Article 113(b)). Models released under a genuinely free and open-source licence, with publicly available weights, architecture, and usage information, are exempt from obligations (1) and (2) above -- but never from the copyright-policy or training-data-summary duties, and never at all if the model is also classified as carrying 'systemic risk.'
EU AI Act Article 6 (High-Risk Classification Rules)
Article 6 of the EU AI Act (Regulation (EU) 2024/1689) is the classification test that determines whether an AI system counts as 'high-risk.' An AI system is high-risk if either: (1) under Article 6(1), it is a safety component of, or is itself, a product covered by EU harmonisation legislation listed in Annex I and that product requires third-party conformity assessment; or (2) under Article 6(2), it falls into one of the eight functional use-case categories listed in Annex III (biometrics; critical infrastructure; education/vocational training; employment/worker management; essential private and public services; law enforcement; migration/asylum/border control; administration of justice and democratic processes). Article 6(3) provides a narrow, documented exception for Annex III systems that perform only a narrow procedural task, improve a completed human activity's result, detect patterns without replacing human assessment, or perform preparatory tasks -- unless the system profiles natural persons, in which case it is always high-risk. Classification under Article 6 is the trigger, not the substance: it determines whether the Title III, Chapter 2 obligations (risk management, data governance, technical documentation, human oversight, and more) apply at all.
Tri-Agency Framework: Responsible Conduct of Research (RCR)
The Tri-Agency Framework: Responsible Conduct of Research is the joint policy of Canada's three federal research funding agencies -- the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC) -- that defines researcher, institution, and Agency responsibilities for research integrity, sets minimum requirements for institutional RCR policies, defines what constitutes a breach of Agency policies, and specifies the process the Agencies follow when addressing allegations of a breach. It applies to research funded in whole or in part by any of the three Agencies, and is administered jointly by the Secretariat on Responsible Conduct of Research (SRCR) and the Interagency Advisory Panel on Responsible Conduct of Research (PRCR). The current edition took effect in 2021, replacing the 2016 version.
EU AI Act Article 5 (Prohibited AI Practices)
Article 5 of Regulation (EU) 2024/1689 (the EU AI Act) lists AI practices that are banned outright across the EU, regardless of sector, risk classification, or intended purpose — including scientific research. A practice falls under Article 5 if it matches one of eight prohibited categories: (a) subliminal or purposefully manipulative/deceptive techniques that materially distort behaviour and cause significant harm; (b) exploitation of vulnerabilities tied to age, disability, or a specific social or economic situation; (c) social scoring by public or private actors leading to detrimental treatment in a context unrelated to the data that generated the score; (d) predictive policing based solely on profiling or personality-trait assessment, without objective, verifiable facts linked to a criminal activity; (e) untargeted scraping of facial images from the internet or CCTV footage to build or expand facial-recognition databases; (f) emotion inference in workplace or education settings, except for narrow medical or safety reasons; (g) biometric categorisation to infer race, political opinion, trade union membership, religion, sex life, or sexual orientation; and (h) real-time remote biometric identification in publicly accessible spaces for law enforcement, prohibited except for three narrowly defined purposes (searching for specific victims of trafficking or missing persons, preventing an imminent and specific terrorist threat, or locating a suspect in specific serious crimes carrying at least a 4-year custodial sentence), each requiring prior judicial or independent administrative authorisation. These provisions applied from 2 February 2025 — six months ahead of most of the rest of the Act — and unlike the Act's high-risk-system obligations, there is no proportionality test, self-assessment route, or conformity-assessment pathway around them: a matching practice is unlawful outright, and violations sit in the Act's highest penalty tier under Article 99 (administrative fines of up to €35 million or 7% of total worldwide annual turnover, whichever is higher).
Favourable Opinion (NHS REC)
The formal outcome an NHS Research Ethics Committee (REC) in the UK issues after reviewing a research proposal, confirming the study raises no outstanding ethical objections -- or only minor points that do not require re-review by the full committee -- so that, subject to any standard conditions, the research may proceed toward HRA Approval (or HCRW Approval in Wales) and site-level activation.
TCPS 2 Article 2.1 (REB Review Requirement)
Article 2.1 of Canada's Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) is the threshold rule that triggers Research Ethics Board (REB) review: research involving living human participants, or research involving human biological materials (including embryos, fetuses, fetal tissue, reproductive materials, and stem cells related to human reproduction), must undergo REB review and receive REB approval before the research commences, and that approval must be maintained for the duration of the research. It is the operational test institutions apply to decide whether a proposed project needs to go to an REB at all -- if a project meets the Article 2.1 description and no Article 2.2-2.4 exception applies, REB review is mandatory; if it does not meet the description (for example, because it is not 'research' as TCPS 2 defines the term, such as certain quality-assurance, quality-improvement, or program-evaluation activities), REB review under this article is not required.
IEEE Plagiarism Policy and Prohibited Authors List (PAL)
IEEE (the Institute of Electrical and Electronics Engineers) investigates plagiarism complaints against its journals, transactions, and conference papers using a published five-level severity scale (Level One through Level Five) set out in IEEE's PSPB Operations Manual and its accompanying 'Plagiarism Levels and Corrective Actions' guidance. The scale grades a case by extent of uncredited or improperly credited verbatim copying, from Level One (an entire paper, or more than 50% of one, copied without credit, or verbatim reuse spanning more than one paper by the same author) down to Level Five (verbatim text copied from a credited source but not clearly marked as a direct quotation). Corrective actions scale with the level and with repeat-offense history, ranging from a required letter of apology through a suspension of an author's submission privileges to specific IEEE publications for a fixed period -- commonly cited ranges run from about one to five years -- up to a lifetime prohibition on publishing in any IEEE-copyrighted venue for the most serious or repeated Level One violations, administered at the discretion of the IEEE Publication Services and Products Board (PSPB) Chair. An author under an active submission suspension is added to IEEE's internal screening list -- long known as the Prohibited Authors List (PAL) and, per more recent PSPB Operations Manual language, formally relabeled the PPL -- which IEEE publication volunteers (editors, program chairs) check via an internal PAL Database tool before accepting a submission, to confirm a listed name is not attempting to submit to a venue it is currently barred from.
IRB Noncompliance Determination
An IRB noncompliance determination is the formal process and written outcome by which an IRB, or an institution's Human Research Protection Program/compliance office acting on the IRB's behalf, investigates a report that an approved protocol or IRB requirement was not followed and classifies the finding as either administrative/minor noncompliance (handled at routine review) or serious or continuing noncompliance under 45 CFR 46.113 / 21 CFR 56.113, together with whatever corrective action or suspension/termination the finding requires. It is the upstream procedure that produces a serious-or-continuing finding; see the separate IRB Violations term for what that threshold means and OHRP's own compliance-oversight role once a finding is reported.
IEEE Conflict of Interest Disclosure
IEEE conflict of interest (COI) disclosure refers to the author- and reviewer-facing conflict-of-interest rules IEEE applies across its journals, transactions, magazines, and conferences, set out through IEEE Author Center guidance and the editorial policies of individual IEEE technical societies. It is distinct from a generic conflict-of-interest disclosure in two ways specific to IEEE's editorial process: IEEE defines a conflict along three tiers -- actual, perceived, and potential -- rather than a single financial-interest dollar threshold, and IEEE devolves the operational specifics (what a reviewer must disclose, how far back a prior collaboration counts, how long a mentorship cooling-off period lasts) to the sponsoring technical society or specific journal rather than fixing one uniform disclosure form across all of IEEE, the same way the specific mechanics of IEEE's peer-review model are set at the society level rather than uniformly.
GDPR Article 5(1)(b) Purpose Limitation (Compatible Research Use)
Article 5(1)(b) of the EU General Data Protection Regulation (GDPR) states the purpose limitation principle: personal data must be "collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes." The same provision then carves out a specific exception: "further processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes shall, in accordance with Article 89(1), not be considered to be incompatible with the initial purposes." In practice, this means a controller who wants to reuse personal data originally collected for another reason (clinical care, a prior study, an administrative register, a commercial service) for a new research purpose does not need to separately satisfy the compatibility test in Article 6(4) for that reuse, provided the processing genuinely falls within one of the four named purposes and Article 89(1) safeguards are in place. It is a compatibility fiction created by the Regulation itself, not a blanket exemption from the rest of the GDPR: the controller still needs a valid Article 6(1) lawful basis for the further processing, still needs an Article 9(2) condition if the data are special category, and still has to apply Article 89(1) safeguards - technical and organisational measures, and pseudonymisation or an equivalent minimisation measure wherever the research purpose can still be fulfilled that way.
GDPR Article 6(1)(e) Public Task Legal Basis
GDPR Article 6(1)(e) is one of six lawful bases in Article 6(1) that can justify processing personal data. It applies where processing is 'necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.' A processing activity qualifies as an instance of this basis only if two conditions both hold: (1) the controller is carrying out a task that is genuinely public-interest or official-authority in nature -- not merely a task the controller happens to think is worthwhile -- and (2) per Article 6(3), that task is 'laid down by Union law or Member State law to which the controller is subject.' The second condition is the operative test: a public university or public research institute cannot simply assert 'research is in the public interest' and stop there. There must be an identifiable legal basis in national or EU law -- a statute, charter, or regulation establishing the institution's research/education function, or (as is increasingly common) an explicit research-processing provision in a member state's GDPR-implementing legislation -- that the controller can point to as the source of the task. Article 6(3) further requires that this legal basis meet an objective of public interest and be proportionate to the legitimate aim pursued, and it permits (but does not require) the law to specify further conditions such as who may process, purpose limitation, storage periods, and processing operations. Public task is distinct from Article 6(1)(f) legitimate interests, which is explicitly unavailable to public authorities 'in the performance of their tasks' (Article 6(1), final sentence) -- meaning a public university carrying out research cannot fall back on legitimate interests if public task is unavailable or fails; it is also distinct from Article 6(1)(a) consent, which remains valid but carries the withdrawal risk described below.
GDPR Recital 33 (Broad Consent for Scientific Research)
GDPR Recital 33 is the preambular text explaining how consent works for scientific research when the exact processing purpose cannot be fully specified at the time of data collection. It states that it is often not possible to fully identify the purpose of personal data processing for scientific research at the time of collection, and that data subjects should therefore be allowed to give consent to certain areas of scientific research, or to parts of a research project, when this is done in keeping with recognised ethical standards for scientific research. A data-processing activity satisfies Recital 33 when: (1) the research purpose genuinely could not be fully specified at collection because the research programme is exploratory, longitudinal, or intends future secondary uses that are not yet known; (2) the consent describes the research area, field, or project scope at a level a reasonable data subject can understand, rather than describing nothing at all; (3) the data controller applies recognised research-ethics oversight (e.g. an ethics committee or IRB/REC review) and appropriate safeguards under GDPR Article 89(1) (data minimisation, pseudonymisation where feasible); and (4) the data subject retains the ability to consent to only part of the described research, or to withdraw later. Recital 33 is not itself an operative legal obligation — recitals explain and interpret the numbered Articles but do not impose independent duties. In the consent context, the operative provisions are GDPR Article 6(1)(a) (consent as a lawful basis) and, for special category data such as health or genetic information, Article 9(2)(a) (explicit consent) or the Article 9(2)(j) research derogation as implemented in national law. Recital 33 is cited by regulators, ethics committees, and the European Data Protection Board to justify why research consent can be broader and more programme-level than the general GDPR consent standard, which otherwise requires a specific, informed, unambiguous indication of the data subject's wishes for a defined purpose.
Human Fetal Tissue Research (NIH Policy Framework)
Human fetal tissue (HFT) research is research using tissue or cells obtained from a deceased human embryo or fetus, most often following a pregnancy loss. Where federal funding is involved and the tissue was obtained from an induced (elective) abortion, HFT research is governed by a distinct statutory and policy layer on top of the general Common Rule: the NIH Revitalization Act of 1993 (42 U.S.C. §§289g-1, 289g-2), which sets informed-consent and donation conditions and establishes a Human Fetal Tissue Research Ethics Advisory Board (EAB) mechanism for reviewing funding decisions on ethical grounds, plus successive HHS/NIH policy notices that have repeatedly changed whether and how such research may be federally funded.
Subrecipient Risk Assessment
The evaluation a pass-through entity must perform on each proposed subrecipient before making a subaward of federal funds, under 2 CFR 200.332(c) — considering prior experience with similar subawards, results of previous audits, new or substantially changed personnel/systems, and the extent and results of any federal agency monitoring — performed specifically to set the intensity of the monitoring plan applied once the subaward is active.
NREC (National Office for Research Ethics Committees, Ireland)
The NREC (National Office for Research Ethics Committees) is the statutory Irish body, hosted by the Health Research Board (HRB) since 2020, that establishes and administers Ireland's National Research Ethics Committees for legally regulated research: clinical trials of investigational medicinal products (NREC-CT) and clinical investigations of medical devices (NREC-MD), plus committees stood up for specific national needs such as the National Irish COVID-19 Biobank (NICB-REC) and COVID-19 research (NREC COVID-19). A study falls under NREC review, rather than a local HSE, hospital, or university Research Ethics Committee, when it is a Regulated Clinical Trial under the EU Clinical Trials Regulation (536/2014) or a regulated medical-device clinical investigation, in which case a single national ethics opinion from the relevant NREC is required, issued in a coordinated procedure alongside the scientific/regulatory assessment carried out by the Health Products Regulatory Authority (HPRA). Outside that regulated scope, most observational studies, most academic health and social-care research, and research within the HSE and HSE-funded hospitals, ethical review remains the responsibility of local HSE and Hospital Research Ethics Committees, not the NREC.
Waiver of Informed Consent (45 CFR 46.116(f))
A waiver of informed consent under 45 CFR 46.116(f) is an IRB determination that a study may enroll subjects, or use their identifiable private information or identifiable biospecimens, without obtaining informed consent at all -- distinct from merely waiving the signed-form requirement under 46.117(c). An IRB (or, for research eligible for expedited review, an IRB chair or designated reviewer) may approve a full waiver or alteration of consent only after finding, and documenting in the study record, that all five criteria in 46.116(f)(3) are met: (i) the research involves no more than minimal risk to the subjects; (ii) the research could not practicably be carried out without the waiver or alteration; (iii) if the research uses identifiable private information or identifiable biospecimens, it could not practicably be carried out without using that information or those biospecimens in identifiable form; (iv) the waiver or alteration will not adversely affect the rights and welfare of the subjects; and (v) whenever appropriate, subjects or their legally authorized representatives will be provided with additional pertinent information after participation. This mechanism is the standard route for retrospective chart-review and secondary-database research, where re-contacting every prior patient to obtain prospective consent is often not feasible and would itself undermine the value or completeness of the dataset.
Concordat to Support Research Integrity
The UK's sector-wide research integrity framework document, originally published by Universities UK in 2012, revised in 2019, and refreshed in 2025, that individual UK universities, funders, and sector bodies formally sign up to as named signatories. A signatory organisation commits to five thematic commitments and is expected to publish an annual public statement evidencing how it has acted on each one.
ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting)
ICH E2A is the ICH tripartite guideline (Step 4, 1994; adopted by FDA, EMA, and Japan) that defines Adverse Event, Adverse Reaction, Serious, and Unexpected, cascades those into the SUSAR (Suspected Unexpected Serious Adverse Reaction) category, and sets the expedited safety-reporting clock -- 7 calendar days for fatal/life-threatening SUSARs, 15 calendar days for all other SUSARs, measured from sponsor awareness. It is the regulatory-standard-level source that IND Safety Reports, Safety Letters, and national expedited-reporting rules (21 CFR 312.32 in the US; EU Regulation (EU) No 536/2014) all implement.
2 CFR 200 Subpart B (General Provisions)
2 CFR 200 Subpart B ("General Provisions," 2 CFR 200.100-200.113) is the foundational, scope-setting subpart of the OMB Uniform Guidance. It does not itself create administrative, cost, or audit requirements the way Subparts C through F do; instead it establishes the purpose and legal authority behind the whole of 2 CFR 200, defines who and what it applies to (and what is excepted), fixes how it interacts with prior and future agency guidance, assigns OMB and federal-agency implementation responsibilities, and sets two obligations that apply across every award regardless of subject matter: a written conflict-of-interest standard (200.112) and mandatory disclosure of certain violations of federal criminal law (200.113). A requirement belongs to Subpart B if it concerns whether and how the Uniform Guidance applies at all, rather than a specific administrative, cost, or audit rule once it does apply.
NSF AI Dear Colleague Letter (DCL)
An NSF AI Dear Colleague Letter (DCL) is any of several topic-specific Dear Colleague Letters the National Science Foundation has issued that have artificial intelligence as their explicit subject -- typically flagging a funding priority and directing proposers toward an existing mechanism (RAPID, Planning Grant, EAGER, or a standing program) rather than creating an independent competition. To count as one, a document must (a) be formally issued as a DCL under NSF's Proposal & Award Policies & Procedures Guide (PAPPG) Chapter I definition, carrying an NSF publication number in the nsf.gov DCL series, and (b) name AI/generative AI as the letter's subject. This is a narrower category than 'NSF AI policy' generally, and it explicitly excludes NSF's December 2023 guidance on generative-AI use in the merit review process, which was issued as a Notice to the Research Community, not a DCL -- a distinction searchers frequently get wrong and this page exists to clarify.
Translated Informed Consent Materials
Consent materials count as compliant "translated informed consent" when they make the required disclosure elements of 45 CFR 46.116 (and, for FDA-regulated research, 21 CFR 50.25) understandable to a prospective participant who does not read or speak English proficiently — satisfied through one of two IRB-approved pathways: (1) a fully translated long-form consent document, reviewed and approved by the IRB before use, or (2) the short-form written consent process under 45 CFR 46.117(b)(2) / 21 CFR 50.27(b)(2), in which a brief document in the participant's language states that the required elements were presented orally, backed by a bilingual witness and the English-language summary the person obtaining consent signs. Neither pathway is optional paperwork — both require prospective IRB approval, and neither can be improvised at the bedside or in the field without one.
Safety Letter (Dear Investigator Letter)
A Safety Letter — almost universally called a Dear Investigator Letter (DIL) in practice — is the direct, investigator-facing document a trial sponsor sends to every participating site in a multi-site clinical trial when new safety information emerges that could affect subjects' welfare, the risk-benefit assessment of the investigational product, or how the trial is conducted. It is the notification artifact itself: the letter (or attached safety report) an investigator physically receives, reads, and is expected to act on — distinct from the underlying regulatory reporting mechanisms (an IND Safety Report to FDA, or a periodic DSUR) that may trigger it. Under US law, the obligation traces to 21 CFR 312.55 ("Informing investigators"), which requires a sponsor to keep every participating investigator informed of new observations on the drug — particularly adverse effects and safe use — "as the overall investigation proceeds," and specifically to ensure investigators are promptly informed of significant new adverse effects or risks. The regulation names periodically revised Investigator's Brochure updates, reprints of published studies, and "reports or letters to clinical investigators" as acceptable means of distribution — the Dear Investigator Letter is that last category in standard industry practice. ICH E6(R2) Sections 5.16–5.18 place the parallel expectation on sponsors internationally: ongoing safety evaluation, and prompt notification of investigators, IRBs/ECs, and regulators when new information could affect the conduct of the trial or the risk to subjects.
Export Control and AI (EAR/ITAR Applied to AI Models and Systems)
Export control and AI refers to how the US Export Administration Regulations (EAR, 15 CFR Parts 730-774, administered by the Commerce Department's Bureau of Industry and Security, or BIS) and the International Traffic in Arms Regulations (ITAR, 22 CFR Parts 120-130, administered by the State Department) apply to artificial intelligence and machine learning software, trained models, model weights, training datasets, and the underlying computing hardware used in research. An AI-related item, dataset, or system is subject to export control analysis if it is US-origin, meets an EAR or ITAR jurisdictional trigger, and either physically leaves the United States, is transmitted electronically to a destination abroad, or is released ('deemed exported') to a foreign national inside the United States who is not a US citizen, lawful permanent resident, or protected individual.
Medicare Clinical Trial Policy (NCD 310.1)
The Medicare Clinical Trial Policy is the national coverage framework, codified as National Coverage Determination (NCD) 310.1 ("Routine Costs in Clinical Trials"), under which Medicare pays the routine patient-care costs of a beneficiary enrolled in a qualifying clinical trial, plus reasonable and necessary costs of treating complications from participation. A trial only qualifies if it meets three threshold criteria (the studied intervention falls within a Medicare benefit category, the trial has therapeutic intent, and trials of a therapeutic intervention enroll patients with a diagnosed disease) and satisfies at least one deeming criterion: funding or endorsement by NIH, CDC, AHRQ, CMS, DOD, or VA (or by a cooperative group/center they support); conduct under an FDA Investigational New Drug (IND) application; or exemption from IND requirements as a drug trial under 21 CFR 312.2(b)(1). A trial that meets none of these is not automatically excluded, but its sponsor must instead complete CMS's qualifying-trial checklist demonstrating the trial's scientific validity and integrity. Separately, since Change Request 5790 (Transmittal 310, effective 2008), Medicare claims for routine costs under a qualifying trial must report the trial's ClinicalTrials.gov identifier (the NCT number) alongside condition code 30 -- so registration in the National Library of Medicine's public registry functions, in practice, as a billing prerequisite: a claim without a valid NCT number is at risk of denial even if the trial itself otherwise qualifies.
Cognizant Federal Agency
A cognizant federal agency (for indirect costs) is the single federal agency assigned, under 2 CFR 200 Appendix III (institutions of higher education) or Appendix IV (nonprofit organizations), to negotiate and approve a given institution's indirect (F&A) cost rate and to review certain institution-wide compliance matters on that institution's behalf for all federal awarding agencies. It is assigned to the institution as a whole, generally based on which agency has provided the largest share of that institution's federal funding over a recent multi-year period -- it is not chosen by the institution, and it is not the same thing as the awarding agency on any single grant.
Pilot Study
A small-scale study that runs a scaled-down but methodologically faithful version of a planned future study’s actual protocol — same recruitment approach, same intervention delivery, same outcome measures and data-collection procedures — in order to test whether the full-scale study is workable, refine its methods and instruments, and generate preliminary parameter estimates (recruitment rate, adherence, rough effect size or outcome variance) before committing to the definitive study. A pilot study is one specific subtype of feasibility study — the one that tests feasibility by actually running the intended methods, rather than assessing feasibility through other means (surveys, record review, capacity audits). It is not designed to formally test whether an intervention works, and it is a distinct concept from a Phase I clinical trial, which is a defined stage in the drug-development regulatory pathway rather than a general research-methodology device.
Section 117 Foreign Gift and Contract Reporting
An institution triggers Section 117 of the Higher Education Act (20 U.S.C. § 1011f) reporting when it is a covered institution — offering a bachelor's degree or higher (or an at-least-two-year transfer program toward one), accredited by a nationally recognized accrediting agency, and receiving federal financial assistance — and it receives a gift from, or enters a contract with, a foreign source valued at $250,000 or more, either alone or cumulatively with all other gifts and contracts from that same foreign source, within a calendar year. Institutions owned or controlled by a foreign source must separately disclose that relationship, with no dollar threshold. Covered institutions report semiannually to the U.S. Department of Education (historically due January 31 and July 31, for the preceding six-month period); as of January 2026, filings go through ED's new foreignfundinghighered.gov reporting portal.
Research Security Officer (RSO)
The Research Security Officer (RSO) is the institutional official or office that coordinates a research institution's research security program under NSPM-33 and the CHIPS and Science Act of 2022 -- owning export control review, foreign-influence and foreign talent recruitment program disclosure, cybersecurity coordination for federally funded research, insider-threat and travel-security policy, training rollout, and certification to funding agencies that the required program is in place. "Research Security Officer" is not a title NSPM-33 itself mandates verbatim -- it is the role most covered institutions have created to hold that accountability.
NIH Closeout
NIH closeout is the agency-specific implementation of the federal closeout requirements at 2 CFR 200.344, layered with NIH's own reporting mechanics: a recipient institution must submit a Final Research Performance Progress Report (Final RPPR), a Final Federal Financial Report (FFR, SF-425), and, where applicable, a Final Invention Statement and Certification (FIS), all within 120 calendar days of the end of the project period. The Final RPPR and any Final Progress Report Additional Materials (FRAM) are submitted through eRA Commons; the FFR is submitted through the federal Payment Management System (PMS), which eRA Commons' FFR module routes recipients to. An award is not considered closed until NIH has received and accepted all three documents and reconciled the award's financial status -- late or missing documents can trigger NIH's unilateral closeout process, in which NIH closes the award administratively without the recipient's final reports, which can result in disallowed costs and complicate future award processing for the institution.
HSE Research Ethics Committee
An HSE Research Ethics Committee (REC) is one of the independent ethics review bodies operating within Ireland's Health Service Executive (HSE) and HSE-funded hospitals to provide ethical approval for health research conducted in the Irish public health system. HSE/Hospital RECs review studies that recruit participants through publicly funded health services, use personal healthcare data or biological samples from service users, involve health and social care staff as participants or researchers, or are hosted within publicly funded healthcare infrastructure. They are distinct from Ireland's National Office for Research Ethics Committees (NREC), a separate statutory body under the Department of Health that provides single national ethical approval only for regulated clinical trials of investigational medicinal products, regulated medical device investigations, and regulated performance studies of in-vitro diagnostic devices. Research falling outside NREC's narrower statutory scope -- including most observational, data-driven, and non-regulated clinical research -- is reviewed by an HSE or Hospital REC instead. The HSE is currently reforming this system, moving from a fragmented set of local committees toward six regional HSE Reference RECs aligned with Sláintecare Regional Health Areas, each operating to a Standard Code of Governance and Management and supported by the HSE Research Ethics Committees Support and Coordination Office, which reports to the National Committee for the Governance, Management and Support of Research.
CARE Case Report Guidelines
The CARE (CAse REport) Guidelines are a 13-item reporting checklist, developed by an international consensus group and published in 2013, that specifies what a clinical case report must include -- patient information, timeline, diagnostic assessment, intervention, and outcome -- for it to be complete, transparent, and usable by other clinicians and reviewers.
Statistical Analysis Plan (SAP)
A Statistical Analysis Plan (SAP) is the pre-specified document that translates a clinical trial protocol's objectives and endpoints into the exact statistical methodology that will be used to analyze the trial's data — which populations are analyzed (e.g. intent-to-treat/full analysis set vs. per-protocol set), which statistical tests and models are applied to each endpoint, how missing data and multiplicity are handled, and what any interim or subgroup analyses will consist of. A document only functions as a genuine SAP if it is finalized and version-locked before database lock and unblinding — that is, before anyone with access to outcome data can see how the results turn out. A statistical methods section written or substantively revised after the analysts already know (or could infer) the results is not a valid SAP in the ICH E9 sense, regardless of what it is called, because it no longer prevents the analytic flexibility (selective reporting, post-hoc subgroup mining, outcome-switching) that pre-specification exists to close off.
Nature Portfolio Reporting Summary
A mandatory, standardized fillable-PDF form Nature Portfolio requires with manuscript submission for life sciences, behavioural & social sciences, or ecological/evolutionary/environmental sciences research articles, disclosing statistics reporting, software/code, data availability, and a field-specific study-design track (sample size, data exclusions, replication, randomization, blinding, or their track-specific equivalents), with negative disclosures required rather than fields left blank; the completed form is shared with editors/reviewers during assessment and published alongside the accepted paper.
ICMJE Generative AI Policy
The International Committee of Medical Journal Editors (ICMJE) sets out its rules on generative AI in Section II.A.4 of its Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, added in the May 2023 update. The policy rests on three linked rules: (1) chatbots and other AI tools cannot be listed as authors because they cannot take responsibility for the accuracy, integrity, and originality of the work and cannot approve a final version for submission, so they fail ICMJE's own authorship criteria by definition; (2) at submission, authors must disclose whether AI-assisted technologies were used, with the disclosure location depending on how the tool was used — writing, editing, or proofreading assistance is described in the Acknowledgments section, while use of AI to collect or analyze data or to generate figures is reported in the Methods section; and (3) human authors remain fully responsible for any submitted material produced with AI assistance, including reviewing and editing AI output carefully, because such tools can generate authoritative-sounding text that is incorrect, incomplete, or biased.
DOE AI Policy
"DOE AI policy" most precisely refers to the U.S. Department of Energy's Generative Artificial Intelligence Policy (DOE P 2031, "Use of Generative Artificial Intelligence," issued December 29, 2025) -- a departmental directive governing how DOE's own federal workforce and National Laboratory staff may adopt, deploy, and use generative AI tools in their work. It sits inside DOE's broader 200-series management directives and was written to align with the October 2023 White House Executive Order on AI and the March 2024 OMB Memorandum M-24-10 on federal agency AI governance. It is an internal governance instrument, not an applicant-facing submission requirement: it does not create a DOE-wide rule that external grant applicants, proposers, or awardees must disclose generative AI use when submitting a funding opportunity announcement (FOA) response. Where DOE's policy does touch research practice directly is inside the agency: when generative AI contributes to an idea, approach, or invention developed at DOE or a National Laboratory, DOE staff are expected to identify that specific contribution and cite the GenAI tool as part of the research methodology, consistent with the department's broader research-integrity and record-keeping expectations. Research administrators should not assume this term is interchangeable with the applicant-facing generative AI disclosure notices published by other funders -- see NSF AI Policy and Nature Portfolio AI Policy for that different category of policy -- and should always check the specific DOE FOA's own instructions and applicable acquisition regulations for any submission-level AI-disclosure requirement, since DOE has not, as of this writing, published a separate proposer-facing AI-disclosure notice comparable to NSF's.
IEEE Generative AI Policy
IEEE has no single unified 'AI policy' document; instead it implements two distinct sets of generative-AI rules, disseminated consistently across its journals, transactions, and conferences via the IEEE Author Center and individual IEEE technical societies. The author-side track requires disclosure of generative-AI use in preparing a manuscript, forbids listing an AI system as a co-author, and holds human authors fully accountable for the accuracy and originality of every word, figure, and citation regardless of how it was drafted. The reviewer-side track is a separate and stricter confidentiality rule: reviewers may not upload any part of a manuscript under review to a public generative-AI platform, and may not use such a platform to draft part or all of a review, because doing so risks exposing confidential, unpublished material to a system that can retain or learn from submitted input.
Comparator Sourcing
Comparator sourcing is the procurement of an already-approved active comparator drug for use as a trial's control-arm treatment (instead of, or alongside, placebo), plus the blinding, chain-of-custody/authenticity verification, and regulatory handling (GMP/GDP, IMP labeling, import licensing) required once that product enters the study.
PHI Exemptions From the HIPAA Privacy Rule
PHI is exempt from the HIPAA Privacy Rule only when it meets one of three conditions: (1) it has been de-identified under the Safe Harbor or Expert Determination method (45 CFR 164.514), (2) it is held by a person or organization that is not a HIPAA covered entity or business associate, or (3) it is a deceased individual's information more than 50 years after death (45 CFR 164.502(f)). PHI that is disclosed for research without individual authorization under a waiver, a review preparatory to research, the decedent-research pathway, or as a Limited Data Set (all under 45 CFR 164.512(i) or 164.514(e)) remains PHI and remains subject to the Privacy Rule -- it is not exempt, merely disclosable through a permitted exception.
Closeout Costs (2 CFR 200.344)
Closeout costs, in the 2 CFR 200 (Uniform Guidance) sense, are not a separate cost category but the set of financial-disposition actions a federal award recipient must complete once the period of performance ends: submitting all required final financial and performance reports, liquidating any remaining obligations, refunding to the federal awarding agency any unobligated balance the recipient is not authorized to retain, and accounting for and disposing of any equipment or property acquired with federal funds. These duties are set out in 2 CFR 200.344 ("Closeout") and, for property specifically, cross-reference 2 CFR 200.310 through 200.316 and 200.330.
Penalty for Misuse of Federal Funds
The 'penalty for misuse of federal funds' is not a single fixed penalty -- it is a tiered range of consequences that scales with the severity, intent, and materiality of the misuse, running from purely administrative remedies through civil liability to, in the most serious cases, criminal prosecution. At the administrative end, a Federal awarding agency acting under 2 CFR 200.339 (Remedies for noncompliance) can temporarily withhold payments, disallow the specific costs and require repayment, impose special (more restrictive) award conditions under 2 CFR 200.208, suspend the recipient's ability to draw down funds from the Payment Management System, or suspend or terminate the award itself in part or in whole. Because misspent federal money routed through a claim for payment or a certified financial report can constitute a 'false claim,' the same conduct can separately trigger civil liability under the False Claims Act (31 U.S.C. 3729-3733) -- treble damages plus a per-claim civil penalty, pursued either by the Department of Justice or by a private whistleblower (a 'relator') in a qui tam action, with no requirement to prove specific intent to defraud ('knowingly' includes reckless disregard). Independent of both administrative remedies and FCA liability, an agency can initiate suspension or debarment proceedings under 2 CFR Part 180, which exclude the recipient (and, government-wide, any of its covered personnel) from receiving further federal awards or subcontracts for a defined period. Where the misuse involves intentional fraud, false statements, or embezzlement of federal funds, criminal statutes -- most commonly 18 U.S.C. 641 (theft or conversion of federal property/funds) and 18 U.S.C. 1001 (false statements) -- can result in prosecution, fines, and imprisonment. These four tracks are not mutually exclusive: a single instance of misused federal grant funds can produce a repayment demand, an FCA settlement, a debarment, and a criminal referral simultaneously, because each track is triggered by a different legal test and pursued by a different actor (the awarding agency, DOJ Civil Division, a qui tam relator, and DOJ Criminal Division or a U.S. Attorney's office, respectively).
NHMRC HREC Registration
NHMRC HREC registration is the process by which an Australian institution formally registers its Human Research Ethics Committee (HREC) with the National Health and Medical Research Council (NHMRC), submitting the committee's membership list, Terms of Reference, and Standard Operating Procedures for review against the composition and operating requirements set out in Section 5 of the National Statement on Ethical Conduct in Human Research. Registration is what makes an institution's HREC eligible to review NHMRC-funded research and is a prerequisite for -- though distinct from -- separate certification under NHMRC's National Certification Scheme for the Ethics Review of Multi-centre Research.
Nature Portfolio AI Policy
Nature Portfolio's AI policy is the set of editorial rules, published on nature.com and applied across Nature, its sister research and Nature Reviews journals, Scientific Reports, and other Nature Portfolio titles, governing generative AI use in submitted manuscripts. A submission is treated as compliant only if: (1) no AI tool (large language model, chatbot, or image generator) is listed as an author or co-author, since authorship requires accountability that a tool cannot hold; (2) any substantive use of an LLM or other generative AI tool in preparing the manuscript is disclosed in the Methods section (or an equivalent alternative section for article types without one) — minor AI-assisted copyediting of already-written text does not require disclosure; and (3) no AI-generated or AI-substantially-modified image, video, or figure is used, except in the narrow case of a piece specifically about AI itself, reviewed case-by-case by the editor, or artwork sourced through an agency with a contractual chain that makes its provenance legally clear.
NIH Guidelines for Human Stem Cell Research
The NIH Guidelines for Human Stem Cell Research is the federal oversight framework, issued by the National Institutes of Health in 2009 (following Executive Order 13505) and amended in 2010, that governs whether federally funded research may use a given human embryonic stem cell (hESC) line. A research activity falls under the Guidelines whenever a US institution seeks NIH funding for work involving hESCs derived from embryos donated after in vitro fertilization (IVF) treatment. Under the Guidelines, two conditions must both be satisfied before federal funds may be used: (1) the specific hESC line must be listed on the NIH Human Pluripotent Stem Cell Registry (hPSCR), which NIH adds a line to only after confirming the embryo was donated voluntarily, with specific informed consent, by IVF patients whose decision to donate was kept separate from their clinical fertility care and was not induced by payment; and (2) many institutions additionally require the protocol to clear review by an institutionally convened Embryonic Stem Cell Research Oversight (ESCRO) committee before the work proceeds, a review that is separate from and in addition to standard Institutional Review Board (IRB) review of the original donor-consent process. The Guidelines govern use of already-derived hESC lines; they do not authorize federal funding of embryo derivation itself, which remains separately restricted by the Dickey-Wicker Amendment, an annual appropriations rider unaffected by the 2009 Guidelines.
Vertebrate Animals Section (VAS)
The Vertebrate Animals Section (VAS) is the required narrative component of an NIH grant application or cooperative-agreement proposal covering any proposed use of live vertebrate animals. Per NIH guidance (originally NOT-OD-10-027, simplified by NOT-OD-16-006), it must describe the proposed procedures and species/strains/ages/sex/numbers; justify the choice of species and why a non-animal alternative cannot achieve the research goals; describe interventions minimizing pain and distress, including analgesia, anesthesia, and humane endpoints; and state whether the planned euthanasia method is consistent with the AVMA Guidelines for the Euthanasia of Animals. It is evaluated by NIH Scientific Review Groups as part of merit review and is distinct from, and does not substitute for, the institution’s own IACUC protocol approval and PHS Assurance.
Office of Sponsored Programs (OSP)
The centralized institutional office (at a university, hospital, or research institute) responsible for administering the full lifecycle of externally sponsored funding — proposal review and submission, award negotiation and acceptance, post-award financial and compliance administration, and closeout — acting as the institution's authorized signing authority on behalf of sponsors such as federal agencies, foundations, and industry partners.
IRB Violations (Serious or Continuing Noncompliance)
An IRB violation, in federal human-subjects-research regulatory usage, is an instance of "serious or continuing noncompliance" with the IRB's requirements, the approved protocol, or applicable regulation — the threshold that triggers the IRB's own suspension/termination authority under 45 CFR 46.113 and 21 CFR 56.113, and that an institution holding a Federalwide Assurance (FWA) is independently obligated to self-report to the HHS Office for Human Research Protections (OHRP) outside the routine continuing-review cycle. This is a narrower, higher-severity category than the broader IRB reportable event umbrella: a single missed signature or a minor, corrected protocol deviation is ordinarily handled as a routine reportable event or logged at continuing review, not escalated as "noncompliance" in the regulatory sense. What makes a finding an IRB violation, operationally, is severity and/or a pattern: (1) the deviation from the approved protocol or IRB requirements is serious — it affected subject safety, subject rights and welfare, or the integrity of study data — or (2) it is continuing, meaning it is a repeated pattern rather than an isolated, corrected lapse, or the investigator/site has been unresponsive to prior IRB direction to fix it.
Biosafety in Microbiological and Biomedical Laboratories (BMBL)
Biosafety in Microbiological and Biomedical Laboratories (BMBL) is the primary US reference manual for laboratory biosafety practice, jointly produced by the CDC and the NIH and now in its 6th edition (2020). It defines the four Biosafety Level (BSL-1 through BSL-4) containment tiers, the risk-group classification system for infectious agents, and the standard and special microbiological practices, safety equipment, and facility design requirements associated with each tier. BMBL is an advisory best-practice document rather than a standalone binding federal regulation, but it carries practical regulatory force because it is incorporated by reference into binding frameworks, including the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the Federal Select Agent Program.
SUSAR (Suspected Unexpected Serious Adverse Reaction)
A SUSAR (Suspected Unexpected Serious Adverse Reaction) is an adverse event in a clinical trial that meets three conditions at the same time: it is serious under the ICH E2A seriousness criteria (death, life-threatening, hospitalization/prolongation, persistent or significant disability, congenital anomaly, or another medically important event), the investigator or sponsor judges there is a reasonable possibility it was caused by the investigational product (a suspected causal relationship, not confirmed causation), and it is unexpected — not listed or not consistent in nature, severity, or specificity with the reference safety information in the current Investigator's Brochure (or approved labeling for an active comparator). All three elements must hold; an event failing any one of them is not a SUSAR. Identifying a SUSAR is what triggers expedited, individual-case safety reporting to regulators, separate from and faster than routine trial adverse-event reporting.
Clinical Trial Transparency
Clinical trial transparency is the umbrella principle that every clinical trial's existence, design, and outcome should be made public regardless of what the results show. A given practice counts as advancing clinical trial transparency when it does at least one of three things: (1) makes a trial discoverable before it enrolls participants (prospective registration in a WHO-recognized registry such as ClinicalTrials.gov, ISRCTN, or EU CTIS), (2) makes that trial's summary results discoverable after it ends, including when results are negative, null, or unfavorable to the sponsor (results reporting, most concretely enforced in the US through FDAAA 801 and its implementing regulation, 42 CFR Part 11), or (3) makes the underlying protocol, statistical analysis plan, or individual participant-level data available for independent scrutiny (clinical data sharing). It is a movement and a set of overlapping obligations and voluntary commitments, not a single regulation -- a trial can satisfy one pillar (say, registration) while failing another (results reporting), which is precisely the gap transparency advocacy has spent over a decade trying to close.
Program Income
Program income is gross income earned by a non-Federal entity that is directly generated by a federally supported activity, or earned as a result of a Federal award, during the award's period of performance (2 CFR 200.307(a)). It must be applied to the original purpose of the award using one of three methods -- deduction, addition, or cost sharing/matching -- as specified by the awarding agency's regulations or the award's terms and conditions; deduction applies by default for most recipients, but addition applies by default for institutions of higher education and nonprofit research institutions when no method is specified.
MRC Guidance on GDPR and Confidentiality in Health Research
MRC GDPR and confidentiality guidance refers to the compliance framework the UK Medical Research Council (MRC), acting through UKRI and its MRC Regulatory Support Centre (RSC), sets out for researchers processing personal data -- especially health data -- in MRC-funded or MRC-affiliated research. It treats UK GDPR/Data Protection Act 2018 (DPA 2018) compliance and the separate common law duty of confidentiality as two distinct, cumulative obligations: satisfying one does not satisfy the other, and MRC-funded research is only compliant when both are addressed. Meeting the standard means (1) identifying a lawful basis for processing under UK GDPR Article 6 -- for MRC/UKRI research this is typically 'public task' or 'legitimate interests' rather than consent, since consent as a GDPR lawful basis carries withdrawal rights that are usually impractical for long-running research datasets -- (2) satisfying a separate condition for processing special category (e.g. health) data under UK GDPR Article 9(2) and DPA 2018 Schedule 1, and (3) independently respecting the common law duty of confidence owed to anyone whose confidential information -- most often identifiable NHS or health/social care data -- is accessed or shared, which GDPR compliance alone does not discharge.
Radiation Safety Committee (RSC)
A Radiation Safety Committee (RSC) is an institutional oversight committee, required as a condition of certain NRC or NRC Agreement State radioactive-materials licenses, that reviews and approves research and clinical uses of radioactive material and radiation-producing equipment and oversees the institution's radiation protection program. A committee qualifies as an RSC when it is established under a broad scope byproduct material license (10 CFR 33.13, with membership including the Radiation Safety Officer, a management representative, and trained/experienced users) or a medical use license authorizing two or more types of use (10 CFR 35.24, with membership including an authorized user for each use type, the RSO, a nursing-service representative, and an independent management representative) -- as distinct from an Institutional Biosafety Committee (IBC), which reviews recombinant/synthetic nucleic acid and biological hazards under the NIH Guidelines, and an IACUC, which reviews live-vertebrate-animal research under the Animal Welfare Act and PHS Policy.
Significant Financial Interest (SFI)
A Significant Financial Interest (SFI) is any financial interest an Investigator (or their spouse/dependent children) holds that meets the dollar or equity thresholds defined at 42 CFR 50.603 -- generally, remuneration exceeding $5,000 in the prior 12 months from a single publicly traded entity, or exceeding $5,000 or any equity at all from a single non-publicly traded entity -- subject to specific regulatory exclusions (e.g., the Investigator's own institutional salary, and compensation from U.S. government agencies or U.S. institutions of higher education for seminars/teaching/review-panel service). Meeting the SFI threshold triggers a disclosure obligation to the institution; it does not by itself mean a conflict of interest exists.
SMART IRB Reliance Agreement
The SMART IRB Reliance Agreement is a master common reliance agreement -- a single legal contract that participating US institutions each sign once with the SMART IRB platform -- that pre-establishes the terms under which any two (or more) participating institutions may rely on one another's IRB review for a given multi-site human subjects study. Once an institution has executed the master agreement, individual studies between it and any other participating institution invoke that existing agreement through an online reliance-determination process, rather than each study requiring its own bespoke IRB Authorization Agreement negotiated and signed from scratch.
Cambridge University Press Open Access Policy
Cambridge University Press's (CUP) approach to open access publishing centred on Read & Publish (R&P) agreements: multi-year deals negotiated with individual institutions or national/regional library consortia that bundle subscription reading access to Cambridge's journal portfolio (400+ titles) with open-access publishing rights for the institution's or consortium's corresponding authors, typically at no additional article processing charge (APC) to the author, or at a reduced/capped cost, up to a negotiated article quota. An author qualifies under a given agreement only if they are the corresponding author and are affiliated with a participating institution at the time of acceptance; the publishing platform identifies eligibility automatically at submission and offers the author an open-access route (usually CC BY) in place of, or alongside, the subscription/hybrid route.
Open Access Publishing Fund
An open access publishing fund is a dedicated pool of money, typically administered by a university library, that pays or reimburses Article Processing Charges (APCs) on behalf of researchers at that institution who have no other funding source available to cover them. Awards are usually capped per article and per researcher, contingent on the article having no other eligible funding, and available only until the fund’s annual allocation is exhausted — distinguishing it from institutional-level Read & Publish or transformative agreements, which cover OA publishing through a negotiated publisher license rather than an individually applied-for grant.
Reviewer Recognition Programs
A reviewer recognition program is a formal mechanism -- run by a publisher, a cross-publisher platform, or a professional society -- that creates a documented, and often verifiable and portable, record of a researcher's peer review activity. It exists because manuscript peer review is, by scholarly-publishing convention, unpaid, uncredited, confidential volunteer labor: an editor solicits a review, the reviewer submits comments, and outside the editor's own records nothing else normally happens. A reviewer recognition program is anything that closes that gap with a verifiable artifact -- a certificate, a platform-logged review history, or a portable credit entry -- that the reviewer can point to, as distinct from an informal 'thank you' with no lasting or checkable record.
IEEE Double-Blind Peer Review
IEEE's double-blind (also called double-anonymized) peer review is a submission-review model, adopted by specific IEEE journals, transactions, and conferences rather than applied IEEE-wide, in which the manuscript sent to reviewers has been stripped of author names, affiliations, acknowledgments, funding sources, and other directly identifying material, and reviewer identities are withheld from authors throughout review. A submission counts as following IEEE double-blind policy only if the venue itself has formally adopted the model (checkable in that publication's author guidelines) and the author has met its specific anonymization requirements at submission -- most IEEE publications instead use IEEE's default single-anonymized model, where the author's identity is visible to reviewers but not vice versa, so double-blind status is never assumed from the IEEE name alone.
CoARA Signatories
An organisation that has formally signed the Agreement on Reforming Research Assessment and thereby joined the Coalition for Advancing Research Assessment (CoARA), as distinct from an organisation that merely endorses the Agreement's principles informally.
SERU (Shared E-Resource Understanding)
SERU (Shared Electronic Resource Understanding) is a NISO Recommended Practice (NISO RP-7-2012) that lets a subscribing library and a content provider (publisher, aggregator, or other vendor) forgo negotiating and signing a bespoke license agreement for an e-resource. Instead, both parties rely on a shared set of expectations grounded in existing copyright law and standard library/publisher practice, plus the model understanding set out in the RP-7-2012 document itself, which addresses the roles of the content provider, the subscribing institution, and authorized users; the scope of permitted and restricted use; privacy and confidentiality of usage data; online performance and service provision; and archiving/perpetual access. A given e-resource transaction counts as SERU-based when both the institution and the provider have indicated, typically by each being listed in NISO's SERU Registry, that they accept SERU's terms for that transaction in place of a signed license — at which point the order can be placed and access provisioned without a license ever being drafted, routed to counsel, or countersigned.
Accessibility Remediation Metadata (ARM)
Accessibility Remediation Metadata (ARM) is a metadata model, in development through a NISO working group that began work in January 2024, for documenting the process and outcome of remediating a publication or other content resource for accessibility -- that is, altering an existing, inaccessible format (for example, a scanned PDF with no text layer, or an image-only textbook chapter) into a version usable with assistive technology, and recording what was done, to what standard, for whom, and where the resulting accessible file can be found or requested. ARM does not describe the accessibility of a resource as originally published; it describes remediation work performed after the fact -- who remediated it, which accessibility standard the remediated version targets (for example WCAG or an EPUB Accessibility conformance level), what format it is in, and how it can be discovered and reused so the same item is not remediated redundantly by multiple institutions. A resource is within ARM's scope if it involves an accessible alternative produced from a source resource, has metadata identifying the remediation process/outcome, and is intended to support discovery and/or deposit of that alternative in a shared repository.
Guest Editor Vetting
The process a journal or publisher uses to confirm that an individual invited to serve as a guest editor for a themed special issue actually holds the institutional affiliation, independent publication record, and editorial independence they claim, before that person is given authority to invite submissions, select peer reviewers, and recommend accept/reject decisions. Vetting is present only when a publisher independently confirms these facts (for example against ORCID, institutional directories, or a prior publication history in the field) rather than accepting a guest editor's self-reported credentials or an unsolicited nomination at face value.
NISO CREC (Communication of Retractions, Removals, and Expressions of Concern)
NISO CREC refers to NISO RP-45-2024, the Communication of Retractions, Removals, and Expressions of Concern Recommended Practice published by the National Information Standards Organization (NISO) on June 27, 2024 (DOI 10.3789/niso-rp-45-2024). CREC is not a new editorial rule about *when* something should be retracted — that judgment remains the domain of editorial-ethics guidance such as COPE's Retraction Guidelines. It is a communication standard about *how* a retraction, removal, or expression of concern (EoC), once decided, gets represented consistently in metadata and on-page display so that both human readers and machine systems (indexers, citation databases, reference managers, library discovery layers, aggregators) can detect and propagate the status automatically, rather than relying on someone noticing a notice. A publisher, platform, or content system is applying CREC when it implements RP-45-2024's paired recommendations: (1) metadata — structured, machine-readable status elements attached to the item's record (classified in the Recommended Practice as Essential, Essential if Available, or Recommended), covering the original publication, the retraction/removal/EoC notice itself, dates, and reasons; and (2) display — visible, human-facing signals, including prepending “RETRACTED:” to the title, watermarking and labelling the content in both HTML and PDF renderings, and linking a distinct, easily located notice to the affected item rather than burying it in an unrelated editorial page.
Journal Article Versions (JAV)
Journal Article Versions (JAV) is the NISO/ALPSP-defined controlled vocabulary (NISO RP-8-2008) for distinguishing the successive states a scholarly journal article passes through between first draft and final publication. A document instance is properly labelled with a JAV term — Author's Original (AO), Submitted Manuscript Under Review (SMUR), Accepted Manuscript (AM), Proof (P), Version of Record (VoR), Corrected Version of Record (CVoR), or Enhanced Version of Record (EVoR) — based on where it sits in the peer-review and publication workflow, not on its file format or where it happens to be hosted; the same PDF hosted in three different repositories is still one JAV stage, and two files with identical content but different peer-review status are different JAV stages.
NISO MECA (Manuscript Exchange Common Approach)
NISO MECA (Manuscript Exchange Common Approach), published as NISO Recommended Practice RP-30, is a technical protocol and package format specifying how manuscript files, associated metadata, and peer review history can be transferred automatically, in a machine-readable way, between different journals' and publishers' manuscript submission systems. A file transfer counts as MECA-compliant only if it (1) packages the manuscript files, metadata, and any transferred reviewer reports into the structured format the recommended practice defines, and (2) moves that package between systems through an automated, standardized transfer mechanism rather than a person manually re-uploading files and re-typing review comments into a second system.
COUNTER 5
COUNTER 5 (formally the COUNTER Code of Practice, Release 5, or 'COP5') is the current international standard governing how publishers, aggregators, and other content platforms must record and report usage statistics — searches, investigations, and requests — for the electronic resources (journals, databases, books, and multimedia items) they license to libraries and consortia. A usage report qualifies as 'COUNTER 5 compliant' only if it is produced from one of COP5's defined Master Report templates, uses COP5's controlled Metric_Types vocabulary, applies COP5's double-click and robot-filtering deduplication rules consistently, and (where automated) is retrievable via the COUNTER API (formerly called SUSHI, the Standardized Usage Statistics Harvesting Initiative). The standard exists so that a usage number from one publisher platform means the same thing as the equivalent number from another, letting libraries compare cost-per-use and make collection-development and renewal decisions on a like-for-like basis.
Cascading Peer Review
Cascading peer review (also called portable or transferable peer review) is a manuscript-handling workflow in which a journal that rejects a submission -- typically for reasons of scope, fit, or relative significance rather than a fatal flaw in the work -- offers the author the option to transfer the manuscript, along with the completed reviewer reports and editorial decision letter, to another journal, most often a sister title within the same publisher's portfolio. The receiving journal's editor can then make a faster decision using the existing reviews (obtaining only a fresh check on any points the original reviewers flagged, or a brief update review) instead of restarting peer review from a blank slate. A workflow counts as cascading peer review only if three things are true: (1) a rejection or a 'suggest transfer' decision already occurred at the first journal, (2) the author has given informed consent for the manuscript and reviews to move, and (3) the receiving journal's editorial process actually reuses the transferred review material rather than treating the submission as brand-new. It is a portfolio-level triage mechanism, not a form of peer review in its own right -- the review methodology itself (single-anonymized, double-anonymized, open, etc.) is whatever the originating journal already used.
Hijacked journal
A journal is operating as a hijacked journal when a website solicits and accepts manuscripts, typically for a fee, under the name, ISSN, and/or editorial identity of a specific real, previously or currently legitimate journal, without authorization from that journal's actual publisher or editorial board. The operational test is genuine continuity with, or authorization from, the real publisher of record, checkable against the ISSN Portal, the journal's own site, or its listing in the index it claims.
Crossref Event Data
Crossref Event Data was a free Crossref service that captured and made available structured records of "events" -- online mentions such as tweets, Wikipedia citations, newspaper articles, blog posts, and Wikipedia edits -- that referenced scholarly content identified by a DOI. Each event linked a source (e.g. a specific tweet or Wikipedia page) to a subject (a DOI-identified research output) with a timestamp, and the resulting data fed into third-party altmetrics tools and dashboards. Crossref formally sunset the service: the public Event Data API and related infrastructure stopped being available from 23 April 2026, after roughly a decade in operation, and it should now be described in the past tense as a discontinued service, not an active one.
Exclusive License (Publishing)
A publishing agreement in which the author keeps ownership of copyright but grants the publisher the sole, exclusive right to publish, reproduce, and distribute the work. It is offered by many journals as an alternative to a Copyright Transfer Agreement (CTA): under a CTA the author assigns copyright ownership itself to the publisher, whereas under an exclusive license the author retains ownership and grants only a defined bundle of exclusive rights, keeping whatever rights the agreement does not expressly grant away.
ACM Artifact Review and Badging
ACM Artifact Review and Badging is a formal peer-evaluation process, run alongside conventional paper peer review at ACM-sponsored conferences and in ACM journals, in which authors of a computer-science research paper voluntarily submit their supporting 'artifacts' -- source code, datasets, containers, build scripts, or other digital objects needed to run the reported experiments -- to a separate Artifact Evaluation Committee (AEC). The AEC checks whether the artifact is documented and runnable, and in stricter tracks, whether running it actually reproduces the paper's reported results. A paper that passes earns one or more standardized badge icons (Artifacts Available, Artifacts Evaluated -- Functional, Artifacts Evaluated -- Reusable, Results Reproduced, Results Replicated), printed on the published paper itself as a visible, per-paper certification distinct from the paper's own peer-review outcome.
Rights Retention Strategy (RRS)
A compliance mechanism, developed by cOAlition S in 2020, under which a funded researcher asserts a CC BY (or CC BY-equivalent) licence over the Author Accepted Manuscript (AAM) at the point of submission -- typically via a standard statement in the cover letter, on the manuscript's first page, or in the acknowledgements -- rather than negotiating open-access rights with the publisher after acceptance. Because the author (via their funder's grant conditions) retained the necessary rights from the outset, the publisher's own copyright transfer agreement, embargo policy, or self-archiving terms cannot override the licence already applied. An instance qualifies as RRS only if the licence statement is made at submission, before any publisher agreement is signed; a rights claim asserted only after acceptance, or general institutional self-archiving without a prior funder-mandated statement, does not count.
Peer Review Fraud
The deliberate corruption of the manuscript peer-review process to obtain a favorable or falsely legitimate-looking editorial decision, via fabricated reviewer identities, reciprocal peer-review rings, or coercive demands unrelated to manuscript merit. Distinguished from good-faith reviewer error, ordinary editorial disagreement, or unconscious reviewer bias by the presence of deliberate intent to subvert the review process itself.
Acceptable Similarity Percentage
There is no single, official percentage that marks a similarity/originality report as acceptable or unacceptable. Turnitin, Crossref Similarity Check, and iThenticate all publish a numeric similarity index, but none of the vendors, COPE, or ORI define a universal cutoff -- individual institutions, journals, and graduate schools sometimes set an informal internal benchmark (commonly cited figures cluster around 15% or 20%) purely as a triage trigger for closer human review, not as a formal misconduct threshold. What actually determines whether a score is a problem is what the flagged text consists of: properly quoted and cited material, a shared reference list or bibliography, standard field terminology, and (for theses) a candidate's own previously deposited coursework all inflate the percentage without indicating misconduct, so a report has to be opened and read, not just scored, before any percentage is meaningful.
Frontiers Collaborative Peer Review
Frontiers Collaborative Peer Review is Frontiers Media's proprietary peer-review workflow in which reviewers and authors are put into direct, real-time dialogue -- typically through an online review forum -- to resolve concerns together, rather than exchanging one-way reports mediated entirely by an editor. A submission qualifies as having gone through this process if it moved through two distinct phases on Frontiers' platform: an independent review phase, where each reviewer prepares and submits a report without seeing the other reviewers' comments, followed by an interactive review phase, where the editor opens a shared online forum and authors, reviewers, and the handling editor can all read and respond to each other's comments directly until the reviewers are satisfied or a decision is reached. The reviewers' and handling editor's names are published alongside the final article, rather than kept anonymous indefinitely.
Open Peer Review
A peer review model in which review reports, reviewer identities, and/or post-publication comment threads are disclosed to readers rather than kept within a confidential editor-reviewer-author loop. A given implementation counts as open peer review to the extent it publishes review information (reports, decision letters, reviewer names) and/or enables open commenting - per the ANSI/NISO Z39.106-2023 peer review terminology framework - not merely because reviewer identity is known internally to the editor or author.
Co-Editor-in-Chief
A co-editor-in-chief structure exists when a journal names two or more individuals to jointly hold the editor-in-chief role, sharing final editorial authority over the journal (policy, contested decisions, ethics escalations) rather than one editor-in-chief delegating subordinate work to associate or section editors beneath a single top authority. Journals use this model to distribute workload, cover distinct subject-area or methodological expertise, manage a leadership transition, or reflect shared governance across co-publishing institutions. The title is applied inconsistently across publishers -- some co-editors-in-chief hold fully independent, co-equal sign-off authority; others function as a senior deputy to one lead editor-in-chief -- so a journal's own editorial policy or masthead documentation, not the title alone, determines actual decision authority.
Work Made for Hire
A work is a "work made for hire" under US copyright law (17 U.S.C. Section 101) when it falls into one of two categories: (1) a work prepared by an employee within the scope of their employment, or (2) a work specially ordered or commissioned for use in one of nine specific categories (a contribution to a collective work, part of a motion picture or audiovisual work, a translation, a supplementary work, a compilation, an instructional text, a test, answer material for a test, or an atlas) where the parties expressly agree in a signed written instrument that the work is a work made for hire. Under 17 U.S.C. Section 201(b), the employer or commissioning party -- not the individual who actually created the work -- is treated in law as the "author" and default owner of the copyright, unless the parties have agreed otherwise in writing. This is distinct from a copyright assignment: an assignment transfers rights the creator originally held; work-made-for-hire status means the creator never held authorship or copyright in the work to begin with.
Heliyon’s Journal Impact Factor (JIF)
Heliyon's Journal Impact Factor (JIF) is a specific, illustrative instance of the general Journal Impact Factor metric published annually by Clarivate in the Journal Citation Reports (JCR) -- with a current wrinkle: Heliyon does not have an active JIF as of this writing (last verified 2026-08-16). Heliyon, launched by Elsevier/Cell Press in 2015, is a broad-scope, open-access megajournal that peer-reviews submissions for technical and ethical soundness rather than perceived novelty. Clarivate placed Heliyon on hold in Web of Science indexing in September 2024 (the same month as Cureus) and lifted that hold on 2026-05-14, per Retraction Watch's reporting, following an Elsevier internal audit that Retraction Watch reports resulted in roughly 1,197 corrections including approximately 687 retractions (RW-sourced, not Clarivate-confirmed). Because its citation data was suppressed for part of the assessment window, Heliyon did not receive a JIF in the June 2026 JCR release; Clarivate is expected to issue one in the October 2026 release instead. CASRAI attempted direct verification against Elsevier's own Heliyon pages (sciencedirect.com/journal/heliyon, cell.com/heliyon/home) this session; both returned HTTP 403 and could not be read. Any pre-hold aggregator figure (historically reported near 4.3 for the 2024 data year) should be treated as superseded historical background, not a current, citable number.
Scientific Data (journal)
Scientific Data is a peer-reviewed, open-access journal published by Springer Nature (Nature Portfolio), launched in 2014 specifically to publish formal, citable descriptions of research datasets. Its primary article type is the Data Descriptor -- not a conventional research article -- which combines a structured, machine-readable description of a dataset (methods, data-collection and processing steps, technical validation, and standardized metadata) with a narrative sufficient for another researcher to understand and reuse the data. A submission qualifies as a Data Descriptor, and is evaluated in peer review, on the technical soundness, completeness, and reusability of the dataset and its documentation -- not on the novelty, scientific impact, or hypothesis-driven conclusions that a traditional research article is judged on. The underlying data must be deposited in a recognized, community-endorsed public repository and made available under an open license; the Data Descriptor itself is the journal article that points to, documents, and formally credits that deposited dataset.
Environmental Science and Pollution Researchs Journal Impact Factor (JIF)
The Journal Impact Factor (JIF) of Environmental Science and Pollution Research (ESPR) is the Clarivate-calculated, Journal Citation Reports (JCR) metric for this Springer (Springer Nature) journal, covering environmental chemistry, ecotoxicology, and pollution-monitoring research. Per third-party JCR-tracking aggregators (Research.com, BioxBio, Resurchify) rather than a direct jcr.clarivate.com subscription check this session, ESPR's JIF rose through the early 2020s -- from roughly 2.6 in 2012 to about 5.8 for the 2022 JCR data year -- before falling to an aggregator-reported figure of approximately 5.59 for the 2024 JCR data year (2025 release), a decline these sources describe as consistent with a broader multi-year retrenchment across the journal's citation counts. As with any single aggregator-sourced figure, treat the exact decimal as indicative rather than authoritative until cross-checked against Clarivate's own JCR platform, and note that a journal's JIF is only ever one input into assessing where to submit or how to read a single paper's citation context -- not a substitute for reading the paper itself.
PLOS Pathogens Impact Factor (2026 Update)
PLOS Pathogens' Journal Impact Factor (JIF) would, if PLOS promoted one, be the Clarivate-computed, journal-level citation ratio published annually in the Journal Citation Reports (JCR). PLOS's own journal-information page states directly that it does not consider Impact Factor 'a reliable or useful metric to assess the performance of individual articles' and will only provide the figure to individuals on request -- CASRAI verified this policy language directly against journals.plos.org on 16 August 2026 (shared boilerplate across PLOS's journal-information pages, including PLOS Pathogens'). PLOS instead promotes article-level metrics, CiteScore, SJR, and the h-index. Because PLOS Pathogens remains a JCR-indexed title, Clarivate does compute a JIF for it (current cycle: 2025 data year, released June 2026), but that figure sits behind institutional JCR access and was not independently checked by CASRAI; it should not be sourced from a third-party JCR-tracking aggregator or Wikipedia. PLOS Pathogens is a selective, subject-specific PLOS title (launched September 2005) restricted to research on pathogens and host-pathogen interaction, distinct from both the broad-scope selective flagship PLOS Biology and the soundness-only multidisciplinary megajournal PLOS ONE.
Self-Citation
Citing one's own previously published work (an article, dataset, preprint, or other output) within a new manuscript. Self-citation is legitimate, and often necessary, when it substantively supports the current work — building on prior results, pointing to a previously validated method instead of repeating it, or situating a study within a sustained research programme. It becomes problematic — citation manipulation rather than ordinary scholarly practice — when self-citations are added primarily to inflate personal or journal-level citation metrics rather than because the cited work is genuinely relevant, including reciprocal citation-stacking arrangements between authors or journals.
Nature Cancer’s Journal Impact Factor (JIF)
Nature Cancer's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Nature Cancer journal receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to Nature Cancer's citable items from the two preceding years, divided by that item count. Independent JCR-tracking aggregators report Nature Cancer's 2-year Impact Factor at approximately 14.3 for the JCR release covering 2024 data, with several aggregators reporting a further jump to approximately 28.0 for the most recent release (2025 data, released June 2026) -- an unusually large year-over-year increase worth treating cautiously. nature.com's own journal-information page could not be directly confirmed for this draft (login-gated), so treat these figures as reported rather than independently verified, and check jcr.clarivate.com or nature.com/natcancer before citing formally. Nature Cancer is a distinct, separately scored journal from Nature, Nature Medicine, Nature Communications, and the other Nature Portfolio titles published by Springer Nature, and is also a separate journal from the similarly-named Nature Reviews Cancer. Per DORA and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in Nature Cancer or the merit of its authors.
MDPI (Multidisciplinary Digital Publishing Institute)
MDPI (Multidisciplinary Digital Publishing Institute) is a Basel, Switzerland-headquartered academic publisher, founded in 1996, that publishes exclusively open access: every article it accepts is made freely readable on publication, funded by an author-side Article Processing Charge (APC) rather than reader subscriptions. MDPI operates several hundred peer-reviewed journals across the sciences, social sciences, and humanities -- examples include International Journal of Molecular Sciences (IJMS), Sustainability, and Nutrients -- structured heavily around themed 'Special Issues' with guest editors, and is known for comparatively fast median times from submission to first editorial decision and to publication relative to many subscription journals. MDPI is a member of the Committee on Publication Ethics (COPE) and the Open Access Scholarly Publishing Association (OASPA). It is a real, currently operating publisher, not a defunct or fictitious one -- but the label 'MDPI journal' does not, by itself, tell you the editorial rigor of any specific title, which varies journal by journal and has been the subject of genuine, documented scrutiny from indexing bodies and parts of the research community (see below).
Society for Scholarly Publishing (SSP)
The Society for Scholarly Publishing (SSP) is a nonprofit, member-based professional association -- not a standards body or an accrediting authority -- for people who work across the scholarly-publishing ecosystem. A person or organization qualifies as 'part of SSP' by joining as a member (individual or organizational), which in practice draws from publishers, librarians, technology and service vendors, researchers, and consultants working in scholarly communication. SSP's core activities are networking and professional development rather than standard-setting: an annual meeting held each spring, ongoing educational seminars and webinars, topical Focus Groups, and -- its best-known public-facing output -- The Scholarly Kitchen, an editorially independent blog SSP publishes on scholarly-communication trends, policy, and industry analysis.
The Lancet’s Journal Impact Factor (JIF)
The Lancet's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the flagship Lancet journal (published by Elsevier since 1823, ISSN 0140-6736 print / 1474-547X online) receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. This term covers only the flagship Lancet title; the wider Lancet family (The Lancet Oncology, The Lancet Neurology, The Lancet Public Health, The Lancet Digital Health, and others) consists of separately edited, separately JCR-indexed journals each with its own distinct Impact Factor, not covered individually here. Third-party JCR-tracking aggregators and Wikipedia's journal infobox report figures that diverge across releases and trackers -- roughly 88.5 attributed to the 2024 JCR data year and roughly 109.0 attributed to the 2025 data year have both been seen, inconsistently labeled -- and CASRAI has not independently reconciled these against a single primary source (jcr.clarivate.com is subscription-gated; thelancet.com's own journal-information page was not independently confirmed at the time of writing). Treat any single number you see cited as time-stamped to a specific JCR release -- Clarivate updates JCR every June -- and check jcr.clarivate.com or thelancet.com directly for the current, release-dated figure before citing it in a formal context such as a CV, grant application, or tenure file. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article The Lancet has published, nor of the researchers who authored it.
mBio’s Journal Impact Factor (JIF)
mBio's Journal Impact Factor (JIF) is the two-year citation ratio Clarivate calculates and publishes annually in the Journal Citation Reports (JCR) for mBio, the American Society for Microbiology's (ASM) broad-scope, gold open-access microbiology journal (ISSN 2150-7511, inaugural issue published 18 May 2010, founding Editor-in-Chief Arturo Casadevall). Because ASM does not publish the underlying JCR figure on the journal's own homepage, an instance of 'mBio's JIF' as used on this site means whichever figure the current JCR release actually reports for mBio, cross-checked across independent tracker sites rather than taken from a single aggregator, since third-party trackers do not always agree with each other or with the prior year's release in the interim before the next JCR update.
Cureus’s Journal Impact Factor (JIF)
Cureus's Journal Impact Factor (JIF) is a specific, illustrative instance of the general Journal Impact Factor metric published annually by Clarivate in the Journal Citation Reports (JCR) -- with one important current wrinkle: Cureus does not have an active JIF as of this writing (last verified 2026-08-16). Cureus (ISSN 2168-8184), an open-access general medical journal owned by Springer Nature since December 2022, was placed 'on hold' by Clarivate in September 2024 and formally removed from the Web of Science Master Journal List in October 2025, following a period of substantial retraction activity and stated article-quality concerns. Removal from Web of Science means Cureus no longer accrues the citation counts a JIF is calculated from and does not receive a JCR figure for 2025 or any subsequent year. Before delisting, third-party JCR-tracking aggregators reported Cureus's most recent 2-year JIF variously as approximately 1.2 (2022 JCR release) and approximately 1.3 (2024 release); cureus.com's own current marketing copy separately cites an undated 'Impact Factor of 1.3' that does not acknowledge the delisting. Any impact-factor number for Cureus found online should be treated as historical, not current, and checked against Clarivate's live Master Journal List rather than cited as an active figure.
Journal of Neuroscience’s Journal Impact Factor (JIF)
The Journal of Neuroscience's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio that JNeurosci -- the flagship weekly research journal of the Society for Neuroscience (SfN) -- receives each year in the Journal Citation Reports (JCR): citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. The journal (ISSN 0270-6474 print, 1529-2401 online) has published continuously since 1981 and is indexed in Clarivate's Science Citation Index Expanded, which makes it JIF-eligible on the same mechanical basis as every other JCR-indexed title. Aggregator trackers (bioxbio.com, Wikipedia's infobox citing JCR) converge on a 2024 JIF of approximately 4.0, down from a reported peak near 6.7-6.9 in 2012-2013 -- a multi-year decline consistent with a broader pattern of JIF compression across many established neuroscience and biomedical titles as the denominator (citable items) and citation landscape have shifted. Treat any single figure as time-stamped to a specific JCR release -- Clarivate updates JCR every June -- and check jcr.clarivate.com or the journal's own page at jneurosci.org directly for the current, release-dated number before citing it in a formal context such as a CV, grant application, or tenure file. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article the Journal of Neuroscience has published, nor of the researchers who authored it.
Blood (ASH Journal)’s Journal Impact Factor (JIF)
Blood's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio that Blood -- the flagship, weekly peer-reviewed journal of the American Society of Hematology (ASH) -- receives each year in the Journal Citation Reports (JCR): citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. This entry is specifically about Blood the hematology journal (ISSN 0006-4971 print, 1528-0020 online), published continuously by ASH since 1946 -- not about the common noun 'blood' or any life-sciences journal with a similar-sounding title. Blood is indexed in Clarivate's Science Citation Index Expanded, which makes it JIF-eligible on the same mechanical basis as any other JCR-indexed title. Reported figures for Blood's current JIF diverge across sources: ASH's own hematology.org materials have cited a figure near 23.9, third-party JCR-tracking aggregators (BioxBio, JournalsInsights, journalmetrics.org) show figures in roughly the 20-24 range for recent releases, and one ASH-affiliated page referenced 21.0 tied to the 2023 JCR release. These differences most likely reflect different JCR release years and aggregator caching lag rather than disagreement about the underlying data -- the same pattern seen across most single-journal JIF pages. Treat any one number as time-stamped to a specific JCR release -- Clarivate updates JCR every June -- and confirm the current, release-dated figure directly against ashpublications.org/blood or jcr.clarivate.com before citing it formally.
PLOS Biology Impact Factor (2026 Update)
PLOS Biology's Journal Impact Factor (JIF) would, if PLOS promoted one, be the Clarivate-computed, journal-level citation ratio published annually in the Journal Citation Reports (JCR). PLOS's own journal-information page states directly that it does not consider Impact Factor 'a reliable or useful metric to assess the performance of individual articles' and will only provide the figure to individuals on request -- CASRAI verified this policy language directly against journals.plos.org on 16 August 2026 (shared boilerplate across PLOS's journal-information pages, including PLOS Biology's). PLOS instead promotes article-level metrics, CiteScore, SJR, and the h-index. Because PLOS Biology remains a JCR-indexed title, Clarivate does compute a JIF for it (current cycle: 2025 data year, released June 2026), but that figure sits behind institutional JCR access and was not independently checked by CASRAI; it should not be sourced from a third-party JCR-tracking aggregator or Wikipedia. Unlike its PLOS sibling title PLOS ONE, PLOS Biology is a selective flagship journal that peer-reviews for perceived significance and broad interest within biology alongside technical soundness, publishing a small fraction of what it receives.
Neuron’s Journal Impact Factor (JIF)
Neuron's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Cell Press neuroscience journal Neuron receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Neuron (ISSN 0896-6273 print, 1097-4199 online) is Cell Press's flagship neuroscience title, published continuously since 1988, and it is distinct from Cell and other Cell Press journals -- each carries its own separately computed JIF. The current JCR cycle is the 2025 data year, released June 2026; CASRAI attempted to verify Neuron's figure for that cycle directly against Cell Press's own pages this session (last verified 2026-08-16) and could not complete the request (redirect/bot-protection behavior), so no current figure is stated as fact. The last figure CASRAI can attribute to a specific, dated cycle is approximately 15.0 for the 2024 data year (June 2025 release), reported by third-party aggregators (journalmetrics.org, bioxbio.com) and Wikipedia's infobox, with a reported JCR Quartile 1 placement in neuroscience -- that figure is one cycle old, not current. Check jcr.clarivate.com or cell.com/metrics for the current, authoritative figure before citing it in a formal context. Per DORA and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
Cancer Discovery’s Journal Impact Factor (JIF)
Cancer Discovery's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the AACR journal Cancer Discovery receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Per journal-metrics tracker data reflecting the JCR release, Cancer Discovery's reported Impact Factor was approximately 29.5 for the 2025 JCR data year (Clarivate's June 2026 release), following a reported 33.3 for the 2024 data year and 29.7 for the 2023 data year -- Clarivate updates this figure every June, so treat any single number, including these, as time-stamped to a specific release rather than a fixed property of the journal. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
Cancer Cell’s Journal Impact Factor (JIF)
Cancer Cell is a peer-reviewed oncology and cancer-biology journal published by Cell Press (an Elsevier imprint), first issued in 2002 (ISSN 1535-6108 print / 1878-3686 online). Its Journal Impact Factor (JIF) is the annual Clarivate Journal Citation Reports (JCR) metric calculated as the mean number of citations, in the JCR year, to articles the journal published in the two preceding years, divided by the number of citable items in that window. Per Clarivate's JCR (as reported via Wikipedia's sourced infobox and corroborated by independent JIF-aggregator sites), Cancer Cell's most recently released JIF is 56.1, based on 2025 citation data (2026 JCR release) -- up from a reported 44.5 for the 2024 data year (2025 release). Always confirm the current figure directly against Clarivate's Journal Citation Reports (subscription-gated) or the publisher's own journal page before citing it in a CV, grant application, or promotion dossier, since JIF is recalculated annually and aggregator sites can lag or round the official release.
Current Biology’s Journal Impact Factor (JIF)
Current Biology's Journal Impact Factor (JIF) is a specific, illustrative instance of the general Journal Impact Factor metric published annually by Clarivate in the Journal Citation Reports (JCR). Current Biology is a Cell Press biweekly life-sciences journal (Cell Press became part of Elsevier in 1998/2001) launched in 1991 (ISSN 0960-9822), covering molecular biology, cell biology, genetics, neurobiology, ecology, and evolutionary biology. Its JIF is calculated and reported entirely independently of the JIF for Cell Press's founding flagship journal, Cell, even though both share the Cell Press imprint. See the general Journal Impact Factor entry for how the metric is defined and its well-documented limitations as a research-assessment tool.
Frontiers in Immunology’s Journal Impact Factor (JIF)
Frontiers in Immunology's Journal Impact Factor (JIF) is the annual Clarivate Journal Citation Reports metric for this Frontiers Media open-access immunology journal, currently reported by the publisher's own journal page as 7.0 for the 2025 JCR data year (June 2026 release), up from 5.9 for the 2024 data year -- a title whose reported JIF has moved unusually widely release to release, so the current figure should be confirmed directly against Clarivate before formal citation.
Advanced Materials’ Journal Impact Factor (JIF)
Advanced Materials' Journal Impact Factor (JIF) is the annual two-year citation metric Clarivate publishes for the journal in the Journal Citation Reports (JCR): citations in a given JCR year to Advanced Materials articles published in the preceding two years, divided by the number of citable items Advanced Materials published in those two years. Advanced Materials is a materials-science journal published by Wiley-VCH since 1989 (independent from an earlier Angewandte Chemie supplement dating to 1988; ISSN 0935-9648 print, 1521-4095 online). Third-party JCR-tracking aggregators report its JIF at approximately 26.8 for the 2024 JCR data year (2025 release); CASRAI attempted to confirm this directly against Wiley's own journal page on 16 August 2026 and could not (subscription/paywall response), so treat the figure as reported/secondary-source only, not primary-verified.
Types of Variables
"Types of variables" is not one classification but shorthand for two independent frameworks used to describe any variable in a study. The first, measurement level (or scale of measurement), classifies a variable by the mathematical properties of the values it can take: nominal (unordered categories), ordinal (ordered categories without equal spacing), interval (equal spacing, no true zero), or ratio (equal spacing with a true zero). The second, design role, classifies a variable by the function it plays in a specific study's causal or descriptive structure: independent/dependent (manipulated or predictor vs. measured outcome in an experimental design), explanatory/response (the same relationship in an observational or correlational design), and confounding (a third variable associated with both that can distort the apparent relationship). Every variable in a study is classified along both dimensions at once -- measurement level is a property of how the variable was recorded, while design role is a property of what a specific analysis is asking the variable to do.
Title Page (Research Paper)
A title page is the first page of an academic manuscript that identifies the work and its authors before the reader reaches the abstract or main text. What makes a page function as a title page — as opposed to just a cover sheet — is that it carries a defined, checkable set of identifying elements: at minimum the full title, the author byline, and institutional affiliation. Beyond that minimum, exactly which additional elements are required, and where each one goes, is set by whichever style guide or journal the manuscript is being formatted for — not by a single universal template. A style manual such as APA's 7th edition and an individual journal's author guidelines can require different elements in different positions, and where they conflict, the target journal's own instructions take precedence over the general style guide.
P-Value
The p-value is the probability of observing a result at least as extreme as the one found in a sample, calculated on the assumption that the null hypothesis is true. It is not the probability that the null hypothesis is true, and it does not measure effect size or practical importance — only how surprising the observed data would be if there truly were no effect.
Category A Bioterrorism Agents
Category A is the highest-priority tier of CDC's three-tier (A/B/C) bioterrorism-agent classification, used for public-health emergency-preparedness planning rather than as a compliance roster. An agent qualifies as Category A if it can be easily disseminated or transmitted person-to-person, causes high mortality with potential for major public-health impact, might cause public panic and social disruption, and requires special action for public health preparedness (e.g., stockpiling, enhanced surveillance, and public-communication planning). CDC groups six agents/diseases under Category A: anthrax (Bacillus anthracis), botulism (Clostridium botulinum toxin), plague (Yersinia pestis), smallpox (variola major), tularemia (Francisella tularensis), and viral hemorrhagic fevers caused by filoviruses (e.g., Ebola, Marburg) and arenaviruses (e.g., Lassa, Machupo). This is distinct from, though heavily overlapping with, the Federal Select Agent Program's regulated roster: Category A is a preparedness-prioritization label with no independent registration or compliance obligation attached to it directly, while the Select Agent List is the specific set of agents and toxins an entity must register to legally possess, use, or transfer.
Critical Literature Review
A critical literature review is a form of literature review whose organizing purpose is evaluative and argumentative rather than descriptive: the writer selects significant sources on a topic, appraises the quality, validity, and coherence of the claims and evidence in each, and uses that appraisal to identify gaps, contradictions, and unresolved debates, ultimately advancing the writer's own interpretation, argument, or conceptual position. It is distinguished from a systematic or scoping review by search strategy (selective and purposive rather than exhaustive and reproducible) and from a purely descriptive literature review by its explicit evaluative stance: a critical review does not just summarize what each source found, it judges the strength of the evidence and the soundness of the reasoning behind it.
IRB Reportable Events
An IRB reportable event is any occurrence, finding, or piece of new information arising during an already-approved, ongoing human subjects study that federal regulation or an institution's Human Research Protection Program (HRPP) policy requires the study team to report to the IRB outside the routine continuing-review cycle. This is distinct from the initial IRB application/approval process (see IRB/REC Approval Process) and from a planned protocol amendment submitted for prior approval before a change is implemented -- a reportable event concerns something that has already happened during the conduct of the study. The umbrella category typically includes: unanticipated problems involving risks to subjects or others (UPIRSOs), protocol deviations (especially those affecting subject safety, rights, or data integrity), adverse events and serious adverse events, subject complaints, breaches of confidentiality, and non-compliance with the approved protocol or applicable regulations.
Statistical Test
A statistical test is a formal procedure for deciding whether a pattern observed in sample data is likely to reflect a genuine feature of the population it was drawn from, or could plausibly have arisen from random sampling variation alone. Every statistical test works the same way at a structural level: it states a null hypothesis (typically 'no effect' or 'no difference'), computes a test statistic from the observed data, and compares that statistic (via its p-value) against a pre-specified significance threshold to decide whether the null hypothesis can be rejected. A specific procedure only counts as 'the right statistical test' for a given analysis if its underlying assumptions match the data actually collected: the measurement type (categorical vs. continuous), the number of groups or variables being compared, the study design (independent vs. paired/repeated observations), and, for parametric tests, the shape of the sampling distribution.
I.e. vs. E.g.
"I.e." (Latin id est, "that is") restates or clarifies the statement it follows with an exhaustive equivalent, while "e.g." (Latin exempli gratia, "for example") introduces one or more illustrative, non-exhaustive examples. The operational test: if you can replace the abbreviation with "that is" or "in other words" without changing the sentence's meaning, "i.e." is correct; if the material that follows is one option among others rather than a full restatement, "e.g." is correct. In academic writing, misuse of either changes what the sentence actually claims -- writing "i.e." before a partial list implies it is complete when it isn't, and writing "e.g." before a defining criterion understates that the criterion is required.
Sampling Methods: Probability and Non-Probability Types Explained
A sampling method is the defined procedure a study uses to select which members of a population are observed or measured. It qualifies as a probability method only if every population member has a known, non-zero chance of selection via a defined chance mechanism (simple random, stratified, systematic, or cluster sampling) -- this is what supports formal statistical inference and generalizability claims back to the population. Non-probability methods (convenience, purposive/judgmental, snowball, quota sampling) select participants without a defined chance mechanism, which is legitimate and standard in qualitative and exploratory research but does not, on its own, support formal population-level generalization.
Delimitations
Delimitations are the boundaries a researcher deliberately sets on the scope of a study during its design -- the population, timeframe, geography, variables, and theoretical framework chosen to include or exclude so the study stays focused and answerable. A factor qualifies as a delimitation, not a limitation, when it was a choice the researcher made rather than a constraint imposed on them: narrowing a survey to one country, one age range, one industry, or one time period are all delimitations because the researcher could have drawn the boundary differently but chose not to for reasons of focus, relevance, or feasibility. Delimitations are stated in the methods or scope section, in the first person and past tense of intentional design ('this study was delimited to...'), and they define what the study's conclusions can legitimately be generalized to.
Descriptive Research
Descriptive research is a research design category whose goal is to accurately describe the characteristics, behaviours, or conditions of a population, phenomenon, or situation as they naturally exist, without manipulating any variable and without attempting to establish a cause-and-effect relationship between variables. A study qualifies as descriptive research if it answers 'what is/are the characteristics of X' rather than 'does X cause Y' -- the researcher observes and records rather than intervenes. Common forms include case studies (in-depth examination of a single individual, group, organisation, or event), cross-sectional surveys (data collected from a population at one point in time), observational studies, and case series/ecological studies in clinical and public-health research. Because it does not involve random assignment to conditions or control of independent variables, descriptive research cannot by itself support causal claims -- it can identify patterns, prevalence, and associations that generate hypotheses for later experimental or quasi-experimental testing, but it cannot confirm them.
Figure Legend
A figure legend (also called a figure caption) is the block of text accompanying a figure -- typically placed directly beneath it, or grouped on a separate legends page/section depending on the target journal's submission format -- that must let a reader understand the figure entirely on its own, without needing to reread the Methods or Results text. To meet that standalone-comprehension bar, a complete figure legend generally includes: a short declarative title sentence stating the figure's main point or finding; a description of what each panel shows (for multi-panel figures, keyed to the panel letters used in the image); definitions of every abbreviation, symbol, and color/line code used in the figure; the statistical test applied and what error bars or shaded regions represent (e.g., SD, SEM, 95% CI); and the relevant sample size (n). A figure legend is distinct from an in-text figure reference or callout (e.g., 'as shown in Figure 2', 'see Fig. 3B'), which is a pointer embedded in the manuscript's running prose directing the reader to look at the figure -- the legend is the self-contained explanatory text that travels with the figure itself.
Research Questionnaire
A research questionnaire is a structured written instrument consisting of a fixed, standardized set of questions (items) with defined response formats, administered identically to every respondent so their answers can be compared and analyzed. It is distinct from a survey, which is the broader data-collection methodology (sampling, administration mode, response-rate reporting) built around the questionnaire; a questionnaire's quality is judged on item wording, question-type selection (closed- vs. open-ended, Likert-type vs. dichotomous), and validity and reliability established through pilot testing before the full study fields it.
Confidence Interval
A confidence interval is a range of values, calculated from sample data using a defined estimation procedure (point estimate plus a margin of error derived from the sampling distribution of the estimator), constructed at a stated confidence level (commonly 95%). The confidence level describes the long-run reliability of the construction procedure across repeated sampling -- the proportion of such intervals that would contain the true, fixed population parameter if the sampling were repeated many times -- not the probability that this specific interval contains the parameter. A range lacking a stated confidence level and a defined estimation procedure (e.g. a bare sample min-max) is not a confidence interval.
Forest plot
A forest plot is the standard graphical display for a meta-analysis: each included study is shown as a point estimate (a square, sized in proportion to that study's weight in the pooled analysis) with a horizontal line marking its confidence interval, stacked one row per study, with a vertical reference line at the value of no effect. A diamond at the bottom of the plot shows the pooled summary estimate across all studies, with the diamond's width representing the pooled estimate's confidence interval. A forest plot is used to visually assess both the direction/size of each individual study's effect and how consistent (or heterogeneous) those effects are with one another before and after pooling.
Chi-Square Test (χ²)
A hypothesis test for categorical data that compares observed category counts to the counts expected under a null hypothesis — either testing whether two categorical variables are independent (chi-square test of independence) or whether one categorical variable's observed distribution matches a specified expected distribution (goodness-of-fit). Distinct from t-tests and ANOVA, which test differences in a continuous outcome's mean rather than differences in categorical counts.
Expansion Cohort
An expansion cohort is a group of participants enrolled at a dose already selected during a Phase 1 trial's dose-escalation stage -- typically the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) -- to further characterize that dose's safety and generate preliminary evidence of clinical activity. A trial design qualifies as using expansion cohorts when it runs dose escalation and one or more fixed-dose expansion cohorts under a single protocol, most commonly in first-in-human oncology trials; multiple expansion cohorts run in parallel (by tumor type or biomarker) at the same dose are described as a multiple expansion cohort (MEC) design.
Simplified Consent Arrangements for Adults Lacking Capacity (UK Clinical Trials)
In UK clinical trials of investigational medicinal products (CTIMPs), "simplified consent arrangements for adults lacking capacity" refers to the alternative consent pathway set out in Schedule 1, Part 5 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) that applies when a prospective or enrolled participant cannot give informed consent for themselves. Rather than the participant's own signature, the regulations require consent from a legal representative acting on the adult's behalf: first a personal legal representative (someone not connected with the conduct of the trial who is suitable by virtue of their relationship with the adult, and who is available and willing to act), or, if no personal legal representative is available, a professional legal representative (typically the doctor primarily responsible for the adult's medical treatment, provided they are independent of the trial, or a person nominated by the relevant health service body). A further, narrower simplification applies to genuinely urgent research: where the trial's protocol has been specifically approved by a recognised Research Ethics Committee for enrolment in urgent situations, an incapacitated adult may be entered into the trial without any prior consultation of a legal representative if urgent action is needed to give the investigational medicinal product and it is not reasonably practicable to consult one first — on condition that consent (or continued participation) is then sought from a legal representative, or the adult themselves if capacity is regained, as soon as reasonably possible afterwards. CTIMPs are explicitly excluded from the separate Mental Capacity Act 2005 research provisions (MCA s.30) precisely because this dedicated Schedule 1 regime governs them instead; other (non-CTIMP) research involving adults who lack capacity in England and Wales instead follows the MCA 2005 consultee-based framework. This term covers the CTIMP-specific, legal-representative pathway only.
MHRA GCP Inspection
An MHRA GCP inspection is an on-site or remote audit conducted by the UK Medicines and Healthcare products Regulatory Agency's GCP Inspectorate to assess whether a clinical trial sponsor, contract research organisation (CRO), or investigator site is conducting research in compliance with the UK Clinical Trials Regulations and the principles of Good Clinical Practice (GCP) set out in ICH E6. Inspections are the mechanism by which the MHRA verifies that trial data submitted in support of a marketing authorisation can be trusted and that participants' rights, safety, and wellbeing were protected during the conduct of the trial.
ICH E9 (Statistical Principles for Clinical Trials)
ICH E9, "Statistical Principles for Clinical Trials," is the International Council for Harmonisation guideline (finalized 1998) that sets out the core statistical methodology expected of a confirmatory clinical trial submitted to a regulatory authority. A trial's design and statistical analysis plan (SAP) are ICH E9-consistent when they are pre-specified before unblinding and address, at minimum: the trial's overall design and hypothesis structure (superiority, non-inferiority, or equivalence, each with its own margin and testing logic); the randomization and blinding scheme; the sample-size/power justification; the choice of analysis populations, most centrally the Full Analysis Set (FAS, an operationalization of the intention-to-treat principle) and the Per-Protocol Set (PPS); the handling of missing data; and the control of Type I error across multiple endpoints, interim looks, or comparisons (multiplicity). ICH E9 was substantially extended, not replaced, by its 2019 addendum ICH E9(R1), which introduced the estimand framework to address a gap the original guideline left largely implicit: how a trial's statistical objective should be translated into a precisely defined treatment-effect question before an analysis method is chosen to answer it.
FDA Biomarker Qualification Program
A biomarker is qualified under FDA's Biomarker Qualification Program (BQP) when FDA has completed formal review under Section 507 of the FD&C Act (added by the 21st Century Cures Act, 2016) and determined the biomarker is reliable for a specific, defined context of use (COU) -- meaning any sponsor may rely on it for that COU across multiple, unrelated drug development programs without independently re-justifying its validity to FDA each time. This is distinct from a biomarker FDA accepts, or does not object to, only within one sponsor's single IND or trial -- that acceptance is program-specific, not portable, and must be independently re-justified for any other use.
ICH M4 (Common Technical Document / CTD)
ICH M4 is the International Council for Harmonisation (ICH) multidisciplinary guideline that defines the Common Technical Document (CTD): a standardized, five-module dossier structure for organizing the quality, safety, and efficacy data submitted to regulatory authorities when registering a pharmaceutical for human use. A submission is CTD-compliant when its content is organized into Module 1 (region-specific administrative information), Module 2 (CTD summaries), Module 3 (quality/CMC data), Module 4 (nonclinical study reports), and Module 5 (clinical study reports), with Modules 2-5 following the same harmonized content and ordering regardless of which ICH regulatory authority receives the application. M4 is a family of related documents rather than a single guideline: the overarching M4 organizational guideline is supplemented by M4Q (Quality), M4S (Safety/nonclinical), and M4E (Efficacy/clinical), each specifying the detailed content and ordering for its respective module.
NIH Inclusion Policies (Women, Minorities, and Across the Lifespan)
A study satisfies NIH inclusion requirements when its application describes the planned participant population by sex/gender, race/ethnicity, and age range appropriate to the science; provides a compelling rationale for any exclusion of women, a minority group, or an age range rather than defaulting to exclusion; and, for Phase III trials, includes a valid analysis plan for whether effects differ by sex/gender and race/ethnicity. This combines two distinct NIH policies: the statutory Inclusion of Women and Minorities policy (sex/gender and race/ethnicity, in force since the 1993 NIH Revitalization Act) and the Inclusion Across the Lifespan policy (age, including children and older adults, in force since January 25, 2019 under NOT-OD-18-116).
USDA Research Security Training Requirement
The USDA Research Security Training Requirement is the U.S. Department of Agriculture's implementation of the government-wide research-security training mandate created by Section 10634 of the CHIPS and Science Act of 2022 (42 U.S.C. Section 19234) and directed by NSPM-33 — the same policy family behind the parallel DOE and NASA requirements. Multiple institutional sponsored-programs offices report that USDA introduced the requirement via Secretary's Memorandum SM 1078-014 (dated July 8, 2025) and folded it into USDA's General Terms and Conditions for financial assistance awards, effective December 31, 2025: named 'covered individuals' on a USDA-funded application or award must complete an approved research-security training course, with completion certified to USDA as part of the award's terms and conditions. CASRAI could not independently confirm this text against a primary usda.gov source at the time of writing (the USDA PDF did not load during verification); treat the SM 1078-014 number and December 31, 2025 effective date as reported-tier pending direct confirmation against USDA's own published memorandum and General Terms and Conditions before relying on them for a compliance deadline.
45 CFR 46 Subpart C (Additional Protections for Prisoners in Research)
The section of the Common Rule (45 CFR 46, §§46.301-46.306) that governs HHS-conducted or HHS-funded biomedical or behavioral research involving prisoners as subjects. A protocol falls under Subpart C whenever a subject meets the §46.303 definition of "prisoner" — involuntary confinement or detention in a penal institution, including pretrial detainees and individuals in alternative-to-incarceration facilities. The reviewing IRB must satisfy the §46.304 composition requirements (a non-prison-affiliated majority plus at least one prisoner or prisoner representative), make the additional findings required by §46.305, and may approve the research only if it fits one of the four categories permitted under §46.306.
NSF AI Policy
NSF AI policy is not a single rule but a set of related National Science Foundation positions on artificial intelligence that a proposer or awardee needs to track separately: (1) guidance, currently framed as encouraged rather than mandatory, on disclosing generative-AI use in preparing a proposal; (2) an explicit statement that fabrication, falsification, or plagiarism committed with the assistance of AI-based tools counts as NSF research misconduct under the Proposal & Award Policies & Procedures Guide (PAPPG); and (3) NSF's own AI research-infrastructure investments, chiefly the National AI Research Resource (NAIRR) and the NSF AI Institutes program, which are funding/access policy rather than proposal-conduct policy. Treat these as three distinct tracks that happen to share the same agency and the same underlying 2023-2025 policy push, not one unified 'AI rule.'
FAR Part 31 (Contract Cost Principles and Procedures)
FAR Part 31 (48 CFR Part 31), 'Contract Cost Principles and Procedures,' is the section of the Federal Acquisition Regulation that governs which costs a contractor -- including a university or research institution performing a federally funded CONTRACT rather than a grant -- may charge to, or recover from, the U.S. government. A cost is chargeable under FAR Part 31 only if it independently satisfies three tests set out in FAR 31.201-2: it must be reasonable (FAR 31.201-3, the 'prudent person' standard), allocable to the specific contract (FAR 31.201-4), and, where the contractor is subject to Cost Accounting Standards, measured, assigned, and allocated consistently with the applicable CAS. Subpart 31.2 (Contracts with Commercial Organizations) is the subpart most relevant to universities and other non-profit or commercial entities performing federal contract research; FAR 31.205 then works through more than 50 named 'selected cost' categories -- compensation, independent R&D and bid-and-proposal costs, entertainment, alcoholic beverages, fines and penalties, lobbying, and more -- either allowing them outright, allowing them subject to a stated limitation, or declaring them expressly unallowable regardless of reasonableness or allocability. FAR 31.201-6 additionally requires a contractor's accounting system to identify and separately account for unallowable costs so they are never included in a billing, claim, or proposal to the government.
Appearance of a Conflict of Interest
An appearance (or perceived) conflict of interest exists when a reasonable, informed outside observer could conclude that a researcher's, reviewer's, or official's outside relationships or interests might improperly influence their professional judgment -- even though, on closer examination, no actual conflict is present (there is no real financial or professional stake in the specific decision, or the relationship in fact has no bearing on it). It is judged from the observer's vantage point, not the individual's own confidence in their objectivity, which is precisely why most institutional, funder, and journal conflict-of-interest policies require an appearance-level situation to be disclosed and managed on essentially the same terms as an actual conflict: unmanaged appearances erode trust in research even when no bias actually occurred.
USDA Covered Species
The set of animal species that fall within the Animal Welfare Act's (AWA) statutory definition of "animal" under 9 CFR 1.1, and are therefore subject to USDA APHIS registration, inspection, and recordkeeping requirements. A species is "covered" if it is a live or dead dog, cat, non-human primate, guinea pig, hamster, rabbit, or other warm-blooded animal used or intended for use in research, teaching, testing, experimentation, or exhibition, or as a pet. Critically, the AWA's definition of "animal" explicitly excludes birds, rats of the genus Rattus, and mice of the genus Mus that are bred for use in research, as well as cold-blooded species (fish, amphibians, reptiles) and most farm animals used for food/fiber production research. Because purpose-bred rats, mice, and birds are the large majority of animals used in US biomedical research, most laboratory animals are, by this narrow legal definition, not "covered species" under the AWA -- even though the same animals are typically still covered under other frameworks (chiefly PHS Policy) when the research is federally funded.
Attending Veterinarian (AV)
The Attending Veterinarian (AV) is the credentialed veterinarian (DVM/VMD) with direct or delegated authority and responsibility for the health and well-being of all research, teaching, and testing animals at an institution. Required under the Animal Welfare Act (9 CFR 2.33) and PHS Policy, the AV is a voting IACUC member and holds documented authority to provide or order veterinary treatment, require appropriate anesthesia/analgesia, and suspend a procedure or study causing unrelieved animal pain or distress.
Clinical Data Registry
A clinical data registry is an organized system that collects standardized, defined-variable clinical and outcomes data on patients sharing a common condition, procedure, exposure, or device, on an ongoing rather than fixed-enrollment basis. What makes a data-collection effort a registry, rather than an ordinary clinical database or a clinical trial, is a combination of: (1) a defined denominator population identified by disease, procedure, or exposure, not by eligibility for a specific tested intervention; (2) a standardized, pre-specified data dictionary applied consistently across contributing sites, enabling pooled and benchmarked analysis; and (3) an ongoing or periodically re-opened collection window rather than a protocol-bound enrollment period. Registries are most often sponsored by a medical specialty society, a health system, a public health agency, or a manufacturer under a post-market surveillance obligation, and their stated purposes typically include quality improvement and benchmarking, observational research, public health surveillance, and, in a growing but still bounded set of cases, support for regulatory decision-making.
45 CFR 46 Subpart A (Basic HHS Policy for Protection of Human Research Subjects)
The foundational section of the Common Rule (45 CFR 46, §§46.101-46.124) that establishes the general framework HHS-conducted or HHS-funded human-subjects research must satisfy: which activities and institutions it covers (§46.101), the core definitions of "human subject" and "research" (§46.102), the institutional assurance and IRB registration structure (§46.103), the eight categories of exempt research (§46.104), IRB membership and operating requirements (§46.107-46.115), and the general standards for informed consent (§46.116-46.117). Subpart A is the baseline every other subpart (B, C, D) layers additional, population-specific protections on top of — in ordinary usage, "the Common Rule" and "Subpart A" refer to essentially the same body of regulatory text.
HIPAA and Retrospective Research
A retrospective study (most commonly a retrospective chart review) uses protected health information (PHI) that was already recorded in the medical record before the research began, rather than PHI generated by a prospective study protocol. Because the individuals were treated in the past and often cannot practicably be found and asked for HIPAA authorization, retrospective research typically proceeds under 45 CFR 164.512(i)(1)(i): an IRB or Privacy Board grants a full or partial waiver of authorization after documenting, per 164.512(i)(2), that (1) the use/disclosure involves no more than minimal privacy risk, based on an adequate plan to protect identifiers, an adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification to retain them, and written assurances against reuse or redisclosure; (2) the research could not practicably be conducted without the waiver; and (3) the research could not practicably be conducted without access to the PHI. A study only qualifies as retrospective-research-under-waiver if it is genuinely using pre-existing records for a defined research protocol -- not if it is a 'review preparatory to research' (164.512(i)(1)(ii), used only to help design a study or assess feasibility, with no PHI leaving the covered entity) or decedent-only research (164.512(i)(1)(iii)), which are the Rule's two other, separate no-authorization pathways.
Data Protection Act 2018, Schedule 2, Paragraph 27 (Research Exemption)
The provision in Part 6 of Schedule 2 to the UK Data Protection Act 2018 that lets a controller processing personal data for research or statistical purposes disapply specific UK GDPR data-subject rights -- the right of access (Article 15(1)-(3)), rectification (Article 16), restriction of processing (Article 18(1)), and objection (Article 21(1)) -- to the extent that applying them would prevent or seriously impair achievement of the research or statistical purposes, provided the processing also satisfies the UK GDPR's research-safeguards requirements. The access-right disapplication carries an additional, narrower condition: it applies only where the results of the research or any resulting statistics are not made available in a form that identifies a data subject.
Retraction Statement
The formal notice a journal or publisher issues to retract a published article — a standalone document, not the article itself, that identifies the article, states who initiated the retraction and why, and is bidirectionally linked to the retracted paper. A publication counts as a retraction statement only when the journal publishes it under its own editorial authority and explicitly labels it as a retraction, distinct from a correction, erratum, or expression of concern.
Exception from Informed Consent (EFIC) for Emergency Research
EFIC (Exception from Informed Consent) is the regulatory pathway under 21 CFR 50.24 that permits FDA-regulated clinical investigations of a drug, biologic, or device to enroll subjects in a life-threatening emergency without prospective informed consent from the subject or a legally authorized representative (LAR). A study qualifies as EFIC only when all of the following are true: (1) subjects are in a life-threatening situation for which available treatments are unproven or unsatisfactory; (2) obtaining informed consent is not feasible because the condition requires intervention before consent from the subject or LAR can reasonably be obtained; (3) participation holds the prospect of direct benefit to the subject; (4) the research could not practicably be carried out without the waiver; and (5) additional protections are in place, most notably community consultation and public disclosure conducted before the study begins, and an independent data monitoring committee. IRB approval of the full protocol, including the community consultation and disclosure plan, is required before enrollment can start under the exception.
45 CFR 46 Subpart B (Additional Protections for Pregnant Women, Human Fetuses, and Neonates)
The section of the Common Rule (45 CFR 46, §§46.201-46.207) that governs HHS-conducted or HHS-funded research in which the subjects are pregnant women, human fetuses, or neonates. A protocol falls under Subpart B whenever a subject meets the §46.202 definition of pregnant woman, fetus, or neonate; the IRB must then apply the specific risk/benefit and consent conditions for the applicable subject category (§46.204 pregnant women/fetuses, §46.205 neonates, §46.206 material obtained after delivery) before approving the research, with §46.207 available as a narrow, HHS-Secretary-level pathway for research that does not otherwise qualify.
OLAW (Office of Laboratory Animal Welfare)
OLAW is the office within NIH's Office of the Director responsible for implementing and interpreting the PHS Policy on Humane Care and Use of Laboratory Animals: it negotiates and approves each institution's Animal Welfare Assurance, evaluates reports of noncompliance from Assured institutions, and runs a nationwide PHS Policy education program. It governs any live vertebrate animal used in PHS-supported (including NIH-funded) research, testing, or training. OLAW does not replace an institution's own IACUC, and it does not conduct the on-site facility inspections that USDA/APHIS carries out under the Animal Welfare Act -- OLAW's authority runs through the PHS funding relationship, not independent statutory inspection power.
Confidentiality Advisory Group (CAG) / Section 251
The Confidentiality Advisory Group (CAG) is an independent advisory body in England and Wales that reviews applications from researchers and other organisations seeking to access or use confidential patient information without patient consent, and advises whether there is sufficient public interest to justify granting that access. CAG does not itself hold decision-making power: for research applications it advises the Health Research Authority (HRA), which makes the final decision; for non-research applications (for example, national disease registries or public health surveillance) it advises the Secretary of State for Health and Social Care, or in some cases NHS England. The legal basis CAG operates under is Section 251 of the NHS Act 2006, which allows the common law duty of confidentiality to be set aside temporarily where anonymised or pseudonymised data cannot meet the research purpose and seeking individual consent is not practicable. Section 251 is given operational effect through the Health Service (Control of Patient Information) Regulations 2002 (the “COPI Regulations”) — specifically Regulation 5 (support for research and other purposes) and Regulation 3 (support for communicable disease surveillance and other public health risks). Approval obtained this way is commonly referred to as “Section 251 support,” “Regulation 5 support,” or a “CAG approval,” and the terms are used largely interchangeably in UK research-governance practice. CAG membership is drawn from a mix of clinicians, academics, and lay members, reflecting the requirement to weigh both the research/public-interest case and the patient-confidentiality interest.
NASA Research Security Training (GIC 26-02)
NASA's research security training requirement, established under Grant Information Circular (GIC) 26-02 (issued February 2026), requires every 'covered individual' -- a Principal Investigator or Co-PI on a NASA grant or cooperative agreement at any level of effort, or a Co-Investigator committing 10% or more effort annually -- to certify completion of qualifying research security training. The requirement takes effect for proposals and annual progress reports due on or after August 5, 2026, and is evidenced through updated NASA Biographical Sketch and Current and Pending (Other) Support forms rather than a separate standalone certificate.
Equipment (2 CFR 200.1 Definition)
Under 2 CFR 200.1 (Uniform Guidance), "Equipment" is tangible personal property, including IT systems, with (1) a useful life of more than one year AND (2) a per-unit acquisition cost equal to or exceeding the lesser of the institution's own capitalization level or $10,000 (raised from a $5,000 federal floor in a 2024 Uniform Guidance revision, effective for awards issued on/after October 1, 2024). NIH applies this same government-wide definition to its own awards rather than a separate NIH-specific threshold. Items failing either prong are classified as "Supplies" instead.
DOE Research Security Training Requirement
DOE's research security training requirement, announced via Policy Flash PF 2025-04 (Financial Assistance Letter FAL 2025-02) under Section 10634 of the CHIPS and Science Act of 2022 (42 U.S.C. Section 19234) and NSPM-33, requires that 'covered individuals' named on a DOE R&D financial-assistance application complete research security training -- addressing cybersecurity, international collaboration/travel, foreign interference, and rules on proper use of funds, disclosure, conflict of commitment, and conflict of interest -- within the 12 months prior to submitting that application. The applicant organization certifies completion for all listed covered individuals via Current and Pending Support disclosure certification; DOE does not require use of any specific pre-approved training course.
PRIM&R (Public Responsibility in Medicine and Research)
PRIM&R (Public Responsibility in Medicine and Research) is a US-based 501(c)(3) nonprofit membership organization, founded in 1974 and headquartered in Boston, Massachusetts, that supports the ethical conduct of research involving human participants and animals. An organization or individual falls within PRIM&R's operational scope when their work touches research oversight -- Institutional Review Boards (IRBs) reviewing human-subjects research, or Institutional Animal Care and Use Committees (IACUCs) overseeing animal research -- rather than the conduct of a specific study itself. PRIM&R does not review protocols or approve studies; it trains and credentials the professionals and administrators who staff the committees that do.
Case Report IRB Exemption
A case report is generally treated as exempt from IRB (Common Rule) jurisdiction when it describes routine clinical care of one patient (or a small, non-systematically-assembled number), written up retrospectively with no predefined data-collection protocol and no intent to test a hypothesis or produce a generalizable conclusion — i.e., it fails the 45 CFR 46.102(l) definition of 'research' even though the patient meets the 46.102(e) 'human subject' definition. The determination is made by the IRB or a delegated research-compliance office, not by the author; institutional thresholds and required documentation vary, and HIPAA authorization/waiver plus patient consent for publication remain separately required regardless of Common Rule status.
Ethical Approval
Ethical approval is the prospective, documented authorization a research ethics body issues before a study involving human participants (or, in a parallel but separate system, live animals) may begin — confirming the protocol's risk-benefit balance, consent process, and participant protections meet the applicable regulatory and ethical standard. It is granted by whichever committee has jurisdiction in a given country, which is why the same underlying requirement is described using different national names.
Close-Out Visit (COV)
A Close-Out Visit (COV) is the final monitoring visit a sponsor or its Clinical Research Associate (CRA) conducts at a clinical trial site after the site has finished its participation in a study -- either because the site reached its last participant's last visit (LPLV) or because the trial or the site's participation was terminated early. A monitoring visit qualifies as a COV, rather than a routine Interim Monitoring Visit (IMV), only when it is the final visit for that site and confirms four things together: all outstanding data queries are resolved (or an agreed plan exists for any that cannot be), all required essential documents are complete and filed in the Trial Master File (TMF), investigational product (IP) has been reconciled and, per protocol/sponsor instruction, returned or destroyed with documentation, and the investigator/institution has notified (or is arranging to notify) the IRB/REB of study closure at that site.
Questionable research practices
A questionable research practice (QRP) is a design, analysis, or reporting choice -- such as p-hacking, HARKing, selective outcome reporting, or salami-slicing -- made after seeing data or results and then presented as if it had been planned in advance, or otherwise used to manufacture a favourable result, without inventing or altering the underlying data itself. QRPs are distinct from research misconduct (fabrication, falsification, plagiarism -- FFP), which does involve inventing or altering data or appropriating others' work; QRPs sit below that legal/regulatory threshold but are still recognised as damaging to research integrity.
Joint Associations Group (JAG) on Indirect Costs
The Joint Associations Group (JAG) on Indirect Costs is a coalition of national higher-education and research associations -- including AAU, APLU, AAMC, ACE, AASCU, AIRI, COGR, NACUBO, NAICU, and the Science Philanthropy Alliance -- formed in 2025 to develop and advocate for a replacement model for how the federal government reimburses universities' facilities and administrative (F&A) costs on federally sponsored research. It is a policy-advocacy coalition, not a standards body or a rate-setting authority: it does not itself negotiate or set any institution's indirect cost rate, and it has no regulatory authority under 2 CFR 200. Its output is a set of recommendations submitted to federal officials and Congress, produced through a subject-matter-experts process that draws on people with direct experience in university finance, grant administration, and F&A cost-rate regulation.
Ag Guide (Guide for the Care and Use of Agricultural Animals in Research and Teaching)
An institution follows the Ag Guide (Guide for the Care and Use of Agricultural Animals in Research and Teaching, FASS, 4th edition 2020) when agricultural animals -- livestock, poultry, and other food/fiber species -- are used in research or teaching whose purpose is agricultural (improving nutrition, breeding, management, production efficiency, or food/fiber quality). The determining factor is the purpose and context of the work, not the species alone: the same species used instead for biomedical purposes (e.g., a pig as a cardiovascular-device model) is typically reviewed under the Guide for the Care and Use of Laboratory Animals rather than the Ag Guide.
Randomization Methods in Clinical Trials
A randomization method is the pre-specified, reproducible procedure by which a clinical trial assigns each participant to a treatment or control arm based on chance rather than on the choice of the investigator, the participant, or any deterministic rule (e.g., alternating assignment or day-of-week). A procedure qualifies as randomization only if the allocation sequence is generated by a chance mechanism, is concealed from whoever enrolls participants until after enrollment (allocation concealment), and is documented so the trial's statistical analysis plan can account for it. The choice of method -- simple, block, stratified, or covariate-adaptive -- determines how tightly the resulting treatment groups are balanced on sample size and on prognostic factors, but all four share the same underlying purpose described by ICH E9, Statistical Principles for Clinical Trials: minimizing selection bias in treatment assignment and providing a sound statistical basis for comparing groups.
Time and Effort Reporting
The institutional system for documenting that salary and wages charged to, or cost-shared against, a federal award correspond to the effort an employee actually performed on that award, satisfying the internal-control standard at 2 CFR 200.430(g). It covers the full cycle -- budgeting effort at proposal stage, recording/monitoring effort during the award period, and after-the-fact review or confirmation (often called effort certification) that reconciles charged percentages against actual activity -- and does not correspond to any single federally mandated form; institutions design their own compliant forms or systems (Plan Confirmation, After-the-Fact Activity Records, Multiple Confirmation Records, or electronic effort-reporting platforms) as long as the underlying system provides reasonable assurance charges are accurate, allowable, and properly allocated based on records reflecting total compensated activity not exceeding 100 percent.
Decentralized Clinical Trials (DCTs)
A clinical trial is decentralized to the extent that trial-related activities normally performed at an investigational site — participant visits, specimen collection, investigational product dispensing, or outcome data collection — are instead performed via telehealth, a local lab/imaging facility or visiting health-care provider, direct-to-participant shipment, or a digital health technology, while the same IND/IDE, GCP, informed-consent, and safety-reporting requirements continue to apply. DCTs range on a spectrum from hybrid (some site visits, some remote) to fully decentralized (no in-person site visits).
Research Ethics Board (REB)
A Research Ethics Board (REB) is the committee constituted under Canada's TCPS2 (Tri-Council Policy Statement) at institutions eligible for CIHR, NSERC, or SSHRC funding that reviews, approves, requires modification of, or disapproves research involving human participants before that research may begin. It is the Canadian institutional counterpart to a US Institutional Review Board (IRB): the same underlying function of prospective ethics review, carried out under different national policy and terminology.
Umbrella Trial
An umbrella trial is a clinical trial design in which multiple investigational therapies are evaluated within a single disease population under one overarching master protocol, with each treatment arm matched to a different biomarker or molecular subtype found within that disease. The disease is held constant across the trial; the drug arm assigned to a given patient varies according to the biomarker their tumor or condition carries. FDA formally recognizes the umbrella trial as one of three related master-protocol designs, alongside the basket trial and the platform trial, in its guidance on master protocols for oncology drug and biologic development.
Endpoint Adjudication Committee (CEC)
An Endpoint Adjudication Committee (EAC) — often called a Clinical Events Committee (CEC) — is an independent group of clinical experts, typically blinded to each participant's treatment assignment, that reviews reported clinical events (deaths, hospitalizations, strokes, myocardial infarctions, and other complex or subjective outcomes) against pre-specified, standardized criteria defined in the trial protocol and a dedicated adjudication charter, and issues a formal, documented determination of whether each event meets the definition of a study endpoint. Adjudication exists to remove site-to-site and investigator-to-investigator variability in how an outcome gets diagnosed and classified — a real risk whenever the endpoint depends on clinical judgment rather than a single objective lab value — and it is a distinct function from safety oversight: a CEC classifies individual events against fixed criteria, it does not conduct comparative interim analyses across arms or recommend stopping the trial.
2 CFR 200 Subpart D (Post-Federal Award Requirements)
2 CFR 200 Subpart D (§§200.300–200.346) is the set of Uniform Guidance provisions governing how an already-made federal grant or cooperative agreement is administered, from the recipient's financial management system and internal controls through property/procurement standards, performance and financial reporting, subrecipient monitoring, record retention, and closeout. A requirement falls under Subpart D if it governs the administration of an active award; requirements governing the application/award-decision process belong to Subpart C, and the allowability of specific costs is governed by Subpart E.
AI and Ethics’ Journal Impact Factor (JIF)
AI and Ethics' Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Springer Nature journal AI and Ethics receives in the Journal Citation Reports (JCR) once it is JCR-indexed and citation-eligible -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. AI and Ethics (ISSN 2730-5953 print, 2730-5961 online) launched in 2021 and publishes on the ethical, regulatory, and policy implications of artificial intelligence, a comparatively young and fast-growing field for a dedicated journal. Third-party tracking sites report differing figures for the journal depending on the metric and window used -- for example, exaly.com reports a 2024 figure of roughly 6.1 alongside a separately labeled '2-year impact' figure of roughly 3.68 for the same year, which do not match each other and may not both be Clarivate JCR figures specifically (aggregators sometimes report Scopus/CiteScore-style metrics under an 'impact factor' label). CASRAI could not independently confirm a single authoritative JCR figure against jcr.clarivate.com (subscription-gated) or link.springer.com/journal/43681 (login-walled at the time of writing). Given the journal's 2021 launch, confirm directly with jcr.clarivate.com or the journal's own Springer page whether AI and Ethics is currently JCR-indexed at all, and if so for which data year, before citing any specific number formally.
FDP Data Transfer and Use Agreement (DTUA)
A Data Transfer and Use Agreement (DTUA) is the standardized data-sharing contract template published by the Federal Demonstration Partnership (FDP) for moving research data between U.S.-based nonprofit and/or governmental organizations for research or public health purposes. An agreement qualifies as an FDP DTUA when it follows the FDP's modular structure -- a Face Page plus a set of standard Attachments -- rather than being negotiated from scratch between the transferring institution (discloser) and receiving institution (recipient). The template is maintained by the FDP's Data Stewardship Subcommittee (within the Research Compliance Committee) and exists specifically to cut the time and legal back-and-forth that fully bespoke data-sharing agreements require, by giving both sides' institutional counsel a pre-vetted starting point with known, community-reviewed language.
Estimand Framework
The estimand framework, introduced in the ICH E9(R1) addendum to 'Statistical Principles for Clinical Trials' (final version adopted November 2019), is the structured approach a clinical trial protocol uses to state precisely, before the trial is analyzed, what treatment effect the trial is actually designed to estimate. A trial's estimand is defined by specifying five attributes: (1) the target population (the patients the clinical question is about), (2) the treatment conditions being compared, (3) the variable or endpoint measured for each participant, (4) the strategy for handling intercurrent events -- post-randomization events, such as treatment discontinuation, use of rescue medication, or death, that affect either the interpretation or the existence of the planned measurement -- and (5) the population-level summary used to compare the treatment conditions (for example, a difference in means, an odds ratio, or a hazard ratio). A trial only has a well-defined estimand when all five attributes are specified together and agreed before unblinding; changing how one attribute is handled (most consequentially, the intercurrent-event strategy) changes what the resulting number actually means, even if the same raw data and the same statistical test are used to produce it.
Assent vs. Consent (in Research)
Assent is the affirmative agreement of a prospective research subject who lacks the legal capacity to give informed consent on their own behalf -- typically a minor -- to take part in a research study. Under 45 CFR 46 Subpart D (§46.402(b), §46.408), assent is distinct from, and required in addition to, the informed permission of a parent or legally authorized guardian: a child's willingness to participate does not substitute for parental permission, and parental permission does not substitute for the child's own assent where an Institutional Review Board (IRB) has determined the child is capable of providing it. Critically, assent must be an affirmative 'yes' -- the regulation explicitly states that a child's mere failure to object, absent some affirmative agreement, may not be construed as assent. The IRB decides, on a study-by-study or even subject-by-subject basis, whether assent is required, how it should be solicited (verbally, in writing, or via an age-appropriate script), and whether it may be waived under the conditions set out in §46.408(a).
JAMA Network Open’s Journal Impact Factor (JIF)
JAMA Network Open's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the journal receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. JAMA Network Open's own journal page (jamanetwork.com) states this figure as 11.7, the highest among large-volume general-medicine open-access journals; CASRAI verified this directly against the publisher's page on 16 August 2026 rather than a third-party tracker or Wikipedia. It reflects the current JCR cycle -- the 2025 data year, released by Clarivate in June 2026. It is a separate, independently computed figure from the flagship JAMA journal's own JIF, and the two should never be quoted interchangeably. JAMA Network Open launched in 2018 as an open-access, general-medicine title within the JAMA Network family published by the American Medical Association (AMA); unlike the subscription-model flagship JAMA, it publishes open access across all areas of medicine rather than a curated weekly selection, which shapes how its citation volume accumulates relative to JAMA's.
International Journal of Molecular Sciences (IJMS) Impact Factor (JIF)
The Impact Factor (JIF) of the International Journal of Molecular Sciences (IJMS) is the Journal Citation Reports (JCR) metric Clarivate publishes for this MDPI-owned title, calculated as the average number of 2026 citations to articles IJMS published in 2024-2025, divided by the number of citable items it published in those two years. As of the most recent JCR release (June 2026, covering 2025 citation data), third-party trackers that mirror Clarivate's JCR figures report a 2-year Impact Factor of approximately 5.6 and a 5-year Impact Factor of approximately 6.3, placing IJMS in JCR Quartile 1 (Q1) of the Biochemistry & Molecular Biology category. CASRAI did not independently fetch jcr.clarivate.com for this figure (subscription-gated); treat the number as REPORTED-tier, cross-corroborated across multiple independent JCR-tracking sites rather than confirmed directly against Clarivate's own portal, and re-verify before citing it in a high-stakes context such as a promotion or tenure file.
Molecular Cell’s Journal Impact Factor (JIF)
Molecular Cell's Journal Impact Factor (JIF) is a specific, illustrative instance of the general Journal Impact Factor metric published annually by Clarivate in the Journal Citation Reports (JCR). Molecular Cell (ISSN 1097-2765) is a Cell Press life-sciences research journal founded in 1997/1998, editorially and commercially distinct from both Cell Press's flagship title Cell and its open-access sister journal Cell Reports — each carries its own, separately computed JIF despite the shared Cell Press imprint.
Journal of Biological Chemistry’s Journal Impact Factor (JIF)
The Journal of Biological Chemistry's (JBC) Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio JBC receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. JBC (ISSN 0021-9258, e-ISSN 1083-351X) is published by the American Society for Biochemistry and Molecular Biology (ASBMB) and has been in continuous publication since 1905, making it one of the longest-running biochemistry journals still active; it converted to a fully open-access model in 2021. Third-party JCR-tracking aggregators report JBC's 2-year JIF at roughly 4.1 for the 2025 JCR data year (released June 2026), up from roughly 3.76 for the 2024 data year, with a reported 5-year JIF near 4.3 and a JCR Quartile 2 placement in biochemistry and molecular biology. These aggregator figures do not always agree with one another, and ASBMB's own jbc.org site was not independently reachable to confirm one authoritative figure at the time of writing. Treat any single number you see cited as time-stamped to a specific JCR release -- Clarivate updates JCR every June -- and check jcr.clarivate.com or jbc.org directly for the current, release-dated figure before citing it in a formal context such as a CV, grant application, or tenure file. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
Nucleic Acids Research’s Journal Impact Factor (JIF)
Nucleic Acids Research's Journal Impact Factor (JIF) is the annual citation metric Clarivate publishes for the journal in the Journal Citation Reports (JCR): citations in a given JCR year to Nucleic Acids Research articles published in the preceding two years (or five, for the 5-year version), divided by the number of citable items the journal published in that window. Nucleic Acids Research (NAR) is an open-access, biweekly molecular biology and biochemistry journal published by Oxford University Press since 1974 (ISSN 0305-1048 print, 1362-4962 online). Per Oxford University Press's own journal page (academic.oup.com/nar), verified 16 August 2026, NAR's 2025 Impact Factor is 15.0 (2-year) and its 2025 Five-Year Impact Factor is 17.6.
JCI Insight’s Journal Impact Factor (JIF)
JCI Insight's Journal Impact Factor (JIF) is the annual Clarivate-calculated citation ratio published in the Journal Citation Reports (JCR) for JCI Insight specifically. JCI Insight is a separate journal from the Journal of Clinical Investigation (JCI): it is the gold open-access companion title the American Society for Clinical Investigation (ASCI) launched in 2016 (ISSN 2379-3708), separately indexed in the JCR with its own figure, whereas "JCI" on its own means ASCI's flagship Journal of Clinical Investigation (ISSN 0021-9738 print / 1558-8238 online), which CASRAI covers on a separate page. JCI Insight's own journal-information page (insight.jci.org/kiosks/about) states an Impact Factor of 6.8 for the 2025 JCR data year, verified 7 August 2026; Clarivate updates the JCR every June, so treat that number as current only as of that release and confirm it before citing it in a CV, tenure file, or funder report. No figure on the JCI Insight page applies to the Journal of Clinical Investigation, or vice versa.
New England Journal of Medicine’s Journal Impact Factor (JIF)
The New England Journal of Medicine's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Massachusetts Medical Society's flagship clinical-medicine journal receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. NEJM (ISSN 0028-4793 print, 1533-4406 online) has published continuously since 1812, making it one of the oldest continuously published medical journals in the world, and is indexed in Clarivate's Science Citation Index Expanded, which makes it JIF-eligible. Third-party JCR-tracking aggregators report NEJM's 2-year JIF in the high-70s to mid-80s range for recent releases -- figures cited include roughly 78.5 and roughly 84.5 for figures described as the '2025 impact factor,' attributed inconsistently to the 2025 versus 2026 JCR release across different aggregator pages -- with a reported 5-year JIF near 84.9. These aggregator figures do not agree with one another even when describing what appears to be the same release, and NEJM's own journal-information page was not independently reachable to confirm one authoritative figure at the time of writing (returned an access-restricted response during verification). Treat any single number you see cited as time-stamped to a specific JCR release -- Clarivate updates JCR every June -- and check jcr.clarivate.com or nejm.org directly for the current, release-dated figure before citing it in a formal context such as a CV, grant application, or tenure file. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article NEJM has published, nor of the researchers who authored it.
Interim Monitoring Visit (IMV)
An Interim Monitoring Visit (IMV) -- also called a routine monitoring visit or periodic site monitoring visit -- is a monitoring contact, on-site or remote, that a sponsor or its designated Clinical Research Associate (CRA) conducts at intervals throughout the active conduct phase of a clinical trial, after a site has been initiated and is enrolling or following participants, and before the site closes out. Its purpose, per ICH E6(R2) Section 5.18.3, is to verify that the rights and well-being of trial participants are protected, that reported trial data are accurate, complete, and verifiable from source documents, and that the trial is being conducted in compliance with the currently approved protocol/amendments, Good Clinical Practice (GCP), and applicable regulatory requirements. A contact only qualifies as an IMV if it occurs during this ongoing conduct period and covers the recurring monitoring activities -- source data verification, investigational product (IP) accountability, regulatory-document currency, and safety-reporting checks -- described below; a visit conducted before a site has enrolled its first participant, or after the site has permanently stopped activity, falls under a different visit type instead.
NEJM AI
NEJM AI is a peer-reviewed monthly journal published by NEJM Group (a division of the Massachusetts Medical Society, the same publisher as the flagship New England Journal of Medicine) that publishes original research, reviews, perspectives, and policy analysis on the application of artificial intelligence and machine learning to medicine and health care. It launched in December 2023, with its inaugural issue in January 2024. NEJM AI is editorially and operationally distinct from NEJM itself: it has its own submission portal (ai.nejm.org), its own editorial board and peer-review process, and a narrower topical scope than the flagship journal's general internal medicine remit. A manuscript is within NEJM AI's scope if its central contribution is an AI/ML method, dataset, or system applied to a biomedical or clinical problem, or an analysis of AI's technical, regulatory, ethical, or health-system implications — not simply a clinical study that happens to use software.
Cell Reports Medicine’s Journal Impact Factor (JIF)
Cell Reports Medicine’s Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio this journal receives each year in the Journal Citation Reports (JCR) — citations in the JCR data year to the journal’s citable items from the two preceding years, divided by that item count. Cell Reports Medicine is a Cell Press open-access journal, launched in 2020, publishing translational and clinical biomedical research — distinct from its broader-scope sister title Cell Reports, which covers life sciences generally and carries its own separate JIF. Multiple third-party JCR-tracking aggregators converge on a figure of approximately 14.0 for the 2025 JCR data year (Clarivate’s June 2026 release), placing the journal in JCR Quartile 1, but CASRAI was not able to independently confirm this against jcr.clarivate.com (subscription-gated) or reach Cell Press’s own metrics page directly at the time of writing, so treat this as a cross-corroborated but secondary-source figure rather than a primary-verified one. Clarivate updates JCR every June; check jcr.clarivate.com or cell.com/cell-reports-medicine for the current, release-dated figure before citing a number in a formal context. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
ACS Nano’s Journal Impact Factor (JIF)
ACS Nano's Journal Impact Factor (JIF) is the annual two-year citation metric Clarivate publishes for the journal in the Journal Citation Reports (JCR): citations in a given JCR year to ACS Nano articles published in the preceding two years, divided by the number of citable items ACS Nano published in those two years. ACS Nano is a nanoscience and nanotechnology journal published by the American Chemical Society since 2007 (ISSN 1936-0851 print, 1936-086X online); its reported JIF has sat in the mid-to-high-teens range across recent JCR releases (approximately 16.0 for the 2024 data year per secondary trackers, up from a reported 15.8 for 2023).
Registrational Trial
A registrational trial (also called a pivotal trial) is a clinical study designed and executed specifically to generate the primary efficacy and safety evidence submitted in a marketing application — a New Drug Application (NDA), Biologics License Application (BLA), or comparable submission — to a regulatory authority such as FDA. What makes a trial ‘registrational’ is not its phase number but its regulatory purpose: it is prospectively designed as an adequate and well-controlled investigation under 21 CFR 314.126, with a prespecified primary endpoint and statistical analysis plan agreed with the regulator (often via a Special Protocol Assessment), and powered to provide the ‘substantial evidence of effectiveness’ the Federal Food, Drug, and Cosmetic Act requires for approval. Most registrational trials are Phase 3 studies, but a well-controlled Phase 2 trial can serve the same function in accelerated-approval or rare-disease programs where a full Phase 3 program is used to confirm benefit post-approval.
Site Qualification Visit (SQV)
A Site Qualification Visit (SQV) is the pre-selection assessment visit a sponsor or CRO conducts at a prospective investigative site, before that site is contracted or selected for a specific clinical trial, to evaluate whether it should be chosen. A visit counts as an SQV when its purpose is evaluative and its timing is pre-selection: it examines the site's facilities and equipment, staff qualifications and prior trial experience, patient population and recruitment feasibility, and quality systems/SOPs, in order to inform a go/no-go selection decision. A visit is NOT an SQV if it occurs after the site has already been selected, contracted, and IRB-approved and is instead confirming the site is ready to begin enrollment -- that is a Site Initiation Visit (SIV) -- or if it occurs during active enrollment to review ongoing conduct, which is a routine monitoring visit.
Confounding Variable
A confounding variable (confounder) is a third factor that is associated with both the independent variable (or exposure) and the dependent variable (or outcome) under study, and is not simply a step on the causal path between them. Because it moves with the presumed cause and also influences the presumed effect, an unaccounted-for confounder can produce, inflate, mask, or reverse an apparent association -- meaning a manuscript's reported effect is partly or wholly attributable to the confounder rather than the variable of interest. A factor only qualifies as a confounder for a given design if it meets all three conditions: it is associated with the independent variable, it independently affects the dependent variable, and it is not a mediator (a variable that lies on the causal pathway between the two, which requires different handling in analysis and reporting).
Effect Size
Effect size is a standardized, quantitative measure of the magnitude of a difference, relationship, or association observed in a study, reported independently of sample size and distinct from statistical significance. Where a p-value indicates only whether an observed effect is unlikely to be due to chance, an effect size (e.g., Cohen's d, Pearson's r, an odds ratio) indicates how large or practically meaningful that effect actually is. The APA Publication Manual (7th edition, Section 6.5) requires reporting an effect size and confidence interval for each primary outcome, and most major journals across the behavioral, social, and biomedical sciences hold manuscripts to an equivalent expectation.
Cancer Research’s Journal Impact Factor (JIF)
Cancer Research's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the AACR journal Cancer Research receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. The last independently corroborated figure is 22.6 for the 2024 JCR data year (2025 release); Clarivate's current release cycle covers the 2025 JCR data year (released June 2026), but CASRAI could not reach the publisher's own journal page (aacrjournals.org/cancerres) to confirm that newer figure as of 16 August 2026. Verify the current figure at the journal's own metrics page or jcr.clarivate.com before citing it formally. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
Nature Medicine’s Journal Impact Factor (JIF)
Nature Medicine's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Nature Medicine journal receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to Nature Medicine's citable items from the two preceding years, divided by that item count. Per Nature Portfolio's own journal-impact page (nature.com/nm/journal-impact), Nature Medicine's 2-year Impact Factor is 52.5 and its 5-year Impact Factor is also 52.5, both for the 2025 JCR data year (JCR release published June 2026); last verified directly against that page August 16, 2026. Nature Medicine is a distinct, separately scored journal from Nature, Nature Communications, and the other 60-plus Nature Portfolio titles published by Springer Nature -- a JIF reported for a sister journal is never Nature Medicine's own figure. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in Nature Medicine or the merit of its authors.
ANOVA (Analysis of Variance)
Analysis of Variance (ANOVA) is an inferential statistical test used to compare the means of a continuous outcome across three or more groups, or across the combined levels of two or more categorical factors, by partitioning total observed variance into a between-group component and a within-group (error) component. The ratio of those two components produces an F-statistic: a study is using ANOVA, rather than a t-test, whenever it is testing for a difference among three or more group means (or a factorial combination of grouping variables) using that between/within variance ratio, rather than comparing exactly two means directly.
Unallowable Cost (2 CFR 200)
An unallowable cost under 2 CFR 200 is any expense that federal cost-principle rules bar an institution from charging to a federal award, whether as a direct charge or through the indirect (F&A) cost rate. A cost becomes unallowable in one of two ways under Subpart E. First, it can fail the general allowability test at 2 CFR 200.403 -- it is not necessary and reasonable for the award, not allocable to it, treated inconsistently with how the institution handles like costs, non-compliant with GAAP or the award's own terms, double-counted toward a cost-sharing commitment, or inadequately documented. Second, and distinctly, it can fall into one of the specifically-named categories in the 'selected items of cost' catalog at 200.421-200.475, which addresses named cost types one by one -- alcoholic beverages, entertainment, lobbying, fines and penalties, bad debts, contributions and donations, fundraising, and dozens more -- regardless of whether the institution would otherwise treat the cost as reasonable or allocable. This second route is what distinguishes 'unallowable' from a cost that merely fails allocability or reasonableness on its own facts: a cost can be perfectly reasonable and allocable to a specific project and still be unallowable outright because Subpart E names that category of cost as barred. Per 200.420, the named-category list is illustrative, not exhaustive -- an unlisted cost item is not automatically allowable; it still has to clear the general 200.403 test and is evaluated by analogy to similar listed items. Unallowable costs must be identified and excluded from any proposal, invoice, or financial report submitted to the federal government, and from the base used to calculate the institution's indirect cost rate -- charging one to a federal award, intentionally or through inadequate internal controls, is one of the most commonly cited findings in a Single Audit under 2 CFR 200 Subpart F.
ALCOA+ (Clinical Trial Data Integrity Principles)
ALCOA+ is the nine-attribute framework regulators use to judge whether a clinical-trial data record is trustworthy enough to support a marketing application or inspection finding. A record satisfies ALCOA+ when it is Attributable (traceable to the specific person or system that created it, with no shared logins or unattributed edits), Legible (readable and permanent for the life of the record, including any correction), Contemporaneous (recorded at the time the activity occurred, not reconstructed later from memory), Original (the first recording of the data, or a verified true copy carrying equivalent authority), and Accurate (free of error, and reflecting what actually happened) -- the original five FDA ALCOA attributes -- plus Complete (nothing selectively omitted, including repeat or rejected results), Consistent (chronologically dated, time-stamped, and internally coherent), Enduring (surviving on durable media for the full required retention period), and Available (retrievable for review, audit, or inspection throughout that period). A record that fails any one of the nine is a data-integrity finding, regardless of whether the underlying clinical result itself is otherwise plausible.
Bayesian Adaptive Design
A Bayesian adaptive design is a clinical trial design in which the statistical framework starts from a prior probability distribution over treatment effects and formally updates that distribution into a posterior distribution as outcome data accumulate during the trial, using Bayes' theorem rather than waiting for a single fixed-sample-size final analysis. What makes a design specifically Bayesian-adaptive, rather than merely adaptive, is that the pre-specified adaptation rules (whether to modify randomization allocation, stop a trial arm early for efficacy or futility, or re-estimate sample size) are driven by these continuously updated posterior probabilities rather than by frequentist p-value or alpha-spending boundaries alone. The most common operational form is Bayesian response-adaptive randomization: the probability that a newly enrolled participant is assigned to a given arm shifts over the course of the trial toward arms whose posterior probability of superiority is higher, based on outcomes observed so far in the shared, concurrently randomized control comparison. This distinguishes a Bayesian adaptive design from a conventional frequentist fixed-sample design, in which the randomization ratio and total sample size are fixed at the outset by a power calculation and the treatment-effect hypothesis is tested once, at a single pre-planned analysis (or at a small number of pre-specified interim looks using a fixed alpha-spending function), with no allocation-ratio changes based on relative arm performance mid-trial.
Pre-Screening
Pre-screening is the informal, preliminary process of assessing whether a prospective clinical trial participant is likely to meet inclusion/exclusion criteria, conducted before the protocol-defined formal screening visit and generally before the participant signs the informed consent form (ICF). It typically takes the form of a brief phone or in-person eligibility interview using an IRB-approved script, or a review of existing medical records/EHR data conducted under a HIPAA waiver of authorization or the reviews-preparatory-to-research provision (45 CFR 164.512(i)). A candidate excluded at this stage never enters the trial's formal screening and enrollment log and is not counted toward the trial's screen failure rate.
HREC (Human Research Ethics Committee)
The Australian term for the committee that reviews and approves research involving human participants before it may lawfully or ethically proceed. An HREC is constituted and registered under the National Health and Medical Research Council (NHMRC)'s National Statement on Ethical Conduct in Human Research, and its review is the Australian institutional counterpart to an IRB (Institutional Review Board) in the United States or an REC (Research Ethics Committee) in the UK/EU. A study is subject to HREC review whenever it involves human participants, their identifiable data, or their tissue and is designed to produce generalisable knowledge; the depth of that review is graded by risk rather than uniform for every protocol.
Experimental Design
A study’s design counts as experimental when the researcher manipulates the independent variable, assigns participants or units to at least one comparison/control condition (ideally via randomization), and builds in mechanisms — randomization, blinding, standardized protocol — to control extraneous and confounding variables, so that any resulting difference in the dependent variable can be attributed to the manipulation rather than to a pre-existing group difference.
SRA International (SRAI)
SRA International (formally the Society of Research Administrators International, founded 24 June 1967) is a professional membership association of roughly 5,000 research administrators across about 40 countries. It is not a regulator or exam-based credentialing body: its main output is a catalog of 11 completion-based certificate programs (e.g. Pre-Award, Financial Management, Clinical Trials Research Administration) earned through conference workshops and electives, distinct from RACC's proctored CRA/CPRA/CFRA credentials and from NCURA, the comparable US-focused membership association.
Science Translational Medicine’s Journal Impact Factor (JIF)
Science Translational Medicine's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the AAAS journal receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Science Translational Medicine (ISSN 1946-6234 print, 1946-6242 online), launched October 2009, is a distinct, separately-indexed AAAS title from Science and Science Advances. The current JCR cycle is the 2025 data year, released June 2026; CASRAI attempted to verify the journal's figure for that cycle directly at science.org/journal/stm this session (last verified 2026-08-16) and the request was blocked by the publisher's Cloudflare bot protection (a 'Cookie Absent' error page was returned), so no current figure is stated as fact. The last figure CASRAI can attribute to a specific, dated cycle is approximately 14.6 for the 2024 data year (June 2025 release), per third-party JCR-tracking sources, with at least one independent aggregator instead reporting a close but distinct figure near 13.6 for the same data year -- an unresolved cross-tracker discrepancy. Per DORA and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in Science Translational Medicine or the merit of its authors.
Communications Biology’s Journal Impact Factor (JIF)
Communications Biology's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Springer Nature journal receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Communications Biology (ISSN 2399-3642) is a Nature Portfolio, fully open-access, broad-scope biology journal launched in 2018, and it is a distinct title from Nature Communications despite the similar name -- each carries its own separately computed JIF, and the two should never be cited interchangeably. Third-party JCR-tracking aggregators report Communications Biology's 2-year JIF at approximately 5.1 for the 2024 JCR data year (2025 release) and approximately 5.8 for the 2025 JCR data year (2026 release, issued June 2026), placing the journal in JCR Quartile 1 within its category. CASRAI could not independently confirm either figure directly against Nature Portfolio's own journal-impact page (nature.com/commsbio/journal-impact), which sits behind an account-gated redirect, or against jcr.clarivate.com directly, at the time this entry was written -- treat both numbers as reported, not CASRAI-verified, and check the journal's own metrics page or jcr.clarivate.com for the current, release-dated figure before citing one in a formal context such as a CV, grant application, or tenure file. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
Descriptive Statistics vs. Inferential Statistics
In a research manuscript, descriptive statistics summarize the data actually collected -- means, medians, standard deviations, frequencies, and proportions that describe the sample in hand -- while inferential statistics use that sample data to draw a conclusion about a larger population, quantifying uncertainty through tools such as p-values, confidence intervals, and hypothesis tests. The distinction is not about which formulas are used but about the claim being made: a descriptive statistic describes only the data collected, while an inferential statistic makes a probabilistic claim that extends beyond it. Manuscripts that report a difference between groups (e.g., a higher mean score in one arm) without an accompanying inferential test are making a descriptive observation, not a generalizable finding -- reviewers routinely flag this conflation in Results sections.
Screen Failure
A participant who provides informed consent and enters the protocol-defined screening process for a clinical trial, but is not subsequently randomized or assigned to study intervention because they fail to meet one or more inclusion/exclusion criteria, withdraw consent before randomization, or otherwise become ineligible prior to enrollment. The defining boundary is randomization/assignment to study intervention: everything before that point that ends without assignment is a screen failure; anything after it is a post-randomization withdrawal or discontinuation, not a screen failure.
Journal of Clinical Investigation’s Journal Impact Factor (JIF)
The Journal of Clinical Investigation (JCI)'s Journal Impact Factor (JIF) is that specific journal's own annual Clarivate metric -- citations in a given year to the articles and reviews it published in the two preceding years, divided by the number of those citable items -- published in the Journal Citation Reports (JCR). It is a single journal's instance of the general JIF metric, not a separate calculation method, and it changes with every annual JCR release (Clarivate updates JCR every June). "JCI" on its own refers to this journal, The Journal of Clinical Investigation (ISSN 0021-9738 print / 1558-8238 online). It is a separate journal from JCI Insight, ASCI's gold open-access companion title launched in 2016 (ISSN 2379-3708), which is separately indexed in the JCR and carries its own, different figure -- see CASRAI's JCI Insight entry, and never substitute one journal's number for the other's. Per the journal's own information page (jci.org/kiosks/about), verified 7 August 2026, JCI's Impact Factor is 14.3 for the 2025 JCR data year.
Cell’s Journal Impact Factor (JIF)
Cell's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the flagship Cell Press journal Cell receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count; a separate 5-year JIF uses a five-year window instead. Cell (ISSN 0092-8674) is Cell Press's founding, subscription/hybrid flagship life-sciences journal, published continuously since 1974, and it is distinct from Cell Reports, Cell Press's open-access sister journal launched in 2012 -- each carries its own separately computed JIF. Third-party JCR-tracking aggregators report Cell's 2-year JIF at roughly 42.5 for the 2024 JCR data year and roughly 45.1 for the 2025 JCR data year, with a separately reported 5-year JIF near 48.9 (not a more-current version of the 2-year figure, but a different window). CASRAI attempted to confirm these directly against Cell Press's own metrics page (cell.com/metrics) on 16 August 2026 and could not (access blocked), so treat all figures as aggregator-reported, not primary-verified -- check jcr.clarivate.com or cell.com/metrics for the current, authoritative figure before citing it formally. Per DORA and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
Umbrella Review
An umbrella review (overview of reviews) systematically identifies, appraises, and synthesizes previously published systematic reviews and/or meta-analyses on a broader topic, using those reviews rather than primary studies as its unit of analysis. Included reviews are typically appraised with AMSTAR-2, checked for overlap of underlying primary studies (e.g. via the Corrected Covered Area metric), and the umbrella review itself is reported per PRISMA 2020 or the purpose-built PRIOR statement.
PLOS ONE Impact Factor (2026 Update)
PLOS ONE's Journal Impact Factor (JIF) would, if PLOS promoted one, be the Clarivate-computed, journal-level citation ratio published annually in the Journal Citation Reports (JCR). PLOS's own journal-information page states directly that it does not consider Impact Factor 'a reliable or useful metric to assess the performance of individual articles' and will only provide the figure to individuals on request -- CASRAI verified this policy language directly against journals.plos.org/plosone/s/journal-information on 16 August 2026. PLOS instead promotes article-level metrics, CiteScore, SJR, and the h-index. Because PLOS ONE remains a JCR-indexed title, Clarivate does compute a JIF for it (current cycle: 2025 data year, released June 2026), but that figure sits behind institutional JCR access and was not independently checked by CASRAI; it should not be sourced from a third-party JCR-tracking aggregator or Wikipedia. PLOS ONE is also a megajournal that peer-reviews for scientific and methodological soundness rather than perceived novelty or impact, which reinforces why a single journal-level citation figure -- where one exists -- is an unusually poor stand-in for the quality of any individual PLOS ONE article.
SCImago Journal Rank (SJR)
SCImago Journal Rank (SJR) is a free, publicly available journal-prestige indicator produced by the SCImago Research Group (a joint initiative of the Consejo Superior de Investigaciones Cientificas and the University of Granada, Spain) and published via scimagojr.com, using citation data licensed from Elsevier's Scopus database. A journal's SJR score is not a simple citation count or average -- it is computed with an iterative, PageRank-style algorithm that redistributes 'prestige' across the citation network so that a citation from a higher-prestige journal counts for more than a citation from a lower-prestige one. The calculation uses a 3-year citation window (citations received in year Y to documents published in years Y-1, Y-2, and Y-3), and caps journal self-citation at a maximum of 33% of a journal's total outgoing references so a journal cannot inflate its own score by citing itself. SCImago also publishes each journal's placement into quartiles (Q1-Q4) within its Scopus subject category, which is what most researchers use day to day to gauge a journal's relative standing among its direct peers.
Equivalence Trial
An equivalence trial is a clinical trial designed to show that a new intervention's effect is neither meaningfully better nor meaningfully worse than an active comparator -- the treatment difference must fall within a pre-specified equivalence margin in both directions. It is one of three ways a comparative trial's primary hypothesis can be framed at the protocol design stage: a superiority trial sets out to show one arm is better than another (or than placebo); a non-inferiority trial sets out to show a new arm is not unacceptably worse than an active comparator, using only a single lower margin; an equivalence trial requires the treatment difference's confidence interval to fall entirely within a symmetric two-sided margin, written (-delta, +delta), that was fixed before the trial started as the largest difference still considered clinically unimportant. Which of the three applies is a design decision documented in the protocol and statistical analysis plan -- it is not something inferred after the fact from a trial's results.
Cell Reports’ Journal Impact Factor (JIF)
Cell Reports' Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio Cell Reports receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Cell Reports is a Cell Press (Elsevier) open-access, broad-scope life-sciences journal, and its JIF has placed it in JCR Quartile 1 for Cell Biology in recent releases; third-party JCR-tracking services report figures in roughly the high-6-to-8 range across the last several JCR releases, but they do not agree on an exact current figure, and Cell Press's own site was not independently reachable to confirm one at the time of writing. Treat any single number you see cited as time-stamped to a specific JCR release -- Clarivate updates JCR every June -- and check jcr.clarivate.com or the journal's own metrics page at cell.com/cell-reports for the current, authoritative figure before citing it in a formal context. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
Study Data Tabulation Model (SDTM)
The Study Data Tabulation Model (SDTM) is a CDISC foundational standard that defines a standard structure for organizing clinical trial data into a set of named, model-conformant domain datasets (e.g. DM, AE, VS) for submission to regulatory authorities such as the FDA and Japan's PMDA. A dataset counts as SDTM-conformant when its observations are classified into one of SDTM's general observation classes (Interventions, Events, Findings, or Findings About), each variable maps to a controlled SDTM domain/variable name, and the dataset is accompanied by a define.xml metadata file describing its structure. SDTM governs the submission-ready tabulation format, not how data is collected at the site (that is CDASH) and not the software used to capture it (that is EDC).
Cross-Sectional Study
A cross-sectional study is an observational research design in which exposure and outcome (or any set of variables) are measured on a defined sample at a single point in time, rather than by following participants forward or reconstructing their history backward. Participants are selected on inclusion/exclusion criteria for the population of interest, not on their exposure or outcome status -- that selection rule is what separates a cross-sectional design from a cohort study (selected on exposure, followed forward) or a case-control study (selected on outcome, examined retrospectively). Because everything is captured in a single snapshot, a cross-sectional design can describe prevalence and association but cannot, on its own, establish temporal sequence or causation.
Serious Adverse Event (SAE)
An adverse event (AE) that meets at least one of six regulatory seriousness criteria defined by ICH E2A, regardless of causality or perceived clinical severity: it results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another medically important event that the investigator judges may jeopardize the subject or require intervention to prevent one of the other outcomes. Seriousness is a fixed regulatory classification, distinct from clinical severity (mild/moderate/severe) and distinct from causality.
Centralized Monitoring
Centralized monitoring is a clinical-trial oversight technique in which qualified personnel -- typically data managers, biostatisticians, or medical monitors -- remotely and systematically review accumulating trial data across all participating sites (via EDC, laboratory feeds, and other data streams), rather than verifying individual records in person at each site. It is a data-level, aggregate, cross-site review aimed at identifying which sites or subjects actually need targeted follow-up, as opposed to applying uniform monitoring effort everywhere regardless of risk. Centralized monitoring is one specific technique within the broader Risk-Based Monitoring (RBM) strategy -- a component of RBM, not synonymous with it.
Survey Research Methods
A data-collection methodology in which a standardized instrument (structured questionnaire or interview protocol) is administered consistently to respondents drawn from a defined sampling frame, to measure self-reported attitudes, behaviors, beliefs, or characteristics in quantifiable, comparable form. Distinguished from qualitative interview methods by its fixed, uniform instrument and from experimental designs by the absence of manipulated independent variables; evaluated on sampling procedure, response rate, and the instrument's reliability and validity.
Platform Trial
A platform trial is a clinical trial conducted under a single master protocol that evaluates multiple interventions against a shared control arm, for a single disease or condition, on a perpetual or long-running basis — arms can be added or dropped over time as interventions are found effective, futile, or superseded, without stopping the trial and writing a new protocol from scratch. The FDA's 2018/2022 master-protocol guidance groups platform trials alongside two related but distinct designs sharing the same master-protocol infrastructure: basket trials (one intervention tested across multiple diseases or molecular subtypes) and umbrella trials (multiple interventions tested for one disease, but with a fixed, pre-specified set of arms rather than an open-ended one). What makes a design a platform trial specifically, rather than a generic multi-arm study, is the combination of (1) a single overarching master protocol and statistical analysis plan governing all arms, (2) a shared, concurrently randomized control group that multiple experimental arms are compared against, and (3) a pre-specified adaptive mechanism — typically Bayesian response-adaptive randomization or interim futility/efficacy stopping rules — for adding, dropping, or reallocating arms as data accumulate.
iThenticate
iThenticate is a text-matching (similarity-checking) service, owned and operated by Turnitin, that is marketed to publishers, journal editorial offices, funding agencies, and research institutions rather than to classroom instructors. A document qualifies as having been "run through iThenticate" when it has been submitted to the service's own web interface or via an API/editorial-management integration, compared against iThenticate's reference corpus (current and archived web content, previously submitted documents, and licensed academic publications, journals, and periodicals), and returned as a similarity report with a percentage-based similarity index and a source-by-source match breakdown. iThenticate is the same underlying detection engine Turnitin uses for its education product, packaged and licensed separately for non-classroom, professional research contexts: manuscript submission, grant proposal screening, and pre-publication or pre-submission self-checks. Crossref Similarity Check is a related but distinct service that Crossref operates on top of the iThenticate engine for its member publishers; a document checked through Crossref Similarity Check is, technically, still being matched by iThenticate's underlying engine, just accessed through Crossref's integration rather than a direct iThenticate license.
Science Advances Impact Factor (2026 Update)
Science Advances' Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio Science Advances receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. CASRAI verified a current figure directly against AAAS's own Journal metrics page (science.org/content/page/journal-metrics): 13.9 (2-year) and 14.8 (5-year) for the 2025 JCR data year, Clarivate's June 2026 release, Quartile 1 in Multidisciplinary Sciences -- cross-corroborated by Wikipedia's infobox and by library-services vendor Wolters Kluwer/Ovid's journal listing, which attributes the same figure directly to the Journal Citation Report/Web of Science. Science Advances is a peer-reviewed, multidisciplinary, fully open-access journal published by AAAS, indexed in Clarivate's Science Citation Index Expanded since its 2015 launch.
Active Voice vs. Passive Voice
In scientific and academic writing, active voice makes the sentence's grammatical subject the agent performing the action ('We measured the samples'), while passive voice makes the subject the recipient of the action, with the agent optional or omitted ('The samples were measured'). Neither is a grammar error — the choice is stylistic and governed by disciplinary convention. Current guidance (APA Style; the author instructions of most high-impact journals, including Nature- and Science-family titles) treats active voice as the default for clarity throughout most of a manuscript, while passive voice remains the traditional — and often still preferred — register in Methods sections, where the procedure is the focus rather than who performed it.
Electronic Clinical Outcome Assessment (eCOA)
The technology/platform category (provisioned device, BYOD app, IVR/IWR, or site-based terminal) used to capture Clinical Outcome Assessment (COA) data — PRO, ClinRO, ObsRO, or PerfO — electronically at the point of assessment, in place of a paper case-report form, typically requiring mode-of-administration equivalence to the original paper instrument and 21 CFR Part 11-consistent audit trails/access controls before the resulting data is relied on for a trial endpoint.
Nature’s Journal Impact Factor (JIF)
Nature's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the flagship Nature journal receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to Nature's citable items from the two preceding years, divided by that item count. Multiple independent JCR-tracking aggregators report Nature's 2-year Impact Factor at approximately 56.1 for the most recent JCR release (2025 citation data, released June 2026), up from approximately 48.5 the prior release; nature.com's own journal-information page could not be directly confirmed for this draft (login-gated), so treat the figure as reported rather than independently verified, and check jcr.clarivate.com or nature.com for the current number before citing it formally. Nature is a distinct, separately scored journal from Nature Communications, Scientific Reports, and the other 60-plus Nature Portfolio titles published by Springer Nature -- a JIF reported for a sister journal is never Nature's own figure. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in Nature or the merit of its authors.
Late-Phase Clinical Study
A late-phase clinical study is a Phase IIIb or Phase IV clinical investigation of a drug or biologic conducted at, or just after, regulatory marketing submission or approval, rather than during the pre-approval IND-governed Phase 1-3 sequence defined at 21 CFR 312.21. Late-phase studies do not primarily generate the initial efficacy/safety data needed for approval; instead they expand the evidence base after (or just before) approval, supporting label expansion, fulfilling FDA-mandated Postmarketing Requirements (PMRs) or voluntary Postmarketing Commitments (PMCs), and generating real-world evidence (RWE) and pharmacovigilance data on an approved product's safety and effectiveness in broader, real-world populations.
Sub-Investigator
A sub-investigator is a member of a clinical trial site team who is designated and supervised by the principal investigator (PI) to perform critical trial-related procedures and/or make important trial-related decisions, without themselves holding overall responsibility for the trial's conduct at that site. Under FDA regulations, the PI signs the FDA Form 1572 (Statement of Investigator) and lists sub-investigators by name as persons assisting in the investigation (21 CFR 312.53(c)); sub-investigators do not sign the 1572 themselves. What specific duties a given sub-investigator is authorized to perform is documented separately, on the site's Delegation of Authority (DoA) log, which the PI is responsible for maintaining under ICH E6(R2) Section 4.1.5. Common sub-investigator duties include obtaining informed consent, conducting protocol-specified assessments, and making eligibility or safety-related clinical judgments -- but the PI retains ultimate accountability for the trial's conduct at the site under 21 CFR 312.60, regardless of which duties are delegated.
3Rs (Replacement, Reduction, Refinement)
The 3Rs -- Replacement, Reduction, and Refinement -- are the founding ethical framework for the humane use of animals in research. A protocol satisfies the 3Rs when it documents, for the specific study: (1) Replacement -- whether a non-animal or less-sentient alternative (in vitro, in silico, or lower-order organism) could answer the scientific question instead; (2) Reduction -- that the number of animals proposed is the minimum needed for a statistically and scientifically valid result, no more; and (3) Refinement -- that procedures, housing, and endpoints are designed to minimize pain, distress, and suffering for the animals that are still used. The 3Rs are not a single compliance checkbox but a standing analytic lens applied at every protocol-review stage by the Institutional Animal Care and Use Committee (IACUC).
Scientific Reports’ Journal Impact Factor (JIF)
Scientific Reports' Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio Scientific Reports receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Nature Portfolio's own journal page (nature.com/srep) states a 2-year impact factor of 4.9 for the 2025 JCR data year (2025 Journal Citation Reports, Clarivate Analytics, released 2026), confirmed directly by CASRAI on 16 August 2026 -- up from approximately 3.9 for the prior (2024 data year) release. Scientific Reports is a large, open-access, multidisciplinary Nature Portfolio journal that accepts submissions on technical soundness rather than perceived novelty, so per DORA and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in it.
APA Authorship Guidelines
APA authorship guidelines are the authorship-determination rules set out in Standard 8.12 ("Publication Credit") of the American Psychological Association's Ethical Principles of Psychologists and Code of Conduct. They govern two separate questions: who qualifies as an author at all (Standard 8.12a: only someone who has actually performed the work or substantially contributed to it — formulating the problem or hypothesis, structuring the experimental design, conducting the statistical analysis, or interpreting the results), and how author order and credit should be assigned once the author list is settled (Standard 8.12b: order must accurately reflect each person's relative scientific or professional contribution, never institutional rank or seniority alone). A separate provision, Standard 8.12c, addresses student work specifically: except in exceptional circumstances, a student is listed as principal (first) author on any multi-authored article substantially based on that student's doctoral dissertation. The guidelines apply within the ethical code psychologists are bound by professionally — they are not a citation-formatting rule, and are distinct from the APA Publication Manual's separate reference-list and in-text citation conventions.
Operational Definition
A statement that specifies the exact, observable procedure used to measure or manipulate an abstract construct or variable within a specific study, so that another investigator could apply the same procedure to the same phenomenon and obtain comparable data. An operational definition is distinct from a conceptual (or constitutive) definition, which states what a construct means in theory without specifying how it will be observed; a definition only counts as operational if it names the instrument, coding rule, threshold, or manipulation used, not just the general idea being studied.
Defining the Population (Study Population)
Defining the population is the step in a research design, before sampling begins, where the researcher states precisely who or what the study's findings are meant to describe or generalize to. It has two working layers that a methods section should distinguish explicitly: the target population (the full group the researcher ultimately wants to draw conclusions about, e.g. "adults with type 2 diabetes") and the accessible or study population (the subset of that target population the researcher can actually reach and sample from, e.g. "adults with type 2 diabetes attending three primary-care clinics in one region between 2024 and 2026"). A population definition is complete only when it specifies inclusion criteria (the characteristics a unit must have to qualify), exclusion criteria (characteristics that disqualify an otherwise-eligible unit), and the relevant time and place boundaries. Defining the population is a distinct step from drawing the sample: the population is the group being described; the sample is the subset actually measured or observed. See Independent vs. Dependent Variable and Operationalizing Variables for the companion steps of specifying a design's other core elements before data collection begins.
OECD AI Principles
The OECD AI Principles are the first intergovernmental standard on artificial intelligence, adopted by OECD member and partner governments in May 2019 and updated in May 2024 to address general-purpose and generative AI. They consist of five values-based principles for trustworthy AI (inclusive growth/sustainable development/well-being; human rights, democratic values and fairness including privacy; transparency and explainability; robustness, security and safety; and accountability) plus five recommendations for policymakers (invest in AI research and development; foster an inclusive AI-enabling ecosystem; shape an enabling, interoperable governance and policy environment; build human capacity and prepare for labour-market transition; and pursue international co-operation for trustworthy AI). As of the 2024 update, 47 countries and jurisdictions adhere to the Principles, including all OECD members, the European Union, and several non-member states. A research institution or research-performing organization can treat the Principles as an operational baseline for AI governance when: (1) it can point to a documented AI risk-management or oversight process addressing all five values-based principles (not just one, e.g. privacy) as applied to a specific AI use case in the research lifecycle; (2) that process is proportionate to the AI system's stage and context of use rather than a single one-time sign-off; and (3) it is paired with actual transparency to affected parties (participants, authors, reviewers) about where and how AI was used. Simply having an internal 'AI policy' document does not, on its own, satisfy the Principles — the OECD frames them as principles for actors across the AI system lifecycle, not a checklist to file away.
Nature Communications’ Journal Impact Factor (JIF)
Nature Communications' Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio Nature Communications receives each year in the Journal Citation Reports (JCR) -- citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Per Nature Portfolio's own journal-impact page (nature.com/ncomms/journal-impact), Nature Communications' directly-sourced 2-year Impact Factor is 18.1 (5-year: 18.9) for the 2025 JCR data year (JCR release published June 2026); last verified directly against that page August 16, 2026. Clarivate updates this figure every June, so treat the number as time-stamped to a specific release, not a fixed property of the journal. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
Esploro (Ex Libris)
Esploro is a commercial current research information management (RIM/CRIS) platform sold by Ex Libris (a Clarivate company). Institutions use it to aggregate and showcase research assets -- publications, datasets, and other outputs -- captured from sources such as ORCID, Scopus, Web of Science, PubMed, and Crossref, alongside researcher profiles, and to expose that data through public-facing research portals, funder/compliance reporting, and open-access workflows. It can be deployed standalone or alongside Ex Libris's Alma library services platform, though the vendor markets it as usable independently of Alma.
PLOS ONE Author Contributions Statement
A PLOS ONE author contributions statement is the mandatory, structured disclosure every PLOS ONE submission must include, attributing specific tasks in the reported work to each named author individually. It is required at online submission, is separate from PLOS's authorship-eligibility criteria (adapted from McNutt et al. 2018 rather than the ICMJE four-point test) and from the acknowledgments section (which credits non-author helpers, not listed authors), and is published alongside the final article. Since PLOS's 2016 taxonomy switch, the statement is built from the 14-role CRediT (Contributor Roles Taxonomy, now ANSI/NISO Z39.104-2022) vocabulary. Before that, from PLOS ONE's 2006 launch through 2016, the same requirement existed but used PLOS's own five-category list: Conceived and designed the experiments; Performed the experiments; Analyzed the data; Contributed reagents/materials/analysis tools; Wrote the paper.
Section 889 (Covered Telecommunications Equipment Ban)
A federal restriction, originating in Section 889 of the FY2019 NDAA and implemented for grant recipients at 2 CFR 200.216 (effective August 13, 2020), that prohibits an institution from using federal award funds to procure, obtain, extend, or renew a contract for telecommunications or video surveillance equipment or services produced by Huawei, ZTE, Hytera, Hikvision, or Dahua (or their subsidiaries/affiliates, or other PRC-government-connected entities so designated), when that equipment or service is a substantial or essential component of a system or constitutes critical technology. It attaches to the federal funding stream used for a specific procurement, not to an institution's equipment inventory generally.
ACM Policy on Authorship
The ACM Policy on Authorship is the Association for Computing Machinery's publisher-wide rule set, applied across its journals, transactions, magazines, and 70+ conference proceedings, defining who may be listed as an author on an ACM-published work, prohibiting generative AI tools from being listed as authors, and requiring authors to disclose any use of generative AI tools and technologies in producing the work — with a narrow exemption for basic word-processing aids such as spelling and grammar checkers.
Good Clinical Data Management Practices (GCDMP)
A clinical data management (CDM) process, procedure, or document is following Good Clinical Data Management Practices (GCDMP) when it is explicitly built against a specific chapter of SCDM's published GCDMP document -- covering an area such as CRF/eCRF design, database design and validation, discrepancy management, medical coding, database lock, or data transfer/archival -- and can be shown to meet that chapter's Minimum Standards tier (the baseline for defensible CDM) or its Best Practices tier (a higher-maturity level beyond the minimum). GCDMP is a practice/process standard, not software: an EDC or CDMS platform is the technology a GCDMP-conformant process typically runs through, not GCDMP itself.
Source Data Verification (SDV)
Source data verification (SDV) is the clinical-trial monitoring activity of comparing data entered on a case report form (CRF or eCRF) against the source document it was transcribed from -- a clinic note, hospital chart, lab report, imaging read, ECG tracing, or participant diary -- to confirm that the CRF entry is accurate, complete, and consistent with the original record. SDV checks a specific, already-transcribed value against its origin; it is a monitoring/quality-control activity, not a data-entry platform. Neither ICH E6 nor FDA guidance has ever required verifying 100% of CRF fields against source; since the early 2010s, regulatory guidance has explicitly encouraged sponsors to target SDV, as part of a broader risk-based monitoring (RBM) strategy, toward the data most critical to participant safety and primary trial endpoints rather than exhaustively verifying every field by default.
Congressionally Directed Funding (Earmarks)
A federal research award is Congressionally Directed Funding (commonly called an earmark, or 'Community Project Funding' / 'Congressionally Directed Spending' in current House and Senate terminology) when Congress specifies, in appropriations bill or accompanying report language, a particular recipient, project, or narrow topic area for a defined amount of budget authority — bypassing the awarding agency's normal competitive, peer-reviewed, or formula-driven selection process. It is distinguished from ordinary agency-administered research funding by the source of the selection decision: for a competitive award, the agency (via merit/peer review) decides who receives funds within a congressionally set appropriation total; for congressionally directed funding, Congress itself (or an individual member, subject to certification and disclosure rules) decides the recipient or topic before the agency ever runs a review. Once such funds reach a university or research institution, two federal anti-lobbying statutes constrain how the recipient can use any federal award dollars in connection with seeking or renewing that funding: 18 U.S.C. § 1913 and 31 U.S.C. § 1352 (the Byrd Anti-Lobbying Amendment), operationalized for grant cost allowability at 2 CFR § 200.450.
Thesis
A formal, original-research document that a student submits, and typically defends before a faculty committee, to satisfy the research requirement of an academic degree. Whether "thesis" denotes master's-level or doctoral-level work depends on country: in the US/Canada it usually means the master's-level document (the doctoral one is a dissertation); in the UK/Commonwealth the convention typically reverses.
Decentralized Clinical Trial (DCT) Platform
A decentralized clinical trial (DCT) platform is the software and connected-service layer that lets some or all trial activities happen away from a traditional investigative site, in line with FDA's trial-conduct model for decentralized elements. In practice a DCT platform is not one thing but an integration of several components under a single participant- and site-facing interface: telehealth/video-visit tooling for remote investigator encounters, eConsent for remote informed consent, home health or mobile-nursing coordination for in-home visits and specimen collection, connections to local or community labs and pharmacies as alternate data-collection or dispensing sites, direct-to-patient (DtP) investigational product (IMP) shipment and chain-of-custody tracking, and eCOA/ePRO or connected devices for participant-reported and sensor-derived data — usually feeding a central EDC and safety database in real time. A trial "uses a DCT platform" when a vendor's connected toolset, rather than a single point solution, is the operational backbone for how remote or hybrid visits are scheduled, conducted, documented, and reconciled against the protocol. The defining administrative complication is that decentralizing activities does not decentralize accountability: the sponsor and the trial's IRB(s) of record remain responsible for GCP compliance, and each local nurse, telehealth clinician, lab, or pharmacy performing a delegated trial activity must be added to the delegation-of-authority log, must practice within a jurisdiction where they are licensed, and must be covered by the same monitoring and oversight expectations as staff at a traditional site.
ARC Research Management System (RMS)
The Research Management System (RMS) is the Australian Research Council's web-based platform for administering the full lifecycle of applications to its National Competitive Grants Program (NCGP): preparing and submitting applications, assigning and recording assessor evaluations, handling applicant rejoinders, announcing outcomes, and managing the resulting grant agreement, including post-award activity such as variations, annual/end-of-year reporting, and final reports. It is accessed at rms.arc.gov.au by registered users, and Administering Organisations (AOs) -- the Australian universities and other eligible institutions through which ARC grants are held -- are generally required to submit NCGP applications through RMS unless the ARC advises otherwise for a specific scheme.
Independent vs. Dependent Variable
In a study's methods section, the independent variable is the factor treated as the presumed cause — manipulated in an experiment or selected as the predictor in an observational design — and the dependent variable is the outcome measured to detect whether it changes with the independent variable. The roles are relative to a specific design: manipulation supports causal language, measurement-only designs support only associative language, and a manuscript should state explicitly which applies.
NSF Broadening Participation
NSF Broadening Participation is the National Science Foundation's coordinated set of programs, funding requirements, and strategic goals aimed at increasing the involvement of individuals, institutions, and geographic regions historically underrepresented in STEM research and education. NSF defines the target groups as individuals -- women, underrepresented racial and ethnic minorities, and persons with disabilities -- plus institutions (women's colleges, minority-serving institutions, institutions primarily serving persons with disabilities) and geographic areas (rural, urban, and EPSCoR jurisdictions) that participate in NSF programs at rates lower than their overall representation in the relevant population. Something is a genuine Broadening Participation activity -- rather than just any diversity-adjacent outreach -- when it is a specific, funded NSF program, plan requirement, or reporting element built around this defined set of target groups, not a generic institutional DEI initiative NSF happens to be aware of.
CRC-P Grants (Cooperative Research Centres Projects)
A funding arrangement qualifies as a CRC-P (Cooperative Research Centres Projects) Grant when it is an Australian Government matched-funding grant, administered under the Cooperative Research Centres Program by the Department of Industry, Science and Resources, awarded to a short-term (up to three years), industry-led research collaboration whose lead applicant is a small to medium enterprise (SME) partnered with at least one additional Australian industry organisation and at least one Australian research organisation, to develop a product, service, or process that solves an identified industry problem. It is distinguished from the flagship, multi-year Cooperative Research Centres (CRC) grants by its shorter duration, smaller and more flexible partner structure, and its explicit industry-led (rather than research-organisation-led) governance.
NRSA (National Research Service Award)
An award is an NRSA (National Research Service Award, formally the Ruth L. Kirschstein NRSA) if it is made under the statutory authority created by Title I of the National Research Act of 1974 (Public Law 93-348) to support predoctoral or postdoctoral research training rather than to fund a specific research project directly. NRSA support is stipend-based (a training allowance to the trainee/fellow, set annually by NIH notice) rather than a PI salary drawn against direct research costs, and it comes in two structural forms: institutional awards (the 'T' series -- T32, T90, TL1, and related mechanisms -- where an institution or program holds the grant, is the grant's PD/PI of record, and nominates individual trainees into funded training slots) and individual fellowships (the 'F' series -- F30, F31, F32, and related mechanisms -- where the trainee or fellow themselves is the named PD/PI, applying with a specific faculty sponsor and research training plan). A postdoctoral NRSA recipient (T- or F-series) also incurs a service payback obligation for the first 12 months of postdoctoral NRSA support, discharged through subsequent NRSA-supported training, health-related research, health-related teaching, or a combination, averaging at least 20 hours per week; predoctoral NRSA recipients incur no payback obligation.
IDE Application (Investigational Device Exemption Application)
An IDE application is the formal submission a sponsor files with FDA's Center for Devices and Radiological Health under 21 CFR 812.20 to request an Investigational Device Exemption -- FDA authorization to ship and use an unapproved medical device in a clinical study before it has been cleared or approved for commercial distribution. A full IDE application, and FDA's affirmative or default clearance to proceed, is required only for significant risk (SR) device investigations; nonsignificant risk (NSR) studies proceed on abbreviated requirements reviewed by the IRB, without a separate FDA-submitted application.
Bibliography
A bibliography is a systematic list of the sources an author consulted or judged relevant while researching a work, presented in a standardized citation format and arranged for reader verification. It is distinct from a reference list or works-cited list, which (under APA and MLA convention) includes only sources actually cited in the text; a bibliography, particularly under the Chicago notes-bibliography system, can additionally include background sources the author consulted but never directly cited. This broader scope is why the bibliography sense persists in literature reviews, monographs, annotated-bibliography assignments, and grant or manuscript submissions that ask authors to document the literature surveyed, not just the literature quoted.
R34 (NIH Planning Grant)
An R34 is an NIH grant activity code for a Planning Grant: a time-limited, relatively small award used to fund the preparatory work needed before a larger study can be competitively proposed, rather than to fund the study itself. Typical R34-supported activities include finalizing a clinical trial design and protocol, developing a manual of procedures, drafting informed consent forms and case report forms, establishing multi-site or community partnerships, piloting recruitment feasibility, and producing milestone and timeline plans. There is no single standing parent funding opportunity announcement (FOA) for the R34 across all of NIH; instead, individual NIH Institutes and Centers (ICs) issue their own R34 Notices of Funding Opportunity (NOFOs) -- as Program Announcements (PAs/PARs) or Requests for Applications (RFAs) -- each with its own scope, eligibility, and review criteria, so whether an R34 is currently open, and for what, depends entirely on which IC's NOFO an applicant is applying under.
Paediatric Investigation Plan (PIP)
A Paediatric Investigation Plan (PIP) is the development plan a sponsor must agree with the European Medicines Agency's Paediatric Committee (PDCO) before an EU marketing authorisation application (MAA) can be validated, under Regulation (EC) No 1901/2006. It sets out the studies, age-appropriate formulations, and timelines needed to support use of a medicine in children, and applies to new active substances and to new indications, pharmaceutical forms, or routes of administration for already-authorised products that are still under patent or supplementary protection certificate (SPC) protection. A product is only exempt from the PIP requirement if it has a PDCO-granted waiver (full or class), if it is a generic, well-established-use, homeopathic, or traditional-herbal application under Article 10 of Directive 2001/83/EC, or if all paediatric studies are formally deferred to a later stage of development while the PIP itself is still agreed and on file.
Metadata
Structured information that describes, identifies, or explains a research output — most often a dataset — independent of the content itself, so that the output can be found, correctly interpreted, cited, and reused without the data (or document, sample, or instrument) having to be opened or examined directly. In research data management, metadata is what a repository, catalog, or search index actually reads to determine whether a record matches a query; the underlying data file is opaque to that process until metadata points to it.
America Invents Act (AIA)
The America Invents Act (AIA) -- formally the Leahy-Smith America Invents Act, Public Law 112-29 -- is the 2011 U.S. patent reform statute that replaced the country's first-to-invent priority system with a first-inventor-to-file system for applications with an effective filing date on or after March 16, 2013. Under first-inventor-to-file, priority between two parties claiming the same invention goes to whoever files first at the USPTO, not whoever can prove they invented it first through lab notebooks and an interference proceeding. The AIA also broadened what counts as prior art to include public use, sale, or availability anywhere in the world (not just the U.S.), replaced interference proceedings with derivation proceedings, and created new post-grant review mechanisms (inter partes review, post-grant review, and the now-expired covered business method review) for challenging an issued patent's validity at the USPTO's Patent Trial and Appeal Board instead of only in federal court. For a technology transfer office (TTO), the operative consequence of the filing-date switch is that filing timing relative to any public disclosure -- a conference talk, a preprint, a poster, a journal submission, even a sales conversation -- became the single most consequential decision in the invention-disclosure-to-patent pipeline.
Inventor
Under U.S. patent law, an inventor is a natural person who contributed to the conception of at least one claim of a patented (or claimed) invention, as governed by 35 U.S.C. § 116. Conception is the operative legal test, not construction, funding, supervision, or manuscript authorship: it is the formation, in that person's mind, of a definite and permanent idea of the complete and operative invention, later reduced to a form a person skilled in the art could reproduce without further inventive work. A person who only executes another's detailed instructions, provides routine technical assistance, funds the research, or supervises a lab does not become an inventor by virtue of that role alone. When two or more people jointly satisfy the conception standard, each is a joint inventor under § 116, even if they worked at different times, contributed unequally, did not work together physically, or each contributed to only some of the claims — provided each contributed to the conception of at least one claim in the resulting application. Inventorship is determined claim-by-claim and can change as claims are added, amended, or cancelled during prosecution, which is why university technology transfer offices (TTOs) routinely revisit the named-inventor list as a patent application matures.
PCT Application
A PCT application (formally, an "international application" under the Patent Cooperation Treaty) is a single patent filing, administered by WIPO, that preserves an applicant's right to seek patent protection in some or all of the PCT's 158 Contracting States without having to file separately in each one at the outset. It does not itself result in a granted patent anywhere -- grant authority stays with each national or regional patent office. For a university invention, something qualifies operationally as a PCT application if it is filed with a receiving office (typically the USPTO, for a US-origin invention) within 12 months of the earliest priority filing (usually a US provisional application), enters an international phase producing a search report and written opinion on patentability, and is then converted into individual national or regional applications -- "national phase entry" -- by the applicable deadline (30 months from priority under the PCT default, though several major offices set 31 months). A TTO's PCT decision is fundamentally a triage decision: it buys roughly 18 extra months, beyond the original 12-month priority year, to assess commercial interest (licensee engagement, industry validation, additional data) before committing to the far higher cost of national-phase filing in specific countries.
Watermark Faculty Success (Digital Measures)
A commercial faculty activity reporting (FAR) and faculty-lifecycle management platform, owned by Watermark Insights, used by institutions to collect faculty teaching, research, and service activity data once and repurpose it into annual activity reports, CVs, promotion and tenure dossiers, accreditation reports, and public faculty profiles. It was originally sold as 'Digital Measures Activity Insight' before Watermark's 2018 acquisition and subsequent rebrand to 'Faculty Success.'
Invention
In the university technology-transfer and Bayh-Dole context, an invention is a new and useful process, machine, manufacture, or composition of matter (or a new and useful improvement to one of those) that a researcher has conceived — formed a definite and permanent idea of the complete, operative thing in their mind, not merely identified a problem or a goal (35 U.S.C. § 101; conception standard confirmed under 35 U.S.C. § 116 joint-inventorship case law). An idea alone is not yet an invention in the legal sense used by a technology transfer office (TTO): it becomes one, for disclosure and patenting purposes, once conception is complete and can be documented — typically in a dated lab notebook entry or an invention disclosure — even before the invention has been built or tested ("reduced to practice"). Whether that invention is also a subject invention under the Bayh-Dole Act turns on funding: 35 U.S.C. § 201(e) defines a subject invention as any invention of a contractor (a university, other nonprofit, or small business) conceived or first actually reduced to practice in the performance of work under a federal funding agreement. Only subject inventions trigger Bayh-Dole's disclosure, election-of-title, and government-license obligations under 35 U.S.C. §§ 200–212; an invention made entirely on private, unrestricted funds is not a subject invention even though it may still be patentable.
Independent Data Monitoring Committee (IDMC)
An Independent Data Monitoring Committee (IDMC) is an independent group of clinical, statistical, and (where relevant) bioethics experts, external to a trial's sponsor and investigators, that periodically reviews accumulating safety and efficacy data from an ongoing clinical trial and recommends to the sponsor whether the trial should continue, be modified, or stop. 'IDMC' is the term used in EMA's dedicated guideline on the subject and, as of the January 2025 finalization of ICH E6(R3), is also the term used in the current ICH Good Clinical Practice guideline itself. It describes the same underlying body and function as a Data Safety Monitoring Board (DSMB) -- the two terms are not different oversight mechanisms but regional/institutional naming variants for one function, with IDMC more common in EU/EMA and ICH-referencing contexts and DSMB more common in NIH- and US-funded trial contexts.
Sponsor-Investigator
A sponsor-investigator is a specific FDA regulatory designation (21 CFR 312.3 for drugs/biologics; 21 CFR 812.3 for devices) for an individual -- never an institution, company, or group -- who both initiates a clinical investigation and actually conducts it, personally directing the administration, dispensing, or use of the investigational product to subjects. Because one person occupies both roles, that individual must independently satisfy the full set of sponsor obligations (21 CFR 312.50-312.59) and the full set of investigator obligations (21 CFR 312.60-312.70) under the same IND or IDE -- there is no reduced or merged standard for holding both roles at once.
Basket Trial
A basket trial is a clinical trial design, formalized by FDA as one of three master-protocol types, that tests a single investigational drug (or drug combination) across multiple disease populations that are grouped not by their tissue of origin but by a shared molecular alteration or biomarker. In oncology, where the design is most established, a basket trial enrolls patients with different cancer types — lung, colorectal, melanoma, and others — into a common protocol as long as their tumors share a specified genomic alteration, and treats them with the same targeted therapy regardless of where the cancer originated. A study qualifies as a basket trial when three conditions hold together: (1) a single drug or drug combination is under evaluation, (2) enrollment is organized around a shared biomarker or molecular subtype rather than a single disease, and (3) the protocol spans what would otherwise be treated as separate diseases or histologies. Basket trials are typically single-arm and use overall response rate as the primary endpoint, since a shared, adequately characterized control group across multiple diseases is often impractical.
arXiv Endorsement System
The arXiv endorsement system is the mechanism arXiv uses to confirm that a first-time submitter, or an existing author submitting to an arXiv subject category for the first time, is a legitimate participant in that field before their submission is accepted for processing. A submission is subject to endorsement whenever the submitting author has no prior accepted-and-announced papers in the specific endorsement domain they are submitting to. To satisfy the requirement, the author must be endorsed by an existing arXiv author (an 'endorser') who is themselves in good standing in that same endorsement domain, meaning the endorser has authored a sufficient number of papers in that domain within roughly the preceding five years (and at least three months old, so very recent authors cannot immediately endorse others). Endorsement confirms only that the submission is topically appropriate for the category and that the author appears to understand the field's basic conventions -- arXiv is explicit that endorsement 'is not peer review' and endorsers are not vouching for scientific correctness. Endorsement is separate from arXiv moderation, the ongoing process by which category moderators can reclassify, hold, or (rarely) reject content after submission on subject-matter or scope grounds.
Simultaneous Submission
Simultaneous submission (also called multiple or concurrent submission) occurs when an author submits the same manuscript, or manuscripts substantively reporting the same data or findings, to more than one journal at the same time, so that it is under active review at two or more venues simultaneously. It is prohibited by virtually all journal policies and by ICMJE's Recommendations, which state that authors 'should not submit the same manuscript, in the same or different languages, simultaneously to more than one journal.' A manuscript counts as under simultaneous submission from the point it is submitted to a second journal until it is formally withdrawn from, or rejected by, all but one of the venues. It is distinct from duplicate publication (also called redundant or self-plagiarized publication), which concerns a manuscript that substantially overlaps with work that has already been published, rather than work that is merely under review elsewhere at the same time.
Medical Writing in Clinical Trials
Medical writing in clinical trials is the specialized discipline of drafting, editing, and maintaining the regulatory and clinical documents that a trial produces from protocol design through final reporting -- protocols and protocol amendments, Investigator's Brochures (IB), informed consent forms (ICF), Clinical Study Reports (CSRs), the clinical sections of regulatory submissions (e.g. the Common Technical Document modules submitted to FDA, EMA, or other regulators), and trial-related publications such as journal manuscripts, congress abstracts, and plain-language summaries. A document counts as an instance of medical writing in this sense when (a) it is a formal, structured deliverable required or expected at a defined point in the trial lifecycle, (b) it must accurately represent clinical and statistical content that the writer did not personally generate, and (c) it is produced to a recognized structural or ethical standard -- most commonly ICH E3 for CSRs, ICH E6 for protocol and consent-related content, and the Good Publication Practice (GPP 2022) guidelines for publication-related writing -- rather than being general-purpose scientific or lay writing about a trial.
Deferential Vulnerability (Research Ethics)
A type of research-subject vulnerability, identified in Kenneth Kipnis's taxonomy commissioned for the U.S. National Bioethics Advisory Commission (NBAC, 2000/2001), arising from a hierarchical or authority relationship between a prospective subject and the person recruiting or conducting the research -- formal or, more often, informal (e.g., professor/student, employer/employee, treating physician/patient, military superior/subordinate) -- in which the subject may feel unable to freely decline or withdraw from participation, whether from fear of offending the authority figure and incurring retribution or from a genuine desire to please a respected other. It is distinguished from juridic vulnerability (formal legal authority, as with incarceration) by the informality of the compelling relationship, and from population-based vulnerability categories (age, pregnancy, incarceration) by being relational and situational rather than a fixed characteristic of the subject.
45 CFR 46 Subpart D (Additional Protections for Children in Research)
The section of the Common Rule (45 CFR 46, §§46.401-46.409) that governs HHS-conducted or HHS-funded research involving children as subjects. A protocol falls under Subpart D whenever its subjects have not attained the legal age for consent to the research procedures under the law of the jurisdiction where the research will be conducted (§46.402). The IRB must classify the protocol into one of four risk categories -- no greater than minimal risk (§46.404), greater than minimal risk with prospect of direct benefit (§46.405), greater than minimal risk with no direct benefit but likely generalizable knowledge (§46.406), or research not otherwise approvable that HHS’s Secretary determines addresses a serious child-health problem (§46.407) -- and must determine what combination of parental/guardian permission and child assent is required under §46.408 before approving it.
Effort Certification
The process by which an individual with direct, first-hand knowledge of the work performed -- historically the employee themselves or a person with suitable means of verification, such as a supervisor -- attests, after the fact and typically on a periodic basis, that the percentage of salary charged to a sponsored award reasonably reflects the actual effort that person expended on that award during the certification period. Under 2 CFR 200.430 (the Uniform Guidance, effective December 26, 2014), effort certification is no longer a federally mandated, one-size-fits-all form -- it is one acceptable method an institution may build into the 'system of internal control' the regulation actually requires, which must provide reasonable assurance that salary charges are accurate, allowable, and properly allocated, and must be based on records reflecting the total activity for which the employee is compensated (not exceeding 100 percent). Institutions may instead rely on budget estimates on an interim basis, provided the estimation process produces reasonable approximations of actual activity, significant changes in work distribution are documented promptly, and the internal-control system includes periodic after-the-fact review with adjustments where needed. A federal awarding agency retains the authority to require personnel activity reports or prescribed certifications from a specific recipient if that recipient's own internal controls fall short of the standard.
ONIX (ONline Information eXchange)
An XML-based family of metadata standards, maintained internationally by EDItEUR (with regional groups Book Industry Communication/BIC in the UK and BISG in the US), used to exchange structured product and rights information across the publishing supply chain. A metadata record qualifies as ONIX when it validates against one of EDItEUR's published ONIX XML schemas/DTDs (the current major version for book-trade metadata is ONIX for Books 3.0, extended by 3.1) and carries the standard's defined composite structure, code lists, and identifiers rather than a proprietary or free-text feed.
Wearable Devices and Digital Health Technologies (DHTs) in Clinical Trials
A digital health technology (DHT) is defined by FDA as a system that uses computing platforms, connectivity, software, and/or sensors for healthcare and related purposes, used to collect, store, and transmit health-related data. In a clinical trial, a device or software is functioning as a DHT specifically when it is used to remotely acquire data from or about a participant that will be used to support a trial endpoint or otherwise inform a regulatory decision — not merely as a convenience app or a participant engagement tool with no bearing on the data package submitted to a regulator. Wearables (heart rate trackers, actigraphy bands, continuous glucose monitors) are the most visible category, but the term also covers non-worn sensors, implantables, and participant-facing mobile apps that capture symptom or functional data, provided that data feeds into the trial's endpoints or safety monitoring. What distinguishes a DHT from an ordinary electronic data-capture tool is the verification and validation burden it creates: a sponsor must demonstrate the technology reliably captures the intended clinical event or physiological parameter, in the population and context of actual use, before that data can support a trial conclusion.
TransCelerate GCP Mutual Recognition Program
The TransCelerate GCP Mutual Recognition Program is an industry framework, run by TransCelerate BioPharma (a nonprofit collaboration of biopharmaceutical sponsor companies), under which Good Clinical Practice (GCP) training completions from a recognized training provider are accepted by multiple participating sponsor companies rather than each sponsor requiring its own separate GCP training for the same investigator or site staff member. It sits within TransCelerate's Site Qualification and Training (SQT) initiative, which targets the duplicative questionnaires, forms, and training courses that clinical trial sites have historically had to complete separately for each sponsor and, in some cases, for each individual trial. A GCP training provider participates by self-attesting that its course meets minimum criteria aligned with ICH E6 Good Clinical Practice; providers that meet the criteria have their courses made available through TransCelerate's Shared Investigator Platform (SIP), where site staff can complete training once, upload the resulting certificate, and have participating sponsors retrieve and accept it during study start-up instead of re-verifying or re-issuing training separately. A record is a genuine instance of the program when the underlying GCP course completion was issued by a provider recognized under TransCelerate's mutual-recognition criteria and is being accepted, without separate re-training, by a second (or subsequent) participating sponsor company for a different trial or company relationship -- not merely any GCP-aligned course completion in general.
National AI Research Resource (NAIRR)
The National AI Research Resource (NAIRR) is a US federal initiative -- currently operating as the NAIRR Pilot -- that provides researchers, educators, and students with shared access to AI computational infrastructure (supercomputing and cloud allocations), AI-ready datasets, pretrained models, and educational resources, rather than direct cash funding. It is led by the National Science Foundation (NSF) in partnership with more than a dozen other federal agencies, including the Department of Energy (DOE) and National Institutes of Health (NIH), who co-lead a security-focused 'NAIRR Secure' track for sensitive data. Eligible US-based researchers, educators, and graduate students (with a faculty sponsor) apply for time-limited resource allocations -- typically a 3-month Start-Up award or a 12-month Research award -- through a competitive, proposal-based process rather than an open-access account. A project 'uses NAIRR' when it draws on the pilot's pooled portfolio of partner-provided compute, storage, or model resources under an awarded allocation; a project that purchases or funds its own AI hardware, or that uses a single university's internal HPC cluster with no NAIRR allocation, is not a NAIRR activity even if the research itself is AI-related.
Medical Monitor (Clinical Trials)
A Medical Monitor is the physician (or other appropriately qualified clinician) designated by a clinical trial sponsor or its CRO to provide ongoing, cross-site medical and safety oversight: reviewing accumulating adverse events for causality and expectedness, answering investigators' medical eligibility and protocol-interpretation questions, and flagging safety signals for the sponsor or a DSMB. The role requires medical qualification, sponsor-side (not site-based) placement with no direct participant-care relationship, and cross-site safety-judgment scope — it is a de facto function of the sponsor's safety obligations under ICH E6 and 21 CFR 312.32 rather than a term either formally defines in its own glossary.
Biosafety and Biosecurity
Biosafety and biosecurity are the two complementary risk-management frameworks that together govern institutional work with biological materials capable of causing harm. Biosafety is the set of containment practices, equipment, and facility design (see Biosafety Level (BSL)) intended to prevent accidental exposure of personnel or unintended release of a biological agent into the environment. Biosecurity is the set of physical security, access control, personnel-reliability, and material-accountability measures intended to prevent deliberate misuse, theft, loss, or diversion of biological agents or toxins -- the concern is an intentional bad actor, not an accident. A given institutional program is a biosafety-and-biosecurity program only when it addresses both halves: containment/exposure-prevention controls administered through an Institutional Biosafety Committee (IBC) under the NIH Guidelines and the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual, and security/accountability controls administered through the Federal Select Agent Program (jointly run by CDC and USDA-APHIS) for any select agent or toxin on the HHS/USDA Select Agent List, plus Dual-Use Research of Concern (DURC) review where applicable. A program that only locks containment (biosafety) without inventory control and personnel vetting for regulated agents is not biosecure; a program with strict access control but inadequate containment practice is not biosafe. The two are reviewed together but are not interchangeable and are not satisfied by the same control.
Research Integrity Officer (RIO)
The institutional official a research institution formally designates, per 42 CFR § 93.233, to administer its written research-misconduct policy: receiving allegations, conducting the initial assessment of whether they meet the fabrication/falsification/plagiarism definition and fall within institutional jurisdiction, deciding whether to open a formal inquiry, sequestering relevant research records, and appointing inquiry/investigation committees. Institutions that apply for or receive PHS support (NIH, CDC, FDA, and other Public Health Service funding) must designate an RIO as a condition of that support.
Blinding and Masking in Clinical Trials
Blinding (or masking, the term FDA/ICH guidance now prefer) in a clinical trial is the procedure of keeping one or more trial parties -- the participant, the investigator/care provider, the outcomes assessor, and/or the data analyst -- unaware of which treatment arm a given participant was assigned to, from the point of randomization onward. It is recorded on ClinicalTrials.gov as the "Masking" data element with levels of None (open-label), Single, Double, Triple, or Quadruple, depending on how many of those roles are kept unaware. Masking is a distinct methodological safeguard from randomization and allocation concealment: it addresses performance bias (differential behavior or care from knowing the assignment) and detection/ascertainment bias (differential outcome judgment), not selection bias at enrollment.
Inventor Recognition Program
An inventor recognition program is a formal, typically non-monetary or symbolic activity run by a university technology transfer office (TTO) or research office to publicly acknowledge faculty, staff, and student inventors for their contributions to invention disclosure, patenting, licensing, and commercialization. It is distinct from — and runs alongside — the financial royalty-sharing terms set out in the institution's intellectual property policy: a program counts as inventor recognition when its primary function is reputational and cultural (visibility, honor, institutional gratitude) rather than a payment obligation, even if it is announced at the same event where royalty distributions are discussed.
15 CFR Part 734 (EAR — Scope and Definitions)
15 CFR Part 734, titled “Scope of the Export Administration Regulations,” is the part of the Export Administration Regulations (EAR) -- the dual-use export control regime administered by the US Department of Commerce's Bureau of Industry and Security (BIS) -- that establishes what the EAR applies to at all and supplies the controlling definitions used throughout the rest of the regulation (15 CFR Parts 730-774). Part 734 does not itself list controlled items -- that is the Commerce Control List, Supplement No. 1 to 15 CFR Part 774 -- instead it defines what is 'subject to the EAR' (15 CFR 734.2-734.3), sets the de minimis US-content threshold for foreign-made items (734.4), and supplies the definitions of 'export' (734.13), 'reexport' (734.14), 'release' (734.15), and 'transfer (in-country)' (734.16), including the deemed-export and deemed-reexport concepts built into those definitions and into the dedicated carve-outs at 734.18 and 734.20. It also states the fundamental research exclusion (734.8): technology or software that arises during, or results from, fundamental research and is intended for publication falls outside the EAR's scope entirely, not merely under a license exception. Because these definitions determine whether the EAR applies to a given item, transaction, or disclosure at all, a research institution's export-control determination almost always starts with a Part 734 definition rather than with a Commerce Control List entry.
Data Safety Monitoring Plan (DSMP)
A Data Safety Monitoring Plan (DSMP) is the written document a study team develops -- usually as part of a grant application or protocol package, before a trial opens -- describing exactly how participant safety data will be monitored throughout the study: who will review the data, how often, what will be reviewed, the mechanism for reporting adverse events to the IRB, the funding agency, and (where applicable) the FDA, and the stopping rules that would trigger pausing or ending the trial. Every NIH-funded clinical trial must have a DSMP, scaled to the trial's size, complexity, and risk -- but not every DSMP requires a full independent Data Safety Monitoring Board (DSMB). A DSMP is the plan document itself; a DSMB is one possible monitoring mechanism a DSMP can specify. For lower-risk trials, the DSMP more commonly designates the principal investigator or an independent safety monitor/medical monitor as the reviewer instead of convening a formal board.
FAR 52.227-11 (Patent Rights — Ownership by the Contractor)
FAR 52.227-11, “Patent Rights—Ownership by the Contractor,” is the patent-rights clause the Federal Acquisition Regulation requires contracting officers to insert into federal procurement contracts awarded to small business firms and nonprofit organizations (including universities) for experimental, developmental, or research work. It is prescribed by FAR 27.303(b)(1) and is the FAR's own codification of the Bayh-Dole Act's contractor-ownership default — the contract-instrument counterpart to the 37 CFR 401.14 Standard Patent Rights Clause used in grants and cooperative agreements. A federally funded project is governed by 52.227-11, rather than 37 CFR 401.14, specifically because of which funding instrument was used (a procurement contract) rather than because the underlying substantive rights differ.
Retraction vs. Redaction
Retraction and redaction are frequently confused because both involve a publisher acting on already-published content, but they answer different questions and have different consequences for the reader. A RETRACTION withdraws an entire published work from the reliable literature: the journal or publisher determines the findings are unreliable (due to error, misconduct, duplication, or other invalidating factors), issues a public retraction notice explaining why, and the article is prominently marked as retracted while typically remaining accessible for the scholarly record (per COPE's Retraction Guidelines). A REDACTION removes or obscures specific sensitive content within a document -- personal data, classified or export-controlled information, or other legally protected material -- while the document as a whole remains published and in circulation, usually with a note indicating that specific content has been withheld and why. Retraction is a judgment about the validity or integrity of the whole work; redaction is a targeted removal of particular information from an otherwise valid, still-published work. The two are not mutually exclusive: a paper can, in principle, be both redacted (to remove sensitive data) and later retracted (if a separate integrity issue emerges), but neither implies the other.
NIGMS Payline
A NIGMS payline, as commonly asked about by analogy to other NIH institutes, does not refer to a published percentile-rank cutoff the way it does at NINDS, NHLBI, or NIAID -- NIGMS is distinctive among NIH institutes for not publishing a fixed payline figure for its standard grant mechanisms. NIGMS has instead described its funding decisions as weighing an application's percentile score, assigned after peer review at an NIH study section, alongside factors including the investigator's current level of NIH support and the balance of NIGMS's overall funded research portfolio, rather than ranking applications strictly against a single published threshold. This is further complicated for NIGMS's flagship Maximizing Investigators' Research Award (MIRA, activity code R35), which consolidates an investigator's overall NIGMS-supported research program into one award and is reviewed on that basis rather than as a single discrete project, making a simple percentile payline concept fit even less naturally than it does for NIGMS's R01 funding generally. As of late 2025, NIH signaled that its payline-publishing institutes and centers would move toward a more holistic, portfolio-aware approach -- directionally similar to how NIGMS has operated for years -- rather than continuing to publish fixed percentile cutoffs; confirm current institute-specific practice against NIGMS's own current guidance rather than assuming a specific figure applies.
eSource (Electronic Source Data)
Electronic source data (eSource) is clinical trial data that is first recorded in electronic form at the point of observation -- typed directly into an electronic health record (EHR), an electronic patient-reported outcome (ePRO) or clinical outcome assessment (eCOA) device, or directly into an EDC system during a study visit -- rather than being first written on paper (a clinic note, a lab printout, a paper diary) and later transcribed into an electronic system. The origination point, not the software used to store or display the data, is what makes a given data point eSource: the same EDC platform can hold both eSource data (entered live, not transcribed) and non-eSource data (transcribed from a paper source document) within the same study.
National Research Act of 1974
The National Research Act of 1974 (Public Law 93-348, signed July 12, 1974) is the U.S. federal statute that created the National Research Service Award (NRSA) training-grant program (Title I) and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, while separately requiring federally funded institutions to use an independent review board for human-subjects research (Title II). It is the statutory origin of the modern IRB requirement and the direct cause of the Belmont Report (1979) and the Common Rule (45 CFR 46).
RTTP (Registered Technology Transfer Professional) and ATTP
RTTP (Registered Technology Transfer Professional) is an individual professional credential -- awarded in three tiers (Candidate RTTP, RTTP, and RTTP Fellow) -- that certifies a knowledge-exchange/technology-transfer (KE/TT) practitioner has met minimum thresholds of professional experience, continuing education, and demonstrated competency across six defined core competency areas. It is awarded exclusively by ATTP (the Alliance of Technology Transfer Professionals), a nonprofit standards body formed by a consortium of national and regional technology-transfer associations -- including AUTM in North America -- rather than by any single national association acting alone. An individual is RTTP-certified only after ATTP has reviewed and approved a formal application/portfolio; association membership, job title, or years of experience alone do not confer the designation.
Researcher Development Concordat
The Researcher Development Concordat (formally the Concordat to Support the Career Development of Researchers) is a UK sector-wide agreement, first launched in 2008 and substantially revised in 2019, that sets out reciprocal commitments among research funders, research organizations (universities and institutes), and researchers themselves for improving the environment, employment conditions, and career development of researchers. An organization is treated as implementing the Concordat when it is a formal signatory, has published a public action plan addressing the Concordat's three principles, and reports progress against that plan on a defined cycle -- not merely by stating general support for researcher development.
IRB Coordinator
The IRB Coordinator (also called IRB Administrator, IRB Analyst, or Human Subjects Protection Coordinator, depending on the institution) is the staff role responsible for the administrative and operational running of an Institutional Review Board (IRB) office — protocol intake and completeness review, meeting scheduling and logistics, correspondence with investigators, tracking continuing-review and other regulatory deadlines, and maintaining the IRB's official records. It is a non-voting, non-determination-making role: the Coordinator supports the board's process but does not review protocols for approval, does not preside over convened meetings, and does not carry the IRB Chair's statutory authority to make or assign expedited-review determinations under 45 CFR 46.110 / 21 CFR 56.110.
Clinical Trial Central Laboratory
A clinical trial central laboratory is a single designated laboratory, or a network of laboratories operating under one standardized protocol, contracted to perform sample testing (e.g., blood chemistry, hematology, biomarker assays, pharmacokinetic analysis) for every investigative site in a multi-site trial, rather than each site using its own local or institutional lab. A vendor relationship qualifies as a central laboratory arrangement when it provides all of: (1) a single set of standardized testing protocols, equipment, and reference ranges applied uniformly across every participating site; (2) site-facing logistics -- specimen collection kits, labeled containers, and standardized courier/shipping arrangements -- so specimens from geographically dispersed sites reach the same analytical instruments; and (3) pooled, harmonized result reporting back into the trial's data set, so that a lab value from Site A and the equivalent value from Site B were generated by the same method and are directly comparable without a site-specific correction factor.
Journal Citation Indicator (JCI)
A journal's Journal Citation Indicator (JCI) is the field-normalized citation-impact score Clarivate calculates for it as part of each annual Journal Citation Reports (JCR) release. It measures the average citation impact of a journal's citable items published in the most recent three-year window, normalized against the average citation rate for all similarly-aged papers of the same document type in the same JCR subject category. A journal qualifies for a JCI if it is indexed in a JCR-eligible Web of Science Core Collection index (SCIE, SSCI, AHCI, or ESCI) with enough citable output in the relevant window for Clarivate to calculate a normalized rate. The score is a decimal where 1.0 equals the world average for that category and document type: a JCI of 1.5 means the journal's papers are cited 50% more than the world average for comparable papers in that field, and a JCI of 0.5 means cited half as often.
IVD Clinical Trials (In Vitro Diagnostic Studies)
An IVD (in vitro diagnostic) clinical trial -- more precisely termed a performance study or, in FDA IDE terminology when one is required, an IVD investigation -- is a study that evaluates a diagnostic test's ability to detect, measure, or characterize a condition or analyte using specimens taken from the human body (blood, urine, tissue, swabs), rather than a study that administers a drug or activates a therapeutic device inside a patient. Because most IVD studies test specimens that have already been collected, or collect them through routine, minimally invasive means, they are regulated as a distinct category from both drug trials (governed in the US by the Investigational New Drug, or IND, pathway) and therapeutic device trials (governed by the Investigational Device Exemption, or IDE, pathway under 21 CFR Part 812). A study is an IVD clinical trial, in the sense this term is used on this site, when its object is establishing or confirming a diagnostic test's analytical performance (does the assay measure the analyte accurately and reproducibly) and/or clinical performance (does the result correlate with the clinical condition it claims to detect) -- not when it evaluates a drug's or device's direct therapeutic effect on a patient.
Technology Licensing Office (TLO)
A Technology Licensing Office (TLO) is the name a research institution gives to its intellectual-property-and-licensing office. Absent institution-specific information, an office named 'Technology Licensing Office' should be treated as performing the same core function as a 'Technology Transfer Office' (TTO) -- receiving invention disclosures, deciding whether to pursue patent protection, and negotiating licenses with companies -- under a different institutional naming convention, not a categorically different kind of office. Some institutions choose the 'TLO' label specifically to signal a renewed or narrower emphasis on the licensing/IP-protection function relative to the broader industry-engagement and sponsored-research-support activities a 'TTO' label can imply, but this is a per-institution branding choice, not a standardized, cross-institutional scope distinction -- confirm actual scope from the specific office's own published mandate rather than inferring it from the name alone.
Scite (Smart Citations)
Scite is a commercial citation-analysis platform whose core feature, Smart Citations, uses a trained natural-language-processing (deep learning) model to classify each individual citing statement of a paper as supporting, contrasting, or mentioning the claim it cites, and displays the actual citation-context sentence alongside that classification. A citation is a Scite Smart Citation, specifically, when it comes with (a) the excerpted sentence from the citing paper that references the cited work, and (b) a supporting/contrasting/mentioning label assigned to that specific citing statement -- not just a tally of how many times the work has been cited.
Commercial IRB
A commercial IRB (also called an independent IRB) is an Institutional Review Board that operates as a standalone, for-profit or non-profit business providing human-subjects ethics review as a paid, fee-for-service function -- rather than as an internal department of the university, hospital, or research institution whose studies it reviews. It is registered with OHRP and, for FDA-regulated research, meets the same 21 CFR Part 56 requirements as any other IRB; the distinguishing feature is organizational independence and a client-billing relationship with the sites and sponsors it reviews for, not a lower regulatory bar. Commercial IRBs (WCG/WIRB and Advarra are the two largest in the U.S. market) are frequently designated as the single IRB (sIRB) of record for multi-site trials, but sites also route single-site industry-sponsored studies to a commercial IRB even when no sIRB mandate applies -- typically because the sponsor requires it, the site has no local IRB, or the site's own IRB lacks capacity or relevant expertise for the study type.
Link Resolver
A link resolver is OpenURL-based library-discovery software that accepts a context-sensitive citation link (from a database, discovery layer, or search engine), checks it against the library's knowledge base of current subscriptions and open-access holdings, and, if a match exists, routes the user to the specific full-text copy that institution has legitimate access to -- rather than to a fixed, publisher-assigned location. It is the software behind a library's "Find It", "Get It", or "Get Full Text" button.
Prior Inventions Disclosure
A prior inventions disclosure is the exhibit or schedule attached to an employment, consulting, or IP assignment agreement in which an individual lists every invention they created before the agreement's effective date, using an affirmative yes/no format, so that pre-existing IP is documented as excluded from the agreement's forward-looking assignment clause rather than left ambiguous.
Cabells Predatory Reports
Cabells Predatory Reports (formerly Cabells' Blacklist, renamed in June 2020) is a commercial subscription database, published by the scholarly-analytics company Cabells, that lists journals its review team has determined exhibit deceptive or predatory editorial and publishing practices. A journal's inclusion is determined by evaluating it against a published, versioned set of behavioral indicators — v1.0 (2017) contained 64 criteria and v1.1 (2019) expanded to 74, organized by category (integrity, peer review, business practices, indexing claims, and similar) and by severity — rather than by a single reviewer's informal judgment. Unlike Beall's List, which is a static snapshot frozen in January 2017, Predatory Reports is actively maintained: journals are added, and the underlying criteria themselves have been revised, on an ongoing basis. Access is by paid subscription, typically arranged at the institutional level through a university library, either as a standalone product or bundled with Cabells' companion Journalytics subscription.
Panel on Research Ethics (PRE)
The Panel on Research Ethics (PRE), formally the Interagency Advisory Panel on Research Ethics, is the body created jointly in 2001 by Canada's three federal research funding agencies (CIHR, NSERC, and SSHRC) to develop, interpret, and steward the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) on the Agencies' behalf; it does not itself review or approve individual research protocols, which remains the role of institutional Research Ethics Boards (REBs).
PRISMA-ScR (PRISMA Extension for Scoping Reviews)
A report is PRISMA-ScR compliant when it satisfies PRISMA-ScR's 20 essential reporting items (Tricco et al. 2018), frames its question in PCC (Population, Concept, Context) rather than PICO terms, and documents evidence "charting" and mapping rather than risk-of-bias-weighted synthesis -- the checklist purpose-built for scoping reviews, distinct from the core 27-item PRISMA 2020 checklist used for systematic reviews of intervention effects.
AUTM Licensing Activity Survey (LAS)
The AUTM Licensing Activity Survey (LAS) is AUTM's annual, voluntary, self-reported data-collection instrument that gathers standardized technology-transfer metrics -- research funding administered, invention disclosures received, patent applications filed and patents issued, licenses and options executed, licensing income received, and startup companies formed -- from participating U.S. and Canadian universities, academic medical centers, hospitals, and research institutions for a given fiscal year. A figure counts as LAS data specifically when it is drawn from an institution's own completed survey submission to AUTM (or from AUTM's aggregated published report or STATT database built from those submissions), not from an institution's separately published internal annual report or from an unrelated third-party estimate of technology-transfer activity.
UPIRSO (Unanticipated Problem Involving Risks to Subjects or Others)
A UPIRSO is an incident, experience, or outcome in human subjects research that meets all three of OHRP’s reporting criteria: it is unexpected in nature, severity, or frequency given the protocol and subject population; it is related or possibly related to participation in the research; and it suggests subjects or others face greater risk of harm than was previously known. All three prongs must be met — an event failing any one of them is not a UPIRSO under OHRP guidance, even if it is still reportable under another category such as a routine adverse event or protocol deviation. The investigator reports a suspected UPIRSO promptly to the IRB per 21 CFR 56.108(b) (FDA-regulated research) and the institution’s Federalwide Assurance procedures (federally-supported research generally); the institution may then have a further obligation to report certain UPIRSOs to OHRP and the supporting federal agency, on a timeframe set by its own written policies rather than one fixed federal number of days.
Product Development Agreement
A product development agreement (PDA) is a contract between a company and a university, research institution, or individual inventor to jointly develop a specific product or technology toward a commercial outcome, combining ongoing development work with pre-negotiated terms for how the resulting IP will be owned and eventually commercialized. An arrangement counts as a product development agreement, rather than one of the adjacent instruments it is routinely confused with, when three elements are present together: (1) the parties jointly perform development work aimed at a defined product or application -- it is not a license of already-existing IP with no development obligation attached, and not open-ended research without a specific commercial product as the target; (2) it sets milestone-based development obligations (technical milestones, timelines, sometimes funding contributions) that both parties are bound to, rather than one party simply performing services for a fee; and (3) it addresses in advance how IP arising from the joint work -- particularly improvements, modifications, or new inventions built on either party's background IP -- will be owned, and how the finished product will ultimately be licensed or otherwise commercialized. A PDA is a general contracting concept, not a term of art created by a specific statute; its content is negotiated case by case, unlike a CRADA, which is a specific federal-laboratory mechanism created by statute.
International Confidentiality Agreement
A confidentiality agreement (NDA) between parties in different countries, which requires provisions a purely domestic NDA does not: export-control screening of the disclosed information for deemed-export risk, a deliberately chosen governing-law/jurisdiction/dispute-resolution clause that will actually be enforceable across the relevant borders, and, when the confidential information includes personal data, transfer safeguards that satisfy the data-protection law of the disclosing party's jurisdiction (most commonly GDPR Chapter V).
Model Clinical Trial Agreement (mCTA)
A Model Clinical Trial Agreement (mCTA) is a standardized, pre-negotiated template Clinical Trial Agreement published by a national body, funder, or multi-institutional consortium, and intended to be used with little or no clause-by-clause negotiation for each new trial. Adopting sponsors and sites fill in trial-specific variables (protocol reference, budget schedule, site details) against core legal language -- indemnification, IP allocation, publication rights, data ownership -- both sides have already pre-agreed is acceptable. It is defined by the contracting strategy (a fixed starting point institutions commit in advance to accept largely unmodified), not by any single clause, since CTA content itself varies by jurisdiction.
Horizon Europe Article 19 (Ethics)
Article 19 of Regulation (EU) 2021/695 is the Horizon Europe framework Regulation's general ethics clause: it requires all Horizon Europe-funded actions to comply with ethical principles and applicable EU/national/international law, mandates a proposal-stage ethics self-assessment plus Commission screening and, where warranted, a formal ethics assessment (automatic for any action involving human embryonic stem cells or embryos), requires participating entities to hold and keep on file all required national/institutional ethics and data-protection approvals before starting the relevant activity, allows ethics checks during a project's lifetime, and excludes certain fields of research (human reproductive cloning, heritable germline genetic modification, and creating human embryos solely for research or stem-cell procurement) from funding altogether.
Good Publication Practice (GPP)
Good Publication Practice (GPP) is a named, industry-authored set of ethics guidelines for planning, writing, and publishing company-sponsored biomedical research -- primarily pharmaceutical, biotechnology, and medical-device studies. It is maintained by a GPP Steering Committee working with ISMPP (the International Society for Medical Publication Professionals) and published as a peer-reviewed article in Annals of Internal Medicine. The current version is GPP 2022, which superseded GPP3 (2015); GPP3 itself superseded the original GPP2 (2009) and GPP (2003). A study, manuscript, or publication process is GPP-compliant when: authorship is assigned strictly against ICMJE's four authorship criteria (not honorary, guest, or ghost authorship); the funding source and the sponsor's role in study design, analysis, and the decision to publish are disclosed; any professional medical writer's involvement is named and their support disclosed, typically in the acknowledgements; named authors have full access to the data (or a summary sufficient to vouch for it) and control over interpretation and the final decision to publish; and there is a documented intent to publish results regardless of outcome, including negative or inconclusive findings.
Editorial Independence
Editorial independence is the principle, formalized by COPE (Committee on Publication Ethics), that a journal's editorial decisions -- to accept, reject, or request revision of a manuscript -- are made solely on scholarly merit and are insulated from influence by the journal's owner, publisher, advertisers, sponsors, or any other commercial or non-scientific interest. It requires that editors hold final, unoverridable authority over content decisions, that advertising/sponsorship functions operate organizationally separate from editorial functions, and that any relationship between the journal and a commercial or sponsoring party is governed by a declared, public policy rather than an informal arrangement.
Horizon Europe Article 39 (Open Access)
Article 39 of Regulation (EU) 2021/695, the Horizon Europe framework regulation, is the legal provision that creates the programme's binding open science obligations for grant beneficiaries. It has two strands: (1) mandatory immediate open access to peer-reviewed scientific publications resulting from Horizon Europe funding, with no embargo period, licensed under the latest version of Creative Commons Attribution (CC BY) or an equivalent licence (a narrower exception permits CC BY-NC or CC BY-ND for monographs and other long-form outputs); and (2) responsible management of research data under the FAIR principles and the default that data should be 'as open as possible, as closed as necessary,' subject to documented, justified exceptions for IP, personal data, confidentiality, or security. Horizon Europe Grant Agreements incorporate both strands as binding funding conditions, not discretionary guidance.
European Code of Conduct for Research Integrity
The European Code of Conduct for Research Integrity is a specific, named document — not a general principle or a professional network — published by ALLEA (All European Academies), the federation of European academies of sciences and humanities. First issued in 2011 (jointly with the European Science Foundation), it was revised in 2017 and again in 2023. It sets out four principles — reliability, honesty, respect, and accountability — and translates them into good research practices covering research design, data management, methodology, authorship, publication, and peer review, alongside a taxonomy of research misconduct and other research integrity violations. A document or practice is 'covered' by the Code when it is cited as the reference standard in a funding agreement, institutional policy, or national code — most consequentially, the European Commission recognises the Code as the primary research-integrity standard for Horizon Europe, and it is incorporated by reference in the Horizon Europe Model Grant Agreement, making adherence a binding condition of EU research funding rather than a voluntary aspiration.
Horizon Europe Article 7: Gender Equality Plan (GEP)
Article 7 of the Horizon Europe framework regulation (Regulation (EU) 2021/695) makes gender equality a cross-cutting priority of the programme and is the legal basis for the Gender Equality Plan (GEP) eligibility criterion: for Horizon Europe calls with submission deadlines from 2022 onward, public bodies, higher education establishments, and research organisations established in an EU Member State or an Associated Country must have a GEP (or an equivalent gender equality strategy) in place to be eligible to receive funding. It is a legal entity-level eligibility check, not a proposal-evaluation criterion -- an applicant either has a qualifying GEP on file or it does not, and non-compliant public-body, HEI, or research-organisation applicants are ineligible for that call regardless of the scientific merit of their proposal. Private, for-profit entities (companies, including SMEs) are exempt from the requirement.
42 CFR Part 11
42 CFR Part 11 is the federal regulation, titled "Clinical Trials Registration and Results Information Submission," that codifies the ClinicalTrials.gov registration and results-reporting requirements originally created by Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801). Issued by HHS as a Final Rule and effective 18 January 2017 (compliance expected by 18 April 2017), it converts FDAAA 801's statutory mandate into binding, enforceable regulatory text: who counts as the "responsible party" for a trial, which trials are "applicable clinical trials" (ACTs) subject to the rule, the specific data elements and deadlines for registration and results submission, and FDA's civil monetary penalty authority for noncompliance. A trial is governed by 42 CFR Part 11 only if it meets the regulation's ACT definition; broader definitions used by ICMJE or by NIH's own separate results-reporting policy can require registration or reporting for trials that fall outside Part 11's narrower scope.
22 CFR Part 120 (ITAR — Purpose and Definitions)
22 CFR Part 120 is the opening part of the International Traffic in Arms Regulations (ITAR), the body of US federal regulations administered by the Department of State's Directorate of Defense Trade Controls (DDTC) that controls the export and temporary import of defense articles and defense services on the US Munitions List (USML). Part 120 does not itself list controlled items -- that is Part 121 (the USML) -- instead it states ITAR's statutory basis and purpose (Subpart A) and, in Subpart C (22 CFR 120.30-120.69), supplies the controlling definitions used throughout the rest of ITAR (22 CFR Parts 121-130), including 'defense article,' 'defense service,' 'technical data,' 'export,' 'US person,' and 'foreign person.' Because these definitions govern how every other ITAR part is read, a research institution's export-control determination for a given item, collaboration, or foreign national almost always traces back to a Part 120 definition rather than to a substantive control provision elsewhere in ITAR.
Adverse Event of Special Interest (AESI)
An Adverse Event of Special Interest (AESI) is an adverse event (serious or non-serious) that a trial sponsor pre-identifies in the study protocol as being of scientific and medical concern specific to the investigational product or research programme, because there is a known or suspected mechanistic, class-effect, or prior-safety-signal reason to watch for it. Unlike a general Adverse Event (AE), which is simply any untoward medical occurrence observed during a trial, an AESI is defined in advance, by name, before the first participant is enrolled -- the protocol (and often a companion safety monitoring plan) lists the specific event, the case definition or diagnostic criteria used to confirm it, and the enhanced procedures for capturing it (e.g. dedicated case report form fields, expedited investigator-to-sponsor reporting timelines, or independent adjudication by a clinical events committee). Because the AESI designation is about the *reason for watching*, not the event's clinical severity, an AESI can be non-serious under the ordinary ICH E2A seriousness criteria (death, life-threatening, hospitalization, persistent disability, congenital anomaly, or 'otherwise medically important') and still trigger the same rapid-reporting and characterization procedures a serious event would. This is the operational test for whether something is an AESI: was it named as a specific event of concern in the protocol/safety monitoring plan before enrollment began, for a documented scientific or regulatory reason -- as opposed to emerging unexpectedly during the trial.
Published Data
Data is 'published' when it has been formally released as a discrete, citable research output: deposited in a repository or registry that assigns it a persistent identifier (typically a DOI), described with metadata sufficient for independent discovery and reuse (at minimum the DataCite mandatory set -- Identifier, Creator, Title, Publisher, PublicationYear, ResourceType), and made accessible under a stated licence. A dataset that is merely stored, backed up, or informally emailed to a collaborator is not 'published' in this sense, even if the underlying files are identical -- publication is a formal act with a fixed citation form, not a description of where the bytes happen to live.
Clinical Trial Protocol
A clinical trial protocol is the formal, version-controlled document that defines a study's rationale, objectives, design, methodology, statistical considerations, and organization -- specifying eligibility criteria, interventions, assessments/procedures and their timing, endpoints, and the responsibilities of investigators and sponsors. Under ICH E6(R3), it is the controlling document that IRB/ethics committee review, investigator conduct, sponsor oversight, and (once locked) the statistical analysis all reference; any conduct outside its terms requires either an approved amendment or documented justification as an immediate-safety deviation.
Microsoft Academic Graph (MAG)
A large-scale, free scholarly knowledge graph built and maintained by Microsoft Research — publications, authors, affiliations, venues, and a machine-generated fields-of-study taxonomy, linked by citation and authorship edges, and distributed via the Microsoft Academic website, the Microsoft Academic Knowledge API, and periodic bulk data dumps — that Microsoft fully retired on December 31, 2021, and no longer maintains, updates, or serves in any form.
Beall’s List
Beall's List refers to the self-published blacklist of publishers and standalone journals that University of Colorado Denver librarian Jeffrey Beall judged to be "potential, possible, or probable" predatory open-access operations, posted on his blog Scholarly Open Access between 2008 and January 15, 2017. It was a single-author evaluation against Beall's own evolving criteria (fake or absent peer review, fabricated editorial boards, false indexing claims, deceptive fee disclosure, and similar red flags), not a criteria-based process run by a standards body, publisher coalition, or institution. Beall removed the entire site in January 2017 and it has not been updated since, so any reference to "Beall's List" today points to a frozen, decade-plus-old snapshot (or to one of several unofficial community mirrors of it) rather than to a live, current resource.
Investigational New Drug (IND)
A drug or biologic that FDA has authorized, via an active IND application under 21 CFR Part 312, to be shipped and administered to human subjects in a clinical investigation before it has received marketing approval — or an already-approved drug being studied outside the bounds of its approved labeling in a way that meets the triggering criteria in 21 CFR 312.2(b). The term refers interchangeably to the drug's regulatory status, the sponsor's application establishing that status, and the FDA-assigned number the study operates under.
Open Science Badges (Open Data, Open Materials, Preregistered)
The Open Science Badges are a set of journal-awarded visual icons, created and administered by the Center for Open Science (COS), that certify a published article met a disclosed openness standard for one of three practices: publicly posting the study's underlying data (Open Data), publicly posting the materials needed to reproduce the reported procedure and analysis (Open Materials), or registering the study design -- and, for the Preregistered+Analysis Plan variant, the analysis plan -- in a public registry before data collection began (Preregistered). A journal awards a badge either on a simple author self-disclosure statement or after independent editorial verification, and displays the badge icon alongside the article together with a link to the disclosed data, materials, or registration.
Dual-Use Research of Concern (DURC)
Research is DURC only when it meets a two-part US Government test: it involves one of 15 enumerated select agents/toxins, AND it is reasonably anticipated to produce an outcome in one of seven defined categories of experimental concern (e.g., enhancing transmissibility/virulence, conferring resistance to countermeasures). DURC review by an institution's Institutional Review Entity/IBC is complementary to, not a substitute for, routine biosafety containment review.
Research Animal
An animal that is used, or intended for use, in research, research training, testing, or experimentation, and that therefore falls under one or both of two overlapping US regulatory frameworks: the Animal Welfare Act (which reaches warm-blooded species other than purpose-bred rats, mice, and birds) and PHS Policy on Humane Care and Use of Laboratory Animals (which reaches any live vertebrate used in PHS/NIH-funded work, including species the AWA excludes). Whether a specific animal is a "research animal" for compliance purposes depends on which framework applies to it and to the funding/registration status of the institution using it.
USPTO Office of Enrollment and Discipline (OED)
The Office of Enrollment and Discipline (OED) is the office within the U.S. Patent and Trademark Office's Office of the General Counsel that controls who may represent inventors and applicants before the USPTO in patent matters. It performs two distinct functions: (1) it administers registration -- reviewing each applicant's scientific/technical qualifications, developing and administering the registration examination (the 'patent bar exam'), and maintaining the official roster of registered patent attorneys and patent agents -- and (2) it investigates grievances and administers discipline (from a warning through suspension or exclusion) against practitioners who violate the USPTO Rules of Professional Conduct (37 CFR Part 11). An individual is a 'registered patent practitioner' only if OED has admitted them to practice and their name remains on the active roster; passing a state bar exam alone does not confer patent-prosecution authority, and OED registration alone does not confer authority to give general legal advice, draft licenses, or litigate -- those require a state law license, which is why a registered practitioner is either a 'patent attorney' (also a licensed attorney) or a 'patent agent' (not a lawyer, authorized only to prosecute patent applications before the USPTO).
Nuremberg Code
The Nuremberg Code is a ten-point statement of ethical principles for research involving human subjects, set out in the August 19, 1947 verdict of the U.S. military tribunal in United States v. Karl Brandt et al. (the 'Doctors' Trial') at Nuremberg. It is the operative reference point for a claim that a given human-subjects study meets the minimum ethical floor for legitimate research: the study is judged against the Code when its consent process, scientific justification, and risk controls are being assessed retrospectively as a historical or foundational benchmark, distinct from applying a current regulation such as the Common Rule or an IRB's own protocol-specific determination. Its first and most influential point establishes that the voluntary, informed consent of the human subject is 'absolutely essential' -- the earliest internationally recognized statement of that requirement, and the direct conceptual ancestor of informed-consent requirements in every later research-ethics code and regulation.
45 CFR 164.512(i) (HIPAA Uses and Disclosures for Research Purposes)
The provision of the HIPAA Privacy Rule, at 45 CFR 164.512(i), that permits a covered entity to use or disclose protected health information (PHI) for research without the individual's written authorization, through one of three specific pathways: (1) an Institutional Review Board (IRB) or Privacy Board has approved a waiver or alteration of authorization under the documented criteria at 164.512(i)(1)(i) and (i)(2); (2) the researcher represents the use is solely a review preparatory to research and no PHI will be removed from the covered entity; or (3) the researcher represents the use is solely for research on a decedent's information. A disclosure only qualifies under 164.512(i) if it fits one of these three pathways exactly as documented — it is not a general research exception.
shortDOI
A shortDOI is a redirect alias, in the form 10/abcde, generated by the International DOI Foundation's shortDOI Service (shortdoi.org) for an existing, already-registered DOI name. It is not a separately registered persistent identifier: it resolves through the same DOI Handle System and https://doi.org/ resolver as the underlying DOI, is issued only once per DOI (requesting a shortDOI for a DOI that already has one returns the existing alias rather than minting a new one), and carries none of a DOI's registration guarantees on its own -- the original DOI remains the identifier of record for citation, archiving, and metadata purposes.
OAIS Reference Model (ISO 14721)
A conceptual framework, standardised as ISO 14721, that defines the functions, information packages, and terminology an archive needs to preserve digital (or physical) information and keep it accessible to a defined community over the long term, independent of the specific technology used to implement it.
Risk-Benefit Analysis
Risk-benefit analysis is the determination an IRB or REC must make, under the Belmont Report's Beneficence principle and its codification at 45 CFR 46.111(a)(1)-(2), that (1) risks to research participants have been minimized through sound research design, and (2) the residual risks are reasonable in relation to the study's anticipated benefits to participants, if any, and the importance of the resulting knowledge. It is a mandatory precondition for IRB approval, made by the board itself before a study proceeds -- distinct from informed consent, which discloses those already-evaluated risks and benefits to participants so each can decide individually whether to accept them.
Data Transfer Agreement (DTA)
A contract governing the mechanics of transferring a dataset between institutions -- authorised senders and recipients, transmission and security method, and destruction-or-return terms -- distinct from a Data Use Agreement's downstream use restrictions and a Material Transfer Agreement's coverage of physical materials.
Case Report Form (CRF)
A case report form (CRF) is the study-specific data-collection instrument -- paper or electronic (eCRF) -- through which a clinical trial's protocol-defined data points are recorded for each participant and transmitted to the sponsor or its designee for analysis. Its content is derived directly from the protocol and the Statistical Analysis Plan: every field on a CRF should map to a specified assessment, visit, or endpoint, and nothing should appear on a CRF that isn't required by the protocol. Data recorded on a CRF must be verifiable against source documents (the original records -- clinic charts, lab reports, imaging, ECGs, patient diaries -- where a data point was first captured), a process called source data verification (SDV). ICH E6(R2)/(R3) hold the CRF to the same data-integrity expectations that apply to source data generally, commonly summarized by the ALCOA+ attributes (attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, available); any correction made after initial entry must preserve an audit trail rather than overwrite the original value. CRF field design commonly follows CDISC's CDASH standard to ease downstream mapping to SDTM submission datasets. A CRF is a distinct concept from a published case report (a journal article type describing an unusual clinical case) despite the similar name.
Crossref Simple Text Query
Crossref Simple Text Query is a free web-based matching tool at doi.crossref.org/simpleTextQuery that takes an unstructured reference or reference list — pasted as plain citation text, not structured fields — and returns the matching DOI for each item it can identify. A submission can hold up to 1,000 references, entered one per line or block, and the tool attempts to return exactly one best-match DOI per reference by default (an option to list all possible matches is available when a reference is ambiguous). No Crossref membership or account is required to use it, and there is no charge. The same underlying free-text matching is also exposed programmatically through the Crossref REST API's query.bibliographic parameter on the /works route (for example api.crossref.org/works?query.bibliographic=your+citation+string), which is the machine-actionable equivalent of pasting a citation into the web form — useful for batch reference-linking pipelines rather than one-off lookups.
Last Author
The name occupying the final position in a scholarly work's byline. In contribution-ranked fields -- most consistently biomedicine and the life sciences -- this position conventionally signals the senior investigator or principal investigator who supervised the study and obtained funding, distinct from the first author who typically performed the primary hands-on work. Last-author position is not itself an ICMJE authorship criterion, and the convention does not apply uniformly: alphabetical-order fields (mathematics, particle physics, much of economics) carry no such signal, and last author is not automatically the same person as the corresponding author.
ISRCTN
ISRCTN — originally an acronym for International Standard Randomised Controlled Trial Number, now used as the registry's own name — is a UK-based clinical study registry that assigns a permanent, unique identifier (an ISRCTN number) to a study at or before its start. A study qualifies as "ISRCTN-registered" when its investigator or sponsor has submitted the required minimum data set (design, intervention, population, primary/secondary outcomes, sponsor, funder) through isrctn.com, the entry has passed the registry's validation checks, and it has been assigned a permanent identifier in the format ISRCTN followed by an eight-digit number (for example, ISRCTN12345678). Unlike its original RCT-only scope, ISRCTN now accepts any study assessing the effect of a health intervention on a human population, including non-randomised interventional studies and some observational designs — the acronym is retained for historical/branding reasons but no longer describes the registry's actual scope.
Research Transparency
Research transparency is the practice of making the specific decisions, materials, data, and code behind a study visible and checkable at the point they are used, not the broader movement to open up research outputs generally (that is open science). A study demonstrates research transparency to the degree it discloses, and ideally shares and cites, what it did: whether hypotheses and analysis plans were specified before or after seeing the data, where materials and data can be obtained, whether analytic code is available, and whether the design and reporting follow a recognized standard. The most widely adopted operational framework for this is the Transparency and Openness Promotion (TOP) Guidelines, published by the Center for Open Science (COS), which turns 'be transparent' into eight checkable standards — citation, data transparency, analytic methods (code) transparency, research materials transparency, design and analysis transparency, study preregistration, analysis plan preregistration, and replication — each ratable at one of three levels of stringency, from disclosure through requirement to independent verification.
Nature Author Contributions
Nature's author contributions policy requires every submitted paper to include a free-text statement describing each author's role, built on authorship criteria drawn from McNutt et al. (2018) rather than ICMJE's four-part test, and without mandating the CRediT taxonomy for the statement itself. It also permits explicit "contributed equally" and "jointly supervised" co-author designations and prohibits authorship changes after acceptance.
Research Data
Research data is the recorded, factual material generated or collected in the course of a research project that is needed to validate, reproduce, or build on that project's findings — raw measurements, observations, instrument readings, survey responses, code outputs, and other structured or unstructured records, regardless of medium or discipline. In U.S. federally funded research specifically, the term carries a narrower, load-bearing regulatory meaning under 2 CFR § 200.315(e)(3) (the Uniform Guidance, which consolidated and replaced the older OMB Circular A-110 in 2014): research data means 'the recorded factual material commonly accepted in the scientific community as necessary to validate research findings.' That specific definition is what determines what a federal award recipient must make available in response to a Freedom of Information Act (FOIA) request, and it is the baseline many institutions use to scope what a data management plan (DMP) is actually obligated to describe. Distinguishing 'research data' in this operational sense from the much larger set of everything a researcher produces during a project — drafts, correspondence, physical samples, unfinished analysis — is the first practical step in scoping a DMP, a repository deposit, or a records-retention schedule, and underpins research data management (RDM) practice generally.
eConsent (Electronic Informed Consent)
eConsent (electronic informed consent) is the use of an electronic system, often incorporating multimedia such as video or interactive comprehension checks, to present IRB-approved informed consent information and capture a participant's electronic signature in place of a paper form. A process counts as eConsent when it delivers the required consent content electronically, preserves a genuine opportunity for the participant to ask questions before signing, captures an attributable electronic signature that is time-stamped and non-detachably linked to the specific document version reviewed, and provides the participant a copy of the signed consent. For FDA-regulated clinical investigations, the electronic signature must meet 21 CFR Part 11's criteria; FDA and OHRP's December 2016 joint guidance additionally recommends that IRBs review the electronic process and interface itself, not just the consent language.
ICH Q1 (Stability Testing Guidance)
ICH Q1 is the International Council for Harmonisation's guideline series covering the stability testing that establishes a drug substance's or drug product's shelf-life (expiration dating period), retest period, and required storage/labeling conditions. The historical Q1 series — Q1A(R2) (stability testing of new drug substances and products, revised 2003), Q1B (photostability testing, 1996), Q1C (stability testing for new dosage forms, 1996), Q1D (bracketing and matrixing study designs, 2002), and Q1E (evaluation of stability data, 2003) — together with the biotechnology/biological product stability guideline Q5C (1995), remain the operative reference guidance as of this writing. ICH is consolidating the entire series (plus Q5C) into a single revised Q1 guideline, extended in scope to cover both synthetic and biological products; that consolidated draft reached ICH Step 2b (public consultation) on 11 April 2025 and has not yet reached Step 4 (final guideline) — until it does, and each region formally adopts it, the existing Q1A-Q1E/Q5C texts remain the applicable standard.
PNAS Author Contributions
PNAS Author Contributions refers to the Proceedings of the National Academy of Sciences' requirement that every published paper carry a structured statement of who did what, plus a corresponding-author guarantor clause. PNAS pioneered this in 1995, using its own fixed checklist that predates CRediT (ANSI/NISO Z39.104-2022) by roughly two decades; current submissions are directed to the standard CRediT taxonomy while PNAS retains its guarantor requirement and adds a mandatory ORCID for the corresponding author.
NSF CISE (Computer and Information Science and Engineering)
NSF CISE (the Directorate for Computer and Information Science and Engineering) is one of the National Science Foundation's major organizational directorates. It is a budgetary and administrative unit, not a single funding program or solicitation: CISE funds fundamental research and education across computer science, information science, and computer engineering, and proposals are routed to specific thematic program areas within it based on subject matter. Following NSF's agency-wide reorganization announced in December 2025, CISE's internal structure moved from its long-standing division model to six current thematic program areas.
Editorial board
An editorial board is the named group of individuals — typically an editor-in-chief (or co-editors-in-chief), one or more associate/section/deputy editors, and a wider roster of board members — appointed by a journal or its publisher to set editorial policy, uphold publication ethics and peer-review integrity, and make or ratify final accept/reject decisions on submissions. Editorial board members are governance/oversight appointees, not, by default, the pool that performs first-pass external peer review of any given manuscript (that is typically done by invited subject-matter reviewers selected per submission, sometimes including board members but not limited to them). A journal without an identifiable editorial board is treated by indexing/vetting bodies (e.g. DOAJ) as a red flag for undisclosed or absent editorial oversight.
FFATA Reporting
FFATA reporting is the mandatory disclosure of subaward and executive-compensation information required under the Federal Funding Accountability and Transparency Act of 2006. A prime recipient of a federal award (or a pass-through entity issuing subawards under it) must report each subaward action of $30,000 or more in federal funds through SAM.gov (successor to the retired FSRS.gov, migrated around March 2025), by the end of the month following the month in which the obligation was made. Recipients meeting a two-part revenue test must also report the compensation of their five most highly compensated executives. The reporting obligation sits with the pass-through entity, not the subrecipient, and the resulting data feeds USASpending.gov for public transparency.
Administrative Metadata
Administrative metadata is the category of metadata used to manage a resource — as distinct from metadata used to describe or discover it. It typically covers four practical areas: rights and permissions (licensing, access restrictions), provenance and acquisition history (who deposited it, when, and how), technical/file-format details (file type, software/equipment used, checksums), and access-control information. NISO's standard three-way split names it alongside descriptive and structural metadata, and treats technical and preservation metadata as administrative subtypes — though usage varies slightly by standard: METS, for example, models technical, rights, provenance, and preservation information together under a single amdSec (administrative metadata section), sitting alongside — not nested inside — its descriptive metadata section (dmdSec).
Tuskegee Syphilis Study
The Tuskegee Syphilis Study refers specifically to the U.S. Public Health Service's Study of Untreated Syphilis in the Negro Male, conducted in Macon County, Alabama from 1932 to 1972, in which roughly 600 Black men (399 with latent syphilis, 201 as an uninformed control group) were enrolled without being told their actual diagnosis or the study's purpose, and were denied treatment -- including penicillin once it became the standard cure in the 1940s -- so researchers could observe the untreated disease's natural progression. The term is invoked today as the specific, documented U.S. case of research conducted without informed consent, through active deception, targeting a vulnerable population defined by race, and involving the deliberate denial of available treatment; its 1972 public exposure is the direct legislative trigger for the National Research Act of 1974 and, through the National Commission it created, the 1979 Belmont Report.
ICH E6(R2) (Good Clinical Practice, 2016 Addendum)
ICH E6(R2) is the 2016 integrated addendum to ICH's original E6(R1) (1996) Good Clinical Practice guideline, reaching ICH Step 4 on 9 November 2016 and adopted as final FDA guidance on 1 March 2018. It layers new provisions onto (not replacing) E6(R1): a new Section 5.0 (Quality Management, including risk-based quality management and quality tolerance limits) and a revised Section 5.18 (Monitoring, formally recognizing centralized and risk-based monitoring alongside traditional on-site visits). It was superseded as ICH's current core guideline by ICH E6(R3) (Principles + Annex 1 finalized January 2025), but remains the applicable GCP text for any trial, institution, or jurisdiction that has not transitioned to E6(R3), including many trials authorized and still running under it.
NIH Genomic Data Sharing (GDS) Policy
A study falls under NIH's Genomic Data Sharing (GDS) Policy (2014) when it is NIH-funded and generates large-scale human or non-human genomic data (GWAS, SNP arrays, WGS/WES, transcriptomic, epigenomic, metagenomic, or gene-expression data). Covered human-data studies must use GDS-specific prospective informed consent language, obtain an Institutional Certification from the awardee institution (via its Signing Official, in coordination with the IRB) confirming consistency with participant consent, and submit data to an NIH-designated controlled-access repository -- dbGaP for most human genomic data -- under a Data Use Certification Agreement. The GDS Policy predates and operates alongside, not inside, the broader 2023 NIH Data Management and Sharing (DMS) Policy.
Study Identifier
The unique code a registry assigns to identify a specific research study — a clinical trial, systematic review, or other registered research project — as that study itself, distinct from an identifier assigned to one of its resulting outputs (a DOI), its underlying dataset, or an individual researcher (an ORCID iD). A study identifier's format, prefix, and issuing authority are registry-specific: ClinicalTrials.gov assigns 'NCT' numbers, the ISRCTN registry assigns 'ISRCTN' numbers, and PROSPERO assigns 'CRD42' numbers. A single study can carry more than one study identifier if it is registered, or cross-registered, in more than one registry.
Group Authorship
Group authorship (also called consortium authorship or collaborative-group authorship) is the practice of listing a named collaboration, consortium, or working group as an author entity on a publication's byline, rather than (or in addition to) listing only individual researchers. ICMJE's own wording is direct on this: "Some large multi-author groups designate authorship by a group name, with or without the names of individuals." Two configurations occur in practice: (1) the group name appears alongside a full list of individually named authors, functioning mainly as citation shorthand; or (2) the group name alone is the primary visible byline, with the full roster of individual contributors published separately (an appendix, supplementary file, or membership list). What qualifies a case as group authorship rather than an ordinary large-author paper is that the collaboration/consortium name itself functions as a citable author entity. Per ICMJE, this naming convention does not relax the underlying bar: every individual credited as an author within the group -- whether visible on the byline or listed separately -- must independently satisfy all four ICMJE authorship criteria (substantial contribution, drafting/critical revision, final approval, and accountability). This is distinct from ordinary multi-institutional co-authorship (many named individuals, no group entity name) and from an acknowledgments section (which by definition credits people or entities that do NOT meet authorship criteria).
CIHR Catalyst Grant
A CIHR Catalyst Grant is a short-term (typically up to one year), relatively small (typically capped in the tens of thousands up to roughly CA$125,000 per award, set per competition) seed-funding mechanism issued periodically by the Canadian Institutes of Health Research under various themed funding opportunities, used to support planning, pilot work, feasibility testing, or generation of preliminary data as a first step toward a larger, longer operating grant such as the CIHR Project Grant.
Technical Metadata
Technical metadata is the category of metadata that documents the digital characteristics of a resource needed to render, verify, and process it correctly over time: file format and version, the hardware and software environment used to create or read it, technical characteristics (size, encoding, resolution, compression), and a record of any technical processing or transformation events (format migration, compression, checksum regeneration) applied since creation. It answers 'what does a machine need to know to open, verify, and correctly interpret this file,' as distinct from what a resource is about (descriptive metadata) or who may use it and under what terms (administrative metadata, in the narrower rights/provenance/access-control sense). Some frameworks, including NISO's influential three-way split, treat technical metadata as a subtype nested under the broader administrative metadata category; others, including the METS schema's own internal structure, give it a distinct named subsection (techMD) alongside rights and provenance subsections rather than folding it into a single undifferentiated administrative bucket. Both framings agree on the underlying content -- format, environment, and fixity information -- they differ only in where they draw the taxonomy line.
Mutual Support Authorship
An arrangement in which two or more researchers agree, explicitly or informally, to reciprocally list each other as authors on each other's papers regardless of whether each individual meets the substantive ICMJE authorship criteria, in order to inflate publication counts on both sides. Unlike gift authorship, which typically flows in one direction, mutual support authorship is a two-way trade of unearned credit.
Metadata Format
A metadata format (also called a serialization format) is the concrete syntactic encoding used to write metadata values out as a machine-readable byte stream for storage, exchange, or transmission — for example XML, JSON, RDF/Turtle, or YAML. It answers 'how is this metadata physically written down,' which is a separate question from what a metadata schema answers: 'which fields exist and what do they mean.' A schema (Dublin Core, DataCite, Darwin Core, PROV-O) defines the field set and semantics; a format defines the byte-level syntax those fields get poured into. The same schema is routinely available in more than one format, and the same format is routinely used to carry many unrelated schemas — so 'metadata format' and 'metadata schema' are not interchangeable, even though the two terms get conflated constantly in casual usage.
ISSN
An eight-digit identifier (ISO 3297), formatted NNNN-NNNC with a modulus-11 check digit as the final character, assigned to a continuing resource's TITLE — a journal, magazine, newspaper, or other serial published indefinitely over time, in print or online — by a national ISSN Centre under the coordination of the ISSN International Centre (CIEPS) in Paris. An ISSN identifies the serial as a whole, not any individual article, issue, or volume within it, and each distinct medium of the same title (print vs. online) is assigned its own ISSN, linked together via an ISSN-L.
Knowledge-to-Action (KTA) Framework
The Knowledge-to-Action (KTA) Framework is a specific conceptual model for how research evidence moves into practice, developed by Ian Graham and colleagues (2006). A project, program, or funder policy is 'using the KTA Framework' when it explicitly structures knowledge translation work around the model's two linked components: (1) a Knowledge Creation funnel of three phases -- knowledge inquiry, knowledge synthesis, and the creation of knowledge tools/products, each stage distilling and tailoring the evidence further -- and (2) a seven-phase Action Cycle -- identify the problem (or identify/select/review knowledge), adapt knowledge to the local context, assess barriers to knowledge use, select/tailor/implement interventions, monitor knowledge use, evaluate outcomes, and sustain knowledge use. The phases are not strictly sequential: they are dynamic and can proceed simultaneously or iterate, and a given initiative rarely needs all seven Action Cycle phases to count as KTA-based, though 'identify the problem' and 'sustain knowledge use' anchor the cycle's start and end. It is a narrower, named instance of the broader knowledge translation concept, not a synonym for it.
AAHRPP (Association for the Accreditation of Human Research Protection Programs)
AAHRPP is an independent, non-profit accrediting body that reviews and certifies an institution's entire Human Research Protection Program (HRPP) -- not an individual researcher, and not a single IRB committee in isolation, but the full organizational system of policies, procedures, and oversight structures that protects human research participants. Accreditation is voluntary and organizational-level: an institution (a university, hospital, independent IRB, government agency, or research organization) applies, undergoes a self-assessment against AAHRPP's published standards, and is then peer-reviewed by a site visit team of experienced research-protection professionals before AAHRPP's Council on Accreditation makes a determination. A program either holds current AAHRPP accreditation or it does not -- there is no equivalent to an individual passing an exam. This is the key distinction from an individual credential such as CIP (Certified IRB Professional) or from completing required human-subjects training through a platform like CITI: those attach to a person; AAHRPP accreditation attaches to the institution's program as a whole.
CRADA (Cooperative Research and Development Agreement)
A formal, written collaborative R&D agreement between one or more federal laboratories and one or more non-federal parties, authorized under the Federal Technology Transfer Act (15 U.S.C. 3710a), under which the federal laboratory may contribute personnel, services, facilities, equipment, or intellectual property (but never funds) while the non-federal partner may contribute funding, personnel, or other resources toward a jointly performed, mission-consistent research effort.
T32 (NIH Institutional Research Training Grant)
A T32 is an NIH Ruth L. Kirschstein NRSA institutional research training grant: NIH funds a university department or program (not an individual) to run a structured predoctoral and/or postdoctoral research training program, and the program's PD/PI selects and appoints trainees into the grant's funded slots. It is distinct from an individual fellowship (F31/F32), where the trainee themselves applies and holds the award.
Priority Review Voucher (PRV)
A priority review voucher (PRV) is a transferable FDA incentive awarded when a sponsor wins approval of a qualifying drug or biologic under the rare pediatric disease PRV program (FD&C Act section 529) or the tropical disease PRV program (FD&C Act section 524). The voucher lets its holder — the original sponsor or a company it is sold to — redeem it for priority review (a six-month FDA review goal) instead of standard review (a ten-month goal) on a different, later marketing application.
Citation Impact
The extent to which a research output, researcher, or venue has been cited by later work, used as a proxy for scholarly influence and measured through a family of metrics that range from raw, unweighted citation counts to field-normalized indicators designed to correct for citation-rate differences across disciplines.
Placebo-Controlled Study Design
A placebo-controlled study is an interventional design in which one or more comparator arms receive an inert or sham intervention (a placebo) instead of, or in addition to, the intervention under investigation, so that any outcome difference between arms can be attributed to the study intervention itself rather than to the act of receiving treatment, participant or investigator expectation, natural disease fluctuation, or regression to the mean. It is one of the standard concurrent-control-group categories set out in ICH E10, alongside no-treatment control, dose-response control, active (positive) control, and external/historical control, and it is most often paired with randomization and blinding so that neither participants nor assessors know which arm a given participant is in.
Coercive Authorship
Coercive authorship occurs when a person with evaluative or supervisory authority over a researcher — typically a principal investigator, department chair, or thesis supervisor — uses that power imbalance to compel the inclusion of an undeserving author (often themselves) or the exclusion of a deserving one, rather than authorship being negotiated on the basis of ICMJE/CRediT contribution criteria. The defining feature is not the resulting byline, which can look identical to a gift-authorship byline, but the mechanism: the junior researcher's assent is not freely given, because dissent carries real, foreseeable career risk the senior party controls — a weaker reference, delayed degree progress, or reduced access to resources or future collaboration.
Research (45 CFR 46.102(l))
Under the Common Rule, "research" is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l)). An activity is IRB-reviewable human-subjects research only if it meets this systematic-investigation/generalizable-knowledge test AND separately involves a "human subject" under 46.102(e); an activity can be highly systematic and still fall outside the definition if it isn't designed to produce generalizable knowledge (the basis for excluding most quality-improvement and program-evaluation work), or if it falls into one of four categories the regulation expressly deems not to be research: scholarly/journalistic activities, public health surveillance, criminal-justice data collection, and authorized national-security operations.
MedDRA (Medical Dictionary for Regulatory Activities)
MedDRA (Medical Dictionary for Regulatory Activities) is the standardized, five-level hierarchical medical terminology -- System Organ Class, High Level Group Term, High Level Term, Preferred Term, and Lowest Level Term -- used to code adverse events, symptoms, diagnoses, and other clinical findings for entry into clinical trial databases and electronic submission to regulators. Developed under ICH and maintained by the MSSO, a MedDRA-coded term is required for electronic individual case safety report (ICSR) submission across ICH-region regulators.
Journal Editor
A journal editor is a person holding operational editorial authority over a journal or over specific submissions to it: authority to select and manage peer reviewers, and to accept, reject, or request revision of a manuscript. This is distinct from serving on the journal's editorial board in a non-operational capacity, and from acting as an invited peer reviewer on a single manuscript. The role commonly splits into editor-in-chief (overall journal direction and final authority on contested decisions) and associate/handling/section editors (day-to-day management of individual submissions through peer review).
NIST SP 800-171
NIST SP 800-171 ("Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations") is a U.S. National Institute of Standards and Technology special publication that specifies the security requirements a nonfederal organization — including a university, hospital, or independent research institute — must implement to protect Controlled Unclassified Information (CUI) when that information resides in, or flows through, the organization's own IT systems rather than a federal government system. A document, dataset, or research record is 'in scope' for 800-171 when it (a) meets the definition of CUI under the NARA CUI Registry categories — commonly Export Controlled, Controlled Technical Information, or Privacy — and (b) is created, received, stored, or transmitted by a nonfederal entity under a federal contract, grant, or agreement that designates it as CUI. The most widely deployed version, Revision 2, organizes 110 security requirements into 14 requirement families: Access Control, Awareness and Training, Audit and Accountability, Configuration Management, Identification and Authentication, Incident Response, Maintenance, Media Protection, Personnel Security, Physical Protection, Risk Assessment, Security Assessment, System and Communications Protection, and System and Information Integrity. Each family groups related controls (e.g., multi-factor authentication and least-privilege access sit under Access Control) rather than prescribing a single monolithic checklist.
Complete Response Letter (CRL)
A Complete Response Letter (CRL) is a formal notice FDA sends a sponsor, under 21 CFR 314.110, stating that a New Drug Application, Biologics License Application, or efficacy supplement will not be approved in its present form. It is distinct from a refusal to file (issued before review begins) and from an outright, final rejection: the sponsor may resubmit after addressing the cited deficiencies, withdraw the application, or request a hearing.
Globus
A non-profit, hosted research data management service - built on GridFTP-based transfer technology and operated by the University of Chicago with Argonne National Laboratory - that provides high-performance, fault-tolerant file transfer, institutional 'endpoints' (via Globus Connect Server/Personal), and controlled sharing between research storage systems, HPC centers, and repositories.
ORCID iD for NIH Senior/Key Personnel
The ORCID iD requirement for NIH Senior/Key Personnel means: every individual designated as Senior/Key Personnel on an NIH grant application — the Program Director/Principal Investigator (PD/PI) plus any other individual who contributes to the scientific development or execution of a project in a substantive, measurable way, regardless of whether they receive salary support from the award — must (1) hold a registered ORCID iD, (2) link it to their own eRA Commons Personal Profile account, an action NIH requires the individual to complete themselves rather than delegate to grants administration staff, and (3) have that iD populate correctly in the Persistent Identifier (PID) field of the NIH Common Form versions of the Biographical Sketch and Current and Pending (Other) Support documents, both generated through SciENcv. This applies to applications with due dates on or after January 25, 2026 (NIH Guide Notice NOT-OD-26-018). An application missing a required, correctly linked ORCID iD for any listed Senior/Key Personnel is not merely flagged — as of May 8, 2026, eRA Commons system validations treat this as a hard error that blocks submission outright (NOT-OD-26-079), after an initial warning-only enforcement period (extended once, via NOT-OD-26-033, through May 7, 2026).
ARC Linkage Project
A grant awarded under the Australian Research Council's Linkage Program that funds collaborative research between a university-based team and at least one external Partner Organisation (industry, government, or community body), where the Partner Organisation(s) must contribute cash and/or in-kind resources whose combined value at least matches the funding requested from the ARC, with cash alone required to be at least 25% of the ARC request.
CIHR Planning and Dissemination Grant
A CIHR Planning and Dissemination Grant is a small, short-duration award funded through CIHR's Institute/Initiative Community Support (ICS) mechanism to support planning activities (for example, convening partners to design a future research program or initiative) or dissemination events (for example, a workshop, symposium, or knowledge-translation event that communicates health research evidence to researcher or knowledge-user audiences). It is distinguished from CIHR's research-funding mechanisms by what it explicitly excludes: it does not fund the direct cost of research, including pilot projects, feasibility studies, primary data collection, or principal/co-investigator salaries. A given competition is 'in scope' for this grant type if its funds are being used to organize an event or plan a future initiative rather than to conduct or seed research itself.
Australian Research Data Commons (ARDC)
The national research data infrastructure provider for Australia: a not-for-profit company, funded through the Australian Government's National Collaborative Research Infrastructure Strategy (NCRIS), that builds, operates, and stewards shared digital research infrastructure — including platforms, skills programs, and persistent-identifier services such as RAiD — for use across the Australian university and public-research sector rather than by any single institution.
Clinical Research
Clinical research is the umbrella term for any systematic investigation involving human participants, or material of human origin traceable to a living individual, that is designed to generate generalizable knowledge about human health or disease. Per NIH's own definition, it spans three broad categories: (1) patient-oriented research, where an investigator directly interacts with human subjects to study disease mechanisms, therapeutic interventions, clinical trials, or new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. A clinical trial is only one subset within the first category — specifically, patient-oriented research in which participants are prospectively assigned to an intervention. Clinical research as a whole also includes purely observational studies (cohort, case-control, cross-sectional), registry-based research, and health-services/outcomes work where no intervention is assigned at all. It is distinct from basic (preclinical, bench-level) research, though the two are connected along a translational research spectrum.
NIH Administrative Supplement
An NIH administrative supplement is non-competing supplemental funding added to the current budget period and project period of an already-active NIH grant or cooperative agreement, requested by that award's PI/PD, to cover unforeseen cost increases or add new research activities that stay within the scope NIH's peer reviewers already approved. It is evaluated administratively by NIH program/grants management staff, not through new scientific peer review, and cannot extend beyond the parent award's existing project period.
ISO 16363 (Formal-Level Certification)
The Formal level of the three-tier trustworthy-repository certification framework: a repository is ISO 16363-certified only when an accredited external auditor (typically PTAB, accredited under ISO 17021/16919) has conducted a full audit against ISO 16363's evidence-based metrics and formally certified the result — distinct from CoreTrustSeal's and the nestor Seal's self-assessment models. Full title: Space data and information transfer systems — Audit and certification of trustworthy digital repositories. Descends from the 2007 TRAC (Trustworthy Repositories Audit & Certification) checklist published by RLG/NARA, formalised by CCSDS as ISO 16363:2012 and subsequently revised.
TCPS2 Chapter 9 (Research Involving Indigenous Peoples)
TCPS2 Chapter 9 is the section of Canada's Tri-Council Policy Statement (TCPS 2, 2022) interpreting how the Policy's core ethical principles apply to research involving First Nations, Inuit, and Métis peoples: it calls for community engagement, a documented research agreement, and, where a recognized community authority exists, review at both the institutional REB and community level before recruitment or data collection begins.
Warranties and Covenants
In a research agreement — a sponsored research agreement, grant or cooperative agreement terms and conditions, subaward, or license agreement — warranties and covenants are two distinct categories of contractual promise, each triggering different remedies if broken. A warranty is a party's assurance that a stated fact is (and, for a continuing warranty, will remain) true, functioning as a guarantee coupled with an implied right to a remedy if the assertion proves false; common research-agreement warranties include a recipient's authority to enter the agreement, its compliance capacity (e.g., having an active federalwide assurance or IRB/IACUC oversight in place), or a licensor's warranty regarding title to intellectual property. A covenant is a promise to do, or to refrain from doing, something in the future over the life of the agreement — for example, a covenant to submit progress reports on a defined schedule, to maintain effort-reporting records for the required retention period, or to obtain sponsor approval before a change in scope. Warranties are tested at a point in time (a warranty is either true or false when made, or when restated); covenants are tested by performance over the agreement's term. A clause labeled a 'representation' is a closely related third category — a statement of past or present fact made to induce the other party to sign — and research contracts frequently combine all three under a single 'Representations, Warranties, and Covenants' article, but the distinction still matters because remedies differ: breach of a warranty is a contract claim measured by the value of what was promised versus what was delivered, while breach of a covenant can, if material, excuse the other party's further performance or support injunctive relief/specific performance in addition to damages.
Metadata enrichment
A record's metadata is enriched when new descriptive, administrative, or relational elements are added to it after initial deposit or harvest — typically by resolving free-text values (author names, affiliation strings, subject terms) against authority files and controlled vocabularies (ORCID, ROR, funder registries, subject-classification schemes), or by pulling additional attributes from an external API (citation counts, open-access status, computed topic classifications). It is distinct from correcting or normalizing values already present (data cleaning) and from the original act of depositing the baseline record (initial deposit) — enrichment specifically adds elements the record did not previously have.
FORCE11 (Future of Research Communications and e-Scholarship)
FORCE11 (Future of Research Communications and e-Scholarship) is a global, member-driven nonprofit community of scholars, librarians, archivists, publishers, and research funders working to make scholarly communication more open, transparent, and reusable across every stage of the research lifecycle -- not only the final journal article. An initiative qualifies as FORCE11's work if it was developed through one of its working groups or endorsed community declarations (for example the FAIR Guiding Principles, the Joint Declaration of Data Citation Principles, the Software Citation Principles, or the Resource Identification Initiative behind RRIDs) and carries FORCE11's name as convener or co-convener, as opposed to work that merely cites or is philosophically aligned with FORCE11's broader open-scholarship goals without having gone through its community process.
Pre-AIA 35 U.S.C. § 102
Pre-AIA 35 U.S.C. § 102 is the version of the U.S. patent novelty statute that governed patentability before the America Invents Act (AIA) took effect on March 16, 2013. It operated on a first-to-invent system: priority between competing claimants to the same invention was resolved by actual date of invention (conception plus reduction to practice, with diligence), not by who filed first, and disputes were resolved through an interference proceeding before the USPTO. It had seven prior-art/loss-of-right subsections, (a) through (g), several of which (abandonment, premature foreign patenting, derivation, and prior invention by another) were eliminated outright when the AIA replaced it with the current first-inventor-to-file version of § 102. Pre-AIA § 102 is not purely historical: under the AIA's transitional rule, any U.S. application that contains or ever contained a claim with an effective filing date before March 16, 2013 is examined in its entirety under pre-AIA §§ 102 and 103, so it still actively governs a real population of applications and issued patents today.
21 CFR Part 50 (Protection of Human Subjects)
21 CFR Part 50 is the FDA's own human-subjects protection regulation. It applies to clinical investigations of products that fall under FDA's regulatory jurisdiction under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act -- drugs, biologics, and medical devices for human use -- regardless of who funds the study. It sets the informed-consent requirements FDA holds sponsors and investigators to (Subpart B), and adds extra safeguards when children are enrolled (Subpart D). A study triggers Part 50 when it is 'regulated by FDA' under sections 505(i) or 520(g) of the FD&C Act (i.e. it supports or could support an IND or IDE, or the drug/device is otherwise subject to FDA jurisdiction) -- not because a federal agency is paying for it. That funding-vs-jurisdiction distinction is what separates Part 50 from 45 CFR 46 (the Common Rule), and many trials involving both a federal funder and an FDA-regulated product must satisfy both simultaneously.
Patent Exhaustion Doctrine
Patent exhaustion (the patent first-sale doctrine) holds that once a patent owner, or someone the patent owner has authorized, sells a patented item, the patent owner's exclusive rights over that specific item are exhausted -- the purchaser and any later owner may use, repair, or resell it without committing patent infringement, regardless of restrictions the patentee attaches to the sale. Under Impression Products, Inc. v. Lexmark International, Inc., 581 U.S. 360 (2017), this applies to authorized sales anywhere in the world, not just U.S. sales, and any post-sale restriction the patentee wants to enforce has to be pursued as a contract claim against the buyer, not a patent infringement claim.
Grant-in-Aid
A grant-in-aid is a payment of funds from one level of government, a government department, or a funding body to another organization to support a defined activity, program, or body of ongoing operations, typically under conditions the recipient must satisfy (eligible use of funds, reporting, sometimes matching or cost-sharing). It is a broader, more programmatic category than a single research project grant: a grant-in-aid can fund an entire program area, an institution's core operations, or a recurring formula-based allocation, whereas a research/project grant funds one specific, time-bound piece of research with a defined scope of work. In UK and Commonwealth public finance, 'grant-in-aid' has a specific technical meaning: funding voted by Parliament (or the relevant legislature) and paid by a sponsoring government department to an arm's-length public body -- most commonly a non-departmental public body -- to finance that body's approved programs and net running costs, governed by the terms set out in the body's framework document. In US federal usage, 'grants-in-aid' is the umbrella term public-finance and public-administration literature uses for the whole family of federal transfers to state and local governments, which is further split into categorical grants (purpose-restricted, project or formula) and block grants (broad-purpose, high recipient discretion).
P01 Grant (NIH Research Program Project Grant)
A P01 (Research Program Project Grant) is an NIH activity code funding one award that supports multiple independent but scientifically interrelated research projects unified by a single central theme, plus shared infrastructure (an Administrative Core and, often, additional scientific cores) that serves all of the projects. It is a grant (not a cooperative agreement), meaning NIH does not anticipate substantial involvement in directing the funded science, and it is distinguished from R01s by its multi-project, cross-project-synergy structure rather than by award size alone.
Secure Data Enclave
A controlled-access computing environment in which approved researchers analyze restricted or sensitive data in place, without the ability to download, copy, or otherwise export the raw underlying records. Access is typically granted only after training, credentialing, and a signed data use agreement, computation happens on infrastructure the data steward controls (an on-site terminal room, a remote-access session, or an isolated cloud workspace), and only aggregate or disclosure-reviewed outputs — tables, statistics, model results — are allowed to leave the environment. The defining feature is not where the data sits but that raw data never crosses the boundary; only vetted outputs do.
Research Council
A research council is a government-established public funding body — typically a national, arm's-length or quasi-autonomous statutory agency — whose core function is to award competitive, peer-reviewed research funding to external researchers and institutions rather than to conduct research itself. It sits between direct ministerial/departmental research funding, philanthropic foundation funding, and government mission agencies that both fund and directly perform research (e.g., NIH's intramural program). The name is a category of funding body, not a single organization: the UK's seven discipline research councils, Canada's NSERC/SSHRC/CIHR, and Australia's ARC/NHMRC are all specific instances of this same institutional model.
Trial Master File (TMF)
The Trial Master File (TMF) is the complete, organized collection of essential documents that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data it produced, as defined by ICH E6(R2) Section 8. A document belongs in the TMF if it is on the ICH E6 essential-documents list (or a sponsor's/site's approved TMF index derived from it) and falls into one of three time-based groupings: documents generated before the clinical phase begins (protocol, investigator's brochure, IRB/IEC approval, signed agreements), documents generated during the conduct of the trial (protocol amendments, monitoring visit reports, informed consent forms, drug/device accountability records, adverse event reports), and documents generated after the trial is completed or terminated (final study report, subject identification code list, audit certificate). A sponsor maintains a central TMF; each investigator site maintains a parallel Investigator Site File (ISF) covering the same essential-document categories at site level. Today the TMF is almost always maintained electronically as an eTMF, commonly organized using the TMF Reference Model's zone/section/artifact taxonomy rather than an ad hoc folder structure.
IND-Enabling Studies
IND-enabling studies are the package of nonclinical (preclinical) pharmacology, pharmacokinetics/ADME, and toxicology studies a sponsor must complete before filing an Investigational New Drug (IND) application with FDA. Their purpose is narrow and specific: to generate the data supporting a reasonable expectation that the drug can be tested safely in humans at a defined starting dose, not to demonstrate efficacy or complete the full nonclinical program a marketing application will eventually require. The scope and design of the package is governed principally by ICH M3(R2), "Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals," which FDA has adopted as guidance. A study is IND-enabling if its data is used to support the safety rationale in an IND submission's pharmacology/toxicology section (21 CFR 312.23(a)(8)) — as distinct from later-stage nonclinical studies (e.g., carcinogenicity, reproductive toxicology at later phases) conducted after first-in-human dosing has already begun, which support later clinical phases or the eventual marketing application rather than the initial IND filing itself.
Converis (Clarivate)
Converis is Clarivate's commercial CRIS (Current Research Information System) product: a configurable platform that ingests publication and bibliometric data (including from Web of Science and other sources), manages pre-award and post-award research-project workflows, and exposes a public research-portal layer for institutions, funders, and national research agencies. An institution's software counts as an instance of Converis specifically when it is the Clarivate-branded, vendor-hosted or vendor-configured platform -- not merely any locally-built research-activity database with similar functions.
NIH Payline
An NIH payline is the percentile-rank (occasionally priority-score) threshold that a given National Institutes of Health institute or center (IC) publishes for a fiscal year as its planning guideline for which peer-reviewed grant applications it expects to fund. It is set independently by each of NIH's 27 ICs -- there is no single, NIH-wide payline -- and is recalculated annually against that year's appropriation, application volume, and research priorities. A payline is a budgeting and planning benchmark, not a binding rule: ICs retain discretion to fund some applications scoring outside the published payline (commonly called "select pay" or "exception pay") and to decline some scoring inside it, based on advisory council input and program priorities. As of late 2025, NIH has directed its ICs to move away from publishing fixed paylines in favor of weighing peer-review scores against institute priorities and budget more holistically -- treat any specific payline figure as time- and institute-bound, and confirm current practice against the awarding IC's own guidance.
HHS Grants Policy Statement (HHS GPS)
The HHS Grants Policy Statement (HHS GPS) is the U.S. Department of Health and Human Services' department-wide reference document setting out the general terms and conditions that apply to HHS discretionary grant and cooperative agreement awards. It is issued and maintained by HHS's Division of Policy, Oversight, Evaluation, and Training (DPOET), within the Office of the Assistant Secretary for Financial Resources (ASFR), and is incorporated by reference into the Notice of Award for HHS discretionary awards it covers. Critically, the HHS GPS is not universal across every HHS component: the National Institutes of Health maintains its own, separate NIH Grants Policy Statement (NIH GPS), and NIH awards are governed by that document rather than the HHS GPS. Other HHS operating divisions -- including CDC, HRSA, SAMHSA, AHRQ, and ACF -- use the HHS GPS as their primary grants policy document, in each case supplementing it with their own agency-specific program guidance where needed.
SciVal
A subscription research-analytics platform, owned and sold by Elsevier, built on Scopus abstract and citation data, that lets research institutions, funders and government bodies benchmark research performance, track collaboration, and analyse societal and funding impact at the level of a researcher, department, institution, country or custom peer group. It is a reporting and benchmarking layer on top of Scopus rather than a separate bibliographic database of its own -- everything SciVal shows is ultimately traceable back to a Scopus record.
FDA Adverse Event Reporting System (FAERS)
A post-marketing surveillance database maintained by the U.S. Food and Drug Administration that collects reports of adverse events and medication errors associated with drugs and biologics already on the U.S. market. FAERS is fed by two distinct report streams: mandatory reports that drug and biologic manufacturers (application holders) are legally required to submit under 21 CFR 314.80 and 21 CFR 600.80, and voluntary reports submitted through MedWatch, FDA's Safety Information and Adverse Event Reporting Program, by healthcare professionals, patients, and consumers. FAERS is scoped to drugs and biologics only: vaccine adverse events go to VAERS (co-managed by CDC and FDA), device events go to MAUDE, and the EU's structural counterpart is EudraVigilance. It is also operationally distinct from the pre-market Investigational New Drug (IND) safety reporting obligations under 21 CFR 312.32: FAERS covers a marketed product's real-world use after approval, not an investigational product still under a trial protocol.
Active Substance Master File (ASMF)
An EU/EEA regulatory submission format for a single active substance's manufacturing and quality-control data, split into a non-confidential Applicant's Part (submitted as part of a marketing authorisation application or IMPD) and a confidential Restricted Part (submitted directly to the competent authority by the active-substance manufacturer), and referenced by — never substituting for — the medicinal-product submission it supports.
FDA Recognized Consensus Standards
An FDA Recognized Consensus Standard is a voluntary standard developed by a recognized standards development organization (SDO) -- such as ISO, ASTM International, AAMI, IEC, or CLSI -- that FDA has formally reviewed and added to its 'Recognized Consensus Standards: Medical Devices' database. A standard qualifies as an instance of this category only once FDA has completed its own review and listed it (with a recognition number and a stated extent of recognition -- full, partial, or recognized with FDA-identified deviations); merely being a published ISO/ASTM/AAMI standard, or being commonly cited in industry practice, is not sufficient on its own. Recognition lets a device manufacturer submit a Declaration of Conformity (DoC) to that standard in a premarket submission -- attesting the device conforms (in full or with disclosed deviations) and providing a summary of test methods and results -- rather than submitting the full underlying test data for independent FDA review. The legal basis is Section 514 of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA), which directed FDA to establish this recognition process specifically to reduce duplicative review burden for both industry and the agency. FDA can also withdraw or limit recognition (for example when a standard is superseded by a newer edition), so the database -- not the standard's existence or prior use -- is the authoritative, current record of what may be cited via a DoC at any given time.
Safety Data Exchange Agreement (SDEA)
A Safety Data Exchange Agreement (SDEA) is a written contract between two or more legally distinct parties who share development, marketing, licensing, distribution, or co-promotion rights to the same medicinal product, defining how each party will exchange safety information -- adverse event and adverse drug reaction reports, product complaints with a safety component, literature findings, and aggregate safety reports -- so that each party can independently meet its own national and regional pharmacovigilance reporting obligations. An agreement qualifies as an SDEA (rather than some other contract) when it specifies, at minimum: which party holds which pharmacovigilance responsibilities (case intake, medical review, causality assessment, expedited and periodic reporting, literature surveillance, signal detection); the format and timelines for exchanging individual case safety reports (ICSRs) and aggregate reports such as PSURs between the parties, typically set tighter than the underlying regulatory deadlines to leave room for each party's own downstream submission; reconciliation procedures to confirm no cases were missed on either side; and named contacts, including each party's Qualified Person Responsible for Pharmacovigilance (QPPV) where EU obligations apply. SDEAs are prepared with reference to ICH E2A/E2B/E2D definitions and reporting standards and, in the EU, to the EMA's Good Pharmacovigilance Practices (GVP) modules; they can be bipartite (two parties) or tripartite (three, e.g. when a contract research organization or specialty distributor is also party to the arrangement).
Repository Citation
A repository citation is the reference used to attribute and locate a dataset (or other research output such as software or a physical sample) deposited in a data repository, built around a persistent identifier — typically a DOI minted via DataCite — rather than around the journal, volume, and page numbers used for an article citation. A citation counts as a repository citation when it points directly to the deposited data object itself (resolving through its own persistent identifier to the repository landing page or the data), not to a journal article, data paper, or other publication that merely describes or analyzes that data.
Limited Data Set (HIPAA)
A dataset qualifies as a HIPAA limited data set under 45 CFR 164.514(e) when a covered entity removes the 16 direct identifiers enumerated at 164.514(e)(2) (names, contact details, medical record/account/certificate numbers, device and biometric identifiers, full-face photos, and similar) while retaining permitted indirect identifiers -- full dates and geographic subdivisions down to town, city, state, and zip code -- and discloses the resulting dataset only for research, public health, or health care operations to a recipient who has signed a Data Use Agreement restricting its use, access, safeguarding, and redisclosure, and prohibiting re-identification attempts. It remains protected health information (PHI) and stays subject to the Privacy Rule, unlike data that has been fully de-identified under 164.514(a)-(b).
R21 (NIH Exploratory/Developmental Research Grant)
An NIH R-series research grant activity code — Exploratory/Developmental Research Grant Award — that funds early-stage, high-risk research not yet ready for the scale and preliminary-data expectations of an R01. R21 support is capped NIH-wide at $275,000 in total direct costs over a project period of no more than two years, with no more than $200,000 in any single year; most R21 Funding Opportunity Announcements (FOAs) explicitly do not require preliminary data. An R21 can stand alone or serve as the first, exploratory phase of a milestone-gated two-phase award paired with an R33 (the combined "R21/R33" mechanism).
Independent Ethics Committee (IEC)
An Independent Ethics Committee (IEC) is the international/non-US regulatory term for the independent body that reviews and approves a clinical trial's protocol, informed consent materials, investigator qualifications, and facilities before enrollment begins, and continues to oversee the trial's ethical conduct throughout its life, to protect the rights, safety, and wellbeing of trial participants. It performs the identical core function as a US Institutional Review Board (IRB): both are independent bodies of medical, scientific, and non-scientific members that review research involving human subjects against the same underlying principles in ICH E6 Good Clinical Practice (GCP). The two terms describe the same regulatory role arising from different national and regional legal traditions, not two different sets of responsibilities -- which is why ICH E6(R2) and industry practice almost always write the pairing as a single unit, 'IRB/IEC.'
New Approach Methodologies (NAMs)
A technology or method (in vitro assay, organ-on-chip/microphysiological system, in silico/computational model, or human-relevant cell-based model) developed or applied specifically to generate safety/efficacy data in place of, or alongside, an animal study a regulatory pathway would otherwise require or expect. The "new approach" framing is relative to the existing animal-testing default in a given regulatory pathway (principally FDA drug/biologic review), not a general claim of scientific novelty for the underlying technology itself.
R25 Grant (NIH Education/Research-Related Grant)
An NIH activity code for a research-education award, not a research-project grant: R25 funds are used to develop and/or deliver educational activities -- courses, curricula, mentored or short-term research experiences, and outreach or career-transition programs -- intended to strengthen the biomedical, behavioral, or clinical research workforce, rather than to fund a PD/PI's own independent research program. A given award is an R25 if its Notice of Award activity code reads 'R25,' its Funding Opportunity Announcement was issued under the NIH Research Education Program mechanism (parent FOAs such as PAR-27-034), and its aims describe an education/training program rather than a hypothesis-driven research plan.
Concordat on Open Research Data
The Concordat on Open Research Data is a UK sector-wide policy framework, published 28 July 2016 by the Higher Education Funding Council for England (HEFCE), Research Councils UK (RCUK, since absorbed into UK Research and Innovation, UKRI), Universities UK, and the Wellcome Trust, setting out ten principles for how researchers, research organisations, and funders should approach making research data openly available. It is not a regulation, mandate, or legal instrument: an institution, funder, or research group operationalises the Concordat when its research data policy, Data Management Plan (DMP) guidance, or grant terms explicitly build in the ten principles — for example, requiring a documented, case-by-case justification for any restriction on data openness (Principle 2), recognising a researcher's right to a reasonable first-use period before data must be shared (Principle 4), or expecting data underlying a publication to be accessible, citable via a persistent identifier, and retained for at least ten years from the publication date (Principle 8).
ICH Q/S/E/M Guideline Categories (Quality, Safety, Efficacy, Multidisciplinary)
The four-letter taxonomy the International Council for Harmonisation (ICH) uses to organize every technical guideline it publishes: Quality (Q) guidelines cover pharmaceutical development, manufacturing, and stability; Safety (S) guidelines cover nonclinical (in vitro and animal) safety testing such as carcinogenicity, genotoxicity, and reprotoxicity studies; Efficacy (E) guidelines cover the design, conduct, safety reporting, and analysis of human clinical trials, including ICH E6 Good Clinical Practice; and Multidisciplinary (M) guidelines cover cross-cutting topics that don't fit uniquely under Q, S, or E, such as the Common Technical Document (CTD) submission format and MedDRA terminology. Each guideline within a category carries a sequential number (e.g. Q1, S1, E1, M1) and, when revised, a parenthetical revision marker (e.g. E6(R2), E6(R3)); a document isn't a true ICH guideline unless it has progressed through the ICH multi-step process to at least Step 4 adoption by the ICH Assembly.
Self-Citation Rate
The self-citation rate is the proportion of an entity's total citations that point back to its own prior output. At the author level, it is the share of citations to a researcher's work that were made by that same researcher (in a later paper, citing an earlier one). At the journal level, it is the share of citations counted toward a journal's metrics (most visibly its Journal Impact Factor in Journal Citation Reports, or its CiteScore in Scopus) that come from articles published in that same journal. In both cases the rate is a simple ratio: self-citations divided by total citations received, usually expressed as a percentage over a defined citation window (JCR uses the same two- and five-year windows it uses for the Journal Impact Factor itself). A nonzero self-citation rate is normal and expected — researchers build on their own prior work, and journals publish follow-on articles in an ongoing research area. The metric becomes a research-integrity concern only when the rate is unusually high relative to field and venue norms, which is treated as a signal of possible citation manipulation rather than of an intrinsic quality problem.
InCites
A subscription research-evaluation and benchmarking platform, owned and sold by Clarivate, built on Web of Science Core Collection publication and citation data, that lets research institutions, funders, publishers and government bodies benchmark research performance, track collaboration, and analyse impact at the level of a researcher, department, institution, country, journal or custom peer group. It is a reporting and benchmarking layer on top of Web of Science rather than a separate bibliographic database of its own -- everything InCites shows is ultimately traceable back to a Web of Science record. It is Clarivate's direct counterpart to Elsevier's Scopus-based SciVal.
Technology Transfer
Technology transfer is the formal process by which discoveries, inventions, data, and know-how created at a university, government laboratory, hospital, or other research institution move into practical, commercial use outside that institution -- typically through patenting and licensing to an existing company, or through the formation of a new company (a spinout or startup) built around the technology. A given activity counts as technology transfer when three elements are present together: (1) an underlying research output capable of being protected or transferred (an invention disclosure, patentable invention, copyrighted software, biological material, or dataset), (2) a formal instrument moving rights or materials to an outside party (a license agreement, material transfer agreement, or equity/founding arrangement for a spinout), and (3) an institutional office or function -- almost always a Technology Transfer Office (TTO), sometimes branded an Office of Technology Licensing or Innovation and Commercialization Office -- that manages the disclosure, IP protection, and negotiation on the institution's behalf. In the United States, technology transfer involving federally funded research operates inside the framework set by the Bayh-Dole Act of 1980, which lets universities and other recipients elect to retain title to inventions made under federal funding, in exchange for specific obligations including timely disclosure, a preference for U.S. manufacturing, and government march-in rights.
Clinical Trial Data
Clinical trial data is any information generated or recorded during the conduct of a clinical trial that documents what happened to a participant, what was measured, or how the trial was run -- from a clinician's original observation through to the frozen dataset submitted to a regulator. A given piece of information qualifies as clinical trial data if it is (a) collected under the trial's protocol, from an enrolled participant or the trial process itself, and (b) subject to the trial's data-integrity and traceability controls (audit trail, source-to-database verification, applicable regulatory retention rules) rather than being incidental or off-protocol information. It is a category, not a single artifact: it spans source data (the first recording of an observation), the case report form (CRF) data derived from that source, and the coded, cleaned, and locked datasets used for statistical analysis and regulatory submission.
Research Pharmacy (Investigational Drug Service, IDS)
A research pharmacy — also called an Investigational Drug Service (IDS) — is the specialized pharmacy unit responsible for the receipt, storage, accountability, preparation, dispensing, and (where applicable) return or destruction of investigational products used in clinical trials, operating under the protocol and Good Clinical Practice (GCP) rather than under routine hospital-formulary dispensing rules. A pharmacy operation qualifies as a research pharmacy when it (1) receives and stores investigational product under sponsor- and manufacturer-specified conditions separate from commercial stock, (2) maintains a full chain-of-custody accountability record for every unit from receipt through final disposition, (3) dispenses only against a valid protocol-specific order tied to subject eligibility and randomization assignment, and (4) where the trial is blinded, restricts access to the randomization code to designated unblinded staff who function independently of the study team members assessing outcomes.
Simulation of Clinical Trials
Simulation of clinical trials is the use of computational and statistical models -- built from preclinical, pharmacokinetic/pharmacodynamic (PK/PD), and prior clinical data -- to predict how a proposed trial design will behave before a single participant is enrolled. A model of the drug, the disease, and the trial process is run many times (commonly via Monte Carlo methods) under different design assumptions to forecast outcomes such as statistical power at a given sample size, the probability of correctly selecting a dose, or the operating characteristics of an adaptive design's decision rules. An activity counts as clinical trial simulation when it (1) uses an explicit quantitative model rather than a rule-of-thumb or expert-opinion estimate, (2) is applied prospectively, during design, to a specific trial or program decision -- not retrospectively to explain results already observed, and (3) produces a distribution of possible outcomes across repeated in-silico trials rather than a single point estimate, letting designers see the probability of success under uncertainty rather than one deterministic answer.
FDA Form 356h
FDA Form 356h ("Application to Market a New or Abbreviated New Drug or Biologic for Human Use") is the standardized cover form an applicant files with a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA). It identifies the applicant and product, states the application type and submission type (original, resubmission, or supplement), indexes the enclosed technical sections, and carries the signed certification statements required for FDA to accept the submission for review. It applies only to drug/biologic marketing applications reviewed by CDER or CBER -- it is not used for medical device submissions, which use a separate CDRH cover sheet (Form 3514).
FDA Priority Review
FDA Priority Review is a designation FDA assigns to a marketing application (a New Drug Application, Biologics License Application, or efficacy supplement) for a drug or biologic that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition, compared with available therapy. A Priority Review designation sets FDA's internal review-clock goal at 6 months from the filing date for a first review cycle, instead of the 10-month goal that applies to a Standard Review application. It is one of FDA's four expedited programs for serious conditions, alongside Fast Track, Breakthrough Therapy designation, and Accelerated Approval, but unlike the other three it is a review-timeline classification tied to a completed application rather than a designation sponsors typically request earlier in development.
IRB Chair
The IRB Chair is the IRB member designated to preside over the board's convened meetings and to personally conduct, or assign to an experienced board member, expedited-review determinations under 45 CFR 46.110 / 21 CFR 56.110 -- distinct from a regular voting IRB member (no presiding or independent expedited-review authority) and from the institution's Designated Institutional Official / FWA-signing Institutional Official (an institution-wide compliance-commitment role, not a board-review role).
Bring Your Own Device (BYOD) for Research Data Collection
In research data collection, BYOD (bring your own device) is a practice in which participants or researchers use their own personally-owned smartphone, tablet, or wearable -- rather than a device supplied, configured, and owned by the study -- to run a data-collection app or sensor. What makes an instance BYOD is device ownership and control: the hardware belongs to the participant or researcher, not the study team, so the study cannot fully standardize, lock down, or reclaim it, and must build its data-integrity and security controls around that constraint.
PREMIS
A resource's metadata qualifies as PREMIS metadata when it is structured according to the PREMIS Data Dictionary for Preservation Metadata (currently version 3.0, maintained by the Library of Congress), populating semantic units under one or more of PREMIS's four in-scope entities — Object, Event, Agent, and Rights — to document what a digital object is, what has happened to it over time, who or what acted on it, and what permissions govern its preservation. PREMIS is a data dictionary, not a file format or package standard in the way METS is; it is most commonly implemented as an XML schema (premis.xsd) embedded inside a METS document's administrative metadata section, or serialized natively inside a repository's own preservation system.
ECCN Determination Process
The process by which a specific item, technology, or piece of software is assigned an Export Control Classification Number (ECCN) under the US Export Administration Regulations (EAR, 15 CFR 730-774), determining whether and how it is controlled for export under the Commerce Control List (CCL) administered by the Department of Commerce's Bureau of Industry and Security (BIS). An item is either classified against a specific ECCN entry on the CCL, or, if it is subject to the EAR but matches no CCL entry, falls into the residual 'EAR99' catch-all category. Determination can be done in-house by self-classification against the CCL, or by requesting a formal, binding Commodity Classification from BIS (a Commodity Classification Automated Tracking System, or CCATS, determination). In a university research setting, the outcome of this determination is a prerequisite input to fundamental research exclusion analysis: the exclusion (rooted in NSDD-189, 1985) can remove a project's published *results* from EAR/ITAR control, but it does not retroactively declassify a controlled *item, software, or technical data set* used to get there -- so export control offices classify the underlying technology first, independent of whether the surrounding research is intended for open publication.
Inducements in Research (Undue Inducement)
An inducement is any payment, benefit, or opportunity a researcher offers to encourage a prospective participant to enroll in or remain in a study. Offering compensation is not itself a problem: the Belmont Report's respect-for-persons and beneficence principles, and their regulatory implementation at 45 CFR 46.116(a)(1) (Common Rule) and 21 CFR 50.20 (FDA), treat reasonable payment for time and burden as compatible with voluntary consent. An inducement becomes an undue inducement when its size or structure is large enough, or contingent enough, to impair a prospective participant's ability to weigh the study's risks and benefits rationally -- functioning as pressure to enroll or stay enrolled rather than as compensation for burden. Under 45 CFR 46.111(b), an IRB must determine that consent will be sought under circumstances that minimize the possibility of coercion or undue influence; review of the payment plan (amount, schedule, and any completion contingency) is the concrete mechanism through which that determination gets made for offers of payment specifically.
Risk Indicators and Risk Thresholds
A risk indicator is a specific, observable fact about an applicant, recipient, or subrecipient that correlates with an elevated likelihood of noncompliance, financial mismanagement, or poor performance on a federal award — for example, a prior single audit finding, financial instability, a new or first-time awardee with no federal-award history, or an irregular or unnegotiated F&A (indirect cost) rate. A risk threshold is the predetermined materiality level at which an accumulation or severity of risk indicators requires an awarding agency or pass-through entity to escalate its oversight response — from routine monitoring to enhanced monitoring, imposition of specific award conditions, or formal high-risk designation. Together they form the operating vocabulary of risk-based monitoring: instead of applying identical oversight to every award in a portfolio, an agency or institution calibrates monitoring intensity to where the indicators and thresholds say the actual risk is concentrated.
Program Officer
A program officer (sometimes called a program director or program official, depending on the funder) is the funding-agency or foundation staff member who manages a defined portfolio of grants within a scientific, technical, or thematic program area and serves as the primary point of contact between the funder and applicants/awardees throughout the funding lifecycle — before submission (fit-to-program questions, letters of intent), during review (assembling panels, contextualizing scientific merit for funding decisions), and after award (progress-report monitoring, no-cost extensions, scope changes, and, at many agencies, the funder's side of pre-award and post-award programmatic decisions). A person or role counts as a program officer when three things are true together: they hold programmatic (not purely administrative/financial) authority over which proposals get recommended for funding within their portfolio; they are the named contact awardees are expected to reach for scientific or programmatic questions about an active or prospective award; and their responsibility is bounded to a defined subject area, directorate, or program rather than the funder's entire portfolio.
Clinical Study Report (CSR)
A Clinical Study Report (CSR) is the comprehensive, standalone document summarizing the design, conduct, and results of a single clinical trial, prepared in the format defined by ICH E3 (Structure and Content of Clinical Study Reports) so that any ICH regulatory authority can evaluate the trial on its own terms. A document qualifies as a CSR, rather than a lesser trial-reporting artifact, when it (a) integrates the full trial narrative -- objectives, methods, efficacy and safety results, and statistical analyses -- into one report keyed to a specific protocol, and (b) is structured to ICH E3's numbered outline (title page; a roughly three-page synopsis; ethics; investigators; introduction; study objectives; investigational plan; study patients; efficacy and safety evaluation; discussion and conclusions; tables, figures, and appendices), whether or not every section header is used verbatim. A CSR is compiled after database lock, once the trial's data are final, and is submitted to regulators as part of a marketing application (e.g., an NDA, BLA, or MAA) rather than published as an independent research output.
Washout Period
In a crossover clinical trial, a washout period is the interval deliberately built between two consecutive treatment periods during which no study intervention is administered, allowing the effects of the treatment given in the prior period to dissipate before the next treatment period begins. Its function is to prevent a carryover effect -- a residual pharmacological, physiological, or symptomatic effect of the earlier treatment contaminating the outcome measurements taken during the following period. A washout period is only meaningful in designs where the same participant receives more than one treatment in sequence (crossover and N-of-1 designs); it has no equivalent in a parallel-group design, where each participant receives only one treatment for the trial's duration. The length of a washout period is a protocol-specified design parameter, not an incidental gap in scheduling: it is set during protocol development, justified in the statistical analysis plan, and reviewed by the IRB/ethics committee as part of the overall trial design.
DDI Codebook
A metadata document is an instance of DDI Codebook (DDI-C) when it is a well-formed XML file rooted at the <codeBook> element and containing the DDI Alliance's standard sections for describing a single dataset: a study description (title, authors, abstract, methodology, sampling procedure), a file description of the physical data file, and a data description that documents each variable individually, including its name, label, question text, value labels, and universe. It is maintained by the DDI Alliance and versioned (current releases in the 2.x line, e.g. 2.5/2.6); it is the single-dataset-focused branch of DDI, distinct from the multi-wave/lifecycle-tracking DDI Lifecycle (DDI 3.x) specification.
Clinical Trial Associate (CTA)
A Clinical Trial Associate (CTA) is an entry-level, sponsor- or CRO-side administrative and project-tracking support role for clinical trials. A CTA maintains the Trial Master File (TMF) and site regulatory documents, schedules meetings and site visits, tracks study timelines and action items, and supports the Clinical Research Associate (CRA)/monitor's workload -- without independently conducting site monitoring visits or exercising the CRA's oversight authority over site conduct. Regardless of exact job title, a role counts as CTA-function work when it is administrative/logistical support performed on behalf of the sponsor or CRO team, not independent site oversight (that is the CRA function) and not day-to-day study conduct at the site itself (that is the Clinical Research Coordinator, or CRC, function).
SCORE (Systematizing Confidence in Open Research and Evidence)
A DARPA-funded research program, run by DARPA's Defense Sciences Office from 2019 to roughly 2022, that tested whether quantitative 'confidence scores' -- generated from human forecasting/prediction markets, expert surveys, and automated algorithms -- could reliably estimate how likely a published social and behavioral science (SBS) claim was to replicate. The program sampled around 3,000 research claims from roughly 60 journals published between 2009 and 2018, had forecasters and algorithms score them before any new data collection, then commissioned independent replications on a subsample to check which forecasting method came closest to the actual outcome. It is now complete; DARPA lists it as inactive and retained for reference.
CAP Biorepository Accreditation Program (CAP-BAP)
The CAP Biorepository Accreditation Program (CAP-BAP) is a voluntary, formal accreditation program run by the College of American Pathologists (CAP), established in 2012 as the first accreditation program specifically for biorepositories. A biorepository is accredited when it undergoes and passes an on-site peer-inspection assessment against a defined set of CAP accreditation checklists covering the Biorepository-specific checklist plus the shared Laboratory General, Director Assessment, and All Common checklists, is re-inspected on-site every two years, and completes a self-inspection using the same checklists in the intervening off-year. The checklists address consent and protection of research participants, specimen collection and chain of custody, institutional governance documents such as material transfer agreements, and long-term preservation infrastructure (equipment maintenance, temperature monitoring, backup systems). CAP-BAP draws on guidance from ISBER, the NCI, and the OECD in building its checklists but is itself a distinct, CAP-branded accreditation credential, not a re-badging of either.
NNN Agreement (Non-Disclosure, Non-Use, Non-Circumvention Agreement)
A hybrid contract -- combining non-disclosure, non-use, and non-circumvention clauses -- used when a research institution or inventor discloses confidential technical information to a prospective foreign manufacturing or licensing partner, most commonly a China-based manufacturer, where a standalone confidentiality (NDA) clause is often difficult to enforce or insufficient in scope.
ICF (Informed Consent Form)
The specific written document, IRB-approved before use, that restates a study's required disclosure elements (45 CFR 46.116(b)-(c); for FDA-regulated research, 21 CFR 50.25) for a prospective participant to read and sign. Distinct from the informed-consent process itself, which is documented separately under 45 CFR 46.117 / 21 CFR 50.27 and can, in limited cases (e.g. a documentation waiver, or the short-form pathway for non-English speakers), occur without a conventional long-form signed ICF.
Phase 1 Trial
A Phase 1 trial is the first stage of human testing for an investigational drug or biologic under an IND (21 CFR 312.21), where the primary endpoints are safety, tolerability, pharmacokinetics/pharmacodynamics, and dosing rather than efficacy. It typically enrolls a small cohort (roughly 20-80 participants), advances doses through a pre-specified dose-escalation design (commonly 3+3 or rolling six) governed by dose-limiting toxicity (DLT) criteria, and concludes by establishing a maximum tolerated dose (MTD) and/or a recommended Phase 2 dose (RP2D) that later phases carry forward.
Conflict of Commitment (COC)
A conflict of commitment (COC) exists when the time and effort a researcher or faculty member devotes to outside professional activities -- consulting, a second job, board service, an external appointment, or a startup role -- interferes with, or exceeds institutional limits on, the effort owed to their primary institutional obligations. It is a time-allocation problem, not a financial-bias problem: a COC can exist with no money involved (an unpaid but time-consuming board seat), and a significant financial conflict of interest can exist with no conflict of commitment at all (passive equity with no time commitment). Institutions typically manage COC through annual outside-activities disclosure, defined time caps, and cross-checking against sponsored-award effort reporting, distinct from the financial-disclosure process used for conflict of interest.
eRA Commons ID
An eRA Commons ID (also called a Commons ID or Commons username) is the individual login credential issued within the National Institutes of Health’s Electronic Research Administration (eRA) system, required for any person who needs to be named on, or take action within, an NIH grant application or award. This includes the Program Director/Principal Investigator (PD/PI), every other Senior/Key Personnel and Other Significant Contributor named on an application, trainees on training and career-development awards, and the institutional Signing Officials and Account Administrators who manage the organization’s eRA profile. The same Commons ID is used across eRA Commons itself and the linked application/reporting modules — ASSIST (grant application preparation and submission), xTrain (trainee appointment and stipend management on T, F, and K training mechanisms), and RPPR (Research Performance Progress Report) — so a person keeps one Commons ID for their entire NIH-facing career rather than a new one per application, institution move, or award. A defining operational feature is that individuals cannot self-register for an eRA Commons ID. Only a Signing Official (the institution’s Authorized Organizational Representative) or an Account Administrator at an institution already registered in eRA Commons can create an account and issue a Commons ID to a PI, trainee, or other key personnel. A PD/PI cannot create their own account and must go through their institution’s Signing Official or Commons administrator to be registered. When a person moves institutions, their existing Commons ID is typically affiliated with the new institution rather than replaced, preserving continuity of their NIH grant history under one identifier.
ISO 20387 (Biobanking)
ISO 20387:2018, Biotechnology — Biobanking — General requirements for biobanking, is the international standard specifying requirements for the competence, impartiality, and consistent operation of biobanks. It applies to organisations biobanking biological material and associated data from humans, animals, plants, fungi, and microorganisms for research and development, covering the full chain of collection, preparation, preservation, storage, and distribution of biospecimens. Structurally, it draws on the general competence requirements of ISO/IEC 17025 (testing and calibration laboratories) and the quality-management-system requirements of ISO 9001, adapted specifically for biobanking. A biobank meets ISO 20387 when a national accreditation body (for example UKAS in the UK or ANAB in the US, both operating under the same international accreditation framework as ISO/IEC 17025 labs) has formally assessed and accredited its quality management system, sample traceability, and impartiality — not merely when it follows informal best-practice guidance.
Data Stewardship Wizard (DSW)
An open-source, self-hostable DMP-authoring platform that generates data management plans from versioned, branching questionnaire 'knowledge models' rather than static funder templates, developed and stewarded as an ELIXIR infrastructure tool and released under the Apache License 2.0.
W3C DCAT (Data Catalog Vocabulary)
DCAT (Data Catalog Vocabulary) is a W3C Recommendation: an RDF vocabulary, published under the namespace http://www.w3.org/ns/dcat#, for describing datasets, dataset series, distributions, and data services within a data catalog so that catalogs published by different organizations can be harvested, aggregated, and searched interoperably. A metadata record qualifies as DCAT (rather than a merely similar, ad hoc catalog schema) when its fields map to DCAT's own RDF classes and properties -- dcat:Catalog, dcat:Dataset, dcat:Distribution, dcat:DataService, dcat:DatasetSeries, and dcat:CatalogRecord, built on top of Dublin Core, FOAF, SKOS, and PROV-O terms rather than a locally invented field set -- and is expressed (or losslessly convertible to) RDF, typically serialized as JSON-LD, Turtle, or RDF/XML.
35 U.S.C. § 282 (Presumption of Patent Validity and Invalidity Defenses)
35 U.S.C. § 282 is the U.S. Patent Act provision that (a) presumes an issued patent, and each claim of it independently, to be valid, and places the burden of proving otherwise on the party asserting invalidity, and (b) lists the categories of defenses available to a defendant in a patent infringement action. A fact pattern is governed by § 282 whenever an issued U.S. patent's validity or enforceability is being contested in litigation — as opposed to during examination at the USPTO, where no presumption of validity yet applies because no patent has issued. Under § 282(a), the presumption attaches at issuance and survives even when the challenged claim relies on prior art the examiner never considered; it does not evaporate simply because a defendant produces new references. In Microsoft Corp. v. i4i Limited Partnership, 564 U.S. 91 (2011), the Supreme Court held that § 282's presumption requires invalidity to be proved by clear and convincing evidence — a heightened standard above the ordinary civil preponderance-of-the-evidence standard — and that this standard applies uniformly, including to prior art the USPTO never examined. § 282(b) enumerates the defenses a party may raise in a patent action: (1) noninfringement, absence of liability for infringement, or unenforceability; (2) invalidity of the patent or any claim on any ground specified in Part II of the Patent Act as a condition for patentability — in practice this reaches novelty (35 U.S.C. § 102), obviousness (35 U.S.C. § 103), and subject-matter eligibility (35 U.S.C. § 101); (3) invalidity for failure to comply with the specification, enablement, written-description, or definiteness requirements of 35 U.S.C. § 112, or of § 251 (reissue); and (4) any other fact or act made a defense by the Patent Act. Indefiniteness under § 112(b) and lack of enablement under § 112(a) are both raised as § 282(b)(3) defenses, distinct from the novelty and obviousness grounds raised under § 282(b)(2).
MSCA Postdoctoral Fellowship
An MSCA Postdoctoral Fellowship is an individually held European Union research grant, funded under Horizon Europe's Marie Skłodowska-Curie Actions (MSCA), awarded jointly to a researcher who already holds a doctoral degree (or has defended a thesis, not yet formally awarded) and a host organisation that will supervise and train them. It is not a consortium grant: unlike MSCA Doctoral Networks, which fund multi-partner training partnerships for pre-PhD doctoral candidates, a Postdoctoral Fellowship is competed for and held by one named researcher at one host institution (with optional short secondments elsewhere). Eligibility is capped at a maximum of eight years of full-time-equivalent research experience since the award of the PhD, excluding documented career breaks, and subject to MSCA's standard mobility rule (the researcher must not have resided or carried out their main activity in the host country for more than 12 of the 36 months immediately before the call deadline). The action comes in two tracks -- European Postdoctoral Fellowships (1-2 years, host in an EU Member State or Horizon Europe Associated Country, open to researchers of any nationality) and Global Postdoctoral Fellowships (2-3 years total: an outgoing phase of 1-2 years at a host in a non-associated Third Country, followed by a mandatory 1-year return phase at a European host, restricted to nationals or long-term residents of an EU Member State or Associated Country). Funding is paid as EU-wide unit costs -- a living allowance, mobility allowance, and, where applicable, family, long-term leave, and special needs allowances, plus separate research/training/networking and management/indirect-cost contributions to the host -- rather than as an institution-set salary. “MSCA Postdoctoral Fellowships” is the Horizon Europe (2021-2027) name for what was called “Individual Fellowships (IF)” under Horizon 2020; the underlying individually-held, PhD-holder-only mechanism carried over largely unchanged through the rename.
File Wrapper (USPTO)
The file wrapper — also called the prosecution history or file history — is the complete official record the U.S. Patent and Trademark Office (USPTO) maintains for a patent application from filing through issuance (or abandonment) and any subsequent post-grant proceedings. It contains every document that passed between the applicant (or the applicant's patent attorney/agent) and the examiner: the application as originally filed, office actions (rejections and objections), applicant responses and claim amendments, examiner's amendments, interview summaries, information disclosure statements (IDS) citing prior art, terminal disclaimers, notices of allowance, and the issued patent itself. The term is a holdover from the paper era, when each application's papers were literally kept in a manila file wrapper; the record is now maintained and served digitally. A document set counts as part of the file wrapper if and only if it was formally entered into the application's official record by the USPTO — informal correspondence, examiner's personal notes not made of record, and an applicant's internal drafts never filed do not qualify, even if they discuss the same application.
Shared Investigator Platform (SIP)
The Shared Investigator Platform (SIP) is an industry-wide technology platform, originally developed by TransCelerate BioPharma and now operated by Cognizant, that lets clinical investigators and site staff maintain a single reusable profile -- credentials, training records, Good Clinical Practice (GCP) certifications, CVs, and facility/equipment information -- and share it across multiple participating sponsors and CROs, instead of re-submitting the same regulatory and qualification documentation separately to every sponsor for every study. A site interaction counts as using SIP, as distinct from a sponsor's own proprietary site portal, when: (1) the site maintains one Facility Profile and individual user profiles through a single central platform account rather than a sponsor-specific login; (2) that profile data -- training certificates, licenses, CVs, financial disclosure and other startup documents -- is entered once and then made visible, on the site's authorization, to any participating sponsor running a study at that site; and (3) study start-up and conduct activities (document exchange, study-specific training assignment, communication) for a given trial route through the shared platform rather than a separate sponsor-built system. TransCelerate's own Shared Investigator Platform Initiative reached completion in 2020 -- TransCelerate states no new deliverables or updates are planned by the organization -- and the platform is now owned and operated by Cognizant; sponsor and CRO adoption is voluntary and platform use for a given study still depends on which sponsor is running it.
FDA Biosimilars (351(k) Pathway)
An FDA biosimilar is a biological product approved under section 351(k) of the Public Health Service Act (42 U.S.C. § 262(k)) — an abbreviated licensure pathway, distinct from the standard 351(a) Biologics License Application (BLA) route, under which a sponsor relies on an existing FDA-licensed reference product rather than generating the full standalone clinical package a 351(a) BLA requires. A product qualifies as a biosimilar only when FDA determines, on the totality of the evidence, that it is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between the two products in terms of safety, purity, and potency. A biosimilar may additionally earn an interchangeable designation, a higher bar that permits pharmacy-level substitution for the reference product without the prescriber's intervention, subject to state pharmacy-substitution law.
ISO 23081 (Records Management Processes — Metadata for Records)
ISO 23081 (Information and documentation — Records management processes — Metadata for records) is the ISO standard that defines the principles and framework governing the metadata records systems must capture so that records can be managed, retrieved, and trusted as evidence throughout their lifecycle. A metadata scheme qualifies as ISO 23081-aligned when it goes beyond simple descriptive metadata (title, creator, date) to capture recordkeeping context: the business process or mandate that created the record, the agents responsible for it, its relationships to other records and aggregations, and its retention/disposition authority. The standard is published in three parts: Part 1 sets out the principles underpinning records metadata; Part 2 gives conceptual and implementation guidance for building a metadata schema consistent with Part 1; Part 3, published as a Technical Report, provides a self-assessment method for evaluating an existing metadata schema against the standard. ISO 23081 was developed by ISO/TC 46/SC 11 as a companion to ISO 15489 (the core international records management standard), translating 15489's principles into a concrete metadata model that records-management systems, archives, and institutional repositories can actually implement.
Peer Review
A work is peer reviewed when, before publication, an editor sends it to one or more independent experts in the same field (peer reviewers) who evaluate its methodology, validity, originality, and significance, and the editor uses that written feedback to decide whether to accept, reject, or require revisions. Three elements distinguish genuine peer review from ordinary editorial handling: (1) the reviewers are subject-matter experts external to the editorial staff, not merely copy-editors; (2) the review is documented (recorded reviewer reports, even if reviewer identity is withheld from the author); and (3) the outcome materially gates publication rather than serving as optional feedback offered after the fact. The specific procedure varies by venue — reviewer and author identities may or may not be disclosed to each other (single-anonymized, double-anonymized, or open review), and some venues review a study's protocol before results exist (registered reports) rather than only the finished manuscript — but the core requirement of independent expert gatekeeping prior to publication is common to all forms. A 'peer-reviewed journal' is simply a journal that applies this process, as a matter of documented policy, to the research articles it publishes.
Development Safety Update Report (DSUR)
The ICH E2F-standardized annual aggregate safety report a sponsor prepares for an investigational product's whole development program as of a single yearly data-lock point, summarizing accumulated safety data across all its trials worldwide and assessing the product's evolving benefit-risk profile — distinct from the event-triggered expedited SUSAR reporting required under 21 CFR 312.32, and often submitted in place of the separate US IND annual report under 21 CFR 312.33.
Google Scholar Metrics
Google Scholar Metrics is a free tool built into Google Scholar that ranks publication venues -- journals, conference proceedings, and some preprint repositories -- by an automatically-computed h5-index, rather than ranking individual authors. A source counts as covered by Google Scholar Metrics only once it clears fixed inclusion thresholds (at minimum roughly 100 articles published within the most recent five complete calendar years, with at least some citations to those articles); anything below that threshold simply does not appear, regardless of quality. It is a venue-level ranking feature, not an author-level metric -- it should never be confused with an individual researcher's h-index or i10-index, which Google Scholar computes separately inside a personal Google Scholar Citations profile.
EU AI Act Article 10 (Data and Data Governance)
Article 10 of the EU AI Act (Regulation (EU) 2024/1689), in Title III, Chapter 2, sets the data-quality and data-governance obligations for the training, validation, and testing datasets used to build high-risk AI systems. A system falls under Article 10 only after it has already met the Act's separate 'high-risk' classification test (an Annex III listed use case, or a safety component covered by Annex I sectoral product law). For a high-risk system built using techniques that involve training models on data, Article 10(2) requires documented data-governance practices covering collection and origin, preparation operations (annotation, labelling, cleaning, updating, enrichment), bias examination, bias-mitigation measures, and identification of data gaps; Article 10(3)-(4) require the training, validation, and testing datasets to be relevant, sufficiently representative, and to the best extent possible free of errors and complete for the system's intended purpose and deployment context. For a high-risk system that does not use such training techniques, Article 10(6) narrows the same requirements to the testing dataset only. Article 10(5) separately permits limited, safeguarded processing of special-category personal data solely to detect and correct bias. It does not apply to AI systems or models developed and used solely for scientific research and development prior to being placed on the market or put into service, per the Article 2(6)/2(8) research exemption.
eCTD (Electronic Common Technical Document)
A regulatory submission qualifies as an eCTD only when its files are organized into the standardized five-module folder hierarchy (Module 1 region-specific administrative/prescribing information, Module 2 CTD summaries, Module 3 quality/CMC, Module 4 nonclinical study reports, Module 5 clinical study reports) AND wrapped in an XML backbone (index.xml) that assigns each file lifecycle-operation metadata (new, append, replace, delete) so a reviewer's system and the sponsor's own submission history can track changes across amendments to the same application. A folder of complete, correctly-labeled PDFs that lacks the XML backbone and Module 1-5 structure is not an eCTD, regardless of content completeness.
Journal Article Reporting Standards (JARS)
Journal Article Reporting Standards (JARS) is the American Psychological Association's set of manuscript-section reporting requirements, published as part of APA Style and incorporated into the Publication Manual of the APA (7th edition). A manuscript is JARS-compliant when the author has followed the module matching its research design: JARS-Quant for quantitative studies (numerical data, statistical analysis), JARS-Qual for qualitative studies (natural-language, descriptive, or interview-based data), or JARS-Mixed for studies combining both. A cross-cutting fourth module, JARS-Race, Ethnicity, and Culture (JARS-REC), adds reporting expectations for how race, ethnicity, and culture are described and analyzed, and applies regardless of which core module a study uses. Each module specifies, section by section (title/abstract, introduction, method, results, discussion), the minimum information a submission must state -- for example, JARS-Quant requires reporting exact sample-size determination and any data exclusions; JARS-Qual requires describing the researcher's own standpoint and role in relation to the data. JARS is APA's own umbrella framework and is distinct from discipline- or design-specific reporting guidelines such as PRISMA (systematic reviews), CONSORT (randomized trials), or COREQ/SRQR (qualitative research specifically) -- a paper can be asked to satisfy JARS alongside one of those other checklists, not instead of it, since JARS covers general manuscript-section content while the others target a specific study design in more procedural depth.
Good Clinical Laboratory Practice (GCLP)
Good Clinical Laboratory Practice (GCLP) is the quality standard governing laboratories that analyze human-derived samples from clinical trials -- most centrally bioanalytical work such as pharmacokinetic (PK) sample analysis, biomarker assays, and other trial-support testing. It is a hybrid standard: it applies the study-control, quality-assurance, and data-integrity discipline of Good Laboratory Practice (GLP) -- normally written for preclinical, non-human studies under 21 CFR Part 58 -- to a clinical-trial, human-sample setting, while also incorporating the trial-conduct and subject-protection principles of Good Clinical Practice (GCP) (ICH E6). A laboratory qualifies as GCLP-compliant when it operates a documented quality management system covering facility/equipment qualification, personnel training records, standard operating procedures, sample chain-of-custody and traceability back to the clinical trial subject, method validation, raw-data integrity and retention, and independent quality assurance oversight -- applied specifically to samples originating from a clinical trial rather than a preclinical study or routine diagnostic workload.
GDPR Article 44 (International Data Transfers)
GDPR Article 44 is the opening provision of Chapter V of the EU General Data Protection Regulation, and states the general principle that governs every transfer of personal data out of the European Economic Area: a transfer to a third country or international organisation may only take place if the conditions in the rest of Chapter V are satisfied, and the level of protection guaranteed by the GDPR must not be undermined -- including for onward transfers from the receiving third country to yet another third country. Article 44 does not itself supply a transfer mechanism; it is the trigger that makes Articles 45-49 mandatory whenever personal data (including pseudonymised research data that remains personal data, per GDPR Article 4(5)) leaves the EEA. For a research collaboration, that means every step of a project involving a non-EEA partner -- shipping a dataset to a US co-investigator, hosting trial data on a non-EEA cloud region, or granting a non-EEA collaborator remote access to an EEA-hosted database -- is a Chapter V transfer, whether or not it is described as a 'transfer' in the project's data management plan.
Human Research Protection Program (HRPP)
A Human Research Protection Program (HRPP) is the complete organizational structure an institution operates to protect the rights and welfare of human research participants -- not a single committee, but the full system of one or more Institutional Review Boards (IRBs), written policies and procedures, an institutional compliance/administrative office, researcher training requirements, conflict-of-interest management, and ongoing monitoring of active research, all operating under the institution's Federalwide Assurance (FWA) with HHS's Office for Human Research Protections (OHRP). The IRB is the HRPP's core review committee, not the whole program; AAHRPP is the external body that voluntarily accredits an institution's HRPP as a unit. An institution operates an HRPP whether or not it ever seeks AAHRPP accreditation -- running a compliant HRPP under the Common Rule (45 CFR 46) and applicable FDA regulations is a baseline legal requirement for institutions conducting covered human-subjects research; AAHRPP accreditation is an optional, additional layer of external, third-party verification on top of it.
U54 Grant (NIH Specialized Center Cooperative Agreement)
A U54 (Specialized Center Cooperative Agreement) is an NIH activity code for a single award that funds a multi-project, multidisciplinary research center built around one specific disease or biomedical problem area, funded as a cooperative agreement rather than a grant. That means NIH anticipates substantial, ongoing programmatic involvement in the funded center after award -- NIH staff assist, guide, coordinate, or participate in center activities -- distinguishing it from the P01 Research Program Project Grant, which funds a similarly multi-project, multi-core structure without that level of federal involvement.
ANSI/NISO Z39.19 (Controlled Vocabularies and Thesauri)
A controlled vocabulary or thesaurus is constructed to ANSI/NISO Z39.19-2005 (R2010), "Guidelines for the Construction, Format, and Management of Monolingual Controlled Vocabularies," when it follows the standard's rules for term selection and form (preferring noun phrases, singular/plural conventions, avoiding ambiguous homographs without a qualifier), and when it displays the three relationship types Z39.19 defines between terms: equivalence relationships (USE/UF, linking a non-preferred synonym to its preferred term), hierarchical relationships (BT/NT, Broader Term/Narrower Term, for genus-species, whole-part, or instance relationships), and associative relationships (RT, Related Term, for terms that are conceptually related but not synonymous or hierarchical). The standard covers several vocabulary types along a spectrum of structural complexity -- authority lists, synonym rings, taxonomies, and full thesauri -- and specifies how each should be tested, formatted, and maintained over time (adding, deprecating, and merging terms as usage and the underlying domain evolve).
Prior Approval
Prior approval (sometimes written “prior written approval”) is the requirement, under 2 CFR 200.407 of the OMB Uniform Guidance, that a federal grant recipient obtain the federal awarding agency’s written sign-off before taking a specified action, rather than proceeding and defending the decision after the fact. Something is genuinely a “prior approval” matter — as opposed to routine project management the recipient can handle on its own authority — only if it falls into one of the categories the regulation or the recipient’s own award terms specifically names. Section 200.407 lists sixteen such categories, including cost sharing (200.306), program income (200.307), revision of budget and program plans (200.308), fixed-amount subawards (200.333), compensation for personal services and fringe benefits (200.430–200.431), equipment and capital expenditures (200.439), exchange-rate losses (200.440), fines and penalties (200.441), fundraising costs (200.442), goods or services for personal use (200.445), insurance and indemnification (200.447), organization costs (200.455), pre-award costs (200.458), rearrangement and reconversion costs (200.462), and travel costs (200.475). The regulation is explicit that the absence of prior approval does not, by itself, make a cost unreasonable or unallocable unless prior approval is specifically required for that item — the requirement only bites where it is named. The most frequently triggered prior-approval events sit inside 2 CFR 200.308, “Revision of budget and program plans,” which requires a recipient to ask before: changing the scope or objective of the project (even without any budget change), changing key personnel identified by name or position in the award, a PD/PI disengaging from the project for more than three months or reducing time and effort on it by 25 percent or more, redirecting participant support costs to other budget categories, adding a subaward not proposed in the original application, changing the total approved cost-sharing amount, needing additional federal funds to complete the project, moving funds between construction and non-construction categories, or extending the project period beyond what the recipient’s own expanded/automatic authority already covers. Because 200.308’s list is itself an enumerated set — not a general “ask if unsure” standard — a change that doesn’t match one of its named triggers, or one of 200.407’s other named cost categories, does not require prior approval merely because it feels significant to the PI.
Rigor and Transparency Index (RTI)
The Rigor and Transparency Index (RTI) is the average SciScore — an automated score of methods-rigor and resource-identification reporting — across a journal's or institution's articles in a given year, published by SciCrunch as a benchmarking metric for reporting quality. It is calculated independently of citation-based metrics such as Journal Impact Factor and is meant to be compared only within the same field or subfield.
Patent Continuation Application
A patent continuation application is any of a family of U.S. nonprovisional applications -- continuation, continuation-in-part (CIP), or divisional -- filed while an earlier-filed 'parent' nonprovisional application is still pending (co-pending), that claims the benefit of the parent's filing date under 35 U.S.C. 120 or 121 and 37 CFR 1.78. What distinguishes the three types is what changes relative to the parent's disclosure and claims: a continuation carries forward the parent's disclosure exactly and pursues new or different claims to the same invention already disclosed; a continuation-in-part repeats a substantial part of the parent's disclosure but adds new matter not found in the parent (the new matter does not get the benefit of the parent's filing date); and a divisional carves out claims to an independent or distinct invention that the parent disclosed but did not claim, typically after the examiner issued a restriction requirement forcing the applicant to elect one invention to pursue in the parent.
eRA Commons Roles
An eRA Commons role is the permission set assigned to an account within NIH's Electronic Research Administration (eRA) system that determines what actions that account can take inside eRA Commons and its connected modules (ASSIST, xTrain, RPPR, and others) -- on behalf of an individual, or on behalf of an institution. Roles fall into two broad categories: institutional/administrative roles (Signing Official, Administrative Official, Business Official, Account Administrator), which carry authority to act for the recipient organization and vary in how much of that authority each one holds, and scientific/reporting roles (Principal Investigator, Assistant, trainee roles, Financial Status Reporter, Financial Conflict of Interest, Public Access Compliance Reporter, Internet Assisted Reviewer), which are scoped to a specific project, report, or review function. A role is distinct from the eRA Commons ID itself: the ID is the individual's persistent login credential, while the role determines what that credential is authorized to do, and only a Signing Official or Account Administrator at an already-registered institution can assign or change a role -- individuals cannot self-assign a role.
PHS Policy (Public Health Service Policy on Humane Care and Use of Laboratory Animals)
The binding NIH policy, administered by the Office of Laboratory Animal Welfare (OLAW) under the Health Research Extension Act of 1985 (42 U.S.C. section 289d), that requires any institution receiving Public Health Service (PHS) funding to hold a written Animal Welfare Assurance accepted by OLAW before conducting or supporting activities involving any live vertebrate animal. It requires the institution's IACUC to review protocols and inspect facilities as OLAW's agent, and requires the animal care program to be based on the Guide for the Care and Use of Laboratory Animals and to comply with USDA's Animal Welfare Regulations as an absolute minimum. It is distinct from the Animal Welfare Act (a separate, funding-independent federal statute with narrower species coverage) and from AAALAC accreditation (a voluntary, non-mandatory private accreditation that does not substitute for the Assurance).
Freedom to Operate (FTO) Analysis
A freedom to operate (FTO) analysis determines whether making, using, selling, offering to sell, or importing a specific product or process would infringe any granted, in-force third-party patent claim in the jurisdiction(s) where that activity will occur. It is distinct from a patentability (prior art) search: patentability asks whether an applicant's own invention is novel and non-obvious enough to be patented; FTO asks whether commercializing a specific product infringes patents already held by others, regardless of whether the product's own contribution is itself patentable. FTO is jurisdiction-specific (patent rights are territorial) and time-bound (it cannot detect unpublished pending applications), so it is typically re-run before entering a new market or launching a materially redesigned product.
FDA Form 3454 (Certification: Financial Interests and Arrangements of Clinical Investigators)
FDA Form 3454 ('Certification: Financial Interests and Arrangements of Clinical Investigators') is the form a marketing-application sponsor submits to FDA to certify -- rather than disclose -- that no clinical investigator (or subinvestigator, and no covered spouse or dependent child) who participated in a covered clinical study has any of the disclosable financial interests or arrangements defined at 21 CFR Part 54. It is used only when the sponsor's inquiry into each investigator's financial interests comes back clean; if any investigator has a reportable interest or arrangement, the sponsor files the counterpart form, FDA Form 3455, disclosing it instead. The form must be dated and signed by the applicant's chief financial officer or other responsible corporate official, and it is submitted with the marketing application it supports (an NDA, ANDA, BLA, or PMA/510(k) as applicable) rather than at the start of the trial.
Expedited Review (IRB)
Expedited review is an IRB review pathway, available only when a proposed research activity (or a minor change to already-approved research) presents no more than minimal risk to participants and falls into one of the categories on OHRP's expedited-review category list. Instead of going to a convened meeting of the full board, it is reviewed by the IRB Chairperson personally, or by one or more experienced reviewers the Chairperson designates from the board's membership, under 45 CFR 46.110 (and the parallel FDA provision, 21 CFR 56.110). An expedited reviewer may exercise all the authorities of the full IRB except one: they may not disapprove the research -- a study can only be disapproved through full-board review at a convened meeting. ’Expedited’ describes who conducts the review (chair or designee, not the full board), not a guaranteed fast turnaround.
FDA Process Validation
FDA Process Validation refers to the FDA's January 2011 guidance document "Process Validation: General Principles and Practices" (issued by CDER in cooperation with CBER, ORA, and CVM, superseding the agency's 1987 process-validation guideline), and to the three-stage lifecycle framework it establishes for demonstrating that a pharmaceutical or biologic manufacturing process consistently produces a product meeting its predetermined quality attributes. A manufacturing process is treated as "validated" under this framework only when all three stages have been satisfied: Stage 1 (Process Design), in which the commercial process is defined based on knowledge gained through development and scale-up activities; Stage 2 (Process Qualification), in which the process design is evaluated to confirm the process is capable of reproducible commercial manufacturing, including facility/utility/equipment qualification and Process Performance Qualification (PPQ) runs; and Stage 3 (Continued Process Verification, or CPV), an ongoing program of collecting and statistically trending process and product data during routine commercial production to confirm the process remains in a state of control. This is distinct from clinical-trial protocol validation or software/computer-system validation -- the term specifically denotes manufacturing-process validation for drug substances, drug products, and biologics under current Good Manufacturing Practice (CGMP).
21 CFR Part 56 (Institutional Review Boards)
21 CFR Part 56 is FDA's own regulation governing Institutional Review Board (IRB) review of clinical investigations that fall under FDA's product-jurisdiction authority — chiefly studies conducted under an Investigational New Drug (IND) application (21 CFR Part 312), an Investigational Device Exemption (IDE) (21 CFR Part 812), or otherwise submitted to FDA in support of a research or marketing permit (21 CFR Part 813). Per 21 CFR 56.103, any such clinical investigation must receive IRB approval before it may begin and must remain subject to continuing IRB review for its duration; FDA may refuse to rely on data from an investigation that lacked this initial and continuing IRB oversight. Part 56's trigger is the product/application jurisdiction of the study, not its funding source — it applies whether or not any federal grant money is involved, which is the structural feature that distinguishes it from the Common Rule (45 CFR 46), whose trigger is federal funding or conduct. A single trial can therefore fall under the Common Rule only, Part 56 only, or both at once (for example, an NIH-funded IND drug trial), in which case both regulatory tracks' IRB-review and informed-consent requirements must independently be satisfied.
Biosafety Level 1 (BSL-1)
The CDC/NIH BMBL laboratory-containment tier assigned to a protocol when the biological agent(s) involved are well-characterized and not known to consistently cause disease in healthy adults, and pose minimal potential hazard to laboratory personnel and the environment. An instance of BSL-1 is basic, open-bench microbiological work performed with standard microbiological practices (handwashing, no eating/drinking/mouth pipetting, decontamination of work surfaces) and no specialized primary containment equipment such as a biosafety cabinet, in a laboratory that is not required to be separated from general building traffic.
Unliquidated Obligations (ULO)
An unliquidated obligation (ULO) is the portion of a federal award's obligated funds that has been legally committed through an obligating action -- such as a purchase order, contract, or subaward agreement -- but for which payment has not yet been made (on a cash-basis report) or the corresponding expenditure has not yet been recorded (on an accrual-basis report). Under 2 CFR 200.1, a 'financial obligation' is created by orders placed for property and services, contracts and subawards made, and similar transactions requiring payment under a Federal award. An 'unliquidated financial obligation' is that same committed amount before it is liquidated -- i.e., before the recipient or subrecipient actually pays it (cash basis) or records the expenditure (accrual basis). A dollar only becomes a ULO once an obligating action has occurred; funds that are merely available but not yet committed to any specific order, contract, or subaward are instead part of the award's unobligated balance, not a ULO.
VC Term Sheet
A VC term sheet is a short, non-binding document, proposed by a venture capital investor and negotiated with a company's founders, that lays out the key economic and control terms of a proposed equity investment before the parties draft the full, binding financing documents (a stock purchase agreement, an amended certificate of incorporation, an investors' rights agreement, and related ancillary documents). A document qualifies as a VC term sheet if it specifies, at minimum, the round's valuation (pre-money and post-money) and the resulting price per share, the class of stock being issued (almost always preferred stock rather than common), the size of the investment, and the investor's proposed rights over the company post-closing -- typically including a liquidation preference, anti-dilution protection, board composition, and pro-rata (or preemptive) rights for future rounds. Because it is explicitly non-binding on the substantive deal terms (most term sheets carry binding provisions only for a narrow set of housekeeping clauses -- confidentiality, exclusivity/no-shop, and governing law -- while everything else is subject to definitive documentation and due diligence), signing one commits a founder to negotiate on the stated terms in good faith, not to close the round on those terms.
NIH Research Security Training (RST)
NIH's Research Security Training (RST) requirement, established under NIH Guide Notice NOT-OD-26-017, requires every 'covered individual' -- meaning every senior/key person listed on an NIH grant application -- to complete research security training within the 12 months before the application's due date. Compliance is evidenced through a dual certification: an institutional certification by the Authorized Organizational Representative (AOR) on the SF424 R&R face page, and an individual certification captured through the person's NIH Biographical Sketch in SciENcv. It applies to applications with due dates on or after May 25, 2026.
License Agreement
A license agreement is a contract in which the owner of intellectual property (IP) -- a patent, copyright, trademark, or trade secret -- (the licensor) grants another party (the licensee) permission to exercise specified rights in that IP, in exchange for agreed-upon consideration, without transferring ownership of the underlying IP itself. A given arrangement counts as a license agreement, rather than some other transaction, when three elements are present together: (1) the licensor retains title to the IP throughout the term of the agreement, (2) the grant is bounded -- limited by scope (which rights: make, use, sell, reproduce, display, etc.), field of use, territory, and/or duration -- rather than an unrestricted, permanent transfer of all rights, and (3) the agreement specifies the consideration and other obligations attached to the grant, typically royalties, an upfront or milestone fee, sublicensing terms, reporting requirements, and termination conditions. Because the licensor keeps ownership, a license agreement is legally distinct from an assignment, which transfers ownership of the IP itself to the assignee; the underlying grant can also be exclusive (only the licensee may exercise the granted rights, even excluding the licensor) or non-exclusive (the licensor may grant the same rights to other parties in parallel).
NIH Financial Conflict of Interest (FCOI) Policy
The federal regulatory framework (42 CFR Part 50, Subpart F for PHS grants/cooperative agreements; 45 CFR Part 94 for PHS contracts) requiring any institution receiving Public Health Service or NIH funding to maintain a written FCOI policy, collect financial disclosures from every Investigator on a covered project, have a designated official review and manage any identified conflict, and report it to the funding agency before award funds are expended.
USPTO Power of Attorney
A USPTO power of attorney is the written document by which a patent applicant or patent owner appoints one or more registered patent practitioners — a patent attorney or patent agent registered under 37 CFR 11.6 — to prosecute a patent application on their behalf before the U.S. Patent and Trademark Office. It is governed by 37 CFR 1.32 and, for applications filed on or after September 16, 2012, is typically executed on Form PTO/AIA/82. Under 37 CFR 1.32(b), a valid power of attorney must be in writing, name one or more representatives who qualify under 37 CFR 1.32(c) (joint inventors, practitioners associated with a Customer Number, or up to ten individually named practitioners with registration numbers), give that representative the power to act on the principal's behalf, and be signed by the applicant or patent owner. Only a registered patent attorney or patent agent — not a general power-of-attorney holder, and not an unregistered representative — may be appointed to prosecute a utility or plant application; practitioners registered for design patents only under 37 CFR 11.6(d) may act solely in design matters.
Site Initiation Visit (SIV)
A Site Initiation Visit (SIV) is the visit -- conducted on-site or remotely by a sponsor or CRO monitor (typically a Clinical Research Associate) -- that formally activates an investigational site for a specific clinical trial, immediately before enrollment may begin. A visit counts as an SIV, regardless of format, when it verifies that all site-activation prerequisites are simultaneously in place: current IRB/IEC approval of the protocol and informed consent form, completed staff training (protocol-specific and Good Clinical Practice) for every individual on the delegation-of-authority log, a complete regulatory/essential-document binder per ICH E6(R2) Section 8, receipt and accountability procedures for investigational product and study supplies, and a working understanding among site staff of source documentation and data-entry (EDC) procedures. A visit is NOT an SIV if it occurs before the site has been contracted and IRB-approved (that is a site-selection/pre-study visit) or after the site has already begun enrolling participants (that is a routine/interim monitoring visit or a close-out visit).
Full Economic Costing (fEC)
Full economic costing (fEC) is the UK methodology, calculated via the Transparent Approach to Costing (TRAC), that institutions must use to cost UKRI grant applications. It sums directly incurred costs, directly allocated costs, and indirect (estates/overhead) costs to state a project's true full cost; UKRI Research Council grants then fund 80% of that fEC figure, with the institution finding the remaining share elsewhere -- in England, substantially via Research England's QR block grant.
AAALAC International
A private, nonprofit accrediting body (founded 1965, headquartered in Frederick, Maryland) that grants voluntary, triennial peer-review accreditation to animal research, teaching, and testing programs worldwide against three primary standards (the Guide, the Ag Guide, and ETS 123), confirming a program meets or exceeds legally required animal-welfare standards -- distinct from the mandatory Animal Welfare Act (USDA-enforced statute) and PHS Policy (NIH funding condition), neither of which AAALAC accreditation replaces or is required by.
ARC Industry Fellowships
A fellowship funded under the Australian Research Council's Linkage Program that provides salary and project-cost support for an individual researcher to work across the academia-industry boundary -- either an academic researcher taking up a placement with an industry Partner Organisation, or an industry-based researcher taking up a placement at a university -- rather than funding a defined project team as an ARC Linkage Project does. The scheme comprises three career-stage streams (Early Career, Mid-Career, and Industry Laureate Industry Fellowships), each with its own salary contribution, duration, and project-cost allowance.
ARMA, EARMA, and INORMS: International Research Management Associations
ARMA (the Association of Research Managers and Administrators), EARMA (the European Association of Research Managers and Administrators), and INORMS (the International Network of Research Management Societies) are three related but distinct professional bodies serving people who manage and administer research rather than conduct it. ARMA is the national professional association for research management in the UK, incorporated in 2006, with roughly 3,800 members. EARMA is the regional professional association for the same profession across Europe, formed in 1994, open to research managers and administrators working in academia, industry, and the public and private sectors. INORMS is not a membership body for individuals at all -- it is an umbrella federation of national and regional research-management societies, founded in 2001, whose own members are organizations such as ARMA, EARMA, and the US-based National Council of University Research Administrators (NCURA) and Society of Research Administrators International (SRAI), alongside other national societies around the world. An individual research administrator typically joins their applicable national or regional body directly (ARMA if UK-based, EARMA if Europe-based, NCURA or SRAI if US-based, and so on); they do not join INORMS directly, because INORMS's own members are the societies themselves, not individual practitioners.
Electronic Trial Master File (eTMF)
An eTMF is a software system -- standalone or a CTMS module -- used to create, store, version-control, quality-check, and track the real-time completeness of a clinical trial’s Trial Master File (TMF) electronically, structured against a reference taxonomy such as the TMF Reference Model and, for FDA-regulated trials, generally within the scope of 21 CFR Part 11.
March-In Rights
March-in rights are the authority under 35 U.S.C. § 203 letting a federal funding agency require the holder of a patent on a federally funded “subject invention” to grant additional licenses to a responsible third party -- or grant one itself -- when the holder isn't achieving practical application, isn't meeting unmet health/safety needs, isn't satisfying regulation-specified public-use requirements, or hasn't met the Section 204 U.S.-manufacturing agreement. Title is not transferred or revoked; only additional licensing is compelled, and only at the funding agency's discretion after a petition and agency review.
NINDS Payline
A NINDS payline is the percentile-rank threshold that the National Institute of Neurological Disorders and Stroke publishes for a given fiscal year and grant mechanism as its planning guideline for which peer-reviewed applications it expects to fund. It is NINDS's own institute-specific application of the general NIH payline mechanism, set independently of every other NIH institute or center against NINDS's own appropriation, application volume, and research priorities. NINDS also publishes a separate, more generous extended payline for Early Stage Investigators, aimed at giving early-career researchers a comparable success rate to established investigators applying for the same mechanism. A NINDS payline is a budgeting and planning benchmark, not a binding rule: NINDS retains discretion to fund some applications scoring outside its published payline (select pay / exception pay) and to decline some scoring inside it, based on advisory council input and program priorities. As of late 2025, NIH signaled its institutes and centers would move away from publishing fixed paylines in favor of weighing peer-review scores against institute priorities and budget more holistically -- confirm current NINDS practice against its own current guidance rather than assuming a specific figure still applies.
Patent Eligibility Restoration Act (PERA)
The Patent Eligibility Restoration Act (PERA) is proposed U.S. federal legislation — not current law — that would rewrite 35 U.S.C. § 101 to replace the judge-made "abstract idea" and "law of nature" exceptions with a shorter, closed list of statutory exclusions. It has been introduced, in varying forms, across the 116th, 118th, and 119th Congresses without being enacted. The current version, S. 1546 (119th Congress, 2025–2026), was reintroduced on May 1, 2025 by Senators Thom Tillis (R-NC) and Chris Coons (D-DE) and Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA). The Senate Judiciary Subcommittee on Intellectual Property held a hearing on the bill on October 8, 2025; as of this writing it has not been marked up by the full committee, passed by either chamber, or signed into law. A page that treats PERA as settled law would be factually wrong — its defining characteristic, for research-administration purposes, is that it is a live legislative proposal responding to an unresolved doctrinal problem, not a rule anyone can rely on yet. The problem PERA is written to address Under current § 101 doctrine, the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories (2012) and Alice Corp. v. CLS Bank International (2014) decisions established a two-step framework (often called the "Alice/Mayo test" or, in USPTO examination guidance, "Step 2A/Step 2B") that lets an examiner or court invalidate a claim as directed to an unpatentable "abstract idea," "law of nature," or "natural phenomenon" even though those categories appear nowhere in the patent statute itself — they are judicial exceptions layered on top of § 101's text. See CASRAI's 35 U.S.C. § 101: Patentable Subject Matter and the Alice/Mayo Eligibility Test for the current test as it actually operates today. Critics across the patent bar, technology-transfer offices, and biotech/software industry groups argue the resulting case law is inconsistent and hard to predict at the claim-drafting stage, disproportionately affecting diagnostic methods, software and AI-related inventions, and certain life-sciences discoveries — exactly the categories a university technology transfer office most often needs to protect before licensing. What PERA proposes to change Rather than amending the Alice/Mayo case-law test directly, PERA's approach is to eliminate judicially-created exceptions from § 101 entirely and substitute a short, enumerated list of statutory exclusions from eligibility (categories such as claims to an unmodified human gene as it exists in the human body, or to a mathematical formula standing alone, are the kind of exclusion prior versions of the bill have specified) while otherwise stating that a claimed invention is eligible if it falls within one of the statute's existing categories (process, machine, manufacture, or composition of matter) and is not excluded. Sponsors describe the goal as restoring eligibility for practical, real-world applications in fields like AI, biotechnology, and diagnostics without reopening genuinely abstract claims to patenting. Because PERA has been revised between reintroductions, the exact exclusion list and definitions in the live S. 1546 text should be checked directly against the bill text on congress.gov rather than assumed to match an earlier version. Why this matters for university tech transfer specifically A technology transfer office evaluating whether to patent a faculty invention has to make a § 101 eligibility judgment long before litigation is ever a possibility — at invention-disclosure triage, at the provisional-filing decision, and again when licensing counsel diligence the claims. Diagnostic-method inventions (a correlation between a biomarker and a disease state) and software/AI inventions (a novel algorithm or model architecture) are the two categories most exposed to Alice/Mayo rejections today, which in turn affects a TTO's practical calculus on whether patenting is worth the cost relative to protecting the same invention as a trade secret or relying on a first-mover/know-how advantage instead. PERA, if enacted, would not retroactively revive an invention a TTO already declined to patent under current doctrine — patentability is assessed as of filing — but it would change the eligibility calculus for inventions disclosed and filed after any effective date, and could affect prosecution strategy for pending applications depending on the bill's final transition provisions. None of that is triggered by introduction or a committee hearing; only enactment would change what is patentable.
Desk Rejection
A desk rejection is an editorial decision made by the handling editor (or an in-house editorial team) to decline a submitted manuscript before it is sent out for external peer review. It is issued at the initial screening stage, prior to any reviewer being invited, and is typically driven by one or more of: a scope mismatch with the journal's aims, insufficient apparent novelty or significance for the target venue, failure to meet basic formatting, language-quality, or file-completeness requirements, or failure to meet the journal's baseline reporting standards (missing ethics statements, required disclosures, or a data-availability statement, for example). Because no reviewer has evaluated the manuscript's methods or findings, a desk rejection reflects a judgment about fit and readiness, not a verdict on scientific merit. Some journals and publishers report a desk rejection rate -- the share of submissions declined at this screening stage -- though the figure varies enormously by journal prestige and field and has no universal benchmark.
xTrain
xTrain is the electronic module within NIH's eRA Commons system used to prepare, submit, and track the paperwork that appoints a trainee to, and later terminates a trainee from, an NIH-supported training or fellowship award. Something qualifies as an xTrain transaction if it involves one of two specific forms: the PHS 2271 Statement of Appointment (used for a new appointment, a re-appointment into a subsequent budget period, or an amendment to an existing appointment) or the PHS 416-7 Termination Notice (used when a trainee's participation on the award ends, whether by completing the training period or leaving early). xTrain covers institutional research training grants (T32 and related T-series mechanisms, with the documented exception of T34), institutional career development awards, individual Kirschstein-NRSA fellowships (F30, F31, F32, F33), and research education awards -- it does not cover research grants that carry no trainee-appointment obligation, and it is not itself a funding mechanism, only the submission system for the appointment/termination paperwork a mechanism like T32 or F31/F32 requires.
FDA FOIA Request
A written request filed under 5 U.S.C. § 552 and FDA's implementing regulation, 21 CFR Part 20, submitted to FDA's Division of Freedom of Information asking the agency to release records it holds but has not proactively published — most commonly the narrative text of a Form FDA-483, the fuller Establishment Inspection Report, warning letters, or IND/NDA/BLA correspondence not already in a public FDA database.
Accelerated Approval
Accelerated Approval is an FDA regulatory pathway that lets the agency approve a drug or biologic for a serious or life-threatening condition on the basis of an effect on a surrogate endpoint, or an intermediate clinical endpoint, that is reasonably likely to predict the product's actual clinical benefit -- rather than waiting for a completed trial to show that benefit directly. It is authorized under 21 CFR Part 314 Subpart H (drugs, 21 CFR 314.500-314.560) and 21 CFR Part 601 Subpart E (biologics, 21 CFR 601.40-601.46). Approval is conditional: the sponsor must conduct a post-approval confirmatory trial to verify the predicted clinical benefit, and, under the Food and Drug Omnibus Reform Act of 2022 (FDORA, part of the Consolidated Appropriations Act, 2023), FDA can now require that confirmatory trial be underway -- not merely committed to -- at the time of approval or shortly after. If the confirmatory trial fails to verify clinical benefit, or other evidence shows the product isn't safe or effective, FDA can withdraw the approval through an expedited withdrawal procedure that FDORA also created.
35 U.S.C. § 154 (Patent Term)
35 U.S.C. § 154 is the U.S. Patent Act provision that (a) defines the substantive right a patent grants -- the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States, or importing it into the United States (and, for a process patent, the right to exclude others from using, offering for sale, or selling products made by that process) -- and states the length of that grant, and (b) authorizes patent term adjustment (PTA), which lengthens a patent's term to compensate for certain USPTO examination delays. A fact pattern is governed by § 154 whenever the question is how long an issued utility or plant patent's exclusionary term runs, or whether USPTO delay during prosecution entitles the applicant to extra term -- as distinct from patent eligibility (35 U.S.C. § 101), novelty (§ 102), the specification requirements (§ 112), or the presumption of validity in litigation (§ 282), each governed by its own provision.
SBIR/STTR Data Rights
The specific FAR/DFARS data-rights clause package (FAR 52.227-20 for civilian agencies, DFARS 252.227-7018 for DoD) that attaches automatically to SBIR/STTR-funded contracts and grants, giving the small-business or STTR awardee exclusive control over the technical data and computer software it generates under the award. During a 20-year protection period running from the date of award (per SBA's SBIR/STTR Policy Directive and, for DoD, DFARS 252.227-7018 effective January 17, 2025), the government may use that data only for internal government purposes and cannot release or disclose it to a third party -- including a competing contractor bidding on follow-on work -- without the awardee's permission. This is a distinct protection from patent rights: it applies to the data/software deliverables themselves, not the underlying invention, and does not require a patent to be filed at all.
Prescription Drug User Fee Act (PDUFA)
The Prescription Drug User Fee Act (PDUFA) is the 1992 U.S. federal law authorizing FDA to collect user fees from companies that submit certain human drug and biologic applications for review, or that are named as sponsors of certain approved prescription drug products. In exchange for these fees, FDA commits to specific performance goals -- most visibly, review-time targets such as the 10-month goal for a Standard Review application and the 6-month goal for a Priority Review application -- set out in a negotiated agreement between FDA and industry that Congress reauthorizes roughly every five years. PDUFA is the funding and accountability mechanism underlying FDA's human drug review program; it is distinct from the individual expedited-review pathways (Priority Review, Breakthrough Therapy, Fast Track, Accelerated Approval) that operate within the review process it funds.
OSF Preprints
A work counts as an OSF Preprints deposit if it is hosted on the preprint infrastructure built and operated by the Center for Open Science (COS) -- either on the generalist osf.io/preprints server itself, or on one of the branded, discipline-specific community servers (PsyArXiv, SocArXiv, EarthArXiv, and others) that run on the same underlying OSF backend but carry their own name, editorial moderators, and disciplinary scope. It is distinct from an OSF project (the private/public research-management workspace) and from OSF Registries (preregistrations): a preprint is a discrete, versioned, publicly posted manuscript that receives its own Crossref-registered DOI, separate from any OSF project it may have originated in.
ARC Discovery Project
An ARC Discovery Project is a competitively awarded research grant funded under the Australian Research Council's Discovery Program, one of the two programs that make up the ARC's National Competitive Grants Program (NCGP) (the other being the Linkage Program). Discovery Projects fund investigator-driven basic, strategic basic, and applied research across all disciplines except clinical and other medical research (which sits with Australia's National Health and Medical Research Council, NHMRC). Funding runs at $30,000 to $500,000 per year, for project durations of one to five years, administered through the ARC's Research Management System (RMS). Unlike the ARC's dedicated fellowship schemes -- the Discovery Early Career Researcher Award (DECRA) and the ARC Future Fellowship -- a Discovery Project grant is not restricted to a particular career stage: it can be held by an individual researcher or, more commonly, a team of investigators spanning early-career to senior levels, and the grant funds a defined research project rather than a single person's salaried fellowship. This is the defining operational distinction: DECRA and Future Fellowship exist to support a person at a specific career point; a Discovery Project exists to fund a specific piece of research, regardless of who on the team is at what career stage.
Data Curation Network (DCN)
The Data Curation Network (DCN) is a membership consortium of academic and non-profit research-data repositories that pools trained data curators across member institutions so that any participating library can call on specialist review for a dataset, rather than each institution having to hire full curation expertise for every data type it receives. It is distinct from 'data curation' the generic activity and 'data curator' the generic role: DCN is a specific, named organization, hosted administratively by the University of Minnesota Libraries, that operationalizes those generic concepts as a shared-staffing service across its member institutions.
CIHR Postdoctoral Fellowship
The CIHR Postdoctoral Fellowship was the Canadian Institutes of Health Research's individually held, individually competed award funding up to two years of mentored postdoctoral research in a health-research field within CIHR's mandate, providing the fellow with a stipend (most recently harmonized at $70,000 per year) portable to an eligible Canadian or international host institution. CIHR has discontinued this standalone program: it has been folded, together with NSERC's and SSHRC's equivalent individual postdoctoral fellowship programs, into the jointly administered Canada Postdoctoral Research Award (CPRA) -- part of the Tri-Agency's Canada Research Training Awards Suite (CRTAS), which also replaces the three councils' separate master's and doctoral scholarship programs. A researcher researching 'CIHR Postdoctoral Fellowship' or 'CIHR Fellowship' today needs the CPRA application process, applied for through CIHR for health-research proposals.
Special Category Data (GDPR Article 9)
Personal data that GDPR Article 9(1) singles out for heightened protection because of its sensitivity — data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, plus genetic data, biometric data used to uniquely identify a person, health data, and data concerning sex life or sexual orientation. Processing any of these categories is prohibited by default; a research controller needs both an Article 6 lawful basis and a separate Article 9(2) condition before touching the data at all, and for most academic and clinical research that second condition is Article 9(2)(j), the research/archiving/statistics derogation.
Discretionary Grant
A federal award in which the awarding agency exercises statutory judgment ('discretion') in selecting the recipient and/or setting the funding amount, typically through a competitive, merit-reviewed process, as distinguished from a mandatory (formula) grant, where funds are allocated automatically to every entity meeting predetermined statutory eligibility criteria with no agency selection judgment involved.
NSF Merit Review Panel
An NSF merit review panel is the group of external subject-matter experts (or, for ad hoc/mail review, individual experts working independently) that the National Science Foundation convenes under PAPPG Chapter III to evaluate a proposal against the two NSB-mandated criteria, Intellectual Merit and Broader Impacts, producing individual Excellent-to-Poor ratings and written reviews that an NSF program officer weighs, alongside program-level considerations and Division Director concurrence, when recommending a funding decision.
AUTM Better World Project
The AUTM Better World Project is a public storytelling and awards initiative run by the Association of University Technology Managers (AUTM) that collects curated case studies of specific inventions, born from federally funded or institutional research, that were licensed and commercialized into products, services, or companies with a documented real-world benefit. An item qualifies as a Better World Project 'story' when it names a specific technology, traces it back to a specific research institution's technology transfer office, and narrates the licensing/commercialization path in lay terms aimed at a public or policymaker audience -- not when it is simply an internal TTO metric or a generic description of what technology transfer does.
ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects — GCP)
ISO 14155:2020, ‘Clinical investigation of medical devices for human subjects — Good clinical practice,’ is the ISO standard defining GCP requirements — protocol design, informed consent, investigator qualification, sponsor monitoring, adverse-event/device-deficiency reporting, and reporting — for clinical investigations of medical devices in human subjects. It is the device-industry counterpart to ICH E6 for drug and biologic trials.
KBART (Knowledge Bases And Related Tools)
A NISO Recommended Practice (currently RP-9-2014, KBART Phase II) that defines a common tab-delimited data format and field set for content providers to supply title-level holdings metadata — title, ISSN/ISBN, coverage dates, embargo, and URL — to knowledge-base vendors, so that link resolvers and discovery services can accurately determine and display full-text availability.
Altmetric Explorer
Altmetric Explorer (formally 'Altmetric Explorer for Institutions,' with a separate 'Explorer for Publishers' edition) is Altmetric's paid, subscription-only dashboard application: a searchable, filterable web tool that lets a research office, library, or communications team browse, analyze, benchmark, and report on the online attention -- news coverage, policy-document citations, social media mentions, blog posts, Wikipedia references, and other sources -- that Altmetric has captured for research outputs. A product/page qualifies as Altmetric Explorer, rather than the free Altmetric Attention Score badge or browser bookmarklet, specifically because it is the paid, institution-wide reporting and analysis layer built on top of Altmetric's underlying attention data and Attention Score -- not the score itself. The Attention Score and the free bookmarklet/journal-embedded badge are available to view for any individual research output without a subscription; Explorer, by contrast, only exists as a licensed institutional (or publisher) account with login-gated search, department/author-level views, benchmarking, and export/reporting functionality layered on top of that same underlying dataset.
Library Publishing Coalition (LPC)
The Library Publishing Coalition (LPC) is an independent, community-led membership association of academic and research libraries and library consortia that operate or are developing scholarly publishing programs -- library presses, journal-hosting platforms, open monograph publishing, and related services. It was formed between January 2013 and December 2014 when 61 academic libraries, working with the Educopia Institute, organized around a shared professional forum for developing best practices and shared expertise in library-based publishing; the founding conversation originated among Purdue University, the University of North Texas, and Virginia Tech, building on an earlier IMLS-funded planning project. LPC is not a publisher, a certification body, or a standards-setting organization in the way NISO or DOAJ are -- it is a community of practice: a membership association whose value is peer knowledge-sharing, an annual member directory, a professional development curriculum, and an annual forum, run day-to-day through Educopia Institute (Atlanta, Georgia), which provides LPC's operational and staff support.
Erratum
An erratum is a formal, published correction notice that a journal or publisher issues to fix a factual error introduced during the publication process itself (e.g. a typesetting mistake, a mislabeled figure, an author name spelled wrong, a column transposed in a table) rather than an error in the authors' own research, analysis, or reporting. It is linked bidirectionally to the original article's metadata (Crossref lists 'erratum' as one of its enumerated update types) so that the correction is discoverable wherever the article is indexed or cited. An erratum does not withdraw or invalidate the article's findings -- by definition, the underlying science is not in question, only how it was rendered in print or online.
Evaluation Agreement
An evaluation agreement (sometimes called an evaluation license) is a short-term, narrowly-scoped contract that a university or research institution's technology transfer office (TTO) uses to let a prospective licensee test a specific technology — a device, material, dataset, or piece of software — before either party commits to a full commercial license negotiation. What makes an agreement an evaluation agreement, rather than something else, is the combination of: (1) a limited internal-use-only purpose (testing, benchmarking, or feasibility assessment — not manufacturing, sale, sublicensing, or use in a marketed product); (2) a short, fixed term (commonly 90 days to one year, sometimes renewable once); (3) non-exclusivity as the default, since the institution is not yet committing the technology to any one party; and (4) little or no financial consideration, since the point is to let the evaluator decide whether the technology is worth licensing at all, not to monetize use during the trial itself. Many evaluation agreements also include, or are paired with, confidentiality terms and a right of first negotiation or option period for a subsequent full license.
Race Equality Charter (REC)
The Race Equality Charter (REC) is an award-mark scheme run by Advance HE, the UK sector body for higher education and research quality, that recognises universities and research institutes for identifying and addressing structural barriers to race equality among staff and students. Modelled on the same self-assessment/award-mark structure as Advance HE's Athena SWAN gender-equality charter, REC requires a member institution to convene a self-assessment team, analyse ethnicity-disaggregated staff and student data across recruitment, promotion, pay and attrition, gather qualitative evidence of lived experience, and submit an application with a costed, time-bound action plan for independent peer review by an Advance HE panel. Institutions that meet the bar receive a Bronze or Silver award (there is no Gold tier, unlike Athena SWAN) tied to delivering that action plan.
For-Cause Audit
A for-cause audit (or for-cause inspection) is a compliance review triggered by a specific, identified finding, complaint, safety signal, or concern -- as distinguished from a routine, scheduled, or directed audit conducted on a periodic or pre-planned basis regardless of any known issue. The defining test is the presence of a triggering event: a monitoring visit report flagging a serious deviation, an adverse-event or safety-reporting concern, a whistleblower complaint, evidence of possible data integrity problems, or a pattern of findings from a prior routine audit. Two related but distinct uses of the term appear in clinical research: (1) an FDA Bioresearch Monitoring (BIMO) for-cause inspection, opened by the agency's field-investigation function in response to a specific complaint, required report, or safety signal, and which may be unannounced; and (2) a sponsor-, CRO-, or IRB-initiated for-cause audit of a trial site, investigator, or vendor, opened internally in response to a monitoring red flag or reported concern rather than as part of the organization's standard audit schedule.
Scholarly Literature
Scholarly literature is the body of research output produced by subject-matter experts, evaluated through a formal quality-control process (typically peer review or editorial vetting by a scholarly body), and published with the primary purpose of advancing a field's knowledge base rather than generating commercial revenue or informing a general audience. A work qualifies as scholarly literature when it satisfies three conditions together: (1) authorship by researchers writing within their area of expertise, usually with an institutional or disciplinary affiliation; (2) formal vetting before or as a condition of publication -- peer review for journal articles, editorial/academic-board review for monographs, programme-committee review for conference proceedings, or committee examination for dissertations and theses; and (3) a citation apparatus (references, methods, data availability) that lets other researchers verify, build on, or reproduce the work. The main forms are peer-reviewed journal articles, scholarly monographs, conference proceedings, and dissertations/theses; preprints and working papers are usually treated as scholarly literature in a provisional, not-yet-vetted form pending peer review.
Knowledge Exchange Framework (KEF)
Research England's national exercise for assessing and benchmarking how English higher education providers perform knowledge exchange activity -- reported across seven perspectives and scored in quintiles relative to a peer cluster, rather than as research quality (REF) or teaching quality (TEF).
Conference Proceedings
Conference proceedings are the published collection of papers, abstracts, or extended abstracts presented at an academic or professional conference, typically compiled and released around the time of the event by the organizing society, a commercial publisher, or the conference itself. They are a distinct scholarly-output type from the journal article, the scholarly monograph, and the preprint: a proceedings paper is tied to a specific dated event and its program committee, not to a journal's rolling editorial process, and unlike a preprint it has already been through whatever acceptance process that specific conference uses -- which ranges from rigorous full-paper peer review to a light abstract screen, depending entirely on the venue.
Person Months (Horizon Europe)
In Horizon Europe, a person-month is the unit used in a proposal's work plan (Gantt chart and effort tables) to show how much staff time each beneficiary allocates to a work package or task. It is an estimation and planning unit, not the basis the European Commission actually pays on — that is a distinct point of confusion with NIH's identically-named unit. Actual personnel costs at reporting time are calculated in person-days against a capped standard number of working days per year, not directly in person-months, and beneficiaries using the Commission's average personnel cost (unit-cost) option may not need to track individual days at all. The European Commission's own indicative conversion, used for translating between days and months at proposal stage, is 220 working days per year = 12 person-months (so 1 person-month ≈ 18.3 working days). This 220-day planning figure is different from the 215 working days per year figure that is the operative ceiling for actual-cost personnel reporting under the Horizon Europe Annotated Model Grant Agreement (AGA), Article 6.2.A — the maximum number of day-equivalents a beneficiary may charge to the action in a given period is calculated as (215 ÷ 12) × number of months in the reporting period, pro-rated by a working-time (FTE) factor for part-time staff. The 220 and 215 figures serve different purposes (proposal planning vs. reporting ceiling) and should not be interchanged.
Clinical Trial Agreement (CTA)
A Clinical Trial Agreement (CTA) is the legally binding contract between a study sponsor (or a Contract Research Organization acting for the sponsor) and the institution/site conducting the trial (and, typically, the Principal Investigator as a party or signatory) that sets the business and legal terms under which the trial will be performed at that site. A document qualifies as a CTA -- as distinct from the protocol, the informed consent form (ICF), or a data/material-transfer agreement -- when it governs the commercial and risk-allocation terms of the relationship rather than the scientific conduct of the study itself: per-subject and milestone budget and payment schedule, indemnification and insurance (including coverage for trial-related subject injury), intellectual property ownership (background vs. foreground), publication and disclosure rights, data ownership and confidentiality, regulatory-compliance representations, and termination and record-retention terms. The protocol defines what will be done scientifically; the ICF discloses risks and obtains a subject's voluntary participation; the CTA is the separate contract that lets the institution and sponsor actually transact -- get paid, allocate liability, and agree who owns and can publish what comes out of the trial.
IND Annual Report
A comprehensive, once-a-year progress summary that a sponsor holding an active Investigational New Drug (IND) application must submit to FDA under 21 CFR 312.33, due within 60 days of the anniversary date the IND went into effect. It covers every study conducted under the IND during the preceding year (status, enrollment, and completion), a summary of IND Safety Reports and subject deaths/dropouts, preclinical findings, manufacturing or microbiological changes, any Investigator's Brochure revisions, Phase 1 protocol modifications, the sponsor's investigational plan for the coming year, and foreign marketing developments. It continues annually for as long as the IND remains active, independent of whether any individual study is enrolling.
Letter of Credit Drawdown
A letter of credit drawdown is the cash-management method under which a recipient institution draws federal grant funds from a Treasury-administered payment system — most commonly the HHS Payment Management System (PMS), but also agency-specific systems used by NSF, USAID, and others — only in the amount needed to cover actual, imminent disbursements, rather than receiving a lump-sum advance at the start of the award. It qualifies as an instance of this method when three conditions hold: (1) the institution holds standing drawdown authority against a Treasury-linked account tied to a specific award or pooled by awarding agency, not a one-time advance payment; (2) each individual drawdown request is sized to actual, immediate cash need rather than banked ahead of spending; and (3) the timing is governed by 2 CFR §200.305, the Uniform Guidance payment section, which requires non-State recipients to minimize the time elapsing between the transfer of funds from the federal awarding agency and the recipient's actual disbursement of those funds, regardless of whether the transfer happens by electronic funds transfer or another means. This distinguishes drawdown from a periodic reimbursement method, where the institution spends its own cash first and is paid back afterward (subject to a 30-calendar-day agency payment window under the same section), and from a single upfront advance payment covering an entire budget period.
Audit Corrective Action Plan (Grants)
An audit corrective action plan is the document a grantee institution (the auditee) prepares under 2 CFR 200.511(c) responding to each finding in its Single Audit's Schedule of Findings and Questioned Costs. For every current-year finding, it must name the contact person(s) responsible for the corrective action, describe the corrective action to be taken, and give the anticipated completion date; if the auditee disagrees with a finding, it must instead include a detailed explanation of the reasons for disagreement. It is prepared by the auditee, not the auditor, and is submitted as a required component of the Single Audit reporting package -- distinct from the auditor's own findings and from a clinical-research quality-system CAPA.
Continuing Review (IRB)
Continuing review is the periodic re-review an IRB conducts of previously approved, ongoing research to decide whether approval should continue. Under 45 CFR 46.109(e), an IRB must conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, and not less than once per year, except for the limited categories the revised Common Rule exempts from continuing review entirely under 46.109(f) (research eligible for expedited review, research receiving limited IRB review under certain exemptions, and research that has closed to enrollment and moved solely into data analysis or long-term follow-up using standard-of-care procedures). FDA's parallel provision, 21 CFR 56.109(f), requires continuing review of FDA-regulated research at intervals appropriate to the degree of risk and not less than annually, and does not carry the same 2018 Common Rule exceptions. The operative distinction for a study posing greater than minimal risk: continuing review of that research cannot be conducted through the expedited procedure, because expedited review (whether at initial approval or at a continuing-review interval) is only available for research that is no more than minimal risk. A greater-than-minimal-risk study must therefore go before the full convened IRB, with a quorum present and a majority vote, at every continuing-review interval for as long as the study remains open to enrollment or active intervention -- not just at initial approval.
IACUC Semiannual Program Review and Facility Inspection
The PHS-Policy-mandated recurring self-governance duties every Institutional Animal Care and Use Committee (IACUC) must perform on its own institution: reviewing the entire animal care and use program at least once every six months against the Guide for the Care and Use of Laboratory Animals, inspecting all of the institution's animal facilities on that same six-month cycle, and preparing and submitting a signed written report of the review and inspection to the Institutional Official that classifies any deficiencies as significant or minor and sets a correction plan and schedule.
Scholarly Monograph
A scholarly monograph is a book-length, single-authored (occasionally co-authored, rarely multi-contributor) work that presents an original, sustained scholarly argument or body of research on one subject, published by an academic or university press after external peer review of the proposal and, typically, the full manuscript. An output counts as a scholarly monograph, rather than a textbook, trade book, or edited volume, only if all of the following hold: (1) it advances a new argument or original research contribution rather than synthesizing existing knowledge for instructional use; (2) it is reviewed by independent subject-matter experts external to the press, evaluating the manuscript or proposal as a coherent scholarly work, not by press editorial staff alone; (3) it is the product of one sustained authorial voice across the whole book (co-authored monographs still meet this test; a collection of separately authored chapters compiled by an editor does not, and is instead an edited volume); and (4) it is published by a press with an identifiable scholarly-monograph series or list, typically a university press or a recognized academic imprint of a commercial publisher.
NIH Shared Instrumentation Grant (S10)
The NIH Shared Instrumentation Grant (SIG) is a National Institutes of Health funding mechanism, identified by activity code S10, that pays for a single high-cost, commercially available scientific instrument (or integrated instrumentation system) for shared use by a group of NIH-funded investigators at one institution -- it is not a project grant to any individual principal investigator. An award counts as an S10/SIG (rather than some other equipment line item) when: the institution, not an individual researcher, is the formal applicant; the requested instrument costs between $50,000 and $750,000; the application documents a defined 'Group of Major Users' of at least three investigators, each the PD/PI of a distinct, active NIH research award with a demonstrated need for the instrument; and the group's combined projected use meets NIH's Accessible Usage Time thresholds. A companion, higher-cost mechanism -- the High-End Instrumentation (HEI) Grant, also under the S10 activity code -- covers the $750,001 to $2,000,000 range using the same group-application model. Both are administered by NIH's Office of Research Infrastructure Programs (ORIP), part of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI).
21 CFR 312.60 (General Responsibilities of Investigators)
21 CFR 312.60 is the FDA regulation establishing that an investigator conducting an IND-regulated clinical investigation is responsible for: conducting the study according to the signed investigator statement (Form FDA-1572) and the investigational plan/protocol; protecting the rights, safety, and welfare of subjects under the investigator's care; and controlling drugs under investigation, including obtaining informed consent under 21 CFR Part 50 and complying with IRB requirements under 21 CFR Part 56.
PlumX Metrics
A proprietary altmetrics product, owned and operated by Elsevier (built on the Plum Analytics platform, acquired by Elsevier in February 2017), that qualifies as PlumX Metrics data specifically when it reports engagement for a research output as five distinct, non-aggregated category counts -- Citations, Usage, Captures, Mentions, and Social Media -- rather than combining those signals into one overall composite score; the category structure itself, not just the presence of altmetrics-style tracking, is what distinguishes it from single-score competitors.
Pharmacovigilance System Master File (PSMF)
The Pharmacovigilance System Master File (PSMF) is the single, maintained regulatory document in which an EU marketing-authorisation holder (MAH) describes its ENTIRE pharmacovigilance system -- not one product's safety data, but the organisational structure, processes, and quality system the MAH uses to detect, assess, and manage the safety of all the medicinal products it covers under that system. Required under GVP Module II (itself issued under the EU's 2010 pharmacovigilance legislation and Directive 2001/83/EC as amended), the PSMF must be kept permanently up to date and made available to EU national competent authorities and the European Medicines Agency (EMA) on request. A document is a PSMF, as opposed to some other pharmacovigilance record, if it (a) is maintained by or on behalf of a specific MAH, (b) describes the pharmacovigilance system as a whole -- covering organisational structure, the Qualified Person Responsible for Pharmacovigilance (QPPV) and their responsibilities, data sources, IT systems, and the quality system that supports the whole -- rather than a single case, study, or product, and (c) has a PSMF location and reference number that the MAH's marketing-authorisation dossiers reference back to, with QPPV and PSMF-location contact details held in the EMA database described in Article 57 of Regulation (EC) No 726/2004.
Maintenance of Effort (MOE)
Maintenance of Effort (MOE) is a condition attached to certain federal (and some state) grant programs requiring a recipient to sustain its own non-federal financial or programmatic effort in a defined area at or above a documented baseline level -- typically the prior year's expenditure, or an average of recent years -- as a continuing condition of eligibility for the federal award, independent of whether the federal funds themselves are spent correctly. Unlike a one-time eligibility test, MOE is assessed on a recurring basis (usually annually) by comparing current-year non-federal spending or effort against the baseline; falling short constitutes an MOE violation even if every dollar of the federal award was used appropriately.
Industry Affiliates Program
A standing, fee-based membership arrangement in which a company pays a recurring (typically annual) membership fee to a university lab, center, or department for a bundle of ongoing benefits -- ordinarily early or preferred access to a defined stream of the center's research output, participation in an advisory or steering committee that helps set the research agenda, invitations to networking and research-showcase events, and access to a student recruiting pipeline -- rather than funding a specific, deliverable-bound project. Membership is typically structured to grant a non-exclusive, use-only license to the resulting research output, not ownership or exclusive rights, which preserves the pre-competitive, multi-member model the program depends on.
NIH Priority Score
An NIH priority score (overall impact score) is the numerical merit rating -- 10 (best) to 90 (worst) -- that a study section assigns a discussed grant application, calculated by averaging each voting reviewer's independent 1.0-9.0 overall impact rating and multiplying by 10. Where percentiling applies, that score is further converted into a percentile rank comparing the application against others reviewed by the same or a related study section over its three most recent meetings. Applications a study section does not select for full discussion (typically those projected to fall in the lower half of the range) receive no overall impact score. Not every scored application is percentiled -- some mechanisms and small comparison groups are scored but not percentiled by policy. The priority score and percentile feed into, but do not by themselves determine, the funding institute's payline-based funding decision.
Fake Citation
A fake citation (also called a fabricated citation or, when the source is a paper never written at all, a phantom reference) is a reference that does not correspond to a real, findable publication -- an invented author, title, journal, DOI, or page range, or some combination of these, presented as if it points to an actual source. It also covers the narrower case of a citation to a real work that is misrepresented: the cited paper exists, but it does not say, show, or support what the citing text claims it does. A citation is operationally 'fake' if a reader who tries to locate and check it cannot verify that the source exists as described, or finds that the source exists but does not support the claim attached to it -- as opposed to an honest error (a typo in a volume number, a wrong year) that still resolves to the intended real work.
TMF Reference Model
The TMF Reference Model is a harmonized, industry-developed taxonomy for organizing Trial Master File (TMF) content into a predictable three-tier hierarchy of Zones, Sections, and Artifacts (with a fourth, more granular Sub-Artifact tier), each artifact carrying a unique ID, a written purpose/definition, and expected trial-phase metadata. A TMF or eTMF is properly described as 'built on' or 'mapped to' the TMF Reference Model when its filing structure and document types trace back to this defined Zone/Section/Artifact scheme rather than an organization's own bespoke folder taxonomy -- it is a classification standard layered on top of the general TMF/eTMF concept, not a synonym for it.
21 CFR Part 314 (Applications for FDA Approval to Market a New Drug)
21 CFR Part 314, "Applications for FDA Approval to Market a New Drug," is the FDA regulation establishing the entire New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) framework: the content and format an application must have (Subpart B, chiefly 314.50), the abbreviated pathway for generics relying on bioequivalence to an already-approved drug (Subpart C), FDA's review process including the filing decision, approval standard, and Complete Response Letter mechanism (Subpart D, 314.101/314.105/314.110), administrative hearing procedures (Subpart E), confidentiality provisions (Subpart G), accelerated approval based on a surrogate endpoint (Subpart H), and approval without human efficacy studies when unethical or infeasible, the "Animal Rule" (Subpart I). It governs a drug from the point a sponsor seeks marketing approval onward, picking up where 21 CFR Part 312 (Investigational New Drug) leaves off at the end of clinical investigation. Two individual Part 314 sections have their own dedicated CASRAI entries: 314.70 (post-approval changes) and 314.80 (postmarketing adverse event reporting), both within Subpart B.
Delegation of Authority (DoA) Log
A Delegation of Authority (DoA) Log is the site-level record, maintained for each clinical trial at each investigator site, that documents which specific trial-related tasks the Principal Investigator (PI) has authorized named study-team members to perform, together with each person's qualifications, their signature or initials, and the exact date range during which that authorization was in effect. It answers one question for anyone reviewing the trial afterward — a monitor, an auditor, or an FDA inspector: was the person who performed this specific task actually authorized to perform it, on the date they performed it? A document set qualifies as a compliant DoA log when it names every individual (co-investigator, sub-investigator, clinical research coordinator, research nurse, research pharmacist, or other delegated staff) who performed a trial-related procedure or made a trial-related judgment; lists the specific tasks delegated to that person, not a generic job title; is signed or initialed by both the delegate and the PI; states the start date (and end date, once applicable) of each delegation; and is kept current as staff join, leave, or take on new responsibilities throughout the trial. Under ICH E6(R2) Section 4.1.5, the investigator must maintain a list of appropriately qualified persons to whom significant trial-related duties have been delegated; the DoA log is the standard operational instrument sites use to satisfy that requirement and to demonstrate it during inspection.
MEDLINE Database
MEDLINE is the U.S. National Library of Medicine's core bibliographic database of biomedical and life-sciences journal literature: a curated set of article citations, indexed with MeSH controlled-vocabulary terms, drawn only from journals that have individually passed NLM's formal journal-selection review. It is distinct from PubMed (NCBI's free search interface, which includes MEDLINE plus some non-MEDLINE records) and from PubMed Central/PMC (NLM's separate full-text repository, with its own, less restrictive inclusion criteria).
Ethical Violation
An ethical violation in research is any act or omission that breaches an accepted professional, institutional, or regulatory research-ethics norm, whether or not it meets the narrower threshold for formal 'research misconduct.' In the US federal system, research misconduct is legally defined by 42 CFR Part 93 as fabrication, falsification, or plagiarism (FFP) only, and explicitly excludes honest error, good-faith disagreement, and behaviors 'not unique to research' such as harassment or grant-management violations. 'Ethical violation' is the broader umbrella: it covers FFP, but also questionable research practices (QRPs), authorship abuse (ghost, guest, or gift authorship; denying deserved credit), undisclosed conflicts of interest, human- or animal-subjects protection breaches (e.g., proceeding without IRB/IACUC approval, exceeding approved protocol scope), peer-review misconduct (manipulating or leaking a manuscript under review), duplicate or salami-slicing publication, and mentorship or supervisory abuse. Whether a specific act rises to the level of an actionable 'ethical violation' is determined by the applicable code of conduct: an institution's own policy, a funder's terms and conditions, a journal's editorial policy (e.g. via COPE), or a national/international integrity code (e.g. ALLEA's European Code of Conduct for Research Integrity, or the UK's UKRIO framework), each of which sets its own scope and remedies.
Investigator Site File (ISF)
A document or record belongs in an Investigator Site File (ISF) if it demonstrates something only the trial site itself can attest to under ICH E6(R2)'s essential-documents framework -- delegation of authority, site-specific IRB/IEC oversight, staff qualifications, signed informed consent, and site-level investigational-product accountability -- created and maintained by the site itself (not the sponsor or CRO) throughout the trial and kept available for monitoring and inspection.
FDA BIMO (Bioresearch Monitoring) Program
FDA's Bioresearch Monitoring (BIMO) Program is the umbrella FDA inspection and data-audit program covering clinical investigators, sponsors/monitors/CROs, IRBs, nonclinical (GLP) laboratories, in vivo bioequivalence facilities, and several narrower tracks (RDRC, PADE, REMS reporting). It exists to verify the quality and integrity of data submitted in support of FDA product approvals and to protect the rights, safety, and welfare of human subjects and animals involved in the underlying research. BIMO inspections can be routine/surveillance, directed data audits, for-cause, or compliance follow-up, and each closed inspection resolves to one of three classifications: No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI).
Site Management Organization (SMO)
A Site Management Organization (SMO) is a company that provides staff, infrastructure, and administrative support directly to clinical trial sites -- as distinct from a Contract Research Organization (CRO), which contracts with the sponsor to manage a trial across multiple sites. An SMO's contractual relationship typically runs to the investigator or site, not the sponsor: it supplies clinical research coordinators (CRCs), regulatory-documentation support, patient-recruitment assistance, and study start-up help to one or more physical sites, and in many cases owns or directly operates a network of sites itself. Unlike the CRO, which is explicitly defined in ICH E6(R2) Section 5.2 and (for FDA-regulated drug trials) 21 CFR 312.52, an SMO has no equivalent formal regulatory definition -- it is an industry business-model term, not a regulatory delegation category.
Stevenson-Wydler Technology Innovation Act
A 1980 federal statute (Public Law 96-480, codified at 15 U.S.C. Chapter 63, Sections 3701 et seq.) that made technology transfer an explicit mission of every federal laboratory, requiring labs to actively work to transfer federally developed technology to state and local governments and the private sector -- as distinct from Bayh-Dole, enacted the same year, which governs patent title for inventions made by universities, nonprofits, and small businesses under federal funding agreements, not the labs' own technology-transfer obligations.
Sole Authorship
The condition of a scholarly or scientific work having exactly one author: a single named individual who alone satisfies the full authorship criteria a publisher or field applies (most commonly the ICMJE's four-part test -- substantial contribution to conception or design, drafting or critically revising the work, final approval of the published version, and accountability for its accuracy and integrity), with no co-authors to share credit, order, or accountability with. Because there is only one contributor, none of the coordination questions that dominate multi-author authorship management -- author order, corresponding-author designation, CRediT role-splitting, gift or ghost authorship, or authorship disputes -- apply: the sole author is, by definition, first author, last author, and corresponding author simultaneously, and carries full responsibility for the entire work rather than a delineated share of it.
Lead Author
A person is called a "lead author" in one of two distinct senses. Most commonly, it is an informal synonym for first author: the name listed first in a scholarly work's byline, conventionally read (in contribution-ranked fields) as the person who did the largest share of the practical work, and used interchangeably with "first author" especially in press releases, journalism, and general prose. Separately, in large team-authored scientific assessment reports (most visibly the IPCC), "Lead Author" is a formal, nominated role responsible for drafting a designated section of a chapter as part of a team, alongside Coordinating Lead Authors -- a role defined by section-writing and coordination responsibility, not by contribution-ranked byline position, and with no single "first author" slot at all.
Period of Performance
Period of performance is the specific time interval -- defined at 2 CFR 200.1 as "the time interval between the start and end date of a Federal award, which may include one or more budget periods" -- during which a recipient or subrecipient is authorized to incur allowable costs and carry out the substantive programmatic work of a federal award. Under 2 CFR 200.309, a non-Federal entity may charge to the award only costs incurred within this window, plus any pre-award costs specifically authorized in advance by the Federal awarding agency or pass-through entity, and a narrow publication/printing-cost exception at 2 CFR 200.461. Costs incurred before the start date or after the end date are not allowable charges to the award outside those exceptions. A multi-year award's single period of performance may be divided into one or more budget periods (annual funding increments, also defined at 2 CFR 200.1), and the period of performance's end date can be modified -- most commonly extended -- through a No-Cost Extension under 2 CFR 200.308(d)(2).
R15 (NIH Academic Research Enhancement Award / AREA)
The R15 Research Enhancement Award (activity code R15, most commonly encountered via its Academic Research Enhancement Award / AREA sub-program, or its REAP sub-program for health professional and graduate schools) is an NIH grant mechanism restricted to institutions that have NOT been major recipients of NIH research funding: a qualifying institution (or its relevant non-health-professional components) must have received no more than $6 million per year in total NIH support in 4 of the last 7 fiscal years. It is designed to fund meritorious research at smaller, teaching-focused institutions while requiring that the research team be composed primarily of students, with a capped budget (currently up to $375,000 in direct costs) over a project period of up to 3 years.
Supplanting
Supplanting is the use of federal grant funds to replace non-federal funds a recipient would otherwise have spent on the same activity, position, or service, rather than using the federal award to add new or expanded effort. It is the prohibited counterpart to the "supplement, not supplant" condition attached to many federal grant programs, and is assessed by comparing the funded level of activity against a documented non-federal spending baseline.
NIH Prior Approval
A post-award change on an NIH grant or cooperative agreement requires NIH prior approval when it falls into one of the categories the NIH Grants Policy Statement (NIH GPS) Section 8.1.2 designates as requiring the awarding Institute or Center's written sign-off before the recipient implements it -- rather than a change the recipient may make unilaterally and simply report after the fact. The request must be submitted by the institution's Authorized Organization Representative/Signing Official (not the PD/PI directly) through the eRA Commons Prior Approval module, or by email to the assigned Grants Management Specialist where the module does not yet cover a given request type, and NIH's practice is to expect submission at least 30 days before the proposed change and to target a response within 30 days of a complete request. Acting on one of these changes without approval is not merely a paperwork lapse: it converts an otherwise defensible administrative decision into a potential audit finding or disallowed cost.
Final Invention Statement & Certification
The Final Invention Statement and Certification (HHS Form 568) is the grant-closeout document by which a federal award recipient certifies, to the funding agency, either a complete list of every subject invention conceived or first actually reduced to practice under the award, or an affirmative statement that no subject invention was made. It is a closeout-stage compliance filing required by NIH and other Public Health Service (PHS) awarding components under the Bayh-Dole Act's standard patent rights clause (37 CFR 401.14), submitted through the Interagency Edison (iEdison) system, and is distinct from the earlier, ongoing obligation to disclose each individual subject invention to the funding agency as it is made.
F&A Waiver
An F&A waiver (indirect cost rate waiver) is an institution's agreement to recover indirect costs on a specific award at less than its full federally negotiated F&A rate -- ranging from a partial reduction to a full waiver to 0%. It is an exception applied award-by-award, not a change to the institution's underlying Negotiated Indirect Cost Rate Agreement (NICRA), which continues to state the institution's full rate for every other award. A waiver is distinct from the de minimis rate (a flat substitute for organizations that have never negotiated a rate at all) and from a sponsor's own published rate cap, though a sponsor cap is the single most common reason institutions grant one.
Risk-Based Quality Management (RBQM)
Risk-Based Quality Management (RBQM) is the quality-by-design framework ICH E6(R2) introduced in its Section 5.0 (2016) and ICH E6(R3) generalized further: sponsors identify and prioritize risks to critical-to-quality trial data and processes starting at protocol design (E6(R2) Section 5.0.1), set predefined quality tolerance limits (QTLs, Section 5.0.4) for a small number of trial-critical parameters, and use centralized statistical monitoring and risk-proportionate on-site/remote monitoring (Section 5.18.3) to detect and correct deviations. RBQM is the overarching quality-management framework; risk-based monitoring (RBM) is one operational technique within it, not a synonym for it.
Clinical Trials Office (CTO)
A Clinical Trials Office (CTO) is the institutional unit -- typically housed within an academic medical center, hospital, or university health science center -- that provides centralized administrative, regulatory, and financial support to investigators conducting clinical trials at that institution. A unit qualifies as a CTO when it performs some combination of budget development and sponsor rate negotiation, clinical trial agreement (CTA) review and negotiation, regulatory-submission support (IRB liaison, FDA correspondence support), coverage-analysis and Medicare Clinical Trial Policy (NCD 310.1) billing-compliance review, and study feasibility/start-up coordination specifically for interventional or observational human-subjects trials -- as distinct from a general Sponsored Programs Office (which administers the institution's full grants and contracts portfolio across all disciplines) and distinct from a Contract Research Organization (an external commercial vendor a sponsor hires to run trial operations, not an internal institutional support office).
Person Months
Person months is NIH's standard unit for expressing the effort a PD/PI, faculty member, or other senior/key personnel devotes to a specific project. It is calculated by multiplying the percentage of a person's total professional effort committed to the project by the number of months in that person's appointment type: calendar year (CY, 12 months), academic year (AY, the institution's defined academic-year length -- commonly 9 months, sometimes 9.5 or 10), or summer term (SM, the institution's defined summer period, commonly 2-3 months). The figure appears in the Senior/Key Person Profile of an NIH budget, in Other Support disclosures, and in the annual Research Performance Progress Report (RPPR), and it must reflect a genuine share of total professional effort -- not clock hours worked or a share of a 40-hour week.
Clinical Operations
Clinical operations (often shortened to "clin ops") is the organizational function responsible for the logistical and operational execution of a clinical trial once it has been designed and funded: selecting and activating sites, staffing and managing the monitoring function, overseeing clinical data management systems, coordinating investigational-product supply, managing third-party vendors (labs, imaging cores, IRT/RTSM providers), and tracking trial progress against timeline and budget. A function is properly described as clinical operations when its output is the trial actually running -- sites open, participants enrolled, data flowing, product supplied -- rather than deciding what the trial should study (clinical development) or generating the wider evidence base a study contributes to (clinical research).
NSF GRFP (Graduate Research Fellowship Program)
The NSF Graduate Research Fellowship Program (GRFP) is a competitively awarded, individually-held fellowship funding three years of graduate study and research (within a five-year eligibility window) for early-career graduate students -- and eligible undergraduate seniors applying in advance -- pursuing full-time, research-based STEM or STEM-education master's or doctoral study. It provides a $37,000 annual stipend to the fellow plus a separate $16,000 Cost of Education allowance paid to the fellow's institution. Eligibility is restricted to U.S. citizens, U.S. nationals, and U.S. permanent residents; applicants must not already hold a doctoral or equivalent terminal degree.
Cost Transfer
A cost transfer is the reassignment of an expense already posted to one sponsored project ledger to a different sponsored project (or from a non-sponsored account onto a sponsored one) after the original transaction has occurred. It is distinct from an initial charge decision made at the time an expense is incurred: a cost transfer is always a correction or reclassification made after the fact, moving a real, previously-recorded cost rather than authorizing a new one. Under the allowability and allocability standards at 2 CFR 200.403 and 200.405, every transferred cost must independently satisfy the same tests an original charge would -- necessary, reasonable, allocable to the receiving award in proportion to the benefit it provides, and consistently treated -- a transfer does not get a lower bar just because the underlying expense was legitimate somewhere. Most research institutions require transfers to be processed within a defined window, commonly 90 calendar days from the date the original charge posted, submitted with documentation specific enough that an independent reviewer, such as an auditor, could understand how the error occurred and confirm the new charge is correct -- a generic note that a transfer corrects "a posting error" or moves a cost "to the correct project" does not meet that bar on its own.
Biosafety Level 5 (BSL-5)
There is no “Biosafety Level 5” (BSL-5) in the biosafety containment framework used in the United States. The CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL, 6th edition, 2020) — the primary US reference for laboratory biosafety practice, and the framework incorporated by reference into the NIH Guidelines and the Federal Select Agent Program — defines exactly four cumulative containment levels, BSL-1 through BSL-4. BSL-4 is explicitly the maximum standard containment level: it is reserved for agents that pose a high risk of life-threatening disease, have no routinely available vaccine or treatment, and carry a realistic risk of aerosol transmission (for example Ebola, Marburg, and Variola/smallpox virus). No recognized national or international biosafety framework — including the frameworks referenced by WHO or by other countries’ biosafety authorities — defines a fifth, more stringent numbered tier above BSL-4. A search for “BSL-5” or “Biosafety Level 5” almost always reflects one of three things: (1) a misremembering or misreading of BSL-4 as if the numbering continued further; (2) informal or journalistic usage describing an especially dangerous, BSL-4-level pathogen as needing “level 5” containment for emphasis, with no formal designation behind the phrase; or (3) conflation of BSL-4’s two distinct primary-containment approaches — cabinet laboratories and suit laboratories — or of facility-specific “enhanced” protocols layered on top of baseline BSL-4 for a small number of especially high-consequence agents, as if these were a separate, higher-numbered level rather than variations within BSL-4 itself.
Research Administrator Day
Research Administrator Day is an annual U.S. professional-recognition observance held on September 25, established in 2015 by the National Council of University Research Administrators (NCURA) and formally proclaimed through National Day Calendar. It is dedicated to recognizing the staff who manage the pre-award and post-award work of securing and administering sponsored research funding -- grants specialists, sponsored-programs officers, compliance staff, and departmental research administrators. The Society of Research Administrators International (SRAI) also promotes the day to its own membership under the same September 25 date, so in practice it functions as a shared, sector-wide observance rather than one sponsored by a single body. It is not a federal holiday and carries no legal or regulatory status; observance is voluntary and institution-by-institution.
NIH Guide for Grants and Contracts
The NIH Guide for Grants and Contracts (grants.nih.gov/guide) is NIH's official publication of record for grants-related announcements: every NIH Institute, Center, and Office is required to publish its official Notices there, each assigned a unique NOT-prefixed number, and a weekly Table of Contents lists everything posted that week. Before FY2026 it was also the official channel for Notices of Funding Opportunity (NOFOs, formerly FOAs) themselves; since FY2026, per NOT-OD-25-143, new NOFOs are posted on Grants.gov instead, while the Guide continues to carry every other Notice type -- policy changes, administrative supplements, requests for information, correction notices, and pre-application announcements.
ESRC Postdoctoral Fellowship
An ESRC Postdoctoral Fellowship is a UK Research and Innovation (UKRI) award, funded through the Economic and Social Research Council (ESRC) but applied for and administered through an ESRC-recognised Doctoral Training Partnership (DTP), not directly through ESRC or UKRI's central funding service. It supports a single named early-career researcher for up to nine months full-time (or up to 18 months part-time, pro-rated) immediately after completing a UK-based PhD, covering the fellow's salary plus additional funds for research and training costs. Eligibility is tightly bounded: the applicant's PhD must have been undertaken at a research organisation inside the ESRC doctoral training network, and no more than 15 months of active postdoctoral experience (full-time equivalent, measured from the viva to the competition closing date) can have elapsed. Fellowship activity must sit at least 50% within the social sciences even where the underlying research is genuinely interdisciplinary, and an applicant may submit to only one DTP per competition round.
ICH Q10 (Pharmaceutical Quality System)
ICH Q10 (Pharmaceutical Quality System) is the ICH Quality-series guideline that defines a model pharmaceutical quality system (PQS) spanning a product's entire life cycle -- pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. A quality system meets ICH Q10 when it (1) sits on top of applicable Good Manufacturing Practice (GMP/ICH Q7) requirements and incorporates ISO 9001 quality-management-system principles, (2) applies the risk-based tools of ICH Q9 (Quality Risk Management) to prioritize and scope quality decisions, (3) uses the science- and risk-based product/process understanding built during development under ICH Q8 (Pharmaceutical Development), and (4) operates four specific management enablers -- a Process Performance and Product Quality Monitoring System, a Corrective and Preventive Action (CAPA) system, a Change Management System, and Management Review -- under documented senior-management responsibility and a stated commitment to continual improvement.
Select Agent List
The Select Agent List is the HHS/USDA-maintained roster (42 CFR Part 73, 7 CFR Part 331, 9 CFR Part 121) of specific biological agents and toxins determined to pose a severe threat to human, animal, or plant health. Any entity possessing, using, or transferring a listed agent above regulatory exclusion thresholds must register with the Federal Select Agent Program (jointly run by CDC and USDA/APHIS), designate a Responsible Official, and ensure every individual with access clears an FBI Security Risk Assessment; a smaller Tier 1 subset carries additional security and suitability-monitoring requirements.
Institutional Base Salary (IBS)
The annual compensation an institution itself pays a faculty or staff member for the appointment covering their full professional effort -- whatever mix of research, teaching, clinical, administrative, or other institutional duties that appointment involves -- regardless of how many separate funding sources (federal, non-federal, institutional) ultimately pay portions of it. Per the NIH Grants Policy Statement (Section 12.8.1, Salaries and Fringe Benefits), IBS excludes any income an individual is permitted to earn outside their duties to the institution (e.g., outside consulting, honoraria, board fees) and excludes discretionary items such as bonuses or incentive pay that are not a fixed part of the base appointment. IBS cannot be inflated after the fact by substituting grant funds for institutional salary funds. IBS is the institution's own determination -- there is no federal formula for calculating it -- but once set, it becomes the base figure federal sponsors require for two distinct purposes: (1) as the denominator for converting a person's percentage of effort on a project into a dollar salary request, and (2) as the figure against which a cap such as the NIH salary limitation is applied, when one exists.
Declaration of Helsinki
The Declaration of Helsinki is the World Medical Association's statement of ethical principles for medical research involving human participants, first adopted in 1964 (Helsinki) and revised at WMA General Assemblies through the most recent revision, adopted October 19, 2024. It is the operative ethical reference a physician-investigator, sponsor, or ethics committee cites specifically for physician-conducted medical research -- distinct from the Nuremberg Code (a fixed 1947 tribunal judgment) and the Belmont Report (a US-specific 1979 national-commission document underlying the Common Rule) -- and it is the ethical source ICH E6 Good Clinical Practice cites as the origin of its own principles. A study or protocol is judged against the Declaration when the question is whether independent ethics-committee review occurred, informed consent was genuinely obtained, any placebo/no-treatment control arm was ethically justified, and results-transparency obligations were met.
Source Documentation (Source Documents / Source Data)
Source documentation is the body of original records -- medical charts, laboratory reports, imaging studies, pharmacy dispensing logs, subject diaries, correspondence, and automated instrument printouts -- in which clinical findings, observations, or other trial-related activities are first captured, at the point and time they occur. The information those records contain is source data; the records themselves are source documents. A record only counts as a source document for a given data point if it is where that data point was originally recorded -- a transcription onto a separate worksheet or data-collection tool is not itself a source document unless no earlier original record exists. Per ICH E6(R2) Section 1.51, source data is 'all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial'; Section 1.52 defines source documents as the original documents, data, and records containing that information. To be inspection-ready and support reconstruction of the trial, source documentation must satisfy the ALCOA-C principles: Attributable (identifies who recorded it and when), Legible, Contemporaneous (recorded at the time of the observation, not backfilled), Original (the first record, or a verified certified copy), Accurate, and Complete.
CAPA (Corrective and Preventive Action)
CAPA (Corrective and Preventive Action) is the formal quality-system process an organization uses to investigate a finding -- an audit observation, a protocol deviation, an FDA Form 483 observation, or any other nonconformity -- determine its root cause, implement a correction and corrective action to eliminate that cause, take preventive action to stop the same or a similar problem recurring elsewhere in the system, and verify afterward that those actions actually worked.
ANZCTR (Australian New Zealand Clinical Trials Registry)
The Australian New Zealand Clinical Trials Registry (ANZCTR) is the primary online registry for clinical trials conducted in Australia and New Zealand, distinguished from clinical trial registration generally by being the specific bi-national system, housed and managed by the NHMRC Clinical Trials Centre at the University of Sydney since 2005, that assigns every registered study a unique ACTRN (Australian Clinical Trial Registration Number) and was, in 2007, one of the first three registries the World Health Organization recognized as a Primary Registry under its International Clinical Trials Registry Platform (WHO ICTRP).
Consensus (AI Academic Search Engine)
Consensus is a named AI-powered academic search engine (built by the company Consensus, at consensus.app) that retrieves peer-reviewed papers relevant to a natural-language research question and generates a synthesis of what the retrieved literature says, rather than returning a plain ranked list of results. For questions phrased as a yes/no/maybe claim, it additionally displays a 'Consensus Meter' -- a visual indicator of how the retrieved papers' findings line up (agree, disagree, or mixed) on that specific claim, generated from the paper set Consensus itself retrieved and summarized. It is a specific product in the 'literature summarization and evidence-synthesis' category, distinct from general-purpose AI chatbots (which do not search a dedicated indexed academic corpus or cite retrieved papers by default) and from citation-graph or general-purpose scholarly search tools such as Semantic Scholar (which surface and rank papers but do not generate a claim-level agreement synthesis across them).
Medical Device Amendments of 1976
The Medical Device Amendments of 1976 (Pub. L. 94-295) is the U.S. federal statute, signed by President Gerald Ford on May 28, 1976, that amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create the modern medical device regulatory framework. Before 1976, FDA had essentially no premarket authority over devices -- only the FD&C Act's general adulteration and misbranding provisions applied, the same standard used for drugs since 1938 but poorly suited to the mechanical, electrical, and implantable nature of devices. The Amendments added Section 513 to the FD&C Act, establishing a risk-based, three-tier classification system (Class I, II, III) and, for the first time, two premarket regulatory pathways keyed to that classification: premarket notification (what the statute's own section number gave us as the now-familiar '510(k)') and premarket approval (PMA) for the highest-risk devices. Devices already legally on the U.S. market when the law took effect were not retroactively required to prove safety and effectiveness from scratch; they were classified based on their existing marketing history, and later devices could establish 510(k) eligibility by claiming 'substantial equivalence' to one of these pre-1976 devices or to a device subsequently cleared through that same route -- the origin of the 'predicate device' concept that still anchors the 510(k) pathway today.
Software export controls
The application of US export control regulations, principally the Export Administration Regulations (EAR, 15 CFR 730-774), to software source code, object code, and related technical data, addressing three issues distinct from general item/equipment export control: (1) whether the software qualifies as 'published' and therefore outside EAR jurisdiction under 15 CFR 734.7 (or fundamental-research-excluded under 734.8), based on whether it was released without restriction on further dissemination; (2) whether the software has cryptographic functionality subject to the separate Category 5 Part 2 encryption controls (ECCNs 5A002/5D002/5E002) and associated License Exception ENC or self-classification requirements; and (3) whether granting a foreign national visual, electronic, or repository access to controlled, non-published source code constitutes a deemed export under 15 CFR 734.13, independent of whether any file is physically transmitted abroad.
Je-S (Joint Electronic Submission)
Je-S (Joint Electronic Submission), hosted at je-s.rcuk.ac.uk, is UK Research and Innovation's (UKRI) legacy online system for submitting grant applications and administering research council awards. UKRI's seven research councils used Je-S for close to two decades before progressively replacing it with the UKRI Funding Service (funding-service.ukri.org) from 2023 onward. A form, account, or award is 'in Je-S' when it was created on, or is still being administered through, that older platform rather than the current Funding Service.
IND Exemption (21 CFR 312.2(b))
The regulatory determination, made by a sponsor under 21 CFR 312.2(b), that a clinical investigation of a drug already lawfully marketed in the United States does not require an Investigational New Drug (IND) application because the study meets all five conditions in the rule: it is not intended to support a new indication or a significant labeling/advertising change, it does not significantly increase the risk (or decrease the acceptability of risk) associated with the drug's approved use, it is conducted in compliance with IRB review (21 CFR Part 56) and informed consent (21 CFR Part 50) requirements, it is not intended to promote the drug for an unapproved use, and it does not involve a route of administration, dosage level, patient population, or other factor that significantly increases the risks associated with the drug's approved use. All conditions must be met simultaneously; failing any one of them means the study needs a full IND regardless of how the others resolve.
21 CFR 314.70 (Changes to an Approved NDA or ANDA)
21 CFR 314.70 is the FDA regulation ("Supplements and other changes to an approved NDA," applied to ANDAs via 21 CFR 314.97) that requires the holder of an approved New Drug Application or Abbreviated New Drug Application to classify every post-approval change to the product, its manufacturing, or its labeling into one of four reporting tracks based on the change’s potential to adversely affect identity, strength, quality, purity, or potency: a Prior Approval Supplement (PAS) for major changes, requiring FDA approval before distribution of product made using the change; a Changes Being Effected in 30 Days supplement (CBE-30) for moderate-risk changes, permitting distribution 30 days after FDA receives the supplement absent an FDA objection; a Changes Being Effected in 0 Days supplement (CBE-0) for a narrower, FDA-designated set of lower-risk changes (most notably certain safety labeling updates), permitting distribution immediately upon FDA’s receipt; and the Annual Report track for minor changes, which are simply documented in the applicant’s next annual report rather than submitted as a standalone supplement. The applicable category is determined by the nature of the specific change, not by applicant discretion.
ePRO (Electronic Patient-Reported Outcomes)
ePRO is the electronic capture of a Patient-Reported Outcome (PRO) directly from a clinical trial participant -- via a provisioned or patient-owned (BYOD) device, app, wearable, or web portal -- without amendment or interpretation by site staff. A data point qualifies as ePRO only when three conditions hold together: (1) the underlying instrument is a validated PRO measure with a defined concept of interest and context of use; (2) the response is entered by the patient at the point of report, not transcribed later by a coordinator or clinician; and (3) the capture system produces a timestamped, attributable, auditable electronic record sufficient to serve as source data for FDA inspection. It is distinguished from Clinician-Reported Outcome (ClinRO) data entered into the trial's eCRF by a site investigator, and from a paper PRO diary that a coordinator later keys into an EDC system -- both of those break the direct-from-patient chain that defines a PRO in the first place.
Medical Device Reporting (MDR)
Medical Device Reporting (MDR) is FDA's mandatory adverse-event reporting system under 21 CFR Part 803, requiring device manufacturers, importers, and device user facilities (hospitals, nursing homes, outpatient facilities) to notify FDA when they become aware that a device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause death or serious injury if the malfunction recurred. It is distinct from the EU's 'MDR' (Regulation (EU) 2017/745, the Medical Device Regulation governing premarket CE marking and market access) -- the two share only an acronym, not a regulatory function.
IND Safety Report
A written or electronic notification that a sponsor holding an active Investigational New Drug (IND) application must submit to FDA, and to every participating investigator, under 21 CFR 312.32, whenever the sponsor determines there is reasonable possibility that the investigational drug caused a serious and unexpected adverse event (i.e., the event qualifies as a suspected unexpected serious adverse reaction, or SUSAR). It is distinct from routine investigator-to-sponsor adverse event reporting, from the IND annual report, and from post-marketing adverse-event reporting under 21 CFR 314.80, which applies only after a drug is approved.
NSF AI Institutes (National AI Research Institutes)
The NSF AI Institutes -- formally the National Artificial Intelligence Research Institutes -- are a cohort of large, multi-year, multi-institution research centers funded through cooperative agreements led by the U.S. National Science Foundation (NSF), typically in partnership with one or more other federal agencies or private-sector funders. An award qualifies as one of these institutes if it (1) was made under an NSF AI Institutes solicitation (the program has issued several since its first, NSF 20-503, in 2019-2020), (2) funds a single institute at roughly $20 million over a five-year period of performance, (3) spans multiple partner institutions organized around a lead awardee, and (4) is scoped around foundational AI research paired with a specific application domain (e.g., agriculture, astronomy, education, cybersecurity, weather) rather than AI research in the abstract. It is administratively distinct from a standard NSF research grant (see NSF PAPPG) both in award mechanism (cooperative agreement, which gives NSF a more active oversight role than a standard grant) and in scale.
Standard Operating Procedure (SOP)
In a research context, a Standard Operating Procedure (SOP) is a written, controlled, step-by-step instruction for performing a specific recurring task the same way every time it is performed, regardless of who performs it -- distinct from a protocol, which specifies what a particular study will do, and from a policy, which states an institution's general position or requirement. A document counts as a research SOP only if it is: (1) task- or process-specific rather than study-specific (e.g. "how this laboratory calibrates a balance" or "how this site receives and stores investigational product," not "what Study ABC-123 will test"); (2) formally approved and version-controlled, with an identifiable author, approver, effective date, and version/revision history; (3) written in enough procedural detail that a trained staff member unfamiliar with that specific instance of the task could follow it and produce a consistent, auditable result; and (4) actually followed and enforced in practice, with deviations documented -- an unused or unenforced document is not functioning as an SOP even if it is labeled one.
Proof-of-Concept Funding
Proof-of-concept (PoC) funding is a category of small, milestone-based, non-dilutive awards used to test and demonstrate the technical and/or commercial feasibility of a discovery that has already been made -- bridging the gap between a research finding and a patentable, licensable, or investable technology. It is distinguished from earlier-stage seed funding by its purpose and starting point: PoC funding assumes a specific invention or result already exists (often already the subject of an invention disclosure or provisional patent filing) and uses the award to move that specific result forward -- validating a prototype, running freedom-to-operate or IP-strategy work, generating the data needed for a licensing conversation, or engaging early industry/investor interest -- rather than to generate the preliminary data needed to justify a larger research grant in the first place. PoC funding is typically administered by, or run in close coordination with, a university technology-transfer office (TTO), a national/regional funder's dedicated PoC scheme, or a translational funding agency, and award activity is usually reported against a technology readiness level (TRL) or an equivalent milestone framework rather than conventional research-progress metrics.
Altmetric Attention Score
A proprietary, automatically calculated weighted count -- produced by the company Altmetric (a Digital Science business) -- of the online attention a specific research output has received across tracked sources, where a mention counts toward the score only if it is captured by Altmetric's tracking and is attributable to a source type in its weighting model (news outlets, blogs, policy documents, Wikipedia, post-publication peer review platforms, X/social media, and others); it is a measure of the volume and reach of attention, not of scholarly quality or citation impact.
Pragmatic Trial
A pragmatic (clinical) trial is a randomized controlled trial designed to measure an intervention's effectiveness under conditions that resemble routine, real-world care, rather than its efficacy under tightly controlled, ideal conditions. It is still an experimental, randomized design -- what distinguishes it from an explanatory trial is a cluster of protocol choices: broad eligibility criteria that mirror the population who would actually receive the intervention, delivery in usual-care settings by usual-care staff, flexible (rather than rigidly standardized) treatment protocols, a usual-care or standard-of-care comparator instead of placebo, and outcomes that matter to patients and decision-makers (e.g., hospitalization, function, quality of life) rather than surrogate or mechanistic endpoints. No trial is purely pragmatic or purely explanatory; every trial sits somewhere on a continuum between the two, and the PRECIS-2 (PRagmatic-Explanatory Continuum Indicator Summary-2) tool is the standard instrument for locating a given trial's design on that continuum, domain by domain, rather than as a single binary label.
DoD Indirect Cost Rate: ONR/DCAA Process
For institutions whose cognizant federal agency for indirect costs is the Department of Defense (assigned via the Office of Naval Research (ONR) under 2 CFR 200 Appendix III), the standard NICRA negotiation process contains one distinct extra step not present for HHS-cognizant institutions: rather than the cognizant agency's own cost-allocation staff reviewing the university's indirect cost rate proposal in-house, ONR contracts that technical review out to the Defense Contract Audit Agency (DCAA), which independently audits the proposal under DCAA Contract Audit Manual (DCAAM) Chapter 13 -- the chapter specifically covering audits at educational institutions, nonprofit organizations, and FFRDCs -- and returns an audit report to ONR, which ONR then uses as the basis for negotiating the final F&A rate with the institution. The resulting agreement is still an ordinary NICRA under 2 CFR 200 Appendix III; the difference is confined to who performs the underlying audit before negotiation, not to a separate rate instrument or rate structure.
Indirect Cost Rate Proposal
An indirect cost rate proposal is the documentation package an institution of higher education compiles and submits to its cognizant federal agency for indirect costs, under 2 CFR Part 200 Appendix III, to support negotiation of an indirect (F&A) cost rate. It identifies and assigns indirect costs to defined cost pools, selects an allocation base for each pool (or, for small institutions using the simplified method, a single base for total indirect costs), calculates proposed rates, and includes a signed Certificate of Indirect (F&A) Costs. The proposal is the institution's submitted request; the resulting signed document the cognizant agency issues after negotiation is the Indirect Cost Rate Agreement (NICRA), a distinct artifact.
Condition Code 30
Condition Code 30 is the two-digit value ("30 – Qualifying Clinical Trial") entered in the condition codes field of an institutional Medicare claim (UB-04 / CMS-1450, or the equivalent field on the electronic 837I transaction) to flag that the claim includes items or services furnished in connection with a qualifying clinical trial under Medicare's Clinical Trial Policy (National Coverage Determination 310.1). A claim requires Condition Code 30 when the trial meets NCD 310.1's qualifying criteria (falls within a Medicare benefit category, has therapeutic intent, and satisfies one of the NCD's deeming criteria — including NIH, FDA IND, or VA/DOD/CDC/AHRQ/CMS-funded/-supported studies) and the provider is billing Medicare for routine patient-care costs alongside the trial. It is reported on ALL clinical-trial-related institutional claims from a qualifying study, whether or not every line item on that particular claim is trial-related, and is submitted together with ICD-10 diagnosis code Z00.6 (encounter for examination for normal comparison and control in clinical research) and the trial's eight-digit National Clinical Trial (NCT) number — reported as UB-04 value code D4, or in loop 2300, REF02 (REF01 = P4) on the 837I. It functions purely as a claims-processing flag: it does not itself create coverage, it tells the Medicare Administrative Contractor (MAC) which coverage rules to apply to the claim.
SF-424 (Application for Federal Assistance)
The SF-424, "Application for Federal Assistance," is the standard cover-sheet form used to open nearly every application for federal grant or cooperative-agreement funding submitted through Grants.gov. A submission qualifies as using "the SF-424" when it supplies the form's core identifying and administrative data — applicant legal name and Unique Entity Identifier (UEI), type of applicant, funding opportunity number, congressional districts, project title, proposed period of performance, requested federal and non-federal funding amounts, and the Authorized Organization Representative's certification — as the umbrella cover page bundled with program-specific forms in a single Grants.gov Workspace submission package. The base SF-424 (OMB Number 4040-0004) is one member of a wider "SF-424 family": SF-424A (Budget Information for Non-Construction Programs, OMB 4040-0006) and SF-424B (Assurances for Non-Construction Programs) are commonly paired with it, SF-424C/D cover construction programs, and a distinct variant, SF-424 R&R ("Research and Related"), is used by NIH, NSF, and other research-funding agencies in place of the base non-research SF-424. A document is NOT "the SF-424" merely because it is a federal grant application — the term refers specifically to this standardized cover form, not to the full application package, the budget narrative, or agency-specific supplemental forms bundled alongside it.
Central IRB / Single IRB (sIRB)
The model in which one IRB of record -- rather than each participating site's local IRB -- conducts the ethical review for a multi-site human-subjects study under a single approved protocol, with all other participating sites relying on that review through a documented reliance arrangement (typically an IRB Authorization Agreement) instead of each convening a duplicate local review.
NIDA GCP Training
NIDA GCP Training refers to the Good Clinical Practice training course developed and administered by NIDA's Center for the Clinical Trials Network (CCTN), the coordinating body for the National Institute on Drug Abuse's Clinical Trials Network (CTN) -- a network of research sites and community treatment programs that conducts multisite trials on substance use disorder treatments. The course is not a separate regulatory standard: its content is built on the same underlying framework as ICH E6 Good Clinical Practice and applicable U.S. Code of Federal Regulations (CFR) provisions for human subjects research, but it is packaged, delivered, and administered specifically by NIDA/CCTN rather than by a third-party provider such as the CITI Program. A record is a genuine instance of 'NIDA GCP Training' when the completion certificate was issued through NIDA's own training platform (gcp.nidatraining.org) rather than through a different GCP course that merely also references ICH GCP.
Letter of Intent (NIH)
An NIH Letter of Intent (LOI) was a short, non-binding, typically one-page pre-application notice -- naming the PI, participating institution(s), and the funding opportunity number/title -- that some (not all) NIH funding opportunity announcements asked prospective applicants to submit, generally around 30 days before the application due date, so NIH staff could estimate peer-review workload and recruit reviewers. It never obligated the sender to apply, was never scored or considered in peer review, and never counted against the application's own page limits. Effective December 3, 2025, NIH discontinued the LOI process NIH-wide via Guide Notice NOT-OD-26-019: NIH no longer requests or accepts letters of intent as part of the standard application process.
ERC Proof of Concept Grant
An ERC Proof of Concept (PoC) Grant is a European Research Council top-up funding scheme, not a standalone competitive research grant. It is open only to principal investigators (PIs) who currently hold, or have held, one of the four ERC frontier-research grants (Starting, Consolidator, Advanced, or Synergy Grant). Its purpose is to help those researchers explore the commercial or societal application potential of results already generated under their ERC-funded project — testing a concept, validating an idea, addressing a technical bottleneck, clarifying an intellectual-property strategy, or engaging early with potential users, licensees, or investors. It is not a mechanism for funding new, unrelated research: the PI must be able to demonstrate a direct link between the proposed PoC activity and the frontier-research project it draws on. For the 2026 ERC Work Programme, PoC Grants are awarded as a lump sum of €150,000 for up to 18 months. Eligible applicants are PIs on an ongoing ERC main grant, or on a main grant that ended on or after 1 January 2025 — the ERC periodically shifts this eligibility window between Work Programme years, so applicants should always confirm the exact cut-off date against the current year's call documents rather than assume it carries over unchanged. Each PI may submit only one PoC application per call, and a single main grant project may receive a maximum of three PoC awards over its lifetime (six for Synergy Grant projects, reflecting their multi-PI structure). Evaluation is single-stage and assessed on breakthrough innovation potential, feasibility of the proposed approach, and the PI's strategic leadership — there is no separate peer-review panel structure comparable to the main schemes' two-stage process.
Protocol Amendment
A protocol amendment is a written, sponsor-initiated description of a change to, or formal clarification of, an already IRB/IEC-approved research protocol. Under ICH E6(R2) Section 1.60, that is the formal definition. An amendment is planned and prospective: it must be submitted to and reviewed by the IRB/IEC (and, for FDA-regulated drug trials, separately reported to FDA under 21 CFR 312.30) and receive documented approval before the changed procedures take effect, with two narrow exceptions -- a change made to eliminate an immediate hazard to subjects, and a change that is purely logistical or administrative (e.g., a monitor's phone number) and does not affect subject safety, rights, welfare, or the scientific integrity of the study. This prospective-approval requirement is what separates an amendment from a protocol deviation, which is an unplanned departure discovered and documented after the fact.
FDA Form 3926
FDA Form 3926, officially the "Individual Patient Expanded Access Investigational New Drug Application," is the streamlined form a treating physician uses to request FDA authorization for a single named patient to receive an investigational drug -- or an approved drug whose availability is restricted by a Risk Evaluation and Mitigation Strategy (REMS) -- outside a clinical trial, under the individual-patient category of FDA's expanded access ("compassionate use") pathway codified at 21 CFR Part 312, Subpart I. A request counts as a Form 3926 submission when: (1) the treating physician (not the manufacturer) files it with the relevant FDA review division, or in a genuine emergency initiates the request by phone/other rapid means and completes the form afterward; (2) the manufacturer/sponsor has agreed, generally via a Letter of Authorization, to supply the product for this specific patient; (3) the physician has documented the patient's brief clinical history, prior therapy, and treatment plan (dose, route, schedule, duration, monitoring) in the form's required sections; and (4) FDA has not objected within the applicable waiting period. Form 3926 is FDA's purpose-built, physician-oriented alternative to filing a full commercial IND application on Form FDA 1571 -- it is not used for multi-patient or sponsor-initiated expanded access categories, and it is not part of the separate Right to Try Act pathway.
RTSM (Randomization and Trial Supply Management)
A system counts as RTSM (Randomization and Trial Supply Management) -- also called IRT (Interactive Response Technology) -- if, within a single platform used by trial sites, it performs at least one of: (1) subject randomization to a treatment arm per the protocol's randomization scheme at enrollment, with blind maintenance and an auditable emergency-unblinding path where the trial is blinded; or (2) trial-supply management -- real-time kit- or dose-level inventory tracking and automatic resupply triggering to sites or depots. Most production RTSM/IRT platforms do both together. A platform that only captures clinical data (an EDC) or only manages site financial, regulatory, and monitoring workflow (a CTMS) is not RTSM/IRT, even though all three are routinely used side by side, and sometimes integrated, on the same trial.
PsyArXiv
PsyArXiv is a free, open-access preprint repository for psychology and related behavioral-science research. It was created by the Society for the Improvement of Psychological Science (SIPS) and is hosted on the Open Science Framework (OSF), the infrastructure built and maintained by the Center for Open Science (COS). A PsyArXiv Scientific Advisory Board oversees policy, and the service is funded by contributions from member institution libraries rather than author or reader fees. Authors upload working papers, preprints, registered reports, and author copies of accepted journal articles covering any area of psychology — clinical, cognitive, developmental, social, and beyond — without going through the peer review a journal would require before an editor even sees the manuscript. Accepted submissions receive a persistent DOI, making the preprint citable on its own before, or independent of, eventual journal publication. Operational definition A deposit is properly identified as a "PsyArXiv preprint" if it meets all of the following: It was submitted through the PsyArXiv service on OSF (osf.io/preprints/psyarxiv), not simply cross-listed or mirrored from another preprint server. It falls within psychology or a closely related behavioral/social-science discipline, per PsyArXiv's scope. Since PsyArXiv moved from post-moderation to pre-moderation in August 2025, it has passed moderator screening confirming the work is scholarly, psychology-focused, and internally consistent (matching author names, titles, and abstracts across the uploaded documents) — moderators do not evaluate scientific merit or methodology, only these threshold, non-substantive criteria. It has not been withdrawn; a withdrawn preprint is replaced by a "tombstone" page that preserves the metadata and DOI but removes the full text. What PsyArXiv is not PsyArXiv posting is explicitly not peer review. A preprint deposited there has not been evaluated by independent subject-matter reviewers the way a journal submission is — pre-moderation checks scope and completeness, not scientific validity. It is also distinct from a journal's own author-manuscript archive: PsyArXiv is a standalone, discipline-specific repository within OSF's family of subject-area preprint servers (alongside services such as SocArXiv for sociology and EdArXiv for education), not a publisher. Examples A cognitive psychology lab posts a working paper on PsyArXiv ahead of journal submission so collaborators and the field can cite and comment on it via its DOI while formal peer review is still underway elsewhere. A research team deposits a registered report's Stage 1 protocol on PsyArXiv as part of an open-science workflow, alongside data and materials hosted in a linked OSF project. Counter-examples Describing a PsyArXiv preprint as "peer reviewed" based on its presence on the server — pre-moderation screens for scope and completeness, not for methodological or scientific rigor, which only happens if and when the manuscript goes through a journal's own review process. Treating a preprint that was later formally published in a journal as unchanged from its PsyArXiv version — journal peer review frequently produces revisions between the preprint and the version of record, so the two should not be cited interchangeably without checking which version is being referenced.
Clinical Data Abstraction
Clinical data abstraction is the process by which a trained abstractor reads unstructured or semi-structured source documents — electronic health record (EHR) notes, paper charts, radiology reports, pathology reports, discharge summaries, operative notes — and extracts, interprets, and re-enters the relevant data points into a structured study database according to a written abstraction protocol and predefined data dictionary. It is distinguished from prospective data entry in two ways: the source material is not a study-specific form filled out by the person generating the data, and abstraction always involves a human judgment step (locating the relevant fact inside free text and mapping it to the correct structured field) rather than transcription of an already-structured value. A process counts as clinical data abstraction, as opposed to routine data entry, when all of the following hold: (1) the source document was created for clinical care or another non-research purpose, not for the study itself; (2) an abstractor applies a documented protocol and coding conventions to decide what counts as a positive/negative finding, which date or value to use when a chart contains conflicting entries, and how to handle missing or ambiguous information; and (3) the resulting structured value is auditable back to a specific location in the source document (a practice generally called source traceability or query-back-to-source).
Institutional Biosafety Committee (IBC)
A standing institutional committee, registered with the NIH Office of Science Policy under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, that reviews, approves, and provides ongoing oversight of research involving recombinant or synthetic nucleic acid molecules before such research may begin.
ICH Q9 (Quality Risk Management)
ICH Q9 (Quality Risk Management) is the ICH guideline establishing a systematic process — risk assessment, risk control, risk communication, and risk review — for evaluating, controlling, and communicating risks to pharmaceutical quality across a product's lifecycle. A quality decision follows ICH Q9 when it (1) is grounded in scientific and clinical knowledge ultimately linked to patient protection, (2) applies effort and documentation proportionate to the level of risk involved, and (3) uses a structured method — such as FMEA, FMECA, or HACCP — rather than an ad hoc or purely subjective judgment.
Crossover Study Design
A crossover study is a trial design in which each participant receives two or more of the interventions under comparison in a randomized sequence, separated by a washout period, so that within-participant outcomes on each intervention can be directly compared. It differs from a parallel-group design (one arm per participant, between-group comparison) and from an N-of-1 trial (identical within-subject logic applied to a single patient rather than a cohort, for an individual rather than a population-level conclusion).
Protocol Deviation
A protocol deviation is any unplanned departure -- by the investigator, study staff, or a subject -- from the procedures, visit schedule, eligibility criteria, or other requirements set out in the IRB/IEC-approved clinical trial protocol, made without prior sponsor agreement and prior IRB/IEC approval. It is distinct from a protocol amendment, which is a formal, prospectively reviewed and approved change to the protocol itself. Deviations are typically classified by severity -- commonly as minor/administrative versus important (also called major or significant) -- based on whether they affect subject rights, safety, or well-being, or the completeness, accuracy, or reliability of study data.
University Intellectual Property (IP) Policy
A university intellectual property (IP) policy is the formal, institution-wide governing document -- adopted by a board of trustees or regents -- that establishes ownership of IP created by faculty, staff, and students using university resources, the obligation to disclose inventions, how resulting revenue is shared with inventors, and how those rules differ for federally sponsored, industry-sponsored, and unsponsored research.
TRAC (Transparent Approach to Costing)
TRAC (Transparent Approach to Costing) is the sector-wide activity-based costing methodology UK higher education providers are required to operate to calculate, on a consistent and auditable basis, what their teaching, research, and other activities actually cost to deliver. It is the named system and annual reporting process -- not a single number -- and it produces several distinct outputs: the Annual TRAC return (institution-wide cost and sustainability data submitted to the Office for Students and, for research, to UKRI/Research England), TRAC for research (the basis for Full Economic Costing, fEC, used on individual grant applications), and TRAC(T) (TRAC for Teaching, used to inform teaching funding). A costing exercise is a genuine TRAC exercise only if it follows the published TRAC methodology and guidance and feeds the institution's formal annual return; an internal cost estimate that isn't built on TRAC-derived rates and doesn't feed that return is not TRAC, whatever else it resembles.
Senior Author
The senior author is the byline position -- conventionally the last-listed author in fields that use a contribution-ranked author list, most consistently biomedicine and the life sciences -- understood to signal the person who supervised the research, secured its funding, and takes overall responsibility for the work's integrity, typically the laboratory head or principal investigator, as distinct from the first author, who is understood to have carried out the largest share of the hands-on experimental or analytical work. Like first-author position, senior-author position is a convention read from byline placement, not a formal authorship criterion: everyone in the position still has to independently satisfy the applicable authorship test (most commonly the ICMJE's four-part test) on the same terms as every other listed author. The convention does not apply in fields with alphabetical byline order (mathematics, economics, parts of theoretical physics), where last position carries no seniority or supervisory signal at all, and it does not automatically confer the corresponding-author role, though the two are often -- not always -- held by the same person.
SAM.gov (System for Award Management)
SAM.gov is the U.S. federal government's official, GSA-operated registration and data system for organizations and individuals doing business with the federal government, including recipients of federal financial assistance. An organization is not eligible to receive a federal grant, cooperative agreement, or contract until it has an active SAM.gov entity registration and a valid Unique Entity Identifier (UEI) -- registration is a precondition for award, not a paperwork step that can be completed afterward, and it must be renewed at least every 12 months to stay active.
Collaborative Research Agreement (CRA)
A Collaborative Research Agreement (CRA) is the umbrella contract that governs a joint research project between two or more independent parties -- typically universities, non-profit research institutes, hospitals, and/or companies -- none of which is a federal laboratory acting under statutory authority. A CRA is the instance of this instrument whenever the document (regardless of its exact title, which varies by institution -- 'Collaborative Research Agreement,' 'Joint Research Agreement,' 'Research Collaboration Agreement,' or 'Consortium Agreement' for 3+ parties) sets out, for a defined project and term: (1) a scope of work and each party's respective research contributions (personnel, facilities, funding, data, or existing background IP); (2) ownership and licensing of resulting (foreground) IP, including how jointly-made inventions are handled; (3) publication rights, including any sponsor/partner review period before a paper is submitted; and (4) confidentiality obligations covering information shared in the course of the collaboration. It is the parent agreement under which narrower, single-purpose instruments -- a Material Transfer Agreement (MTA) for a specific biological or physical material, a Confidential Disclosure Agreement (CDA/NDA) for pre-agreement or ancillary confidentiality, or a Data Use Agreement (DUA) for a specific dataset -- are frequently executed as subordinate or referenced agreements for one particular exchange within the larger project.
NHMRC Personnel Support Package (PSP)
A Personnel Support Package (PSP) is the fixed, banded salary-and-on-cost rate that Australia's National Health and Medical Research Council (NHMRC) sets for specified categories of research personnel — technical support staff, research assistants, and junior postdoctoral researchers — employed on NHMRC Research Support-type grants (such as Ideas Grants and other project-based schemes). Rather than reimbursing an institution's actual salary cost for a named staff member, NHMRC pays a fixed rate tied to the role's level (PSP1, PSP2, PSP3, and so on), published in an annual PSP rate table and indexed periodically. A cost is a PSP, rather than some other NHMRC budget line, when it is (a) salary for personnel other than a named Chief Investigator A on an Investigator Grant, and (b) claimed at NHMRC's published fixed band rate for that role rather than the individual's actual on-costed salary.
Catalog of Federal Domestic Assistance (CFDA)
The Catalog of Federal Domestic Assistance (CFDA) was the government-wide, program-by-program listing of every US federal grant, loan, and other domestic assistance program, established under the Federal Program Information Act of 1977 and maintained by the General Services Administration (GSA). Each program was assigned a unique identifying number in the format XX.XXX -- a two-digit federal agency code followed by a three-digit program code. In June 2021, GSA retired the standalone CFDA.gov site and the CFDA name, moving the same program listing to SAM.gov under the new name 'Assistance Listings.' The XX.XXX numbering scheme itself did not change -- only the label did -- so the legacy CFDA number and the current Assistance Listing Number (ALN) identify exactly the same program-level number, and the two terms are used interchangeably in practice, including in current federal regulation.
Indirect Cost Rate Agreement (NICRA)
An Indirect Cost Rate Agreement -- commonly called a NICRA (Negotiated Indirect Cost Rate Agreement) -- is the formal document issued by an organization's cognizant federal agency under 2 CFR 200.414 and its supporting appendices, setting out the specific indirect cost (F&A) rate(s), the distribution base each rate applies to, the rate type (provisional, predetermined, fixed, or final), and the period for which each rate is authorized for use on federal awards.
NIAID Payline
A NIAID payline is the percentile-rank threshold that the National Institute of Allergy and Infectious Diseases (NIAID), one of NIH's 27 institutes and centers, sets for a fiscal year and grant mechanism as its planning guideline for which peer-reviewed applications it expects to fund. It is NIAID's own institute-specific application of the general NIH payline mechanism, set independently of every other NIH institute or center against NIAID's own appropriation, application volume, and research priorities -- so a NIAID figure should never be assumed to match NINDS's, NHLBI's, or any other institute's figure for the same fiscal year and mechanism. NIAID historically published interim paylines early in the fiscal year, updated them as budget and application volume became clearer, and set a more generous extended payline for Early Stage Investigators. Following NIH's November 2025 Unified Funding Strategy announcement, NIAID's own paylines page has been retitled to reflect a shift away from a single published percentile cutoff toward weighing peer-review scores against institute priorities and budget more holistically -- confirm current NIAID practice against its own current guidance rather than assuming a specific figure or format still applies.
Preclinical Development
Preclinical development (or nonclinical development) is the drug/biologic development stage between candidate selection and the filing of an Investigational New Drug (IND) application, during which a sponsor generates the animal and in vitro pharmacology, toxicology, and pharmacokinetic (ADME) data — chiefly under Good Laboratory Practice, 21 CFR Part 58, for pivotal safety studies — needed to establish a reasonable basis for testing the candidate safely in humans, alongside early formulation and manufacturing (CMC) work. It does not involve human participants and is therefore distinct from a clinical trial; the common phrase “preclinical trials” is a misnomer — the correct terms are preclinical or nonclinical studies.
Chemistry, Manufacturing, and Controls (CMC)
A regulatory submission qualifies as containing CMC information when it documents, for a specific drug substance and/or drug product, the identity, composition, and manufacturing process used to produce it; the in-process controls and specifications (analytical test methods and acceptance criteria) used to confirm its strength, quality, and purity at each stage; and the stability data supporting the proposed container closure system and shelf life. In an eCTD-formatted submission to FDA or another ICH-aligned regulator, this material is filed as Module 3 (Quality) -- CMC is the informal, universally-used shorthand for that module's content, not a separate submission or a formal ICH-defined term itself. A document that describes only the clinical protocol, nonclinical toxicology, or regulatory administrative forms, with no data on how the product is made, tested, or controlled, does not constitute CMC information regardless of how complete it is on those other dimensions.
EU Clinical Trials Regulation (CTR) & CTIS
A clinical trial is governed by the EU Clinical Trials Regulation (Regulation (EU) No 536/2014, the "CTR") -- and therefore must be authorised and registered through the EU's Clinical Trials Information System (CTIS) -- when it (1) is an interventional trial (not a purely observational/non-interventional study), (2) tests a medicinal product for human use (not a medical device, which falls under the MDR/IVDR instead), and (3) includes at least one trial site in an EU/EEA member state. Since CTIS became the sole authorisation and registration route on 31 January 2025 -- completing a three-year transition away from the prior Clinical Trials Directive 2001/20/EC and the EudraCT/EU Clinical Trials Register it used -- this applies whether the trial runs in a single member state or spans multiple countries via one application, one Reporting Member State (RMS), and any number of other Member States Concerned (MSC).
Plant Variety Protection Act (PVPA)
The Plant Variety Protection Act (PVPA), 7 U.S.C. §§ 2321-2582, is a U.S. federal law, enacted in 1970, that gives plant breeders a certificate-based intellectual-property right in a new, distinct plant variety. It is administered not by the USPTO but by the Plant Variety Protection Office (PVPO), part of USDA's Agricultural Marketing Service. A PVP certificate covers a specific reproducible variety -- as bred, not an underlying gene, trait, or breeding method -- that is new, distinct from existing varieties, and genetically uniform and stable across generations. Originally limited to sexually reproduced (grown from seed) and tuber-propagated varieties, the Agricultural Improvement Act of 2018 (the 2018 Farm Bill) extended PVPA eligibility to asexually reproduced varieties as well, creating overlap with the older plant-patent system for the first time.
Conflict of Interest in Human Subjects Research
A conflict of interest in human subjects research exists when an investigator's, institution's, or IRB member's financial or personal interest could compromise -- or reasonably appear to compromise -- the design, conduct, oversight, or reporting of a study involving human participants. Unlike the general research-COI concept, review here is tied directly to the IRB approval decision: federal guidance and institutional policy require that a significant financial conflict be evaluated and, where warranted, managed under a documented plan before the IRB may approve the protocol, and require any IRB member with a conflicting interest in a specific protocol to recuse from reviewing or voting on it.
21 CFR 314.80 (Postmarketing Reporting of Adverse Drug Experiences)
The FDA regulation (21 CFR Part 314, Subpart B) requiring holders of an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), and nonapplicant manufacturers/packers/distributors named on the drug's label, to surveil for, evaluate, and report postmarketing adverse drug experiences to FDA. It defines what makes an event "serious" (death, life-threatening, hospitalization, persistent disability, congenital anomaly, or an important medical event requiring intervention) and "unexpected" (not described in the drug's current approved labeling), and sets three reporting tracks: 15-day Alert reports for events that are both serious and unexpected, quarterly periodic reports for the first 3 years post-approval, and annual reports thereafter. It is the regulatory mechanism that populates the FDA Adverse Event Reporting System (FAERS) with mandatory manufacturer reports, distinct from FAERS's voluntary MedWatch stream and from pre-market IND safety reporting under 21 CFR 312.32.
OIG Work Plan
An OIG Work Plan is the forward-looking list an agency's Office of Inspector General maintains of audits, evaluations, and inspections it has planned or has underway for the coming period. Unlike an OIG report, which documents a completed piece of work and its findings, a Work Plan entry is a statement of intent -- it names a program area, population, or compliance topic the OIG has decided to examine, before the examination has produced any findings. For research administrators, the Work Plan is the single clearest public signal of where a funding agency's oversight attention is headed next, which is why sponsored-programs and compliance offices routinely cross-check active Work Plan items against their own institution's award portfolio.
21 CFR Part 54 (Financial Disclosure by Clinical Investigators)
21 CFR Part 54 is the FDA regulation requiring sponsors of a covered clinical study to obtain, and FDA to evaluate, information about certain financial interests and arrangements held by the clinical investigators who conducted the study. It applies to any 'covered clinical study' -- a study in humans that a marketing applicant or FDA relies on to establish a product's effectiveness (including a study demonstrating equivalence to an approved product), or a study in which a single investigator's data makes a significant contribution to the demonstration of safety -- submitted in support of an NDA, ANDA, BLA, or a device marketing application (PMA or certain 510(k)s). Rather than banning financially interested investigators from participating, Part 54 requires the sponsor to certify (via FDA Form 3454) that no covered investigator has a disclosable financial interest, or to disclose (via FDA Form 3455) any that exist, so FDA can factor that information into its evaluation of the study's reliability. Sections 54.5 and 54.6 -- FDA's authority to act on disclosed interests and the sponsor's recordkeeping obligation -- are part of Part 54 itself but are not addressed by either form.
FDA Form 3455 (Disclosure: Financial Interests and Arrangements of Clinical Investigators)
FDA Form 3455 ('Disclosure: Financial Interests and Arrangements of Clinical Investigators') is the form a marketing-application sponsor files with FDA when its financial-interest review, conducted under 21 CFR Part 54, finds that one or more clinical investigators (or a subinvestigator, spouse, or dependent child) participating in a covered clinical study has a disclosable financial interest or arrangement -- e.g. compensation tied to study outcome, equity in the sponsor exceeding the regulatory thresholds, a proprietary interest in the tested product, or significant payments beyond direct study costs. Rather than certifying the interests' absence (the role of the counterpart form, FDA Form 3454), Form 3455 requires the sponsor to disclose the interest completely and accurately -- its nature and, where applicable, its value -- and, per 21 CFR 54.4(a)(3), describe what steps, if any, were taken to minimize its potential to bias the study's design, conduct, or reporting. It is submitted with the marketing application the covered study supports.
Low- and Middle-Income Countries (LMIC)
LMIC is a World Bank income-classification category, combining the low-income, lower-middle-income, and upper-middle-income groups, used as a proxy for national economic development level. The World Bank sorts every economy into one of four groups (low-income, lower-middle-income, upper-middle-income, high-income) once a year, effective every 1 July, based on Gross National Income (GNI) per capita for the prior calendar year, converted to US dollars using the Atlas method. 'LMIC' is shorthand for the three non-high-income groups combined. In research administration, LMIC status determines eligibility for a large number of funder schemes, informs risk and vulnerability considerations in ethics review, and is used as a proxy variable in equity-in-research-participation and authorship analyses. A country's classification can and does change from year to year as its GNI per capita moves relative to the thresholds, so an eligibility list or dataset citing 'LMIC' status should always specify the fiscal year it draws on.
Corporate Authorship
Corporate authorship is the practice of naming an organizational or collective entity -- a consortium, study group, working group, network, or corporate body -- as the author of record on a byline, in place of (or alongside) individually named researchers. It is distinguished from co-authorship by what appears on the byline itself: co-authorship is two or more named individuals who each independently meet the authorship criteria for the work, while corporate authorship substitutes or supplements those individual names with a group name that stands for the collective. The individuals who did the work still have to be identifiable and accountable -- ICMJE guidance requires the corresponding author to specify the group name and clearly identify which group members can take credit and responsibility as authors -- but the byline itself reads as the entity, not the roster.
Open Science Framework (OSF)
A free, open-source web platform operated by the nonprofit Center for Open Science (COS) that lets a research team manage a project's full lifecycle from one persistent, citable project page: file storage and version control, collaborator permissions, preregistration of hypotheses and analysis plans, and public archiving with a DOI. 'Open Science Framework' is often shortened or misremembered as 'Open Science Foundation' — the organization that builds and runs OSF is the Center for Open Science, not an 'Open Science Foundation'; no organization by that name operates this infrastructure.
UKRI PhD Stipend
The UKRI minimum doctoral stipend is the annual, tax-free subsistence allowance UK Research and Innovation sets each year as the floor payment for students on a UKRI-funded PhD studentship, applied uniformly across all seven research councils, with a fixed £2,000/year supplement for London-based host institutions; it is set centrally by UKRI, reviewed roughly annually, and takes effect each 1 October.
ORCID Featured Works
A record is using ORCID Featured Works when the iD holder has designated one or more of their public works (up to a maximum of five) to appear in a dedicated "Featured" section at the top of the Works list on their ORCID record, each marked with a star icon. Featuring is a curation layer applied on top of an already-public work: only works whose visibility is already set to "Everyone" are eligible to be featured, and a work is automatically removed from the Featured list the moment its visibility is changed away from public. As of verification, the feature applies to the Works section only — there is no equivalent "Featured" mechanic for Employment, Education, Funding, Peer Review, or Distinctions entries on the record.
Clinical Equipoise
Clinical equipoise is the state of genuine uncertainty, held within the expert medical community as a whole (not necessarily by any one investigator), about the comparative therapeutic merit of a randomized controlled trial's arms. It is the ethical precondition that justifies randomizing participants to a control or comparator arm rather than assigning known-superior treatment to everyone; it is disturbed, and randomization becomes unethical, once credible evidence resolves that community-wide uncertainty toward one arm.
Electronic Batch Record (EBR)
An Electronic Batch Record (EBR) is the electronic-system equivalent of a paper batch record in GMP-regulated manufacturing: the record documenting, for one specific manufactured batch, that each step of the validated Master Production Record was performed -- by whom or by which qualified automated equipment, when, with what materials and quantities, and with what in-process results -- retained in a system meeting 21 CFR Part 11 controls (validation, independent audit trail, access control, attributable electronic signatures) because it is the electronic record being used to satisfy the GMP predicate requirement at 21 CFR 211.188. A record only functions as an EBR, rather than a digitized image of a paper record, if the generating system itself is validated and Part-11-compliant.
SSHRC Partnership Grant
An SSHRC Partnership Grant is the largest and longest-running funding instrument in the Social Sciences and Humanities Research Council of Canada's partnership-funding stream: a two-stage, competitively adjudicated award of up to $2.5 million over 4 to 7 years, supporting a formal, already-substantiated research partnership between an academic team and one or more non-academic partner organizations. What distinguishes it operationally from SSHRC's smaller partnership instruments (Partnership Engage Grants, Partnership Development Grants) is scale and maturity: a Partnership Grant funds an established collaborative governance structure -- shared intellectual leadership, a defined program of research, training, and knowledge-mobilization activities, and a mandatory minimum cash/in-kind contribution from partners -- rather than a first-time or exploratory partnership still being tested or built.
Real-World Evidence (RWE)
Real-World Evidence (RWE) is clinical evidence about the usage, benefits, or risks of a medical product derived from the analysis of Real-World Data (RWD) -- data relating to patient health status and/or care delivery that is routinely collected outside the controlled setting of a randomized controlled trial (RCT). RWD sources include electronic health records (EHRs), medical claims and billing data, product and disease registries, and data from digital health technologies or patient-generated sources. RWE becomes regulatory-grade evidence only after the underlying RWD has been assessed as fit for use -- relevant, reliable, and sufficiently complete for the specific question being asked -- and the study design (e.g., pragmatic trial, prospective registry study, or retrospective database analysis) adequately addresses confounding and bias, since RWE studies typically lack the randomization and blinding that isolate causal effect in a traditional RCT.
ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients)
ICH Q7 ("Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients") is the International Council for Harmonisation's harmonized GMP guideline governing the manufacture of active pharmaceutical ingredients (APIs) -- from starting materials through the finished API -- as distinct from finished-dosage-form manufacturing (governed by 21 CFR 210/211 or EudraLex Volume 4 Part I). FDA adopted it as guidance (originally "Q7A," effective September 25, 2001, later recodified to Q7); it also forms the basis of EudraLex Volume 4, Part II in the EU.
Persistent Identifier (PID)
A unique, actionable, long-term identifier assigned to a single entity in the research ecosystem -- a work, a person, an organisation, a piece of equipment, a project, or a dataset -- that is registered with a scheme-specific provider, stays associated with that entity even as its location or attributes change, resolves (typically over HTTP) to current metadata or the resource itself, and is designed to remain valid for decades, well beyond the lifetime of any one repository, publisher, or institutional system.
Author Affiliation
The institutional identifier attached to a specific named author on a scholarly output, stating the organization the author was formally associated with while doing the reported work (conventionally at the time of the research, not necessarily the author's current employer), carried as structured byline metadata distinct from corresponding-author contact details or an internal CRIS affiliation record.
Metadata Schema
A defined, published set of descriptive fields (elements or properties) — each with a name, definition, expected data type or controlled vocabulary, and obligation/cardinality rules — used to describe a resource consistently enough for people and systems to find, cite, exchange, and reuse it. Distinct from a metadata record, which is one specific instance of data filled into that specification.
Fair Information Practice Principles (FIPPs)
Fair Information Practice Principles (FIPPs) are a U.S.-originated framework of privacy norms governing how organizations collect, use, disclose, and secure personal information. First articulated in the 1973 HEW report Records, Computers, and the Rights of Citizens, they underpin the Privacy Act of 1974 and were later reflected in the OECD's 1980 Guidelines on the Protection of Privacy. A dataset-handling or systems practice qualifies as FIPPs-aligned when it addresses, at minimum: transparency/notice about what personal data is collected and why; purpose specification and use limitation (data used only for stated, compatible purposes); data minimization (collecting no more than necessary); individual participation (the ability to access, correct, or contest one's own records); data quality and integrity; security safeguards; and accountability for compliance. There is no single canonical numbered list — the original HEW report set out five principles, the Privacy Act of 1974 codified eight statutory safeguards, and later agency restatements (for example the U.S. Department of Homeland Security's widely cited 2008 formulation) group them into eight principles: Transparency, Individual Participation, Purpose Specification, Data Minimization, Use Limitation, Data Quality and Integrity, Security, and Accountability and Auditing. FIPPs is a governance framework, not itself a statute — it becomes binding only where a specific law (such as the Privacy Act of 1974 for federal agency records, or a sector law like the Family Educational Rights and Privacy Act) incorporates it.
SSHRC Postdoctoral Fellowship
The SSHRC Postdoctoral Fellowship was the Social Sciences and Humanities Research Council of Canada's individually held, individually competed award funding mentored postdoctoral research in the social sciences and humanities. Like its counterparts at Canada's other two federal research funders, SSHRC has discontinued this standalone program: it has been folded, together with the equivalent individual postdoctoral fellowship programs previously run separately by the Natural Sciences and Engineering Research Council (NSERC) and the Canadian Institutes of Health Research (CIHR), into the jointly administered Canada Postdoctoral Research Award (CPRA) -- part of the Tri-Agency's new Canada Research Training Awards Suite (CRTAS), which also replaces the three councils' separate master's and doctoral scholarship programs. A researcher researching 'SSHRC Postdoctoral Fellowship' today needs the CPRA application process, applied for through whichever of the three agencies best matches the proposed research area -- SSHRC for the social sciences and humanities.
NSF Postdoctoral Fellowship
There is no single 'NSF Postdoctoral Fellowship' program at the U.S. National Science Foundation. NSF funds postdoctoral researchers through a family of separately named, directorate- or division-specific fellowship competitions -- each with its own NSF publication number, solicitation, eligibility rules, term length, and stipend -- rather than one central award a researcher applies to directly. Current examples include the Postdoctoral Research Fellowships in Biology (PRFB, NSF 26-504), the Mathematical and Physical Sciences Ascending Postdoctoral Research Fellowships (MPS-Ascend), the Mathematical Sciences Postdoctoral Research Fellowships (MSPRF), the SBE Postdoctoral Research Fellowships (SPRF), the NSF Astronomy and Astrophysics Postdoctoral Fellowships (AAPF), the Atmospheric and Geospace Sciences Postdoctoral Research Fellowships (AGS-PF), an Engineering Directorate postdoctoral fellowship, and the Innovative Postdoctoral Entrepreneurial Research Fellowship (I-PERF). All are individually held, individually competed awards -- the fellow, not their host institution, is the recipient -- which is the trait that distinguishes any of them from a postdoctoral researcher paid as staff out of a principal investigator's NSF research grant.
Researcher Identifier
A persistent, unique digital identifier assigned to an individual person -- as distinct from an identifier for a work, an institution, or a grant -- that disambiguates that researcher across name variants, career moves, and multiple scholarly systems, and that is designed to stay resolvable and machine-readable for the researcher's whole career.
Data Dredging
Searching a dataset for statistically significant relationships across many variables, subgroups, or model specifications without a hypothesis specified in advance, then reporting whichever pattern crosses a significance threshold as if it had been the study’s pre-specified object of investigation, without correcting for the number of comparisons actually performed.
Medical Research Future Fund (MRFF)
The Medical Research Future Fund (MRFF) is the Australian Government's dedicated long-term financing vehicle for health and medical research and innovation, established under the Medical Research Future Fund Act 2015. A grant is an MRFF grant when its funding is drawn from the investment earnings of the MRFF's invested capital (rather than from annual Budget appropriations, as with most NHMRC National Competitive Grants Program funding) and is disbursed against a specific MRFF grant opportunity listed on GrantConnect, typically under one of the MRFF's Research Missions or the broader MRFF Strategy and Priorities set by the Australian Medical Research Advisory Board (AMRAB) — even where the grant opportunity is administered day-to-day by NHMRC, a Business Grants Hub, or another delegated body on the Department of Health, Disability and Ageing's behalf.
NSERC Postdoctoral Fellowship
The NSERC Postdoctoral Fellowship was the Natural Sciences and Engineering Research Council of Canada's individually held, individually competed award funding two years of mentored postdoctoral research in the natural sciences and engineering, providing the fellow with a stipend (most recently $70,000 per year) portable to an eligible Canadian or international host institution. NSERC has discontinued this standalone program: it has been folded, together with CIHR's and SSHRC's equivalent individual postdoctoral fellowship programs, into the jointly administered Canada Postdoctoral Research Award (CPRA) -- part of the Tri-Agency's new Canada Research Training Awards Suite (CRTAS), which also replaces the three councils' separate master's and doctoral scholarship programs. A researcher researching 'NSERC Postdoctoral Fellowship' today needs the CPRA application process, applied for through whichever of the three agencies best matches the proposed research area.
Human Research Participant (Human Subject)
A human research participant (the regulatory term is "human subject") is a living individual about whom an investigator conducting research either obtains information or biospecimens through intervention or interaction, or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens (45 CFR 46.102(e)). "Subject" is the term used in the Common Rule and IRB paperwork; "participant" is the term preferred by APA style and many journals for manuscript prose. Both refer to the same regulatory category of person.
Scopus Author ID: What It Is and How It’s Assigned
A Scopus Author ID is a numeric identifier that Elsevier's Scopus database automatically generates and attaches to a researcher's profile once that researcher has two or more documents indexed in Scopus — it is algorithmically assigned from article metadata (name variants, affiliation, subject area, co-authors, citation patterns), not requested or self-registered by the researcher, and a given person can end up with more than one Scopus Author ID if the algorithm fails to match all of their work to a single profile.
National Health and Medical Research Council (NHMRC)
The National Health and Medical Research Council (NHMRC) is the Australian Government's independent statutory authority for health and medical research funding, research translation, and health/medical research ethics guidance, established under the National Health and Medical Research Council Act 1992. A grant, ethics guideline, or research-translation activity falls within NHMRC's remit when it concerns health or medical research — the causes, treatment, diagnosis, monitoring, management, or prevention of human disease — administered through NHMRC's own National Competitive Grants Program (via its Sapphire platform) or through NHMRC's ethics-guidance function (e.g. the National Statement on Ethical Conduct in Human Research), rather than through the Australian Research Council's (ARC) National Competitive Grants Program, which covers all other fields of research.
Non-Interventional Study
A non-interventional study is a clinical study of a medicinal product in which treatment assignment is not decided in advance by a protocol, prescribing and enrollment decisions are kept separate, and no diagnostic or monitoring procedures beyond normal clinical practice are imposed. Under EU Regulation (EU) No 536/2014, Article 2(2)(4), it is defined directly as any clinical study that is not a clinical trial. The classification determines whether a study needs prior competent-authority/ethics approval under the EU Clinical Trials Regulation, whether it triggers an FDA IND, and which registration/reporting regime applies.
Investigational Device
A device is an "investigational device" under FDA's IDE regulation (21 CFR 812.3(g)) when it is "the object of an investigation" -- being studied in a clinical investigation to generate safety or effectiveness data for a use FDA has not already cleared or approved, rather than being used strictly within its existing cleared/approved labeling. Whether the study needs a full IDE application and FDA approval, or only abbreviated requirements, depends on whether the device is classified significant risk (SR) or nonsignificant risk (NSR) under 21 CFR 812.3(m).
AI Research Tool
An AI research tool is software that applies machine learning — typically a large language model (LLM), an embedding-based semantic search index, or both — to a specific stage of the research workflow: finding and screening literature, extracting or summarizing data from papers, mapping citation relationships, drafting or revising manuscript text, or analyzing research data. "AI research tool" is a category label, not the name of any single product: it covers named tools with genuinely different scopes (a citation-mapping tool like Connected Papers does not do what a writing-assistance tool like Paperpal does), and a page or citation that treats it as one interchangeable thing is usually mis-scoped. What makes a tool an instance of this category, rather than a general-purpose AI assistant that happens to get used for research, is that it is built or marketed specifically around a research task — an academic search index, a citation graph, a manuscript-formatting model trained on published literature — rather than being a general chat interface pointed at an arbitrary prompt.
First Author
First author is the person listed first in a work's byline (author list). In fields that use a contribution-ranked byline -- most consistently biomedicine, the life sciences, and much of the natural sciences -- that position is a convention, not a formal criterion: it signals that this person is understood to have done the largest share of the hands-on work behind the paper, typically including the bulk of the experimental or analytical work and the first draft of the manuscript. Being listed first does not, by itself, make someone an author -- they still have to independently satisfy the applicable authorship criteria (most commonly the ICMJE's four-part test: substantial contribution to conception, design, or data; drafting or critically revising the work; final approval of the version submitted; and agreement to be accountable for it). First-author position answers a different question from that test: not "does this person qualify to be an author" but "where does this particular author's contribution rank relative to the other authors on this specific paper." It is also field-dependent rather than universal -- in mathematics, economics, and parts of theoretical physics, author order is conventionally alphabetical and carries no contribution ranking at all, so "first author" in those fields signals nothing about relative effort.
NSERC Discovery Grant
An NSERC Discovery Grant is Canada's core, investigator-held operating-funds award for research programs in the natural sciences and engineering: a competitively evaluated grant, held individually by a faculty researcher (or a small team on a joint application) at an NSERC-eligible Canadian institution, that funds an ongoing program of research — not a single fixed-scope project — for up to five years, renewable through a subsequent competition. It is administered by the Natural Sciences and Engineering Research Council of Canada (NSERC), one of Canada's three federal granting councils alongside CIHR and SSHRC.
Consolidated Screening List (CSL)
A single, merged database published by the US Department of Commerce (trade.gov) that consolidates the restricted- and denied-party lists maintained separately by the Departments of Commerce (BIS: Denied Persons List, Entity List, Unverified List, Military End-User List), State (AECA Debarred List, Nonproliferation Sanctions list), and Treasury (OFAC's Specially Designated Nationals List and related sanctions lists). Institutions screen a party's name against the CSL once to check for a match on any contributing list, then trace a hit back to the underlying regulation (EAR, ITAR, or an OFAC sanctions program) it falls under. Source lists are updated daily.
Major Contributor
A "major contributor" is an informal, functional description — not a defined category in ICMJE, NISO CRediT (ANSI/NISO Z39.104-2022), or any research-integrity standard — used to describe someone whose input to a research output is substantial and broad enough that it typically meets, or is expected to meet, the threshold for authorship, as opposed to a "minor" contribution that is real but narrower and more appropriately handled through acknowledgement rather than a byline. A contribution generally reads as "major" when it (a) spans more than one narrow, delegable task — for example design plus analysis plus interpretation, not just running one requested test; (b) is difficult to substitute without changing the direction or validity of the work; and (c) is accompanied by the kind of ongoing engagement (reviewing drafts, defending choices, approving the final version) that ICMJE's four authorship criteria and most journals' own policies expect of an author, not just a task contributor.
ClinicalTrials.gov
ClinicalTrials.gov is the NLM-operated (NIH, with FDA) public registry and results database for clinical studies, distinguished from clinical trial registration generally by being the specific U.S. system launched in 2000 (FDAMA Sec. 113) whose mandatory-registration and results-reporting requirements were established by the FDAAA 801 final rule (effective 18 January 2017), and which assigns every registered study a unique NCT identifier.
Grants.gov Registration
The prerequisite entity-registration process an organization -- university, nonprofit, or small business -- must complete before it can submit an application through Grants.gov, the federal government's shared portal for discretionary federal grant opportunities. Registration is built on a SAM.gov entity record and a Unique Entity Identifier (UEI), not on Grants.gov itself; Grants.gov authenticates against SAM.gov rather than maintaining a separate applicant database.
NSF Dear Colleague Letter (DCL)
A Dear Colleague Letter (DCL) is a formal written communication issued by the U.S. National Science Foundation (NSF) — typically by a directorate, division, or cross-cutting NSF initiative — to inform the research community of a matter that does not require the structure of a full program solicitation. Per NSF's Proposal & Award Policies & Procedures Guide (PAPPG), Chapter I, a DCL is used to provide general information to the community, clarify or amend an existing NSF policy or document, or inform prospective proposers about upcoming funding opportunities and areas of programmatic interest. A communication counts as a DCL, rather than a program solicitation, when it does NOT itself impose a distinct set of eligibility restrictions, proposal-preparation instructions, or a dedicated review process beyond what already exists under NSF's standing proposal types and the PAPPG — a DCL points proposers toward using an existing mechanism (most often Rapid Response Research (RAPID), EArly-concept Grants for Exploratory Research (EAGER), Rapid Assessment of Immediate/Systemic Effects (RAISE), Planning Grants, or Conference/Workshop proposals) rather than creating a new one. If a document instead establishes its own eligibility criteria, submission deadlines, and a standalone competitive review framework, it is a program solicitation (or, more broadly, a funding opportunity announcement), not a DCL, regardless of what it is titled.
Perverse Incentives (in Research)
In research integrity, a perverse incentive is a feature of an evaluation, funding, or reward system that motivates behavior contrary to that system's stated goal. Research is organized around proxy metrics for quality — publication count, journal impact factor, citation counts, grant dollars secured — that are easier to measure than the underlying goals they stand in for (rigor, originality, real-world value). When careers, tenure, promotion, and funding decisions are tied tightly to these proxies, researchers face pressure to optimize the measurable proxy rather than the underlying goal, even when doing so degrades the research itself. A situation exhibits a perverse incentive when three conditions hold together: (1) a metric or reward is used as a stand-in for research quality, (2) career or funding consequences are attached to that metric, and (3) the metric can be increased through behavior that does not improve, or actively harms, the actual science.
Community Advisory Board (CAB)
A Community Advisory Board (CAB) is a standing group of community members, patient/participant representatives, and other local stakeholders that provides ongoing, non-scientific input into the design, conduct, and dissemination of a research study or program from the perspective of the population it affects. A body qualifies as a CAB when it (1) is composed primarily of community members or affected-population representatives rather than research staff or clinicians, (2) advises on matters such as protocol acceptability, recruitment and retention strategies, informed-consent language, culturally appropriate messaging, and dissemination of results, and (3) operates on an advisory, non-binding basis — it does not have authority to approve, halt, or scientifically review the study. This distinguishes a CAB from bodies with formal regulatory or scientific-oversight authority, such as an Institutional Review Board (IRB), which reviews and approves research for ethical and regulatory compliance, or a Data Safety Monitoring Board (DSMB), which reviews accumulating safety and efficacy data during a trial. A CAB's role is community voice and engagement, not protocol approval or safety monitoring.
OFAC List (SDN List)
The "OFAC list" ordinarily refers to the Specially Designated Nationals and Blocked Persons List (SDN List) maintained by the US Department of the Treasury's Office of Foreign Assets Control (OFAC). OFAC administers and enforces economic and trade sanctions based on US foreign policy and national security goals, targeting foreign countries, regimes, terrorists, international narcotics traffickers, weapons-of-mass-destruction proliferators, and other threats. The SDN List names individuals, companies, research institutions, non-profits, vessels, and aircraft with which US persons -- including US universities and their employees -- are generally prohibited from dealing at all: their property and interests in property that come within US jurisdiction are "blocked" (frozen), and virtually all transactions between them and a US person are prohibited absent a specific OFAC license or applicable general license. OFAC also maintains a broader Consolidated Sanctions List (which folds in several narrower sectoral and program-specific lists) and country-based comprehensive sanctions programs (for example, on Cuba, Iran, North Korea, Syria, and the Russia-related programs); an entity or person can be sanctioned by inclusion in one of those programs without appearing on the SDN List specifically. For research institutions, "checking the OFAC list" is shorthand for restricted-party screening: running a prospective international collaborator, visiting scholar, subrecipient, vendor, or payment counterparty through OFAC's Sanctions List Search tool (which uses fuzzy-name matching) before entering into the relationship or releasing funds or controlled items.
Independent Review Committee (IRC)
An Independent Review Committee (IRC) — also called a Blinded Independent Central Review (BICR) in oncology trials — is a panel of qualified, external reviewers (typically radiologists or other specialists) who re-assess protocol-specified efficacy endpoint data, most commonly medical imaging, according to a predefined charter and standardized criteria (e.g., RECIST for tumor response). Reviewers work independently of the trial sponsor, investigators, and local site assessors, and are blinded to treatment assignment and to the local site's own read, to produce a bias-minimized, reproducible determination of endpoints such as objective response rate (ORR), progression-free survival (PFS), or time to progression (TTP). FDA guidance on cancer drug approval and on clinical trial imaging endpoints recommends or requires an IRC/BICR specifically when a trial is not fully blinded and endpoint assessment could otherwise be influenced by knowledge of treatment assignment.
The National Research Act (Public Law 93-348) is the U.S. federal statute, signed into law by President Nixon on July 12, 1974, that created the modern legal framework for protecting human subjects in research. It established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and charged it with identifying the basic ethical principles that should govern human-subjects research; that mandate is what produced the Belmont Report in 1979. Separately, the Act amended the Public Health Service Act to require that any institution receiving federal funding for biomedical or behavioral research involving human subjects establish an Institutional Review Board (IRB) to review and approve such research before it begins -- the statutory origin of mandatory IRB review, later codified in regulation at 45 CFR 46 (the Common Rule). A statute qualifies as "the National Research Act" in this sense only if it is Public Law 93-348 itself (or a provision directly traceable to it); the Belmont Report and the Common Rule are downstream products the Act required or made possible, not the Act itself.
IRB Number (IRB ID)
The unique identifier an Institutional Review Board assigns to a single approved research protocol at the time of initial submission, used to track and reference that specific study throughout its review lifecycle (approval, amendment, continuing review, closure) and to cite in manuscripts, consent forms, and funder reports — distinct from the institution's OHRP IRB Registration Number (identifies the review board itself) or Federalwide Assurance (FWA) number (identifies the institution as a whole).
Early Stage Investigator (ESI)
An Early Stage Investigator (ESI) is an NIH designation for a Program Director/Principal Investigator (PD/PI) who (1) has completed their terminal research degree, or the end of their post-graduate clinical training (e.g., medical residency), whichever date is later, within the past 10 years, AND (2) has not yet competed successfully as PD/PI for a substantial NIH independent research award (most commonly an R01 or an award NIH treats as equivalent to one). Both conditions must hold at the time of application; meeting only one does not qualify a PD/PI as an ESI. NIH determines ESI status automatically from the eRA Commons personal profile at the time of application submission, based on the degree-completion date the applicant enters, so keeping that profile field current and accurate is what actually controls whether a given application receives ESI consideration -- not a separate application or self-certification step.
Continuing Professional Development (CPD)
An ongoing, documented pattern of continuing education a research-administration or clinical-research professional completes after entering the field, used either to maintain an active professional credential (via a certifying body's mandatory continuing-education requirement) or, more generally, to keep current with an evolving regulatory and operational landscape. To count operationally, the activity must be tracked (hours/points logged against a reporting period), applied (submitted as evidence toward a recertification cycle, for credential holders), and relevant to the professional's field of practice.
Clinical Study
A clinical study is the umbrella term ClinicalTrials.gov and the U.S. National Library of Medicine (NLM, part of NIH) use for any research study involving human volunteers (participants) that is intended to add to medical knowledge. Under this definition, every clinical study is one of two subtypes: an interventional study — commonly called a clinical trial — in which participants are prospectively assigned, according to a protocol, to receive a specific intervention (a drug, device, procedure, or behavioral change) so its effect can be evaluated; or an observational study, in which participants are assessed for health-related outcomes or characteristics as they occur naturally, without the investigator assigning any intervention. "Clinical study" is therefore broader than "clinical trial": every clinical trial is a clinical study, but not every clinical study is a clinical trial. This is a separate axis of classification from NIH's own narrower, funding-and-policy-consequential test for whether a specific study is an "NIH-defined clinical trial" (prospective assignment to an intervention to evaluate its effect on a health-related biomedical or behavioral outcome) — a study can be a clinical trial in the general ClinicalTrials.gov sense while the NIH four-question test is what actually determines registration, reporting, and funding-opportunity obligations for NIH-funded work.
National Science Foundation (NSF)
An independent agency of the United States federal government, established by the National Science Foundation Act of 1950 (Public Law 81-507), that funds basic research and education in non-medical fields of science and engineering. NSF is not part of a cabinet department -- it reports directly to the President and Congress, governed by a Director (who runs day-to-day operations) and the presidentially-appointed, 24-member National Science Board (NSB), which sets policy and must approve awards or actions above certain dollar thresholds. An entity qualifies as "NSF" for research-administration purposes when it is the specific federal agency headquartered in Alexandria, Virginia that issues funding opportunities, applies the Proposal & Award Policies & Procedures Guide (PAPPG) to its awards, and organizes its research portfolio through a set of subject-based directorates rather than through the disease- or institute-based structure NIH uses. NSF's stated mission, carried over from its founding legislation, is to "promote the progress of science," "advance the national health, prosperity, and welfare," and "secure the national defense." As of the current NSF organizational structure, the agency's research and education activity is organized into seven research directorates -- Biological Sciences (BIO); Computer and Information Science and Engineering (CISE); Engineering (ENG); Geosciences (GEO); Mathematical and Physical Sciences (MPS); Social, Behavioral and Economic Sciences (SBE); and Technology, Innovation and Partnerships (TIP, established 2022, the first new directorate in three decades) -- plus a STEM Education directorate and offices including International Science and Engineering and the National Center for Science and Engineering Statistics. NSF funds roughly 11,000 competitive awards a year and, by its own account, its investments make up approximately a quarter of federal support for basic research at U.S. colleges and universities.
Partnership Development Grant
A funding request qualifies as a SSHRC Partnership Development Grant when it is submitted by a researcher affiliated with an eligible Canadian postsecondary institution to Canada's Social Sciences and Humanities Research Council (SSHRC), and involves a genuine non-academic partner organization that will help shape (not merely receive the outputs of) a bounded, developmental research or knowledge-mobilization activity. The mechanism funds $75,000 to $250,000 over 1 to 3 years (2026 competition figures) and is explicitly developmental in purpose — testing or building a partnership approach rather than sustaining an already-mature, large-scale collaboration.
Electronic Medical Record (EMR)
An electronic medical record (EMR) is the digital equivalent of a single healthcare provider's paper chart: a patient's medical and treatment history as captured, stored, and used within one clinical practice or healthcare organization. An artifact is an EMR (rather than an EHR) when its data model, access controls, and interoperability are scoped to a single organization's internal clinical workflow, not designed for structured exchange with external providers, payers, or research systems -- even if the underlying software vendor also sells EHR-branded products elsewhere.
Vulnerable Populations in Research
A research participant or class of participants that 45 CFR 46 (the Common Rule) subjects to additional, IRB-enforced protections beyond ordinary informed-consent review: either because they fall into one of three subparts with dedicated, codified requirements (Subpart B — pregnant women, human fetuses, and neonates; Subpart C — prisoners; Subpart D — children), or because the IRB determines under §46.111(b) that they are otherwise likely to be vulnerable to coercion or undue influence (e.g., individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons) and documents the additional safeguards included to protect their rights and welfare.
NSF REU (Research Experiences for Undergraduates)
An NSF Research Experiences for Undergraduates (REU) award is either an REU Site — an independently proposed, competitively awarded institutional program (under NSF solicitation 23-601) that brings a cohort of undergraduates, typically 8–10 per year, to conduct mentored research over a defined period, most often an 8–10 week summer program — or an REU Supplement — additional funding added to a new, renewal, or already-active NSF research grant or cooperative agreement specifically to support undergraduate participants in that project's existing research. Eligible student participants must be U.S. citizens, U.S. nationals, or U.S. permanent residents; each Site or Supplement runs its own application and selection process independently of NSF.
Non-Practicing Entity (NPE)
An entity that owns one or more issued or pending patents but does not manufacture, sell, or otherwise commercially practice the invention itself, and instead generates value from the patent through licensing, litigation/demand-letter assertion, or both. "Non-practicing" describes the entity's relationship to the patent, not the patent's validity -- individual inventors, universities and research institutions, pre-commercialization startups, failed operating companies holding residual portfolios, and dedicated patent-acquisition/licensing firms are all NPEs in this technical sense, even though only a narrower subset of them (the FTC's "patent assertion entity," or PAE, category, and the pejorative "patent troll" label) draw the negative connotation the term is often assumed to carry.
Elicit (AI Research Assistant)
Elicit is a named AI research-assistant platform (built by the public benefit corporation Elicit, spun out of the nonprofit lab Ought in 2023) that searches an indexed academic-literature corpus and performs structured evidence-extraction tasks -- summarizing papers, extracting and tabulating data points across many papers with sentence-level source citations, and supporting systematic-review-style screening and data-extraction workflows aligned to PRISMA 2020. It is a specific product, not a generic label for "AI that helps with research" -- distinct from citation-graph discovery tools (Connected Papers, ResearchRabbit) and general-purpose AI writing assistants -- and its extraction/screening output requires independent verification against the source papers rather than being treated as ground truth.
Investigator-Initiated Study (IIS)
An investigator-initiated study (IIS), also called an investigator-initiated trial (IIT), is a clinical trial that an individual investigator -- not a pharmaceutical or device company -- designs, initiates, and holds primary regulatory responsibility for conducting. The distinguishing test is not whether an academic clinician is involved (nearly every clinical trial has one), but who originates the protocol and holds the regulatory authorization to conduct it: the Investigational New Drug (IND) application for a US drug/biologic trial, or the Investigational Device Exemption (IDE) for a device trial. Under 21 CFR 312.3, an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered, is a "sponsor-investigator" -- a single person who simultaneously carries the regulatory obligations FDA assigns to a sponsor (21 CFR 312 Subpart D, sections 312.50-312.59) and those assigned to an investigator (sections 312.60-312.69). 21 CFR 812.3 defines the equivalent role for device studies conducted under an IDE. This is what distinguishes an IIS from a physician serving only as a participating-site principal investigator in an industry-sponsored multi-site trial, where a company holds the IND/IDE and remains sponsor of record.
SciScore
SciScore is an automated text-mining tool from SciCrunch that scores a manuscript's methods section (0-10) against named rigor and resource-transparency criteria -- randomization, blinding, sample-size justification, sex as a biological variable, and RRID-identified research resources -- drawn from NIH rigor guidelines, MDAR, ARRIVE, CONSORT, and STAR Methods, integrated into journal submission workflows at publishers such as the American Heart Association, Rockefeller University Press, and FASEB.
Journal Registration (ISSN Registration)
Journal registration is the process of obtaining an International Standard Serial Number (ISSN) for a serial publication -- an 8-digit identifier assigned exclusively by the ISSN Network (a national ISSN Centre, or the ISSN International Centre for countries without one) that uniquely identifies a specific title in a specific medium. A publication counts as "registered" only once the relevant Centre has verified the title, publisher, and format and formally assigned it an ISSN through the ISSN Portal -- not merely because a publisher claims or advertises one. It is a bibliographic-identification step, distinct from peer-review vetting, DOAJ inclusion, database indexing, or any copyright/trademark filing.
Humanitarian Use Device (HUD)
A device qualifies as a Humanitarian Use Device (HUD) when it is intended to treat or diagnose a disease or condition that affects, or is manifested in, not more than 8,000 individuals in the United States per year (FD&C Act Section 520(m); 21 CFR Part 814, Subpart H). For a diagnostic device, the threshold is applied to the number of people who would be subject to diagnosis by the device, not to the prevalence of the disease itself. HUD designation, granted by FDA's Office of Orphan Products Development, is the required first step before a sponsor may submit a Humanitarian Device Exemption (HDE) application -- a marketing authorization that permits FDA approval based on a finding of probable benefit outweighing risk, rather than the reasonable assurance of effectiveness a standard Premarket Approval (PMA) requires.
FDA (Food and Drug Administration)
The U.S. Food and Drug Administration (FDA) is the federal agency within the Department of Health and Human Services (HHS) responsible for protecting public health by regulating the safety and effectiveness of human and veterinary drugs, biological products, and medical devices, along with the U.S. food supply, tobacco products, and cosmetics. In a research context, FDA is the authority that reviews and authorizes Investigational New Drug (IND, 21 CFR Part 312) and Investigational Device Exemption (IDE, 21 CFR Part 812) applications before a human clinical investigation of an unapproved drug, biologic, or device may proceed, and it inspects trial sites, sponsors, IRBs, and manufacturing facilities for compliance with its regulations. FDA is organized into center-level components with jurisdiction over different product categories -- principally CDER (drugs), CBER (biologics), and CDRH (devices) for research purposes -- plus a field-inspection arm, the Office of Inspections and Investigations (OII, renamed from the Office of Regulatory Affairs in an October 2024 reorganization).
Operationalizing Variables
Operationalization is the process of translating an abstract theoretical construct that cannot be observed or measured directly (for example, “job satisfaction” or “research productivity”) into a concrete, specific operational definition: a stated procedure or instrument, a defined unit or range of values, and a rule precise enough that a researcher who did not design the study could apply it to new data and get a comparable result. A variable is operationalized only when all three hold together — naming the construct, or describing it in general terms, is not the same as operationalizing it.
NRSA Stipend Levels
NRSA stipend levels are the fixed, NIH-mandated annual stipend amounts published (roughly annually, via a Notice in the NIH Guide) for individuals supported on a Ruth L. Kirschstein National Research Service Award -- whether held as an individual fellowship (F30/F31/F32) or an institutional training grant slot (T32/T90/TL1). What determines the applicable level: career stage (predoctoral vs. postdoctoral) and, for postdoctoral trainees/fellows only, full years of relevant prior postdoctoral research experience at the time the award is issued. Predoctoral levels are a single flat rate regardless of year in the doctoral program; postdoctoral levels step up across eight tiers (Level 0 through Level 7+) by experience year. The published level is a floor the federal award must provide, not a ceiling institutions are barred from supplementing under NIH's own rules.
OMB Compliance Supplement
The OMB Compliance Supplement is the annual publication, issued by the US Office of Management and Budget and codified as 2 CFR Part 200, Appendix XI, that gives independent auditors the compliance requirements and suggested audit procedures to test, program by program, when conducting a Single Audit of a non-federal entity under 2 CFR 200 Subpart F.
Australian Code for the Responsible Conduct of Research
Australia's foundational research-integrity governance document (the "2018 Code"), jointly issued by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), and Universities Australia in June 2018, replacing the more prescriptive, rules-based 2007 Code. It is a principles-based document setting out eight principles of responsible research conduct (honesty, rigour, transparency, fairness, respect, recognition of the rights of Indigenous peoples to be engaged in research that affects or is of significance to them, accountability, and promotion of responsible research practices) plus 29 specific responsibilities — 13 for institutions (R1–R13) and 16 for researchers (R14–R29). Unlike the National Statement on Ethical Conduct in Human Research, which governs the ethical review of studies involving human participants specifically, the Code covers research-integrity conduct broadly across all disciplines: authorship, data management and retention, supervision, publication and dissemination, peer review, conflicts of interest, and how institutions must manage and investigate potential breaches.
ARC Future Fellowship
An ARC Future Fellowship is a competitively awarded, individually held four-year fellowship from the Australian Research Council’s Discovery Program that funds an outstanding mid-career researcher’s salary plus a flexible, non-project-specific pool of research support (reported at up to A$60,000/year), held through an eligible Australian Administering Organisation. Eligibility is set by a PhD-award-date window (adjusted for allowable career interruptions) that shifts with each funding round, not by job title, and the scheme excludes any research meeting the ARC/NHMRC definition of medical research.
ABRF (Association of Biomolecular Resource Facilities)
ABRF (Association of Biomolecular Resource Facilities) is the U.S.-based, membership professional association for people who operate, direct, staff, or support shared research core facilities and other biotechnology resource laboratories -- it is not a facility, funder, or accrediting body itself. Organized in 1988 and formally incorporated in Delaware in 1989, growing out of a 1986 gathering of protein-sequencing core operators, ABRF today counts more than 4,000 members representing 400+ member laboratories and administrative offices across government, academic, industrial, and commercial settings. Membership and participation in ABRF's Research Groups, annual meeting, and journal is what distinguishes 'the ABRF community' from the broader population of core-facility staff generally -- someone who runs a core facility without ever engaging with ABRF is still a core-facility professional, just not part of this specific association.
Trademark
A word, phrase, symbol, design, or combination of these that identifies and distinguishes the source of goods or services in commerce (a mark used with goods is a trademark; the identical protection used with services is a service mark). Trademark rights arise automatically from actual use of the mark in commerce, under the Lanham Act (15 U.S.C. § 1051 et seq.); federal registration with the USPTO is not required to have enforceable rights but converts geographically-limited common-law rights into a nationwide, publicly recorded claim. Unlike a patent (protects an invention), a copyright (protects a creative work), or a trade secret (protects confidential information via secrecy), a trademark protects only the identifier itself, and lasts indefinitely as long as the mark stays in active use and any registration is maintained.
Cover Letter for Journal Submission
A short letter addressed to a journal's editor that accompanies a manuscript submission, as a separate document from the manuscript itself, in which the corresponding author states the manuscript's novelty and significance in their own words, confirms it is not simultaneously under consideration elsewhere, discloses relevant conflicts of interest (or confirms none exist), confirms all authors have approved the submission, and — where the specific journal's instructions permit — suggests or excludes potential peer reviewers.
Software License Agreement
A software license agreement, in a university technology-transfer context, is the contract a TTO uses to grant an outside company or party rights to use, modify, and/or distribute software the university itself developed — the university acting as licensor of its own copyright (and occasionally an associated patent), not as a licensee of someone else's commercial software. Because software is protected primarily by copyright rather than patent (computer programs are "literary works" under 17 U.S.C. § 101, added by the Computer Software Copyright Act of 1980), the agreement's exclusivity controls the specific codebase and its expression, not the underlying idea or method (17 U.S.C. § 102(b)) — a materially different scope of exclusivity than a patent license conveys. Typical negotiated terms include exclusive vs. non-exclusive scope, field-of-use and territory restrictions, royalty/fee structure (upfront fees, running royalties, minimums, or equity), source code delivery/escrow, maintenance and support obligations, ownership of derivative works, sublicensing and audit rights, termination, and — for federally funded software — flow-down of the government's 2 CFR § 200.315 use rights.
Electronic Data Capture (EDC)
Electronic Data Capture (EDC) is the general category of software systems that collect clinical or research study data directly in electronic form -- via electronic case report forms (eCRFs) -- at the point of collection, in place of paper-based data collection. A system counts as EDC when it provides study-specific eCRFs, direct point-of-collection data entry, field-level validation and query management, and an audit trail sufficient to make the electronic record the study's data of record. EDC is the site-facing data-entry layer within the broader discipline of clinical data management; a full Clinical Data Management System (CDMS) is the broader term covering EDC plus surrounding query-management, coding, and database-lock workflow. EDC is distinct from a Clinical Trial Management System (CTMS), which manages trial operations rather than the research data itself. Both non-profit/academic platforms (e.g., REDCap) and commercial, enterprise-scale platforms (e.g., Medidata Rave EDC, Oracle Clinical One) fall within the EDC category.
Clinical Trials Unit (CTU)
A unit is a Clinical Trials Unit (CTU) when it is a centralized institutional infrastructure -- organizationally part of the same academic medical center, hospital, or university as the investigators it serves, not a separately contracted external entity -- that provides shared, reusable operational services (regulatory support, data management, monitoring, biostatistics, and/or budgeting) to more than one investigator or study across the institution, so no individual Principal Investigator has to build that infrastructure from scratch for a single trial. Investigators engage a CTU internally, through a service agreement, cost-recovery charge, or institutional mandate for certain trial types -- not through a Clinical Trial Agreement the way an external sponsor engages a Contract Research Organization (CRO).
NIH Study Section
An NIH study section (formally a Scientific Review Group, SRG) is a peer-review panel — chartered/standing or a temporary Special Emphasis Panel (SEP) — convened by NIH’s Center for Scientific Review (or, for RFAs and some program-specific competitions, by the awarding Institute/Center) to evaluate the scientific and technical merit of grant applications assigned to it, producing a priority score and summary statement as the first of NIH’s two required levels of peer review.
NIH Standard Due Dates
NIH Standard Due Dates are the recurring, government-published submission deadlines NIH sets for applications to its standing funding opportunities (Parent Announcements, PARs, and PAS) — three annual receipt dates per calendar year, occurring on the same months for every cycle, with the exact day varying by activity code (R01; R03/R21/R33/R34/R36/U34/UH2/UH3; K series; F series; T/D series; R15/AREA) and by application type (new vs. renewal, resubmission, or revision, which are typically offset one month later). They are set by NIH policy notice and apply automatically to every standing announcement that references them, in contrast to an RFA's own single, non-recurring receipt date, which each RFA sets independently.
Fly America Act
The requirement, under 49 U.S.C. § 40118 and its implementing Federal Travel Regulation (41 CFR part 301-10, subpart B), that air transportation paid for with U.S. government funds -- including federal grants and cooperative agreements -- be provided by a U.S. flag air carrier, unless a specific, narrowly defined exception applies (an Open Skies bilateral/multilateral agreement, documented necessity, or a defined travel-time/connection threshold).
Electronic Theses and Dissertations (ETD)
A thesis or dissertation prepared, submitted, and archived in digital form (typically a PDF plus any supplementary files) rather than only as a bound print copy, submitted to satisfy a degree requirement. A work qualifies as an ETD once digital deposit — most often to an institutional repository, and often onward to a national or international aggregator such as NDLTD — is the accepted or required submission format, even if the institution also retains a print copy alongside it.
Biosafety Level 3 (BSL-3)
The CDC/NIH BMBL laboratory-containment tier assigned to a protocol when the biological agent(s) involved can cause serious or potentially lethal disease through inhalation of infectious aerosols, but for which a licensed vaccine or effective treatment is routinely available. An instance of BSL-3 combines controlled/restricted access, sustained directional inward airflow through a double-door entry, HEPA-filtered exhaust, biosafety-cabinet use for all open agent manipulation, and respiratory protection where indicated, with the level itself formally assigned through an Institutional Biosafety Committee (IBC) risk assessment before laboratory work begins.
Software Patent
A software patent is a utility patent under 35 U.S.C. § 101 whose claims are directed to a computer-implemented invention — an algorithm, data-processing method, or system whose novelty lies substantially in what a computer program does. There is no separate statutory category for software; instead, software claims are tested against the same judicially created "abstract idea" exception to § 101 that applies to every utility patent, using the two-step framework the Supreme Court set out in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and applied directly to computer-implemented claims in Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014): (1) is the claim, as a whole, "directed to" an abstract idea, and if so, (2) do the claim elements, individually or in combination, supply an "inventive concept" that amounts to "significantly more" than the abstract idea itself? Generic computer hardware performing a well-known process does not supply that inventive concept. Because software claims reach Step One's abstract-idea inquiry far more often than claims in most other technology areas, and because Step Two sets a genuinely demanding bar, software patents are markedly harder to obtain and to defend against post-grant invalidity challenges than most other utility patents.
Academic Journal
A publication counts as an academic (scholarly) journal when it is issued on a continuing basis under a stable title and ISSN, publishes original research or scholarship vetted through a documented peer-review or formal editorial-review process, is overseen by a named editorial board of subject-matter experts, states an explicit aims-and-scope, and is cited within and indexed by the scholarly literature — as distinct from a magazine (general audience, no peer review), a trade publication (practitioner audience, editorial but not scholarly peer review), or a blog/preprint server (no editorial board, no peer review).
Social Sciences Citation Index (SSCI)
A journal is considered SSCI-indexed when Clarivate's independent, in-house editorial reviewers have evaluated and accepted it into the Social Sciences Citation Index — the social-sciences-scoped citation index within the Web of Science Core Collection — based on Clarivate's quality criteria (peer review, editorial rigor, timeliness, ethical publishing standards) and its own separate impact/citation-influence assessment. SSCI inclusion is evaluated independently of the Science Citation Index Expanded (SCIE) and the Arts & Humanities Citation Index (AHCI): a journal is not automatically SSCI-indexed just because it appears in one of those companion indexes, and indexing is not permanent — a journal can later be suspended or delisted if it stops meeting Clarivate's criteria.
PRISMA Flow Diagram
The standardized figure PRISMA 2020 uses to report the flow of records through a systematic review or meta-analysis, organized under three labeled phases (Identification, Screening, Included), with a numeric box for every stage of attrition and a stated reason for every full-text exclusion.
OHRP (Office for Human Research Protections)
OHRP is the HHS office that oversees institutional compliance with the Common Rule (45 CFR 46) for HHS-conducted or HHS-supported human-subjects research. It administers the Federalwide Assurance (FWA) program institutions file to commit to Common Rule compliance, registers the IRBs designated under those assurances, and conducts compliance oversight -- not-for-cause evaluations and for-cause investigations -- of institutions and IRBs, issuing determination letters and, where warranted, corrective-action or FWA-restriction remedies. OHRP's jurisdiction is the institution's assurance and its IRB's registration and conduct, not direct review or approval of individual study protocols.
Research fellowship
A research fellowship is a competitively awarded, individually held package of support for a defined program of research -- distinguished from staff pay on a principal investigator's grant, an institutionally-held training slot, or a titled faculty position by who holds the award and why, not by career stage or seniority. It funds a fixed period (commonly one to five years, depending on stage) of research, structured as a stipend, salary-replacement, or salary-plus-allowance package tied to the research itself rather than wages for institutional duties. The same test applies across career stages -- graduate/doctoral fellowships (e.g. NSF's GRFP), postdoctoral fellowships (e.g. NIH F32, NSF postdoctoral programs, MSCA), and senior/faculty fellowships (e.g. Guggenheim, ACLS, Fulbright Scholar) -- though the specific mechanics differ: predoctoral and postdoctoral fellowships are typically portable to a funder-approved host institution, while senior-stage fellowships more often fund a period of leave from an existing faculty position rather than a portable appointment.
Research Study Types
A research study's design type is the structural classification of how it relates to the exposure or intervention under study, decided at the protocol stage: whether the researcher assigns the exposure (experimental) or only observes it occurring naturally (observational), and, for observational designs, whether data collection looks forward from exposure (cohort), backward from outcome (case-control), or captures exposure and outcome at a single point in time (cross-sectional). It is a separate axis from research methodology (qualitative vs. quantitative vs. mixed methods, which describes data type, not design structure).
Good Pharmacovigilance Practices (GVP)
Good Pharmacovigilance Practices (GVP) is the European Medicines Agency's formal, numbered set of guidelines (GVP Modules I-XVI, with Modules XI-XIV void) governing how EU marketing-authorisation holders, national competent authorities, and the EMA itself must detect, assess, and prevent adverse effects and other medicine-related problems across an authorised medicine's lifecycle. Issued under Article 108a of Directive 2001/83/EC as amended, GVP requires an EEA-resident Qualified Person Responsible for Pharmacovigilance (QPPV), a maintained Pharmacovigilance System Master File (PSMF), and EudraVigilance-routed safety reporting. GVP incorporates but is not identical to the internationally harmonised ICH E2 guideline series (E2A/E2B/E2C(R2)/E2D): ICH E2 sets the global base definitions and formats several GVP modules cite directly, while GVP adds EU-specific structures (QPPV, PSMF, EudraVigilance, GVP-specific inspection) that ICH E2 does not itself require.
CFIUS (Committee on Foreign Investment in US)
CFIUS (the Committee on Foreign Investment in the United States) is the US federal interagency committee, chaired by the Secretary of the Treasury and acting under Section 721 of the Defense Production Act of 1950 (as amended by FIRRMA in 2018) and its implementing regulations at 31 CFR Part 800, that reviews “covered transactions” — foreign acquisitions of control of a US business, and, since FIRRMA, certain non-controlling foreign investments granting governance or information rights in a critical-technology, critical-infrastructure, or sensitive-personal-data US business (a “TID US business”) — for national security risk.
Patentability of Biological Subject Matter
Whether a claimed invention involving a living organism, cell, or genetic/biological material is patent-eligible subject matter under 35 U.S.C. § 101 turns on one question: has a human being changed it into something with markedly different characteristics from what exists in nature, or is the claim, in substance, directed to the product or law of nature itself, merely isolated, purified, or observed? "Manufacture" and "composition of matter" in Section 101 reach human-made, human-altered living organisms — the fact that something is alive is not, by itself, a bar to patenting (Diamond v. Chakrabarty, 447 U.S. 303 (1980)). But those same terms do not reach a naturally occurring nucleic-acid sequence merely separated from its surrounding genetic material, because isolating something nature already made is not an act of invention (Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)). A synthetic construct that does not occur in nature — such as complementary DNA (cDNA), which omits the non-coding intron sequences present in the genomic original — remains patent-eligible even under Myriad, because a lab technician creates something structurally new when cDNA is synthesized.
DOAJ (Directory of Open Access Journals)
DOAJ (Directory of Open Access Journals) is an independent, community-curated online directory that indexes peer-reviewed open-access journals meeting its published inclusion criteria. A journal counts as "DOAJ-indexed" only once it has applied and DOAJ's editorial team has evaluated and accepted that application against DOAJ's own checkable standards for genuine open access, documented peer review, an identifiable editorial board, ISSN registration, licensing/copyright transparency, and public disclosure of any author-facing fees -- self-describing as open access, or being under DOAJ review, is not the same claim as being listed.
Certificate of Confidentiality (CoC)
A Certificate of Confidentiality (CoC) is a federal legal protection, under Section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) as amended by the 21st Century Cures Act, that shields a researcher from being legally compelled -- by subpoena, court order, or similar legal, administrative, or legislative demand -- to disclose names or other identifying information about research participants. For NIH-funded research collecting or using identifiable, sensitive information, a CoC has attached automatically, as a standing term of the award, since October 1, 2017 (NOT-OD-17-109), replacing the prior application-based system under which investigators had to request a certificate for each project. A CoC does not de-identify or otherwise secure the underlying data -- it is a legal shield against compelled disclosure through legal process, not a data-security or data-masking control, and it does not protect against every disclosure (recognized exceptions include participant consent, certain legally mandated reporting, and DHHS or FDA regulatory access).
Qualitative Data Collection Techniques
A qualitative data collection technique is the specific, repeatable procedure a researcher uses to generate or capture non-numeric primary data within a qualitative study — distinct from the broader methodological tradition (ethnography, phenomenology, grounded theory, narrative research, case study) that determines how techniques are combined, sequenced, and interpreted. Four techniques account for most qualitative primary data: the semi-structured interview (a predetermined but flexible guide of open-ended questions, allowing probes and reordering); the focus group (a facilitated discussion among roughly 6-10 participants per group, in which group interaction itself, not just individual answers, is the data source); participant observation (the researcher observes, and to a chosen degree takes part in, a setting's ordinary activities, recording field notes); and document or artifact analysis (systematic review of pre-existing texts, records, or images the researcher did not create). A single technique can appear inside more than one tradition — semi-structured interviews show up in phenomenology, grounded theory, and case-study designs alike — so naming the technique alone does not establish a study's overall methodological design.
Good H-Index
A "good" h-index is not a fixed number: it is only interpretable relative to a researcher's specific field (citation density and publication norms vary widely by discipline), career stage (h-index can only increase over time, so it partly measures career length), and the database it was computed from (Google Scholar, Scopus and Web of Science produce different values for the same person) — and even then should be used only as one input alongside qualitative review of the actual body of work, not as a standalone pass/fail threshold or cross-researcher ranking.
NSF Biosketch (SciENcv)
The Biographical Sketch that a proposer submits for NSF senior/key personnel counts as an NSF Biosketch (SciENcv) only when it is generated inside SciENcv using NSF's Biographical Sketch module and follows the NSPM-33 Common Form structure (Identifying Information, Organization and Location, Professional Preparation, Appointments and Positions, Products, Certification) -- a hand-typed PDF built outside SciENcv is no longer an accepted substitute for proposals subject to the current PAPPG.
Data Breach Response Plan
A data breach response plan for research data is a documented, pre-established procedure -- distinct from a generic enterprise IT incident response plan -- specifying how an institution or research team will detect, contain, assess the impact of, and report a security incident involving research data, with particular attention to data subject to a specific regulatory, contractual, or funder obligation: HIPAA-covered protected health information (PHI), data obtained under a signed Data Use Agreement or a controlled-access repository's data use certification (e.g., NIH's dbGaP), export-controlled technical data (EAR/ITAR), or identifiable human-subjects data subject to IRB oversight. What distinguishes it from a general IT incident response plan is not the detection/containment mechanics -- those follow the same ISO/IEC 27001 Annex A.5.24-A.5.28 discipline any organization uses -- but an explicit notification-routing step naming, for each data type, which additional party (an IRB, a funding agency, a repository's Data Access Committee, an export control office) must be notified, and on what timeline, on top of whatever an institution's central IT security office already does for any security incident.
SBIR Phase II
The second stage of the U.S. Small Business Innovation Research (SBIR) program: a full research-and-development award, typically up to two years and substantially larger than a Phase I feasibility award, funding prototype development and validation toward commercialization. At most participating agencies a business must have already been awarded (and largely completed) a Phase I award for the same project to be eligible, though a handful of agencies allow a Direct-to-Phase-II exception for firms that can document equivalent feasibility results using non-SBIR funds.
Utility Patent
A utility patent is a patent granted under 35 U.S.C. § 101 for a new and useful process, machine, article of manufacture, or composition of matter, or a new and useful improvement of one of those four categories -- it protects how an invention works or functions, not its ornamental appearance (design patent, 35 U.S.C. § 171) or its status as a newly-created asexually-reproduced plant variety (plant patent, 35 U.S.C. § 161). It is the default patent category: an application is a utility application unless expressly filed as design or plant. Something qualifies as a utility patent if its claims are directed to one of the four § 101 categories and it separately satisfies novelty, non-obviousness, utility, and enablement during USPTO examination.
Designated Institutional Official (DIO)
The individual appointed by an ACGME-accredited Sponsoring Institution's Governing Body who holds institution-wide authority and responsibility for the oversight and administration of every graduate medical education (GME) program the institution sponsors, and who is accountable to the Accreditation Council for Graduate Medical Education (ACGME) for the institution's compliance with its Institutional, Common, and specialty-specific Program Requirements -- distinct from the "Institutional Official" role used in federal human-subjects and financial-conflict-of-interest compliance.
FDA Form 1572 (Statement of Investigator)
FDA Form 1572 ("Statement of Investigator") is the signed document by which an individual becomes an "investigator" of record on an FDA-regulated drug or biologic trial conducted under an Investigational New Drug (IND) application. Under 21 CFR 312.53, a sponsor may not permit an investigator to begin participating in the study until this form -- along with the investigator's curriculum vitae and financial disclosure information -- is completed and signed. The investigator's signature affirms they are qualified to conduct the study and constitutes a written commitment to comply with FDA's clinical-investigation regulations, including protocol adherence, IRB oversight, informed consent, adverse-event reporting, and recordkeeping. Only the person who meets the 21 CFR 312.3 definition of "investigator" -- the responsible leader of the site's study team, commonly the principal investigator -- signs the form; subinvestigators are listed on it but do not sign their own.
Mixed Methods Research
Mixed methods research is a study design in which a researcher deliberately collects and analyzes both quantitative and qualitative data within a single study and integrates the two strands at one or more defined points in the design (through merging, connecting, or embedding) for a stated rationale such as triangulation, complementarity, or development — not a study that simply uses one method for one question and a different method for an unrelated question, and not a study that collects both data types but reports them independently without ever connecting them.
IMRaD Structure
The four-part sectional structure -- Introduction, Methods, Results, and Discussion -- used to organize a manuscript reporting original empirical research. A paper qualifies as IMRaD-structured when: (1) the Introduction states the research question against existing background without previewing findings, (2) the Methods (or Materials and Methods) section describes the procedure in enough detail to permit assessment or replication and contains no findings, (3) the Results section reports what was found without interpreting it, and (4) the Discussion interprets those findings against the research question and prior literature. Content placed in the wrong section -- most commonly, interpretation appearing in Results instead of Discussion -- is a structural defect even when all four section headings are present.
Biosafety Level 4 (BSL-4)
The CDC/NIH BMBL's maximum laboratory-containment tier, assigned when a protocol involves biological agent(s) that pose a high risk of life-threatening disease, for which no vaccine or treatment is routinely available, and for which aerosol transmission (or an unpredictable transmission risk tied to a known aerosol-transmissible agent) is a realistic exposure route. An instance of BSL-4 combines a dedicated, physically isolated facility; either a positive-pressure supplied-air suit or a Class III biosafety-cabinet line for all agent manipulation; redundant, dedicated, HEPA-filtered air supply and exhaust; and a mandatory personnel decontamination shower on exit -- with the level itself formally assigned through an Institutional Biosafety Committee (IBC) risk assessment, and, for most BSL-4 agents, additional oversight under the Federal Select Agent Program, before laboratory work may begin.
Athena SWAN Gender Equality Charter
An accreditation charter run by Advance HE that recognises an institution's or department's commitment to gender equality in higher education and research, awarded at Bronze, Silver, or Gold level after a structured self-assessment of staff/student gender data and working practices and a resulting time-bound action plan. Originated in the UK in 2005 (as Athena SWAN, focused on women in STEMM), broadened in scope in 2015, relaunched as a 'transformed' Charter in 2021, and now has internationally-adapted counterpart schemes (Athena Swan Ireland, SAGE in Australia, SEA Change in the US, Dimensions in Canada).
Biosafety Level 2 (BSL-2)
The CDC/NIH BMBL laboratory-containment tier assigned to a protocol when the biological agent(s) involved pose a moderate hazard to personnel and the environment, are generally treatable or preventable, and are transmitted primarily by direct/mucous-membrane contact, ingestion, or percutaneous exposure rather than by infectious aerosol. An instance of BSL-2 combines restricted laboratory access, biohazard signage, a certified biosafety cabinet for any aerosol- or splash-generating procedure, and standard PPE, with the level itself formally assigned through an Institutional Biosafety Committee (IBC) risk assessment before laboratory work begins.
F32 (NIH Postdoctoral Individual NRSA Fellowship)
An F32 is an NIH Ruth L. Kirschstein National Research Service Award (NRSA) individual fellowship that funds a postdoctoral researcher's own mentored training plan under a named faculty sponsor, typically at an institution other than the one that granted their doctorate. What makes an award an F32 rather than another NRSA/career-development mechanism: the applicant already holds a qualifying doctoral degree and applies directly for their own mentored postdoctoral training support -- as opposed to a predoctoral F31, an institution-held T32 training-grant slot, or a K99/R00 bridge-to-independence award that funds independent research once a faculty position is secured.
NSF PAPPG (Proposal & Award Policies & Procedures Guide)
NSF's primary, comprehensive statement of the policies and procedures governing NSF proposal preparation, submission, review, and award administration; specific sections become binding on a given award when referenced in that award's Notice of Award or NSF's Grant General Conditions (GC-1). Organized into Part I (Proposal Preparation and Submission Guidelines, Chapters I-V) and Part II (Award, Administration and Monitoring of NSF Assistance Awards, Chapters VI-XII). Current base edition is NSF 24-1 (effective May 20, 2024), supplemented by targeted policy notices (Supplement 1, NSF 26-200; Supplement 2, NSF 26-202) rather than a full renumbered edition.
Letter of Reference (Academic and Research Careers)
A formal, signed endorsement of a specific researcher's qualifications, scholarly record, and professional character, written by someone with direct first-hand knowledge of that researcher's work and submitted at the request of a tenure and promotion committee, fellowship or award nominating body, or hiring committee -- distinguished from a letter of support, which endorses a proposed project rather than a person.
Data Ownership
The allocation of legal title to and decision-making control over a research dataset. Because raw data is rarely copyrightable and no single U.S. statute assigns default ownership of research data, the operative answer in practice comes from a combination of institutional policy, the funder's terms and conditions, the Data Management Plan, and any executed data sharing/use agreement -- not from a single ownership doctrine. Distinguish from data stewardship/custodianship, which describes accountability for a dataset's day-to-day management regardless of who holds title.
HIPAA Accounting of Disclosures
A disclosure of protected health information (PHI) is subject to the HIPAA accounting-of-disclosures requirement at 45 CFR §164.528 when a covered entity makes it without the individual's authorization and it does not fall into one of the Privacy Rule's enumerated exempt categories (treatment/payment/health care operations, disclosures to the individual, incidental disclosures, authorized disclosures under §164.508, facility-directory/care-related disclosures, national-security/law-enforcement disclosures, limited-data-set disclosures under §164.514(e), or disclosures made before the covered entity's Privacy Rule compliance date). An individual has the right to request — and the covered entity must provide within 60 days, extendable once by 30 — a written accounting of every disclosure meeting that definition made in the six years preceding the request.
NIH Grants Policy Statement (NIH GPS)
NIH's primary, comprehensive statement of the policy requirements that serve as the terms and conditions of NIH grant and cooperative agreement awards, incorporated by reference into every NIH Notice of Award; organized into Part I (general information), Part II (terms and conditions, split into Part IIA general and Part IIB award-specific), and Part III (points of contact), and revised periodically to consolidate NIH Guide Notices issued since the prior edition.
CTCAE (Common Terminology Criteria for Adverse Events)
The Common Terminology Criteria for Adverse Events (CTCAE) is NCI/CTEP's standardized terminology and 5-point severity-grading scale (Grade 1-5) for adverse events in clinical trials. An event is graded under CTCAE when a study team assigns it the grade whose published, term-specific criteria it meets in the version specified by the protocol -- from Grade 1 (mild; observation only) to Grade 5 (death related to the event) -- not an ad hoc severity judgment. CTCAE grades severity only; it is distinct from whether an event separately meets regulatory 'serious adverse event' (SAE) criteria or is causally related to the study intervention.
Regulatory Affairs
Regulatory affairs, in a research-institution context, is the function -- an office, unit, or role -- responsible for identifying which regulatory frameworks apply to a given study (human-subjects protections, FDA drug/biologic/device rules, biosafety and recombinant-DNA oversight, controlled-substance handling, export control, and comparable frameworks outside the US), preparing and maintaining the submissions those frameworks require (e.g., an Investigational New Drug (IND) application under 21 CFR Part 312, or an Investigational Device Exemption (IDE) under 21 CFR Part 812), and keeping the study's regulatory record current for the life of the project. It is distinct from Institutional Review Board (IRB) review, which evaluates a study's ethics and human-subjects protections, and from Good Clinical Practice (GCP) conduct, which governs how a trial is run day to day -- regulatory affairs is the function that determines which of those requirements attach to a study in the first place and manages the paper trail with the regulator.
Open Innovation Networks
An open innovation network is a multi-party, ongoing arrangement in which a university (typically through its technology transfer office) intentionally sources and shares R&D and intellectual property across organizational boundaries, per Henry Chesbrough's open innovation framework (2003) -- rather than relying solely on internally generated, exclusively-held R&D. Three elements distinguish it from an ordinary bilateral deal: (1) multiple external parties (not a single sponsor), (2) a standing, often membership-based structure rather than a one-off transaction, and (3) non-exclusive or shared IP access as the default rather than one party holding exclusive rights. Common forms at research universities include NSF-style Industry-University Cooperative Research Centers (IUCRC), university innovation hubs and accelerators, open-source hardware/software collaborations, and pre-competitive research consortia.
protocols.io (concept)
protocols.io is a free, open platform (owned by Springer Nature since 2023) for developing, versioning, and sharing detailed step-by-step research method protocols across life-science, physical-science, and computational disciplines. Each published protocol receives a DataCite DOI, so a specific, citable version of a method persists even as the protocol is later revised, forked, or optimized by other labs.
PROSPERO Registration
PROSPERO registration is the prospective submission of a systematic review's protocol (research question, PICO, search strategy, eligibility criteria, and analysis plan) to the International Prospective Register of Systematic Reviews (PROSPERO), maintained by the Centre for Reviews and Dissemination (CRD) at the University of York and funded by the UK's NIHR, before the review has progressed beyond data extraction. Eligible reviews must have a health-related outcome; a registered record receives a permanent, publicly citable CRD42-prefixed identifier.
NIH Salary Cap
The NIH salary cap is the maximum annual rate of institutional base salary that NIH (and other HHS agencies applying the same limitation, including CDC, AHRQ, and SAMHSA) will reimburse against a grant, cooperative agreement, or contract. It is not a limit on what an institution may pay an investigator — it is a limit on what federal grant funds may reimburse. The cap is set by statute at the rate for Executive Level II of the Federal Executive Pay Schedule and, since FY2026, can change more than once within a fiscal year: for awards issued October 1, 2025 through December 31, 2025, the cap is $225,700; for awards issued January 1, 2026 through September 30, 2026, it is $228,000 (per Guide Notice NOT-OD-26-034, effective date corrected by NOT-OD-26-038). For a 9-month academic-year appointment, the proportional equivalent of the $228,000 rate is approximately $171,000. Since FY2025 (NOT-OD-25-025), the cap applies to both direct salaries of individuals working on NIH projects and indirect salaries (executive salaries in uncapped cost pools) — not direct salary alone, as was the case FY1990–FY2024. Any portion of an investigator's institutional base salary above the applicable cap, for the percentage of effort charged to an NIH award, cannot be charged to that award — the institution must either cost-share the excess from non-federal funds or reduce the effort percentage charged to stay within the capped amount.
ResearcherID
ResearcherID is Clarivate's proprietary author identifier for the Web of Science ecosystem: a unique alphanumeric code (format letter(s)-numbers-year) assigned when a researcher creates a Web of Science Researcher Profile, used to disambiguate that person's publications and citation metrics within Web of Science and InCites. Since Clarivate retired Publons as a separate product in April 2022, ResearcherID exists as the identifier component of the unified Web of Science Researcher Profile rather than a standalone product, and (once a researcher explicitly connects the two accounts) two-way syncs publications with a connected ORCID iD.
Canada Foundation for Innovation (CFI)
The Canada Foundation for Innovation (CFI) is an independent, not-for-profit corporation established by the Government of Canada in 1997 (Budget Implementation Act, 1997) that funds research infrastructure — facilities, major equipment, computing hardware, software, and databases — at Canadian universities, colleges, research hospitals, and non-profit research institutions; it does not fund research operating costs, personnel, or stipends, which is what distinguishes it from Canada's Tri-Agency granting councils (CIHR, NSERC, SSHRC).
OIG Reports
An OIG report is any audit, evaluation, investigation, or periodic report published by a federal agency's Office of Inspector General (OIG) -- an independent oversight unit created under the Inspector General Act of 1978 -- documenting findings, recommendations, questioned costs, or enforcement referrals concerning that agency's own programs, operations, grantees, or contractors.
Cost-Reimbursable Contract
A FAR Subpart 16.3 contract type in which the federal government pays a contractor's allowable, allocable costs actually incurred, up to a negotiated ceiling, plus a fee. Used instead of a fixed-price contract when requirements or costs cannot be estimated with sufficient accuracy at award (FAR 16.301-2) — most commonly for research and development work whose technical approach is not yet firmly established (FAR 35.006).
Inspection Readiness
Inspection readiness is the continuously maintained state of an institution's or clinical trial site's preparedness to undergo a regulatory inspection -- an FDA Bioresearch Monitoring (BIMO) inspection, a GMP or GLP inspection, or a sponsor/CRO audit -- at any time, rather than a set of tasks performed reactively once a specific visit is scheduled. Operationally, a site is "inspection ready" when its essential documents and regulatory binder (or Trial Master File) are organized and current as a matter of routine, staff know their assigned roles for an inspection visit, internal quality reviews or mock audits are conducted on a recurring schedule (not only pre-visit), and open corrective and preventive action (CAPA) items are being tracked and closed continuously. A site that only assembles its files, briefs its staff, and closes outstanding issues after receiving notice of an inspection is "preparing" for that one visit -- it is not inspection ready in the operational sense, because the same gaps would exist if FDA showed up unannounced.
Parenthetical Citation
An in-text citation enclosed in parentheses that gives a source's identifying information -- author and date, or author and page number, depending on the governing citation style -- directly within the sentence, as opposed to a superscript footnote/endnote marker or a bracketed numbered reference pointing to a separately numbered list. The exact contents and punctuation inside the parentheses are set by the citation style in use (e.g., APA's author-date system, MLA's author-page system, Chicago's author-date variant); the defining feature is the parenthetical container itself carrying the identifying information, not any one style's specific formatting.
Animal Welfare Act (AWA)
The primary US federal law (7 U.S.C. §2131 et seq., originally enacted 1966 as the Laboratory Animal Welfare Act, Pub. L. 89-544) that sets minimum standards for the humane care, handling, and treatment of certain warm-blooded animals used in research, teaching, testing, exhibition, and transport, enforced by USDA APHIS under the Animal Welfare Regulations (9 CFR Parts 1-3). It excludes rats and mice bred for research, birds bred for research, and cold-blooded animals from its definition of "animal," and — together with PHS Policy — is one of two legal bases requiring a research institution to convene an IACUC.
Journal Citation Reports (JCR): What It Is and What Is In It
Journal Citation Reports (JCR) is Clarivate's annual analytics database and publication reporting citation-based metrics — including the Journal Impact Factor, Journal Citation Indicator, Eigenfactor Score, Article Influence Score, and quartile (Q1-Q4) category rankings — for journals in the Web of Science Core Collection. A figure counts as "the JCR number" only when it is what Clarivate itself calculates and publishes in a specific annual release (e.g. JCR 2026), sourced from Web of Science citation data — not a similar-looking figure mirrored by a third-party site or a metric from a different database such as Scopus.
Originality Report
An automated text-matching report generated by a plagiarism-detection service (such as Turnitin or iThenticate) that compares a submitted manuscript, thesis, or dissertation against prior publications, previously submitted papers, and web content, expressing the proportion matched as a similarity index — a screening aid for human reviewers, not an automated finding of plagiarism.
Pseudonymous and Anonymous Authorship
Pseudonymous authorship is publication under a consistent, invented author name that is not the author's legal name but that the journal or publisher can trace back to a real, accountable person even though that identity is withheld from the public byline -- the same pseudonym is typically used across multiple works, building a durable scholarly identity distinct from the legal one. Anonymous authorship is narrower: the published work carries no attributable name or durable alias at all, though COPE's guidance expects the editor to still hold the real author's identity on file even when no name is published. Both are treated as narrow, conditional exceptions to the default expectation of a named, accountable author -- legitimate chiefly where disclosure would compromise the author's safety, or (for pseudonyms specifically) by durable convention such as a shared or house pen name -- and not where the goal is simply to distance a paper from an employer, avoid a workplace dispute, or preserve general privacy.
Dimensions (Research Database)
A record is part of Dimensions when Digital Science's Dimensions platform has ingested it — as a publication, grant, patent, clinical trial, dataset, or policy document — through its largely automated ingestion pipeline (funder data feeds, publisher metadata, patent-office records, clinical-trial registries, and full-text/acknowledgment mining), rather than through the title-by-title editorial selection Scopus and Web of Science apply. Where a funding relationship between a grant and the outputs it produced can be identified, Dimensions represents that link directly in its data model — this explicit funding-to-output linkage is the feature that most consistently distinguishes a Dimensions record from an equivalent Scopus or Web of Science record.
REDCap (Research Electronic Data Capture)
REDCap (Research Electronic Data Capture) is a secure, metadata-driven, web-based software platform for building surveys and case-report-form databases for research, originated at Vanderbilt University in 2004. An instance only counts as REDCap if it runs the actual Vanderbilt-distributed software, licensed at no cost to non-profit institutions through the REDCap Consortium and installed/administered by that partner institution -- there is no direct commercial purchase path or self-service individual signup. Typical uses include participant surveys, longitudinal case report forms, and multi-site clinical data capture, frequently chosen specifically because the platform supports HIPAA, FDA 21 CFR Part 11, FISMA, and GDPR compliance controls at the institutional level.
Google Scholar API
Google, as a matter of long-standing, publicly stated policy, does not operate an official, sanctioned application programming interface for Google Scholar -- there is no documented endpoint, no API key registration process, and no rate-limited free or paid tier comparable to those offered by Crossref, ORCID, Scopus, or OpenAlex. "Google Scholar API" as a search term almost always refers to one of two distinct things instead: (1) a third-party commercial scraping service (e.g. SerpApi, Apify, Oxylabs) that queries Google Scholar's public web pages on a customer's behalf and returns the result as structured JSON, or (2) an open-source scraping library (e.g. the Python package "scholarly") that automates a browser or HTTP session against the same public pages with no official sanction from Google. Both categories work by parsing Google Scholar's HTML search-results and profile pages, not by calling an endpoint Google built or documents for that purpose, and both are constrained by Google Scholar's robots.txt disallow rules and general Google Terms of Service language prohibiting automated querying without prior permission.
3-2-1 Backup Strategy
A data-protection rule requiring that any dataset worth protecting exist as at least three total copies, stored across at least two different storage media or systems, with at least one of those copies kept at a location or system genuinely separate from where the working copy lives. All three conditions must hold simultaneously -- extra copies on the same medium, or an offsite copy with no independent local redundancy, do not satisfy the rule on their own.
Cooperative Agreement
The federal legal instrument (31 U.S.C. § 6305; 2 CFR 200.1) used instead of a grant when the awarding agency anticipates substantial involvement -- active agency participation in carrying out the funded activity, such as approving a work plan, sitting on a steering committee, or holding milestone go/no-go authority -- not just routine grants-management oversight.
NHMRC Ideas Grant
An NHMRC Ideas Grant is a competitive, project-specific research funding scheme administered by Australia's National Health and Medical Research Council (NHMRC), open to a team of up to ten Chief Investigators pursuing one or more defined research questions across any area of health and medical research, from discovery to implementation. It funds the project itself — a fixed-term, budgeted piece of research work of one to five years, assessed up to roughly A$750,000 — rather than a researcher's salary or an open-ended program of research; that project-specific scope is what separates it from the NHMRC Investigator Grant, which instead funds a researcher's Salary Support Package plus a flexible, evolving program of research. An application counts as an Ideas Grant, not an Investigator Grant, when its ask is to fund a bounded piece of research work rather than a person's ongoing research direction, and it must not have a clinical trial or cohort study as its primary objective (NHMRC directs those proposals to its separate Clinical Trials and Cohort Studies scheme).
NHMRC Investigator Grant
An NHMRC Investigator Grant is a five-year Australian National Health and Medical Research Council award that consolidates an individual researcher's salary support (where needed) and a Research Support Package (RSP) into a single scheme funding that investigator's broader multi-year research program, rather than a single discrete project. Applicants are assessed and funded at one of five levels across two categories — Emerging Leadership (EL1, EL2, for researchers within 10 years post-PhD) and Leadership (L1, L2, L3) — with the RSP fixed per level ($75,000 p.a. at EL1, $200,000 p.a. at EL2, and $400,000 p.a. across L1-L3) and salary support scaled separately to the CI's seniority. A Chief Investigator (CI) may hold at most one Investigator Grant, and may submit only one Investigator Grant application per NHMRC funding round.
National Statement on Ethical Conduct in Human Research
Australia's core ethics-governance document for research involving human participants, jointly developed and issued by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), and Universities Australia under the National Health and Medical Research Council Act 1992. Every Human Research Ethics Committee (HREC) in Australia applies it when reviewing a proposed study; it is organised around four core values (research merit and integrity, justice, beneficence, respect) plus topic-specific chapters, and functions as Australia's counterpart to the US Common Rule/Belmont Report and Canada's TCPS2. The current operative edition is the 2025 update (released 1 April 2025, effective from 23 June 2026), which revised Section 4; the prior 2023 update (effective 1 January 2024) revised Chapter 2.1 and Section 5.
PubPeer
PubPeer is an independent, web-based platform where anyone can post public comments — anonymously or under their own name — on papers already published in the scholarly literature, identified by DOI, PubMed ID, or a title/author search. It is a venue for open, informal post-publication commentary, not a peer-review, editorial, or investigative body: it has no authority to correct, retract, or adjudicate a paper, and the mere existence of a PubPeer comment thread on a paper is not, by itself, evidence of research misconduct.
Funding Opportunity Announcement (FOA)
A Funding Opportunity Announcement (FOA) is NIH's (legacy, pre-April-2023) umbrella term for a formal, published solicitation of grant or cooperative agreement applications in a defined scientific area. Every NIH FOA is one of two sub-types: a standing, recurring Program Announcement (PA, including Parent Announcements, PARs, and PAS) with no dedicated funds and standard due dates, or a one-time Request for Applications (RFA) with set-aside funds and, usually, a single receipt date. Since April 2023 (NOT-OD-23-109), NIH itself calls new announcements Notices of Funding Opportunity (NOFO) instead, matching the government-wide term standardized in the April 2024 revision to 2 CFR Part 200 -- the document type and its two sub-types are unchanged by the rename.
HIPAA (Health Insurance Portability Act)
Something is properly described as "HIPAA" (rather than another privacy regime) when it derives from the Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191) or the federal regulations HHS issued under its Title II Administrative Simplification authority -- principally the Privacy Rule (45 CFR Part 160 and Subparts A/E of Part 164), the Security Rule (45 CFR Part 160 and Subparts A/C of Part 164), and the Breach Notification Rule (45 CFR Part 164, Subpart D, added via the HITECH Act of 2009). These rules apply only to a 'covered entity' (a health plan, health care clearinghouse, or health care provider that transmits health information electronically in connection with a standard transaction) or its business associates, and only to 'protected health information' (PHI) -- individually identifiable health information, as defined at 45 CFR 160.103, held or transmitted by one of those entities. HIPAA is a distinct federal regime from the Common Rule (45 CFR 46), which governs the ethics of human-subjects research (IRB review, informed consent) rather than the privacy/security of health data; the two frequently apply to the same study but are evaluated against different criteria by different offices.
Acknowledgments Section
The part of a scholarly manuscript, typically placed after the discussion/conclusion and before the reference list, where the corresponding author names people and entities that contributed to the work but do not meet the journal's or field's authorship criteria (most commonly ICMJE's four-part test), together with any required disclosure of funding sources and grant/award numbers. A contribution belongs here rather than on the byline when it is real but falls short of authorship on at least one prong — ICMJE's own examples include acquisition of funding, general supervision of a research group or general administrative support, and writing assistance, technical editing, language editing, or proofreading. Because naming someone can be read as implying their endorsement of the paper's data and conclusions, ICMJE recommends that editors require the corresponding author to obtain each acknowledged individual's written permission before publication.
Participatory research
Research in which people affected by the topic under study — community members, patients, practitioners or service users — share power over one or more phases of the research process (framing questions, designing methods, collecting or interpreting data, or disseminating findings) as co-researchers rather than as subjects or a consulted stakeholder group. The defining test is who controls the process, not which specific method is used.
Open Science
The umbrella movement and set of practices for making every stage of the research process — publications, data, code, methods, and materials — openly accessible, transparent, and reusable, rather than treating openness as something that applies only to the final published article. UNESCO’s 2021 Recommendation on Open Science, the first international normative instrument on the subject, organizes it into four pillars: open scientific knowledge, open science infrastructures, open engagement of societal actors, and open dialogue with other knowledge systems.
Cost Accounting Standards (CAS)
A cost accounting practice at a US institution of higher education is governed by the Cost Accounting Standards (CAS) when the institution has received $50 million or more in federal awards subject to 2 CFR Part 200 Subpart E in its most recently completed fiscal year, triggering compliance with CAS 501, 502, 505, and 506 (48 CFR 9905.501/.502/.505/.506) as incorporated via 2 CFR 200.419 and Appendix III. The operative test is consistency, not any single accounting method: the same institution must use the same cost-accounting practice when it estimates a cost in a proposal, when it accumulates that cost in its books, and when it reports that cost on an award, and it must apply the same direct-vs-indirect classification to like costs in like circumstances institution-wide. An institution below the $50 million threshold is not CAS-governed in this sense, even though it still must satisfy the separate, universally applicable cost-principle tests of allowability, allocability, and reasonableness.
Postdoctoral fellowship
A postdoctoral fellowship is an award of research-training support that is individually competed for and held in the name of the doctorate-holder themselves -- typically with a named faculty sponsor or mentor -- rather than paid to them as staff out of a principal investigator's grant or held by their department as an institutional training-grant slot. It funds a fixed, time-limited period (commonly two to three years) of mentored postdoctoral research, usually via a stipend or salary plus a separate research/travel/relocation allowance, and because the award belongs to the individual rather than the institution, it is typically portable to a different funder-approved host institution. Examples include NIH's F32, NSF's family of directorate-specific postdoctoral fellowship programs, foundation fellowships (e.g. HFSP, EMBO, Damon Runyon), and the EU's MSCA Postdoctoral Fellowships.
Data Safety Monitoring Board (DSMB)
An independent group of clinical, statistical, and (where relevant) bioethics experts, external to a trial's investigators and sponsor, that periodically reviews accumulating -- typically unblinded -- safety and efficacy data from an ongoing clinical trial at pre-specified intervals, and recommends to the sponsor whether the trial should continue, be modified, or stop, for safety, demonstrated efficacy, or futility. Generally required by NIH policy for multi-site trials with substantial participant risk, most notably Phase III trials. Distinct from bodies that review a protocol before it opens (a Scientific Review Committee), advise on organizational strategy (a Scientific Advisory Board), or conduct human-subjects ethics review (an IRB) -- a DSMB's function begins only once a trial is enrolling and is confined to ongoing data monitoring.
Conflict of Interest (COI) in Research
A conflict of interest (COI) exists whenever a researcher's, reviewer's, official's, or institution's outside financial or personal interests could reasonably be seen to compromise, or actually do compromise, objective and unbiased conduct, review, or oversight of research. The test is whether a reasonable person could conclude the secondary interest created a risk of undue influence over the primary interest -- not whether bias in fact occurred. COI is distinct from research misconduct: an undisclosed or unmanaged conflict is treated as a violation, but the underlying interest itself is not, by default, evidence of wrongdoing.
Graphical Abstract
A graphical abstract is a single image (typically one panel combining minimal text with icons, diagrams, or illustrations) that visually summarizes a paper's central finding or methodology, submitted as a separate file from the manuscript and displayed by the publisher alongside the text abstract -- in the online table of contents, search-result listings, and the article page -- to let a reader grasp the paper's core message without reading the full text.
Prior Art
Prior art is any evidence — a patent, a published patent application, a journal article, a conference presentation or poster, a thesis, a product already on sale, or a device already in public use — showing that a claimed invention, or something that would render it obvious, was already publicly known or otherwise available before the patent application's effective filing date (or, for an application claiming priority from an earlier filing, the priority date). Under 35 U.S.C. 102(a)(1), prior art includes material the inventor made public themselves, not only material originating from someone else. Under 102(a)(2), an earlier-filed U.S. patent application naming a different inventor also counts as prior art as of its filing date once it later publishes or issues — so-called "secret prior art" — even though it was not publicly visible at the time. A reference or event functions as prior art only if it discloses the claimed invention outright (defeating novelty under 35 U.S.C. 102) or, in combination with other references, would have made the invention obvious to a person having ordinary skill in the art (defeating non-obviousness under 35 U.S.C. 103).
Office of Extramural Research (OER)
The NIH Office of Extramural Research (OER) is the National Institutes of Health's Office of the Director component that owns the corporate, NIH-wide infrastructure, policy, and systems for extramural (externally performed, grant-funded) research administration — the functions shared across all grant-awarding NIH Institutes and Centers (ICs) rather than any single IC's own programmatic decisions. A policy, notice, or system belongs to OER when it applies NIH-wide: eRA (Commons, ASSIST, Reporter), the NIH Guide for Grants and Contracts (the venue for NOT-OD-YY-### Guide Notices), the NIH Grants Policy Statement, and cross-cutting extramural workforce, data-sharing, and research-integrity policy. It does not include an individual IC's own funding priorities or program-officer decisions, and it does not include the scientific peer review of applications, which since 2025 has been centralized in the separate Center for Scientific Review (CSR).
Risk-Based Monitoring (RBM)
Risk-based monitoring (RBM) is a clinical trial monitoring methodology, formally incorporated into ICH E6(R2)/(R3) Good Clinical Practice and described in FDA's 2013 guidance for industry, in which a sponsor allocates monitoring resources -- the mix of centralized, remote, and on-site activities, and the extent of source data verification (SDV) -- according to a documented, protocol-specific risk assessment of what is most likely to affect participant safety and the reliability of trial results. It replaces the older default of fixed-frequency on-site visits with 100% SDV at every site, regardless of actual risk, with a monitoring plan that is proportionate to identified risk and revisited as the trial progresses.
Traditional Ecological Knowledge (TEK)
A cumulative body of knowledge, practice, and belief about the relationship of living beings (including people) with one another and their environment, developed through direct experience over generations and passed down by cultural transmission within a specific Indigenous or local community. Following Berkes' foundational framework, TEK operates at four levels: species-specific local knowledge, resource-management practice, the social institutions governing its use, and the worldview that gives it meaning. It is the environmental/ecological subset of the broader concept of Traditional Knowledge (TK).
F31 (NIH Predoctoral Individual NRSA Fellowship)
An F31 is an NIH Ruth L. Kirschstein National Research Service Award (NRSA) individual fellowship that funds a doctoral student's own dissertation research training under a named faculty sponsor. What makes an award an F31 rather than another NRSA/career-development mechanism: the applicant is an individual predoctoral student (not a department), enrolled in a research doctoral program and at the dissertation-research stage, applying directly for their own mentored training support -- as opposed to a slot inside an institution-held T32 training grant, a postdoctoral F32/F30, or a career-development K award.
Continued Process Verification (CPV)
Continued Process Verification (CPV) is Stage 3 of the FDA's three-stage process validation lifecycle, set out in the FDA's January 2011 guidance "Process Validation: General Principles and Practices." It is an ongoing program -- required under 21 CFR 211.180(e) -- of collecting and statistically trending process and product data during routine commercial production to confirm the manufacturing process remains in a validated "state of control" after Stage 1 (Process Design) established the process and Stage 2 (Process Qualification) demonstrated it was capable of reproducible commercial manufacturing. A single Process Performance Qualification run is Stage 2, not CPV -- CPV is the continuing program that follows it for the life of the product.
ICH E6(R3) (Good Clinical Practice Guideline Revision)
ICH E6(R3) is the current, staged-adoption revision of ICH's core Good Clinical Practice guideline, replacing E6(R2) (2016). It comprises overarching Principles plus Annex 1 (traditional interventional trials -- ICH Step 4 6 January 2025; EU/UK/Switzerland effective 23 July 2025; FDA final guidance 8 September 2025, non-binding) and Annex 2 (non-traditional/decentralized trial designs -- ICH Step 4 3 June 2026; EU effective 15 January 2027; FDA has not yet issued Annex 2 guidance). Substantively it shifts to a risk-proportionate, quality-by-design approach, adds explicit technology/electronic-systems and decentralized-trial provisions, and restructures investigator/sponsor responsibilities around the Principles rather than as a standalone checklist.
Adverse Event (AE)
Any untoward medical occurrence in a subject administered a pharmaceutical or investigational product, whether or not it is considered related to that product — the causality-neutral base definition set by ICH E2A, from which the narrower Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) categories are derived.
Laboratory Safety (OSHA Chemical Hygiene Plan)
A written, laboratory-specific compliance program required under OSHA's Laboratory Standard (29 CFR 1910.1450) whenever hazardous chemicals are used in a laboratory on a non-production basis; it sets out procedures, engineering/administrative controls, PPE, training, exposure monitoring, and a designated Chemical Hygiene Officer, and is distinct from biosafety programs governing biological agents.
Categorical grant
A grant restricted by the awarding government to a narrowly defined purpose or category of activity, as set out in the authorizing statute, program regulations, or notice of funding opportunity — the recipient may spend the funds only on the specified purpose and cannot redirect them to other uses at its own discretion. This is a term from US public administration and fiscal federalism, applied here to federal research funding: most federal research grants (an NIH R01, an NSF standard award) are categorical in this sense because the award funds the specific proposed project defined in the application, not general institutional research activity.
i10-index
A Google Scholar-specific author metric equal to the count of a researcher's publications that have each individually accumulated at least 10 citations, computed automatically from the citation data attached to a Google Scholar Citations profile.
NIH Public Access Policy
A specific NIH funding-compliance requirement — not a general "open access" commitment — under which any peer-reviewed journal article arising in whole or in part from NIH funds must have its Author Accepted Manuscript submitted to PubMed Central (PMC) upon acceptance for publication. For articles accepted for publication on or after July 1, 2025, the manuscript must be made publicly available in PMC immediately, with zero embargo, at the article's official date of publication; articles accepted before that date remain governed by the prior policy's 12-month embargo. Compliance is tracked through a PMCID that grant recipients must cite in progress reports and in any subsequent application or progress report referencing that publication.
Intent-to-Treat (ITT) vs. Per-Protocol Analysis
An analysis-population choice for a randomized trial: an intent-to-treat (ITT) analysis includes every participant in the treatment group to which they were originally randomized, regardless of whether they received, adhered to, or completed that assigned treatment. A per-protocol (PP) analysis instead restricts the analysis to the subset of participants who received the assigned treatment as specified in the protocol, with no major deviations. ITT answers "what happens if this treatment is assigned"; per-protocol answers "what happens if this treatment is actually taken as directed" — and which of the two gives the more conservative estimate depends on whether the trial is testing superiority or non-inferiority.
ICH (International Council for Harmonisation)
The international standard-setting body — a Swiss non-profit association of drug regulatory authorities and pharmaceutical-industry associations — that develops and maintains the harmonised technical guidelines, grouped into Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) series, used to register medicines for human use across its member jurisdictions; ICH E6 Good Clinical Practice is one specific guideline it publishes, not a synonym for the organization itself.
Dublin Core
Dublin Core is the cross-domain metadata vocabulary, governed by the Dublin Core Metadata Initiative (DCMI), built around fifteen core resource-description elements (Title, Creator, Subject, Description, Publisher, Contributor, Date, Type, Format, Identifier, Source, Language, Relation, Coverage, Rights) formally standardized as ISO 15836, ANSI/NISO Z39.85, and IETF RFC 5013 (Simple Dublin Core), plus the larger DCMI Metadata Terms ("dcterms:") vocabulary that adds element refinements, encoding schemes, and additional properties/classes for more precise description (Qualified Dublin Core). A metadata record is a Dublin Core record when its fields map to this DCMI-maintained element set or the extended dcterms vocabulary, rather than to an unrelated, locally invented field set or an unrelated domain-specific schema.
Investigational Medicinal Product Dossier (IMPD)
The Investigational Medicinal Product Dossier (IMPD) is the EU/UK clinical-trial-application document presenting the quality (chemistry, manufacturing, controls), nonclinical, and clinical data on a specific medicinal product being used in a clinical trial -- submitted under Regulation (EU) No 536/2014, Annex I, Section G (via CTIS) or, in the UK, to the MHRA under SI 2004/1031. It documents the product; it is not the product itself (see Investigational Medicinal Product). A full IMPD follows the ICH CTD Module 3/4/5 format; a simplified IMPD -- referencing a current Summary of Product Characteristics (SmPC) instead -- is permitted for an already-authorised product used within its marketing authorisation, a previously-assessed unmodified product, or most placebos.
FDA Form 483
An FDA Form 483 is a written list of "inspectional observations" that an FDA investigator hands to a firm's or site's management at the conclusion of an on-site inspection, whenever the investigator judges that observed conditions or practices may violate the Food, Drug, and Cosmetic (FD&C) Act or related FDA regulations. A Form 483 is not a final Agency determination of a violation and does not itself carry legal force — FDA's own guidance is explicit that inspectional observations "do not represent a final Agency determination regarding compliance." The form is used across every type of FDA-regulated inspection — drug and biologic cGMP facilities, medical device manufacturers, food facilities, nonclinical (GLP) testing laboratories, and Bioresearch Monitoring (BIMO) inspections of clinical trial sites, sponsors, and IRBs — wherever an FDA investigator identifies conditions serious enough to document as an observation.
Human Tissue Act (UK)
The Human Tissue Act 2004 is the UK statute (England, Wales, and Northern Ireland) governing the removal, storage, and use of human tissue from both the living and the deceased for defined "scheduled purposes," including research into disorders or the functioning of the human body. It makes "appropriate consent" the legal precondition for these activities and establishes the Human Tissue Authority (HTA) to license and inspect the organisations -- including research tissue banks -- that store human tissue for research.
Belmont Report
The Belmont Report is the 1979 statement titled "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (created by the National Research Act of 1974 in response to the Tuskegee Syphilis Study). It establishes three basic ethical principles for human-subjects research -- Respect for Persons, Beneficence, and Justice -- each linked to a specific application (informed consent, risk/benefit assessment, and equitable selection of subjects, respectively). It is not itself a regulation, but its principles were subsequently codified into binding federal regulation at 45 CFR 46 (the Common Rule) and remain the ethical basis every U.S. IRB applies when reviewing human-subjects research.
Allocability
A cost is allocable to a federal award under 2 CFR 200.405 if it is assignable to that award in proportion to the relative benefit received — because it was incurred specifically for the award, benefits both the award and other work in proportions that can be reasonably determined, or is necessary to the organization's overall operation and assignable to the award under the applicable cost-accounting principles. Allocability is distinct from, but works alongside, allowability (200.403) and reasonableness (200.404) as part of the three-part test for whether a cost can be charged to a federal award.
Data Curator
A data curator is an institutional role — usually in a library, research data service, or research-computing unit — that prepares research data for deposit, applies metadata standards, checks FAIR readiness, and advises researchers on repository selection and data management plans, distinct from owning the underlying research itself.
Data Curation
The active, ongoing management of research data across its lifecycle -- organizing files into a coherent structure, describing them with standardized metadata, validating and cleaning values, and taking preservation actions such as format migration and fixity checking -- carried out specifically so the data remains findable, interpretable, and reusable by someone other than its original creator, long after the project that produced it ends. Curation is a defined set of actions applied to data over time; it is distinct from simply storing a copy of it.
dbGaP (Database of Genotypes and Phenotypes)
The NIH/NCBI repository for genotype-phenotype study data (GWAS results, sequencing/omics data, linked phenotype data), split into an open-access tier (study documentation, summary statistics) and a controlled-access tier (de-identified individual-level genotype and phenotype records) gated by Data Access Committee review of a Data Access Request -- distinct from a general sequence archive because the individual-level linkage, not just the data type, is what triggers controlled access.
De-identification
De-identification is the process of removing or altering direct and indirect identifiers in a dataset so that a specific individual cannot reasonably be identified from it, either alone or combined with other information a realistic recipient could obtain. It is a general concept operationalized differently across frameworks — HIPAA defines two concrete de-identification methods that remove data from the Privacy Rule's scope entirely, while the GDPR distinguishes reversible pseudonymisation (still personal data) from full anonymisation (outside GDPR's scope) and never uses the term "de-identification" itself. Whether a given approach is adequate always depends on the residual risk of re-identification, not simply which fields were removed.
ORCID Sign-In / Authentication
ORCID sign-in ("Sign in with ORCID") is the OAuth 2.0/OpenID Connect process by which a third-party system (a journal, funder, or institutional platform) redirects a researcher to orcid.org to authenticate, then receives back an authenticated ORCID iD and, if broader scopes were requested and approved, an access token to read or write specific parts of the researcher's ORCID record. It is distinct from simply holding an ORCID iD: an iD is a registered identifier; signing in is the act of a specific external system verifying, at that moment, that the researcher controls it, and optionally being granted ongoing record access.
Web of Science
Web of Science is Clarivate’s citation-indexing and research-discovery platform, not a single index in its own right. A publication counts as covered by Web of Science only once it has been evaluated and accepted into at least one of the platform’s underlying citation indices — most often the Science Citation Index Expanded, Social Sciences Citation Index, or Arts & Humanities Citation Index within the Web of Science Core Collection, or one of the platform’s regional indices — each governed by its own independent Clarivate selection criteria; being published, or indexed elsewhere such as in Scopus, does not automatically make a title searchable on Web of Science.
Open Source Software
Software distributed under a licence that meets the Open Source Initiative's ten-criteria Open Source Definition: the source code is included and modifiable, and the licence permits free redistribution, creation of derivative works, and use for any purpose (including commercial and research use) without discriminating against particular users or fields of endeavour.
PDF/A (ISO 19005)
A file is PDF/A-conformant only when it validates against one of the four parts of ISO 19005: every font it uses is embedded rather than referenced, color is specified in a device-independent way, and the file contains no encryption, no JavaScript or executable content, no audio or video, and no reference to external content the renderer would need to fetch. These restrictions make the file self-contained and reproducible without depending on the specific software environment that created it.
Copyediting
The mechanical and stylistic edit applied to an accepted manuscript after peer review and the editorial acceptance decision, and before typesetting/layout — correcting grammar, spelling, and punctuation, and enforcing the journal or publisher's house style (commonly built on a named style guide such as AMA, APA, or Chicago) and internal consistency in terminology, abbreviations, units, and formatting, without altering the manuscript's structure, argument, or content.
21 CFR Part 11: Electronic Records & Signatures
21 CFR Part 11 is FDA's regulation establishing the criteria under which an electronic record or electronic signature is considered trustworthy, reliable, and equivalent to a paper record or handwritten signature, for any record an FDA predicate rule (e.g., Good Clinical Practice, Good Manufacturing Practice, Good Laboratory Practice) already requires a regulated organization to create, modify, maintain, archive, retrieve, or transmit. It does not create new record-keeping obligations on its own -- and, per FDA's 2003 scope-and-application guidance, its full electronic-record controls apply only when the record is maintained electronically in place of paper to satisfy that predicate requirement.
Investigational Medicinal Product (IMP)
An Investigational Medicinal Product (IMP) is the EU and UK clinical-trials regulatory term (Regulation (EU) No 536/2014, Article 2(2)(5); the UK's Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031, as amended) for a medicinal product -- a drug, biologic, or placebo -- that is being tested or used as a reference in a clinical trial, including an already-authorised product used, formulated, or packaged differently than its approved marketing authorisation, used for an indication it isn't approved for, or used to gain further information about an approved use. It is functionally equivalent to, but not the same regulatory term as, the US FDA's "investigational new drug" (21 CFR 312.3) or the ICH E6 GCP-harmonised umbrella term "investigational product" (E6(R2) §1.33).
HIPAA in Clinical Research
A research activity falls under 'HIPAA in clinical research' when a HIPAA covered entity (or its business associate) creates, uses, or discloses protected health information (PHI) in connection with a systematic investigation designed to develop or contribute to generalizable knowledge (45 CFR 164.501). Because research is not treatment, payment, or health care operations, the Privacy Rule's general TPO permissions do not apply -- a covered entity may use or disclose PHI for research only through one of the pathways the Rule specifically authorizes: (1) a subject-signed Authorization meeting the core-element and required-statement standards of 45 CFR 164.508; (2) an IRB- or Privacy Board-granted waiver or alteration of Authorization under 45 CFR 164.512(i), documented against the Rule's minimal-risk criteria; (3) disclosure as a Limited Data Set under a Data Use Agreement (45 CFR 164.514(e)); (4) de-identification under the Safe Harbor or Expert Determination method (45 CFR 164.514(a)-(b)), which removes the data from HIPAA's scope entirely; or (5) narrower exceptions for reviews preparatory to research and for research on a decedent's information (both at 45 CFR 164.512(i)(1)). HIPAA governs this data-privacy layer only -- it is a separate federal regulatory regime from the Common Rule (45 CFR 46) and FDA human-subjects regulations that govern the ethical conduct of the research itself (IRB review, informed consent to participate). A single study involving PHI at a covered entity typically must satisfy both regimes concurrently, through separate, though often procedurally combined, analyses and documents.
Good Laboratory Practice (GLP)
Good Laboratory Practice (GLP) is the FDA quality-system regulation (21 CFR Part 58) governing how nonclinical (preclinical) laboratory safety studies — chiefly animal toxicology and safety-pharmacology studies — are planned, conducted, monitored, recorded, and reported when submitted to support an IND, NDA, BLA, or other FDA research or marketing application; internationally, the OECD Principles of GLP serve the same function under the Mutual Acceptance of Data (MAD) system.
Biosafety Level (BSL)
The graded laboratory-containment classification -- BSL-1 through BSL-4 -- assigned under the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) framework, combining a biological agent's Risk Group with the specific laboratory practices, personal protective equipment, and facility engineering controls a given protocol requires. For research involving recombinant or synthetic nucleic acid molecules, the BSL is formally assigned through an Institutional Biosafety Committee (IBC) risk assessment under the NIH Guidelines before any lab work may begin.
Pseudonymisation
Under GDPR Article 4(5), pseudonymisation is the processing of personal data so that it can no longer be attributed to a specific data subject without additional information, provided that additional information is kept separately and is protected by technical and organisational measures ensuring non-attribution. Pseudonymised data remains personal data under GDPR (Recital 26) because re-identification stays technically possible with the separately-held key — unlike anonymised data, where re-identification is not reasonably possible and GDPR no longer applies. GDPR Article 89(1) names pseudonymisation directly as an accepted safeguard for processing personal data for scientific/historical research, archiving in the public interest, or statistical purposes, supporting research-specific derogations from certain data subject rights.
PROV-O (Provenance Ontology)
PROV-O is the W3C's OWL2 ontology (a W3C Recommendation since 30 April 2013) for expressing data provenance as machine-readable RDF: it defines Entity (a thing with fixed aspects), Activity (something that acts upon or generates entities over time), and Agent (something responsible for an activity or entity), connected by properties such as wasGeneratedBy, used, wasAssociatedWith, and wasDerivedFrom.
R33 (NIH Exploratory/Developmental Grant)
An NIH R-series research grant activity code that funds the second, expanded-development phase of a milestone-driven, two-phase award — typically paired with an R21 or R61 exploratory first phase (as "R21/R33" or "R61/R33") — where transition into R33 funding depends on NIH confirming predefined go/no-go milestones were met, rather than a new competing application.
Canada Research Chair (CRC)
A Canada Research Chair (CRC) is a Tier 1 or Tier 2 professorship funded through the Government of Canada's Tri-Agency Canada Research Chairs Program (CIHR, NSERC, and SSHRC) and held at an eligible Canadian postsecondary institution; only the institution, not the individual researcher, nominates a candidate for a chair, against a fixed allocation of chairs assigned to that institution.
Clinical Research Coordinator (CRC)
A Clinical Research Coordinator (CRC) is the site-based professional who manages the day-to-day conduct of a clinical trial at a single investigational site under the delegation and direction of the Principal Investigator (PI) -- screening and consenting participants, scheduling and conducting study visits, entering data into case report forms, and maintaining source documents and regulatory files in compliance with the protocol, Good Clinical Practice (GCP), and applicable regulations. A CRC is employed by the investigational site itself (a hospital, academic medical center, or dedicated trial site), not by the trial sponsor or a contract research organization (CRO) -- this employer/authority distinction is what separates a CRC from a Clinical Research Associate (CRA), who is sponsor/CRO-employed and independently monitors a portfolio of sites, including verifying the CRC's own source data, rather than executing day-to-day site operations.
Scopus
Scopus is Elsevier's proprietary, subscription-based abstract-and-citation database of peer-reviewed journal articles, conference proceedings, books, and book chapters, launched in November 2004. A title is "in Scopus" only once Elsevier's Content Selection and Advisory Board has evaluated and accepted it against criteria including peer-review policy, publication ethics, and editorial diversity — inclusion is an ongoing editorial decision, not automatic, and previously indexed titles can later be suspended or discontinued if they stop meeting those criteria.
Federalwide Assurance (FWA)
A Federalwide Assurance (FWA) is a written, time-limited agreement an institution files with HHS's Office for Human Research Protections (OHRP) committing the institution -- not any single study -- to comply with the Common Rule (45 CFR 46) for the nonexempt human-subjects research it conducts or supports through funding from HHS or any other U.S. federal department or agency that has adopted the Common Rule and relies on OHRP's FWA. It is signed by an institutional Signatory Official, names a Human Protections Administrator, and must designate at least one IRB already registered with OHRP to perform the review the FWA commits the institution to.
Technology Control Plan (TCP)
An institutional document, developed and implemented by a research institution (typically coordinated by the export control office or research security office together with the Principal Investigator), that specifies the physical, IT, and administrative safeguards used to prevent unauthorized access to a specific set of ITAR- or EAR-controlled technology, technical data, software, or equipment. A TCP is required whenever controlled technology is present in a project or lab and no exclusion (fundamental research exclusion) or license exception/exemption fully removes the access restriction — most commonly because a foreign national who is not a US person, per 22 CFR 120.62 and 15 CFR 772.1, will otherwise have physical, visual, electronic, or oral access to the controlled item or data. Its defining feature is that it names the specific controlled technology, identifies by name and citizenship every individual authorized to access it, and sets out concrete, auditable controls — not general policy language — covering access restriction, physical and IT security, personnel screening, and training.
FERPA (Family Educational Rights and Privacy Act)
FERPA (20 U.S.C. § 1232g; 34 CFR Part 99) is the U.S. federal law giving eligible students privacy rights over their education records and restricting a federally funded institution from disclosing personally identifiable information from those records without consent; a research project is subject to FERPA whenever it accesses, uses, or receives education records the institution already maintains — as distinct from new data collected directly from consenting participants — and the institution may disclose those records only under a recognized exception (school official, studies exception, de-identified/coded data, or directory information) or with the eligible student's written consent.
Technology Readiness Level (TRL)
A rating on a standardized 1-9 scale describing how mature a specific technology is, from basic scientific principles observed and reported (TRL 1) through an actual system proven through successful operations in its real deployment environment (TRL 9). Originally developed at NASA in the 1970s and formalized as a nine-level scale in the early 1990s, TRL (used interchangeably with the phrasing "technical readiness level") is assigned to a technology based on demonstrated physical/functional maturity alone -- what has actually been built and tested, and under what conditions -- independent of funding source, patent status, or commercial promise. The U.S. Department of Defense, the Department of Energy, the European Commission (Horizon Europe), and university technology transfer offices (TTOs) all use the same nine-level scale, with only minor wording differences at the upper levels.
Bayh-Dole Act
The Bayh-Dole Act (Public Law 96-517, enacted December 12, 1980, codified at 35 U.S.C. §§ 200–212) is the federal statute allowing universities, nonprofit institutions, and small businesses to retain title to inventions made under federal funding agreements -- grants, cooperative agreements, or contracts -- in exchange for disclosing the invention to the funding agency, electing within a set window whether to keep title, filing a patent application, and accepting the government's retained rights, including a nonexclusive government-use license, march-in rights (35 U.S.C. § 203), and a U.S. manufacturing preference on exclusive licenses (35 U.S.C. § 204). It applies only to a 'subject invention' conceived or first reduced to practice under a qualifying federal award held by an eligible recipient; it does not apply to inventions made without federal funding.
Trade Secret
Information that (1) derives independent economic value from not being generally known or readily ascertainable by others who could profit from it, and (2) is subject to reasonable efforts by its owner to maintain its secrecy, per the two-element definition shared by the federal Defend Trade Secrets Act (18 U.S.C. § 1839(3)) and the state-law Uniform Trade Secrets Act. Unlike a patent, a trade secret is never registered or examined by a government office and carries no fixed term: it lasts exactly as long as both elements continue to hold, and ends the moment either fails.
Google Scholar Citations profile
A self-created, self-curated author page on scholar.google.com that displays a researcher's publications alongside auto-updating citation count, h-index, and i10-index figures computed from Google Scholar's own web index, distinct from database-issued author records such as a Scopus Author ID or an ORCID iD.
Gateway to Research (GtR)
UKRI's free, public web portal (gtr.ukri.org) that publishes structured data on UKRI-funded research and innovation projects -- overview, organisations, people, publications, and outcomes -- for all seven UKRI research councils and Innovate UK, distinct from Researchfish, the grantee-facing system through which much of that outcome data is originally submitted.
RRID (Research Resource Identifier)
A string of the form RRID: followed by an accession number issued by an authoritative source database (the Antibody Registry for AB_ numbers, Cellosaurus for CVCL_ cell-line codes, MGI/ZFIN/RGD/IMSR for model organisms, or SciCrunch's own SCR_ registry for software and databases) that resolves, via the SciCrunch resolver or a compatible resolver such as n2t.net, to a single curated record describing exactly one research resource. Developed through FORCE11's Resource Identification Initiative and maintained via SciCrunch's Resource Identification Portal, an RRID exists specifically so a research resource used in a study's methods can be cited unambiguously and traced across the literature, the way a DOI identifies a publication or an ORCID iD identifies a researcher.
Publication Bias
A study's result (statistically significant/positive vs. null/negative) measurably affects its odds of being submitted for and accepted into publication, so the published literature systematically over-represents positive findings relative to everything that was actually studied.
UKRI Funding Service
The UKRI Funding Service is the single online platform (funding-service.ukri.org) that UK Research and Innovation (UKRI) and its seven research councils use to advertise funding opportunities, receive applications, and manage awards through to reporting. An application, account, or award is 'on the Funding Service' when it was created and processed through this platform rather than UKRI's retired Joint Electronic Submission (Je-S) system, which the Funding Service progressively replaced for competitive research council funding from 2023.
Australian Research Council (ARC)
The Australian Research Council (ARC) is the Australian Government statutory agency that funds and, historically, evaluates research across all disciplines except clinical medicine and dentistry — a boundary set out in the ARC's own Medical Research Policy, which reserves funding for research into the causes, treatment, prevention, diagnosis, monitoring, or management of human disease for the National Health and Medical Research Council (NHMRC) instead. A grant, fellowship, or infrastructure award falls within the ARC's remit if it is administered through the ARC's National Competitive Grants Program (NCGP) — delivered via the Discovery Program or the Linkage Program — rather than through NHMRC's separate, parallel national competitive grants program.
Clinical Outcome Assessment (COA)
A measure that describes or reflects how a clinical trial participant feels, functions, or survives, captured via a clinician's report (ClinRO), the patient's own report (PRO), a non-clinician observer's report (ObsRO), or a standardized performance task (PerfO) — used, per FDA's COA framework, as a direct measure of clinical benefit rather than a substitute (as a biomarker-based surrogate endpoint is).
Contract Research Organization (CRO)
An organization counts as a Contract Research Organization (CRO) for a given clinical trial when a sponsor has contracted it, under a written agreement (per ICH E6(R2) Section 5.2 and, for FDA-regulated trials, 21 CFR 312.52), to assume one or more specific trial-related duties and functions -- such as site management, monitoring, data management, biostatistics, pharmacovigilance, or regulatory submissions -- on the sponsor's behalf. The sponsor retains ultimate responsibility for trial data quality and integrity regardless of which functions are transferred, and must actively oversee the CRO's performance of those functions, including any further subcontracted work.
Data Repository
A system or platform dedicated to the long-term storage, curation, preservation, and dissemination of research data, providing persistent identifiers, standardized metadata, and defined access/reuse terms -- distinct from general-purpose file storage (a network drive or cloud folder), which does not guarantee a dataset stays findable, citable, or usable once active work on it ends.
Clinical Research Associate (CRA)
A Clinical Research Associate (CRA) is the industry job title for the professional who performs the ICH E6(R2)-defined clinical trial "monitor" function on behalf of a trial sponsor or a contract research organization (CRO): overseeing an investigational site's conduct, verifying source data against case report forms, confirming protocol and Good Clinical Practice (GCP) compliance, and reporting site-visit findings back to the sponsor. CRAs are employed by the sponsor or a CRO -- not by the investigational site itself -- and typically travel to a portfolio of assigned sites across the life of a trial.
Randomized Controlled Trial (RCT)
A prospective clinical study design in which participants are allocated to two or more comparison groups purely by chance (randomization), with at least one group — the control arm — receiving a placebo, an active comparator, or standard-of-care rather than the intervention under investigation. Randomization is what distinguishes an RCT from an observational study; the presence of a control arm is what distinguishes it from a single-arm trial. Blinding (masking) of participants, investigators, or outcome assessors is a common but analytically separate design feature — an RCT can be randomized, controlled, and still unblinded (open-label).
Clinical Research Assistant
An entry- to early-career, site-based clinical trial support role that assists study staff with participant scheduling, data entry, specimen handling, and documentation under supervision -- without independent authority to monitor site compliance, review regulatory documents, or verify source data, which distinguishes it from a Clinical Research Associate (CRA).
Research fellow
A "research fellow" is a job title used inconsistently across academic systems for a doctorate-holder in a research-focused role -- and the two dominant conventions genuinely disagree. In UK/Commonwealth usage, it commonly names a distinct, more senior career grade on a research-only pathway that sits above the entry-level postdoctoral stage (research associate), may be fixed-term or open-ended depending on institution, and can carry a moderate amount of teaching and/or postgraduate supervision. In US usage, it is applied inconsistently: sometimes as a direct synonym for "postdoc" (especially for fellowship-funded, as opposed to grant-funded, positions), and sometimes for a more senior non-tenure-track research faculty rank distinct from the postdoc stage. The title alone does not reliably signal seniority across borders -- contract type, funding mechanism, and years post-PhD have to be checked directly.
Co-First Authorship
The convention of designating two or more authors as having contributed equally to a work, typically signaled by a shared symbol (a dagger or asterisk) next to each name resolving to a footnote such as "These authors contributed equally to this work." Co-first authorship does not replace or loosen the underlying authorship test -- every co-first author must still independently meet the applicable authorship criteria (most commonly ICMJE's four-part test) -- it only clarifies that the printed byline order should not be read as a ranking of relative contribution among the marked names. It is a first-author-position-specific instance of the broader equal-contribution signalling convention covered generally by co-authorship.
Corresponding Author
The author formally designated, usually at submission, as a manuscript's single point of contact with a journal — responsible for administrative correspondence during submission and peer review, and for remaining reachable for reader queries, data requests, and correction or retraction correspondence after publication. The designation is independent of author order: it can, but need not, be the same person as the first or senior author.
Core metadata
The minimal, standard set of descriptive fields — typically title, creator, date, persistent identifier, subject/keywords, format, and rights — that a dataset or research output must carry in order to be findable and citable, independent of any richer, discipline-specific metadata layered on top of it.
TCPS2 (Tri-Council Policy Statement)
TCPS2 is the joint policy of Canada's three federal research funding agencies (CIHR, NSERC, SSHRC) that sets the ethical principles and requirements Research Ethics Boards (REBs) apply when reviewing research involving human participants, their data, or their biological materials, and compliance with it is a condition of institutional eligibility for Tri-Agency funding.
Scientific Advisory Board (SAB)
An external, independent panel of subject-matter experts convened by a company, research institution, foundation, or funded program to advise leadership on scientific direction and strategy — which programs, indications, or research questions to prioritize, and how the organization's science compares with the field. An SAB is advisory only: it has no governing, regulatory, or fiduciary authority, no independent power to approve, halt, or modify a specific study or protocol, and its recommendations are non-binding.
Qualitative Research
An approach to research, not a single method, defined by four things holding together across a whole study: it collects non-numeric data (words, images, observed behavior, or documents) as primary evidence; it asks a meaning- or process-focused question rather than one aimed at measuring a variable or testing a pre-specified hypothesis; its analysis is iterative and inductive, developing codes and themes from the data itself, often while more data is still being collected; and it reports findings as contextualized, thick description rather than a statistical estimate. A study counts as qualitative research only when this bundle governs the design end-to-end, not merely because some of its raw data happens to be text.
Co-Authorship
The state of two or more people jointly meeting the criteria for authorship on the same output (most commonly the ICMJE's four-part test), which each co-author must satisfy independently -- co-authorship itself is not a separate authorship test but the layer of practice that governs how a qualifying group of authors is organized: byline order (contribution-ranked, alphabetical, or chronological, depending on field convention), whether an equal-contribution note is used, who is designated corresponding author (or co-corresponding authors), and, for cross-institutional teams, how each author's affiliation is listed and which institution mediates if a dispute arises. Co-authorship does not require a shared institution, funder, or country.
Creative Commons License
A standardized, pre-written public copyright license published by Creative Commons that a rights holder attaches to a work to grant reusers specified permissions (attribution, share-alike, noncommercial, no-derivatives, in any standard combination) in advance, without individual negotiation. CC0 is a related public-domain dedication, not technically a license.
Abstract
A standalone summary placed at the start of a research paper that states the study's purpose or background, methods, principal results, and conclusions in enough detail that a reader or an indexing database (e.g. PubMed, Scopus, Web of Science) can judge the paper's relevance and content without reading the full text. An abstract is standalone in a specific operational sense: it must be intelligible on its own, so it does not cite other works by reference number, does not rely on abbreviations defined only in the body text, and does not assume the reader has already read (or will go on to read) any other part of the paper. Journals require either a structured abstract (explicit labeled subsections, e.g. Background, Methods, Results, Conclusions) or an unstructured abstract (a single continuous paragraph covering the same elements), and each journal sets its own word limit, most commonly somewhere in the 150-350 word range.
Patent Prosecution
Patent prosecution is the administrative process of pursuing a patent grant from a patent office (the USPTO in the US, or a foreign equivalent such as the EPO) -- drafting and filing the application, responding in writing to the examiner's office actions, amending claims, and carrying the application through to allowance and issuance. It is distinct from patent litigation, which enforces or challenges a granted patent's validity in court after the fact.
Science Citation Index (SCI/SCIE)
A journal is considered SCI/SCIE-indexed when it has been formally evaluated and accepted by Clarivate into the Science Citation Index Expanded — the sciences-scoped citation index within the Web of Science Core Collection — based on Clarivate's editorial quality criteria (peer review, editorial rigor, ethical publishing standards) and impact criteria (citation influence). Indexing is not permanent: a journal can be added, and can later be suspended or delisted, if it stops meeting those criteria.
Scientific Review Committee (SRC)
An institutional committee — distinct from the IRB — that reviews a research protocol’s scientific merit and feasibility (originality, study design, statistical plan, and accrual feasibility) before or alongside IRB ethical review. Most commonly a formal requirement at NCI-designated cancer centers, where it forms part of the NCI-mandated Protocol Review and Monitoring System governing cancer clinical trial protocols.
SBIR (Small Business Innovation Research)
A U.S. federal program, established by the Small Business Innovation Development Act of 1982, that reserves a statutory share of participating agencies' extramural R&D budgets for phased, non-dilutive (no equity, no government IP claim) Phase I/II awards to small, for-profit businesses developing technology with both federal-mission relevance and commercial potential; the awardee of record must always be the small business itself, never a university.
Journal Reviewer
A journal reviewer (also called a peer reviewer or referee) is a subject-matter expert an editor invites, from outside the journal's own staff, to independently evaluate a submitted manuscript's validity, originality, significance, and clarity, then report a written assessment and a recommendation — accept, revise, or reject — back to the editor who requested it. Someone is a journal reviewer only while performing this evaluator role for a specific editor and a specific submission: it is a per-manuscript assignment, not a standing staff position, an authorship credit, or publication-decision authority in its own right.
Authorship
The formal status of being credited, by name, as a creator of a scholarly or scientific output (an article, dataset, software package, preprint, or similar citable work) because the named person meets a publisher's or field's explicit authorship criteria -- most commonly the ICMJE's four-part test: substantial contribution to the work's conception, design, or data; drafting the work or reviewing it critically for important intellectual content; final approval of the version to be published; and agreement to be accountable for all aspects of the work. All four conditions must be met together (an AND test, not an OR test) -- meeting some but not all of them qualifies a person for acknowledgement, not authorship. Authorship is deliberately narrower than 'did real work on this': doing qualifying work without being listed is a form of misattribution (ghost authorship), and being listed without doing qualifying work is also a form of misattribution (gift/honorary authorship).
CrossMark
A Crossref member service in which a publisher embeds a button on a published item (its HTML landing page, PDF, and/or ePub) that a reader can click to check the item's current status directly from within the item itself, rather than having to separately search the publisher's site. Clicking the button opens a panel showing whether the record has been updated since original publication -- including a correction, retraction, expression of concern, or one of the other editorially significant update types Crossref's schema defines -- alongside supporting metadata such as key dates (submission, revision, acceptance), funder information, licence terms, handling editors, and peer-review information where the publisher has chosen to provide it. A publication only counts as CrossMark-enabled if its publisher has (a) registered a DOI-assigned update policy, (b) referenced that policy in the item's Crossref metadata record even when no update yet exists, and (c) implemented the button so the status check happens at the item, not just on a separate corrections page a reader would have to know to look for.
Darwin Core
A data standard ratified by TDWG (Biodiversity Information Standards) — a glossary of defined terms organized into a small set of classes (Occurrence, Taxon, Event, Location, MaterialEntity, Identification, and others) — used to structure and exchange biodiversity data documenting the occurrence of organisms and the specimens or observations that record them. A dataset counts as Darwin Core data when its fields are actually mapped to defined Darwin Core terms (e.g. dwc:scientificName, dwc:eventDate, dwc:decimalLatitude), not merely because it describes species or specimens in some other format.
Ecological Metadata Language (EML)
The XML-based metadata specification (current stable release EML 2.2.0) used to document a research dataset, or an associated literature/software/protocol resource, as a single machine-readable package: its identity and citation information, collection methods and sampling design, taxonomic/geographic/temporal coverage, and the structure and attributes of its constituent data tables or other entities. Something is an EML record if it validates against the EML XML schema maintained via the NCEAS/eml specification and describes a dataset (or related resource) at the package level, rather than encoding the individual records within that dataset.
RightsLink
RightsLink is the automated permission-clearance and licensing platform operated by the Copyright Clearance Center (CCC), embedded on the article or book-chapter page it covers as a "Get Rights and Content" / "Request Permissions" control. A given reuse falls under RightsLink when the underlying content is traditionally copyrighted (all rights reserved, or held by the publisher under a copyright transfer agreement) and the reader needs the rightsholder's affirmative permission before reusing it beyond fair use/fair dealing -- e.g., republishing a figure, including an excerpt in a coursepack, or translating a chapter. Clicking the control routes the request through CCC's hosted workflow, which returns either a generated price and license, a no-fee license for many standard academic uses, or escalates to the publisher's rights department for non-standard requests.
Debarment and suspension verification (SAM.gov)
Verifying, before a subaward or covered federal contract, that the other party and its principals are not debarred, suspended, or excluded from federal funds. Required by 2 CFR 200.214 and 2 CFR Part 180 via a SAM.gov Exclusions search, a signed certification, or a contract clause under 2 CFR 180.300.
Cost Accounting Standards Disclosure Statement (DS-2)
A formal document, tied to 2 CFR 200.419 and reproduced as Appendix III to 2 CFR Part 200, in which an institution of higher education (IHE) describes how it accounts for costs charged to federally sponsored awards -- how it distinguishes direct costs from Facilities & Administrative (F&A/indirect) costs, and how it treats items such as depreciation, leave, and deferred compensation. Any IHE receiving an aggregate total of $50 million or more in federal awards subject to Subpart E of the Uniform Guidance during its most recently completed fiscal year is subject to the Cost Accounting Standards Board's standards CAS 501, 502, 505, and 506 (48 CFR 9905.501, .502, .505, .506) -- consistency in estimating/accumulating/reporting costs, consistency in allocating costs incurred for the same purpose, accounting for unallowable costs, and cost accounting period, respectively. Before 1 October 2024, crossing that same $50 million threshold also created a standalone obligation to file a DS-2 with the institution's cognizant federal agency for indirect costs (usually HHS or the Department of Defense's Office of Naval Research, assigned by whichever agency provides the majority of the institution's federal funding). OMB's April 2024 revision to the Uniform Guidance, effective for awards made on or after 1 October 2024, removed the standalone DS-2 filing requirement from the regulatory text -- the underlying obligation to comply with CAS 501/502/505/506 at the $50 million threshold was not removed, only the separate mandate to submit a dedicated disclosure form documenting it. In practice, many institutions still maintain a DS-2-format document as their internal cost-accounting governance record and as the basis for F&A rate negotiations, even though a fresh regulatory filing is no longer independently required.
Retraction Watch
An independent, non-CASRAI nonprofit project — a blog plus the Retraction Watch Database — that identifies, documents, and publicly reports individual retractions, expressions of concern, and corrections across the scholarly literature. It aggregates and investigates after a publisher's own retraction decision; it has no editorial or regulatory authority to retract anything itself.
Extended level certification (trustworthy repository)
The middle tier of a three-level trust framework for research-data repositories, positioned above core level (CoreTrustSeal, a peer-reviewed self-assessment against 16 requirements) and below formal level (ISO 16363, a full external audit). A repository holds extended level certification when it has been awarded the nestor Seal for Trustworthy Digital Archives — a plausibility-checked self-assessment against the 34 criteria of the German standard DIN 31644, administered by the nestor competence network at the Deutsche Nationalbibliothek. It is more rigorous than a core-level self-assessment (more criteria, external plausibility review of the evidence submitted) but, unlike formal level, does not involve an accredited external auditor conducting an on-site or fully independent audit.
ANSI/NISO Z39.106-2023 (Peer Review Terminology Standard)
The ANSI/NISO standard (Z39.106-2023, Standard Terminology for Peer Review, published July 5, 2023; DOI 10.3789/ansi.niso.z39.106-2023; ISBN 978-1-950980-27-7) that gives journals and publishers a common, structured vocabulary for describing how a manuscript's peer review was actually conducted. Developed from a taxonomy first built by an STM Association working group (convened 2019, brought to NISO in 2021) and refined through public comment and publisher piloting, it organizes description around four dimensions: (1) identity transparency — e.g. single anonymized, double anonymized, all identities visible; (2) who the reviewer interacts with — e.g. editor only, author and editor; (3) what review information is published alongside the article — e.g. none, reviewer identities, review reports, decision letters; and (4) whether post-publication commenting is enabled. A journal's peer-review policy is described using Z39.106 terminology when it states a position on all four dimensions with the standard's controlled terms, rather than a single unqualified label like "blind" or "peer reviewed."
NISO Alternative Assessment Metrics (Altmetrics) Initiative
A NISO-run standards-development initiative (2013–2016), funded by the Alfred P. Sloan Foundation, whose three working groups on (A) definitions and use cases, (B) output types and persistent identifiers, and (C) data quality produced NISO RP-25-2016, “Outputs of the NISO Alternative Assessment Metrics Project” (September 2016) — the first community-vetted recommended practice covering altmetrics terminology, use cases, non-traditional output types, and provider transparency (via the associated Altmetrics Data Quality Code of Conduct). Something counts as an output of this initiative if it was produced by one of its three working groups and published in or alongside RP-25-2016. It names the specific NISO project and its documented deliverables — not the general altmetrics concept those deliverables define, and not any single vendor's proprietary scoring methodology, which the initiative explicitly did not attempt to standardize.
NISO Access and License Indicators (ALI)
NISO RP-22: machine-readable metadata (free_to_read, license_ref) letting systems determine an article's access status and reuse terms without parsing prose.
DOAJ Native XML schema
DOAJ Native XML is the XML metadata format that DOAJ (Directory of Open Access Journals) defines and maintains for publishers to submit article-level metadata directly into DOAJ's index: title, authors and their ORCID iDs, affiliations, abstract, DOI, ISSN(s), volume/issue/page, publication date, and full-text URL. A file counts as an instance of this schema when it validates against DOAJ's own XSD (not a third-party schema) and arrives through one of DOAJ's inbound submission channels — file upload via a publisher's DOAJ account, DOAJ's API, or an OJS (Open Journal Systems) export plugin that generates DOAJ-conformant XML automatically. It is one of two XML dialects DOAJ accepts for article submission, the other being Crossref XML (versions 4.4.2 or 5.3.1); the two cannot be mixed within a single upload file, and a Crossref XML submission must carry an ISSN for DOAJ to process it.
NISO Recommended Practice (RP)
A consensus-based guidance document published by the National Information Standards Organization (NISO) that describes an accepted, emerging, or leading-edge method, format, or convention for information exchange. A Recommended Practice is developed through NISO's normal working-group and public-comment process but is approved without the formal ANSI ballot of NISO's Voting Members that a full ANSI/NISO Standard requires, and it is identified with the sequential designation RP-[number]-[year] (e.g., RP-9-2014) rather than the Z39.xx numbering used for Standards.
Researcher Profile Optimization Study (RPOS)
An in-progress Federal Demonstration Partnership (FDP) initiative, run under FDP's Open Government: Research Administration Data (OG:RAD) subcommittee, that surveys researchers and research-administration offices across FDP's member institutions to document how federally required researcher profile information -- biosketches, current & pending support, and collaborator disclosures -- is captured across agencies and platforms, and to recommend changes that reduce duplicate data entry and support interoperability, research security, and compliance.
NISO Institutional Identifier (I2)
A now-inactive NISO initiative (2008–2013) whose output, ANSI/NISO RP-17-2013, is a Recommended Practice for identifying organizations in the scholarly information supply chain. It did not define a new identifier syntax of its own; instead it specified how to apply the existing ISNI standard (ISO 27729) to institutions. The working group has not been active since publishing the Recommended Practice in 2013, and I2 has no ongoing registry of its own — in current research-infrastructure practice, ROR is the identifier institutions actually register for and that funders, publishers, and CRIS systems require.
Research Data Alliance (RDA)
The Research Data Alliance (RDA) is a global, community-driven organisation, launched in March 2013 by the European Commission, the US National Science Foundation, the US National Institute of Standards and Technology, and the Australian government, to build the social and technical infrastructure needed for open data sharing across disciplines, technologies, and national borders. RDA operates chiefly through two kinds of groups: time-bounded Working Groups, which typically run around 18 months and produce concrete, adoptable deliverables, and open-ended Interest Groups, which coordinate ongoing discussion, surveys, and less formal outputs across a topic area. Formally endorsed Working Group deliverables are published as RDA Recommendations; less formal outputs from any group type are published as Supporting Outputs. Something qualifies as "RDA" only when it refers to the organisation itself — its membership, governance (Council, Technical Advisory Board, Secretariat), plenaries, and working/interest-group structure — not to any single recommendation, schema, or standard an RDA group has produced, which are distinct, separately citable outputs.
ORCID service
An affiliation entry in an ORCID record documenting an ongoing donation of a researcher's time or expertise to an organization or community — board, committee, or editorial-board membership, review panels, or extension work — captured with a role title, disambiguated organization identifier, and start/end dates.
Clinical Trial Registration
The act of submitting a clinical trial's identifying and design information — sponsor, condition studied, intervention, key eligibility criteria, and primary/secondary outcome measures — to a recognized public clinical-trial registry (ClinicalTrials.gov or any other WHO ICTRP primary registry) so the trial's existence and design are publicly discoverable independent of whether or how its results are ultimately published. Registration identifies the trial before or during its conduct; posting the trial's results to the same registry after completion is a separate, later obligation (results reporting), not part of registration itself.
Prospective Clinical Trial Registration
Registration of a clinical trial in a public, WHO-recognized registry (for example ClinicalTrials.gov or another WHO ICTRP primary registry) at or before the date of first participant consent for enrollment — ICMJE's operative date is when the registry record was submitted, not when it was posted publicly. Registration submitted after enrollment has already begun is retrospective, not prospective, regardless of how far before manuscript submission it occurs.
Double-anonymized peer review
A manuscript review model in which neither party can identify the other during review: the reviewer does not know who the author is, and the author does not know who the reviewer is, up to and including the editorial decision. A given review counts as double-anonymized only if both conditions hold - the manuscript file sent to reviewers has been stripped of author names, affiliations, and other directly identifying material, and the editorial system withholds reviewer identity from the author throughout. Withholding only one identity (author-blind but reviewer known, or vice versa) is single-anonymized review, not double.
ITAR and EAR
The two primary US federal regimes restricting the export of controlled items, software, technology, and technical data to foreign persons or destinations. The International Traffic in Arms Regulations (ITAR, 22 CFR 120-130) are administered by the State Department's Directorate of Defense Trade Controls (DDTC) and cover defense articles, services, and technical data on the US Munitions List (USML). The Export Administration Regulations (EAR, 15 CFR 730-774) are administered by the Commerce Department's Bureau of Industry and Security (BIS) and cover dual-use items (civil plus military/WMD-related applications) on the Commerce Control List (CCL), classified by an Export Control Classification Number (ECCN). A given controlled item or technical data set falls under one regime or the other, determined by its classification, not by the institution's general research posture.
Exempt human subjects research
Human subjects research that an institution's IRB or another authorized reviewer — never the investigator personally — has formally determined falls within one of the eight categories listed at 45 CFR 46.104(d) of the U.S. Common Rule, and has accordingly been relieved from the initial full-board or expedited review pathway and from ongoing continuing review. 'Exempt' describes the outcome of a review decision, not an absence of review: a study is not exempt merely because an investigator judges it low-risk, anonymous, or otherwise harmless. It becomes exempt only once someone with institutional authority has checked the protocol against the specific regulatory category and recorded that determination, typically through the IRB office rather than a convened committee meeting. Four of the eight categories — (d)(2), (d)(3), (d)(7), and (d)(8) — additionally require a 'limited IRB review' of privacy, confidentiality, or broad-consent safeguards before the exemption applies, so even exempt research can pass through IRB scrutiny once; it is only relieved of the continuing, ongoing review that non-exempt research remains subject to.
ICMJE (International Committee of Medical Journal Editors)
Working group of medical journal editors whose Recommendations set de facto authorship, disclosure, and trial-registration standards, not a formal regulator.
Ethics approval statement
A statement within a manuscript — typically in the Methods or a dedicated ethics-declarations section — asserting that a study involving human participants, human data or tissue, or animals received prior approval from a named, independent ethics review body, and identifying that body, an approval or protocol reference number, and the date of approval (or documenting an applicable exemption or waiver), sufficient for an editor or reader to verify that ethical oversight preceded the research rather than merely occurred at some point.
Single-anonymized peer review
The peer-review model in which reviewers are told the identity of a manuscript's authors, but authors are not told the identity of the reviewers assessing their work. Traditionally called "single-blind" review — the STM Association's 2020 peer-review terminology recommends "single-anonymized" instead, since "blind"/"blinded" have an ableist origin, though "single-blind" remains in very wide use in journal policy pages and search queries for the identical practice. It is the long-standing default across most STEM and biomedical publishing, including the majority of Elsevier, Springer Nature, and Wiley journals in those fields, and is distinguished from double-anonymized review (both parties' identities withheld from each other) and open review (some part of the process — identities, reports, or both — made public, before or after publication).
euroCRIS
euroCRIS is the international not-for-profit membership association of research-information professionals and institutions that holds custodianship of the CERIF data model and coordinates community infrastructure (the DRIS directory, the CRIS Conference, membership meetings, working groups) for interoperability among Current Research Information Systems. Something qualifies as "euroCRIS" only if it refers to the organisation itself — its governance, membership, task groups, and services — not the CERIF standard or a CRIS software product it helps make interoperable.
Principles of Transparency and Best Practice in Scholarly Publishing
A joint framework of 16 disclosure and practice criteria — organized around journal content (name, website, publishing schedule, archiving), journal practices (publication ethics and editorial policies, peer review, access, copyright and licensing), organization (ownership and management, an advisory body, a named editorial team with contact information), and business practices (author fees, other revenue sources, advertising, direct marketing) — jointly developed and maintained by the Committee on Publication Ethics (COPE), the Directory of Open Access Journals (DOAJ), the Open Access Scholarly Publishers Association (OASPA), and the World Association of Medical Editors (WAME). First published in December 2013; subsequent versions were released in 2015, January 2018 (v3), and September 2022 (v4, the current version). A journal or publisher is an instance of 'meeting the Principles' when each of the 16 items is disclosed, verifiable, and consistent with what the framework specifies — not when a publisher merely asserts general trustworthiness. COPE, DOAJ, and OASPA each use the Principles as part of their own membership/indexing assessment criteria, and WAME applies them as part of its membership evaluation — meaning the framework functions as an operational, checkable definition of what a legitimate journal must show, not an aspirational statement. Compliance with the Principles is also cited as one of the criteria major indexing services (e.g. Scopus) weigh when assessing a journal for inclusion, though each index applies its own separate, additional criteria on top of it.
ORCID Invited Position
An affiliation item in an ORCID record asserting that the iD holder holds or held a paid or unpaid invited role — such as a visiting lectureship, honorary or guest-researcher appointment, or emeritus professorship — at a named organisation, as distinct from an ordinary employment relationship. Captured with the organisation's name and disambiguated identifier (typically a ROR ID), department, role/title, start date, and optional end date.
Pending publication (Crossref)
A Crossref record type that lets a publisher (a Crossref member) register a DOI and a minimal metadata record -- at minimum the member name, journal title, and the manuscript's accepted date -- for a manuscript that has already cleared peer review and received a formal editorial acceptance decision, but has not yet been published online. Until the work is formally published, the DOI resolves to a Crossref-hosted landing page carrying an acceptance notice and the deposited metadata, not to the article itself. The publisher must later update that same DOI's metadata record to a full journal-article registration once the work is published; only then does the DOI resolve directly to the published content. A record qualifies as a pending publication only if it was deposited by the eventual publisher for an already-accepted manuscript -- an unrefereed preprint, or a manuscript still under review, does not qualify.
Responsible Conduct of Research (RCR) training
Funder-mandated instruction, required of specific categories of NIH- and NSF-supported researchers and trainees, covering a defined set of research-ethics and integrity topics (authorship, data management, mentoring, peer review, research misconduct, conflicts of interest, and related areas) — distinct from a general institutional code-of-conduct orientation because its topic list, format, and recurrence are set by the funding agency, not the institution alone.
Metascience
The empirical, quantitative study of science itself: applying research methods to research methods, reporting practices, evaluation systems, and incentive structures, in order to describe how research is actually conducted and to test interventions that make it more reliable and efficient. Something counts as metascience when its object of study is the research process across a field — study design, statistical power, reporting completeness, peer review, replication rates, or how funding and career incentives shape researcher behavior — rather than a first-order scientific question within a specific discipline. Also called meta-research or, informally, "the science of science."
OPEN Government Data Act
A federal agency data asset falls under the OPEN Government Data Act's open-by-default requirement when it was created by, collected by, or is under the control, direction, or maintenance of a federal agency, and its public release as machine-readable data in an open format under an open licence is not otherwise restricted by law (e.g., privacy, national security, confidentiality, or other statutory non-disclosure provisions). Agencies may weigh a cost-benefit analysis before converting an asset to an open format, but the statutory default is publication, not withholding.
Lab Equipment Lifecycle Assessment
A structured environmental impact assessment of a laboratory instrument or equipment item across all life-cycle stages, from raw-material extraction and manufacture through use, maintenance, and end-of-life.
Carbon accounting (research)
The systematic measurement, calculation, and reporting of greenhouse gas emissions across research activities, applying standard methodologies and emission factors to produce auditable CO2-equivalent totals.
Scope 1 / 2 / 3 emissions (research org)
The categorisation of a research organisation's greenhouse-gas emissions following the GHG Protocol: scope 1 (direct on-site combustion), scope 2 (purchased electricity, heat, steam, cooling), and scope 3 (indirect emissions across the value chain, including procurement, commuting, travel, and waste).
Climate impact statement (in DMP)
A structured section in a data management plan or research proposal that estimates and discusses the environmental impact of planned research activities, including travel, computing, equipment, consumables, and data storage.
Climate-aware funding
Research funding policies and award practices that explicitly incorporate climate and environmental sustainability considerations into eligibility, proposal review, and reporting.
Open infrastructure energy efficiency
The energy and carbon performance of shared, community-governed scholarly infrastructure (open repositories, identifier services, preservation systems), considered as part of the sustainability profile of the open scholarship ecosystem.
Sustainable procurement (research)
The process of purchasing research goods and services with explicit consideration of environmental, social, and governance criteria across the full supply chain, in addition to price and performance.
5R Framework (lab sustainability)
A hierarchical decision framework applied to laboratory consumables and waste: Refuse, Reduce, Reuse, Repurpose, Recycle, considered in that order of preference.
Hybrid conference
A scholarly meeting that simultaneously supports in-person and remote participation, with intentional design choices to give remote attendees substantive interactivity rather than passive viewing.
Virtual conference
A scholarly meeting held entirely online, with no physical venue or in-person attendance, using video-conferencing, virtual poster halls, and asynchronous discussion channels.
Conference travel emissions
The subset of academic travel emissions specifically attributable to attendance at conferences, workshops, and scholarly meetings.
Travel emissions (academic)
The greenhouse gas emissions arising from academic business travel, principally air travel for conferences, fieldwork, collaboration visits, and external examining.
Carbon-aware computing
The practice of scheduling, shifting, or routing computational workloads in response to real-time grid carbon intensity, so that flexible jobs run when and where electricity emissions are lowest.
Energy proportionality (computing)
The property of computing systems whose energy consumption scales linearly with workload, so that idle or lightly utilised systems draw correspondingly little power.
Green software engineering
The discipline of designing, building, and operating software with explicit attention to its energy and carbon impact, as defined by the Green Software Foundation.
Sustainable HPC
High-performance computing operations and procurement choices that minimise energy use, carbon emissions, water use, and hardware waste while delivering scientific compute capacity.
Compute carbon footprint
The greenhouse gas emissions attributable to the electricity consumed by computational research activities, including local workstations, on-premises HPC clusters, and cloud or commercial compute services.
Research carbon footprint
The total greenhouse gas emissions (expressed in CO2-equivalent) attributable to research activity, encompassing direct laboratory energy use, computing, procurement, travel, and end-of-life of research equipment.
Lab waste audit
A structured exercise in which a laboratory measures and categorises the volume, type, and disposal route of waste generated over a defined period to identify reduction, re-use, and recycling opportunities.
Single-use plastic alternatives
Materials and product designs that substitute for traditional single-use polymer consumables in research workflows, including bio-based polymers, autoclavable glassware, reduced-plastic packaging, and refill-and-wash systems.
Reusable consumables
Laboratory items historically used once and discarded that are redesigned, repurposed, or substituted with multi-use alternatives, including washable tip-box racks, autoclavable glass tubes, refillable spray bottles, and washable lab coats.
Plastic waste (research lab)
The single-use and multi-use polymer waste generated by laboratory research activities, including pipette tips, tubes, plates, gloves, packaging, and serological pipettes, much of which is contaminated and routed to incineration rather than recycling.
-80 degC freezer management
The set of operational practices applied to ultra-low temperature (ULT) freezers to minimise energy use, extend equipment life, and preserve sample integrity, including sample inventory control, temperature setpoint optimisation, and preventive maintenance.
Cold-storage energy (research)
The electrical energy consumed by research cold-storage equipment (-20 degC freezers, -80 degC ultra-low temperature freezers, liquid nitrogen Dewars, cold rooms) used to preserve biological, chemical, and reagent samples.
Orphan (unclaimed) freezer sample
A sample held in ultra-low-temperature (ULT, -80 degC) or -20 degC cold storage with no identifiable current owner, provenance record, or active research use -- commonly called an orphan or unclaimed sample -- and a standard target for freezer clean-out and sustainability audits.
Green Lab Certification
Any formal third-party assessment that verifies a laboratory meets defined sustainability criteria, most commonly issued by LEAF or My Green Lab.
My Green Lab
A US-based non-profit organisation and certification programme that assesses laboratory sustainability across behaviour, equipment, infrastructure, and culture, issuing tiered certifications used by pharmaceutical, biotech, and academic labs worldwide.
LEAF (Laboratory Efficiency Assessment Framework)
A standards-based assessment framework developed by University College London that scores wet and dry laboratories on energy, waste, water, procurement, and research-quality practices, awarding Bronze, Silver, or Gold accreditation.
Updated project plan
The revised project-planning document -- updated work packages, timeline, budget allocation, or personnel roles -- issued after a sponsor has approved a change request. It is the downstream artefact of an approved change, not the change request itself and not the underlying pivot that prompted it.
Project plan
The project plan is the operational blueprint approved as part of a funded award — the document that sets out what work will happen, in what sequence, against what timeline, using what resources, and by whom. It is the reference an institution and a sponsor both compare actual progress against during interim and final reporting across the project lifecycle . Funder-specific forms The project plan doesn't have one universal template; it takes the form a given funder's application process produces. For Horizon Europe projects, Annex 1 of the Grant Agreement (the "description of action
Project metadata
The structured descriptive and administrative fields -- title, PI, funder, award identifier, project period, budget -- that identify a funded research project within a CRIS, grants system, or funder database.
Project ID (RAiD-anchored)
A persistent, machine-actionable identifier for a research project, typically issued under the Research Activity Identifier (RAiD) standard ISO 23527, used to unambiguously identify the project across systems, funders, institutions, and outputs.
Output legacy planning
Planning, undertaken before or during a project's final phase, for what happens to its outputs, deliverables, and communities of practice once dedicated funding ends -- preservation and licensing of data, software, or other outputs, and succession arrangements for networks or infrastructure the project created. Distinct from project closure documentation, which records what was done, not what should happen next.
Post-project sustainability
Post-project sustainability is the broader planning question a funder increasingly expects an applicant to answer: what continues, and how, once dedicated project funding stops? It sits at proposal and reporting stage as a distinct planning requirement in its own right — Horizon Europe's sustainability plans, NIH's data-management and sharing expectations, and UKRI's exploitation plans are the most commonly cited funder-specific forms it takes. The questions it typically has to answer Who will maintain project-built software once the grant ends and dedicated developer time disappears; ho
Lessons learned
A structured retrospective summary of what worked well, what did not, and what the project team would do differently, capturable at any major lifecycle milestone, not only at closeout, to inform future projects.
Project closure documentation
The set of documents produced at project closeout to record final outcomes, lessons learned, deliverables submitted, data archived, equipment disposition, and outstanding obligations, providing an auditable trail for future reference -- the output of the closeout phase, not the process itself.
Offboarding (project)
The structured process of transitioning a team member, or an entire project, out of active involvement, including knowledge transfer, data and code hand-off, access revocation, exit interview, and documentation of outstanding items -- distinct from the award-level closeout phase.
Onboarding (project)
The structured process of bringing a new member -- or, for a consortium partner, an entire new organisation -- into active, compliant participation in an already-running project: provisioning access, delivering mandatory training, and formally accepting the newcomer into the project's governance documents.
Hand-off (between phases)
The structured transfer of project responsibility, knowledge, and artefacts from one lifecycle phase to the next, or between project teams or roles, to ensure continuity and minimise loss of context.
Project hold
A temporary pause of project activity initiated by the project team, the institution, or a regulatory body, for example pending an ethics re-approval, equipment repair, IRB decision, or while a key team member is on leave.
Continuation decision
The sponsor's programmatic and administrative determination, made after reviewing a periodic or annual report, of whether an already-approved multi-year project may proceed into its next budget period as planned. The decision itself -- satisfactory, satisfactory with comments, or unsatisfactory -- is distinct from the continuation award, which is the funding-release mechanism that follows a satisfactory decision.
Suspension (grant)
A sponsor-imposed halt to a recipient's authority to draw down funds and continue award activity, imposed under 2 CFR 200.339 as a remedy for noncompliance the agency has determined cannot be resolved by imposing specific conditions alone. This is distinct from suspension and debarment under 2 CFR Part 180, a separate, more severe exclusion action that can bar an entity from receiving future federal awards at all.
Termination (grant)
The formal ending of a grant award before its scheduled end date, initiated by the sponsor or recipient, due to non-performance, mutual agreement, loss of funding, or other defined cause.
No-cost extension (lifecycle context)
In the project-lifecycle sense, a no-cost extension (NCE) is the change-request event that shifts a project's end date -- and with it, the start date of every downstream phase -- without adding funds or changing scope. See the tighter ledger/agreement definition at no-cost extension for the funding-instrument view; this entry covers what an NCE does to phase timing and governance.
Change request (project)
A formal request a recipient submits to the sponsor to amend an already-approved aspect of a funded project -- scope, key personnel, budget category, subaward activity, or timeline -- required whenever the change falls on the sponsor's prior-approval list, most concretely enumerated at 2 CFR 200.308(f) for US federal awards.
Project pivot
A substantive change in a funded project's scientific approach, methodology, or direction, made in response to early results, external circumstances, or a changed environment -- normal and often necessary, but compliant only once it has been assessed against the sponsor's prior-approval rules and, where it changes the project's scope or objective, formalized as a change request.
End-of-project review
A formal evaluative meeting or process held at or near a project's end to assess whether it met its stated objectives against the original plan, typically involving the funder's programme or project officer and, for larger awards, external experts -- distinct from a mid-project interim review, and from the later, broader impact evaluation that may follow independently.
Mid-term review
A formal review conducted at approximately the midpoint of a research project, evaluating progress against aims, resource utilisation, and the realism and feasibility of the plan for the remaining project duration.
Interim project review
A formal, funder-initiated progress check conducted at a defined mid-point of a multi-year project -- assessing whether work is on track against the plan and informing continuation, adjustment, or corrective-action decisions -- distinct from the routine interim report it draws on and from the end-of-project review held at project close.
Annual report (grant)
The reporting deliverable a recipient submits once per year of a multi-year award, combining a narrative account of progress with, where the sponsor requires it, a financial update -- the most common cadence for the interim report in US federal and UK funding, but not itself a synonym for either 'financial report' or 'final report.'
Archive phase
The final lifecycle stage, beginning once closeout reporting is complete, in which a project's outputs -- data, code, documents, and equipment records -- are placed into long-term stewardship: deposited in repositories, registered with persistent identifiers, and retained for whatever period funder policy and 2 CFR 200.334 require. It formalises what happens to a project's outputs after the award itself has formally ended.
Reporting phase
The recurring lifecycle activity during which scheduled progress and financial reports are planned, drafted, internally reviewed, and submitted to the sponsor -- distinct from the reporting period it covers and the interim report it produces.
Execution phase
The main project lifecycle phase during which the planned research activities are carried out, deliverables produced, milestones achieved, and the bulk of grant expenditure occurs.
Award phase
The stage of the research-project lifecycle between formal award issuance and project close-out, covering budget execution, progress reporting, personnel management, and amendments.
Proposal phase
The lifecycle phase covering preparation, drafting, internal review, institutional approval, and submission of a research proposal to a funder, ending with proposal submission.
Idea phase
The earliest phase of the research project lifecycle, in which a researcher identifies a question, surveys the literature, drafts a research concept, and explores potential funders and collaborators before committing to proposal preparation.
Project lifecycle
The full sequence of stages a research project moves through from first concept to final archival, used as the organising framework for governance, planning, and hand-offs across a project's life: idea, proposal, pre-award, post-award (execution), closeout, and archive. "Project lifecycle" names the whole sequence; "project phase" names any one stage within it.
Subtask
An internal subdivision of a project task, used for detailed planning, effort tracking, and execution management, typically not formally reported to the sponsor but tracked within the consortium or research group -- distinct from a formally reported task.
Task (Horizon Europe)
A subdivision of a Horizon Europe work package, representing a specific activity with defined objectives, contributing partners, person-month allocation, and link to particular deliverables or milestones, defined in the Application Form and Grant Agreement Annex 1.
Work package (Horizon Europe)
A defined sub-component of a Horizon Europe project that groups related tasks, deliverables, and milestones under a single work-package leader, with its own budget allocation and timeline.
Project deliverable
A tangible, verifiable output produced by a project, such as a report, dataset, software release, prototype, or publication, formally documented in the project plan with a due date and responsible work package or partner.
Project milestone
A significant intermediate point in a project, marking achievement of a key activity, completion of a deliverable, or successful transition between phases, used to monitor progress against the project plan.
Project phase
A defined segment of a research project's lifecycle, characterised by a specific objective, set of activities, deliverables, and decision gates, used to structure planning, execution, and reporting.
Financial report (grant)
The financial component of grant reporting -- an accounting of expenditures against the approved budget, submitted to the sponsor on its own cadence and in its own format (for example the US federal SF-425 Federal Financial Report, or Horizon Europe's Form C financial statement) -- defined by its content (expenditure data), not by when in the award's lifecycle it is due.
Final report
The single report filed once, at or shortly after the end of a project's period of performance, closing the technical and financial record of the award -- unlike an interim or annual report it supports no further continuation decision, and it is one deliverable within, not the whole of, the closeout phase.
Interim report
A progress and/or financial report submitted to the sponsor during a multi-period grant, covering activities up to a defined intermediate point and supporting continuation decisions -- distinct from the final report and from the reporting period it covers.
Reporting period (grant)
A defined time window within a multi-period grant for which the recipient must submit progress and/or financial reports to the sponsor, fixed in the award terms and often aligned with budget years or a set periodic-reporting cycle.
Lump-sum grant (Horizon Europe)
A Horizon Europe funding model in which the Commission pays a pre-agreed fixed amount per work package on satisfactory completion of that work package's activities, rather than reimbursing actual costs incurred -- eliminating financial reporting, unit-cost declarations, and cost-related audits for the beneficiary, in exchange for the beneficiary accepting completion risk against a fixed budget agreed at proposal stage.
Milestone payment
A funding disbursement triggered by the achievement of a defined project milestone, used in fixed-price or hybrid funding mechanisms to align sponsor payment with verifiable progress.
Fixed-price grant
A grant or contract in which the sponsor pays a pre-agreed fixed amount on satisfactory completion of the work or defined milestones, without reimbursement of actual costs, transferring cost-overrun risk to the recipient.
Cost reimbursement
A funding mechanism in which the sponsor reimburses the recipient for actual allowable costs incurred during the performance of the award, typically up to a stated funding ceiling, with periodic invoicing and supporting documentation required.
Pass-through entity
Under 2 CFR 200.1, a pass-through entity is a non-federal entity -- including a state, tribal government, institution of higher education, or nonprofit organization -- that provides a subaward to a subrecipient to carry out part of a federal program. A university holding a federal prime award and issuing a subaward to a partner institution is acting as a pass-through entity for that subaward, while remaining a recipient with respect to its own prime award.
Prime award
The grant or contract directly between the funder and the lead recipient organisation, which holds primary responsibility for the project's scope, deliverables, and compliance, and may issue subawards to other entities.
Subrecipient monitoring
The activities undertaken by the prime award recipient (pass-through entity) to ensure that subrecipients comply with the terms of their subawards, including financial, programmatic, and audit oversight.
Subaward
A subaward is the funding instrument — not the organization, not the oversight activity — by which a pass-through entity transfers part of a prime award 's funding and a defined, substantive scope of research work to a subrecipient. A subrecipient carries out programmatic work under its own principal investigator and budget and is judged, at least in part, against the subaward's own performance measures — unlike a contractor, which simply provides goods or services within a market relationship. 2 CFR 200.331 sets out the factors used to make that subrecipient-vs-contractor de
Sponsored research agreement
A contractual agreement between a research-performing organisation and a sponsor (industry, foundation, or government), defining the scope of work, deliverables, IP terms, publication rights, payment terms, and reporting obligations for a research project.
Crowdfunded research
Research projects funded by aggregated small contributions from many individuals, typically solicited through online platforms (Experiment, Kickstarter, GoFundMe, institutional giving sites) rather than from traditional grant-making bodies.
Endowment income
The investment returns generated by an institution's or foundation's permanent endowment fund, used (typically at a defined spending rate, e.g., 4 to 5 percent of a multi-year smoothed average) to support operations, scholarships, or named research programmes.
Foundation grant
A grant awarded by a private, charitable, or family foundation rather than a government agency or industry sponsor, typically funded from endowment income and governed by the foundation's mission and giving guidelines.
Indirect cost recovery
The income an institution receives from sponsors as reimbursement for indirect (overhead) costs incurred in support of sponsored projects, calculated by applying the negotiated or sponsor-imposed indirect cost rate to the relevant direct-cost base.
Single Audit (US)
A US federal annual organisation-wide audit required of non-federal entities expending more than a defined threshold of federal funds, conducted under 2 CFR 200 Subpart F (formerly OMB Circular A-133).
Audit (grant)
A formal examination of an institution's or project's financial records, internal controls, and compliance with sponsor terms, conducted by external or internal auditors to provide independent assurance of proper stewardship of grant funds. For US federal grants specifically, "federal grant audit" most often refers to the annual, organisation-wide Single Audit required under 2 CFR 200 Subpart F once an entity's federal expenditures cross the statutory threshold (see Single Audit (US)); an entity whose federal expenditures come from only one federal program may instead elect an equivalent program-specific audit under 2 CFR 200.501(c). Either is distinct from an agency-initiated audit -- for example by a funding agency's Office of Inspector General -- of a single award outside the routine Single Audit cycle.
Closeout phase
The sponsor-facing administrative and financial wind-down of an awarded project once its period of performance ends -- submitting required final reports, reconciling final expenditure, resolving unliquidated obligations, and disposing of equipment per sponsor rules -- distinct from offboarding (the people/access side of a project ending) and from project closure documentation (the paper trail closeout produces).
Post-award phase
The grant lifecycle phase covering the period of performance, from account activation through the end of funded work, including expenditure, reporting, monitoring, modifications, and subaward management -- distinct from the closeout phase that follows it.
Pre-award phase
The grant lifecycle phase covering activities from identification of a funding opportunity through proposal preparation, submission, and award negotiation, prior to the start of the period of performance.
Encumbrance
A reservation or commitment of grant funds against a future expenditure (such as a purchase order, a multi-year salary commitment, or a subaward), recorded in the institution's financial system to prevent over-commitment.
Burn rate (grant)
The rate at which a grant's funds are being expended over time, typically expressed as currency-per-month or as a percentage of the budget consumed per period, used to forecast end-of-period spend and identify under- or over-spend trajectories.
Underspend
The condition in which a grant budget period ends with unspent funds, indicating actual expenditure was lower than planned and requiring action (carry-forward, reduction of next-year award, or return to sponsor).
Carry-forward
The authorised transfer of unobligated grant funds from one budget period to the next within a multi-year grant, allowing the recipient to use those funds in a subsequent period rather than losing them.
No-cost extension (NCE)
An approved extension of the period of performance of a grant beyond the original end date, without additional sponsor funds, to enable completion of the funded scope.
Continuation award
The routine, non-competing release of funding for the next budget period within an already-awarded, already-peer-reviewed multi-year project -- issued once the recipient submits the required progress and financial report for the prior period, and requiring no new scientific review. NIH designates this a Type 5 application.
Renewable award
A grant mechanism whose terms allow the recipient to submit a new, fully peer-reviewed competing application -- a competing renewal -- for a further period of support once the current project period ends, competing on equal footing with new applications. NIH designates this a Type 2 application; it is distinct from the routine, non-competing continuation awards issued within an already-approved project period.
Discretionary funding
Funds that an institution, dean, or unit head may allocate at their own judgement, without a formal competitive call, typically used for strategic investments, recruitment startups, bridge support, or unforeseen needs.
Non-competitive grant
A funding award made without a comparative peer-reviewed competition, either through direct invitation, formula allocation, or as a routine continuation of an existing multi-year award.
Competitive grant
A funding award made following a peer-reviewed, merit-based competition against other proposals, in which only a subset of applicants are funded.
Catalyst grant
A targeted, often small-to-medium-value funding mechanism designed to catalyse strategic activity in a specific area, such as building a new research network, piloting a methodology, or de-risking a translational step.
Pump-priming funding
Small grants intended to initiate new collaborative or interdisciplinary research activity that is not yet ready for full external funding competition, typically with an explicit expectation of follow-on external grant capture.
Seed funding
Small-value, short-duration funding awarded to develop a novel research idea to the point where it can compete for larger external grants, typically provided by institutions, learned societies, or pilot-grant programmes.
Bridge funding
Short-term funding provided to maintain a research programme between an expiring grant and an anticipated new award, typically from institutional sources rather than external sponsors.
Match funding
A funding model in which one party's contribution is conditional on a matching contribution from another party, typically expressed as a ratio (e.g., 1:1, 2:1) of sponsor funds to recipient or third-party funds.
Cost share (voluntary)
A cost-sharing contribution a recipient offers beyond what a sponsor requires, typically to strengthen a proposal. Once written into the approved budget as 'voluntary committed' cost share it becomes a binding, auditable obligation under 2 CFR 200.306 -- unlike unrecorded 'voluntary uncommitted' effort.
Cost share (mandatory)
A cost-sharing contribution a recipient is legally required to provide as a condition of the award -- set by statute, the funding notice, or the award terms, not offered voluntarily -- tracked and audited under 2 CFR 200.306 like any other allowable project cost.
Direct charging
The practice of charging a specific cost directly to a sponsored project's budget as a direct cost rather than recovering it through the indirect cost rate, when the cost meets allowability, allocability, and reasonableness criteria.
APC reimbursement (funder)
This term answers a mechanism question: once an APC has been determined to be grant-eligible , how does the money actually reach the publisher? In practice this happens through one of four routes, which a given institution and funder combination may support in parallel. Four common routes (a) Direct charge against the specific project's own open-access publication budget line, drawn straight from grant funds and processed like any other project expense. (b) Institutional block grants — UKRI and Wellcome both fund a lump sum to the institution, which the institution then administers and d
Open access publication cost (grant-eligible)
This term answers an eligibility question: which open-access publication costs — principally article processing charges (APCs) , but also cases such as data-publication or repository-deposit fees — a funder will let a grant budget actually pay for, and under what conditions or caps. It does not describe the mechanics of how an eligible cost gets paid; that's the separate, closely related question covered at APC reimbursement (funder) . The general pattern among major funders Most major research funders — UKRI, Wellcome, NIH, the European Research Council/Horizon Europe &mdash
Travel cost (grant)
Travel cost is the direct-cost budget line covering airfare, lodging, ground transport, per diem/subsistence, and conference registration incurred to carry out project work — site visits, fieldwork, collaborator meetings, and dissemination at conferences. It is allowable when it is reasonable, necessary for the project, and consistent with the institution's own written travel policy (or, absent one, US federal per diem rates), the same reasonableness test applied to direct costs generally. US federal rule: 2 CFR 200.474 and the Fly America Act Under 2 CFR 200.474 (Travel costs), costs ar
Equipment cost (grant)
Equipment, for grant-budgeting purposes, is tangible personal property with a useful life of more than one year whose per-unit acquisition cost meets a capitalization threshold. Below that threshold, an item is ordinarily budgeted as a supply cost instead. A "lesser of" test, not a flat $10,000 line Under 2 CFR 200.1, equipment means a per-unit acquisition cost that equals or exceeds the lesser of the capitalization level the recipient has established for its own financial-statement purposes, or $10,000 . An institution that capitalizes at $5,000 for its own accounting must use $5,00
Personnel cost (grant)
The portion of a grant budget that pays the salaries, wages, and associated fringe benefits of staff who work on the funded project -- typically the largest single direct-cost category in a research grant, and the category most exposed to effort-reporting, key-personnel, and salary-cap compliance requirements.
Single-year project
A funded research project whose period of performance is one year or less, with a single budget period and a single reporting cycle (interim if applicable, plus final).
Multi-year project
A funded research project whose period of performance spans more than one year, typically divided into successive annual (or otherwise defined) budget periods released through non-competing continuation awards, and potentially eligible for a competing renewal once the full project period ends.
Grant Agreement (Horizon Europe)
The legally binding contract signed between the European Commission (or designated funding body) and the beneficiaries, defining the action's scope, budget, deliverables, payment, IP, reporting, and dissemination obligations for a Horizon Europe project.
Consortium agreement
A private-law contract signed among all beneficiaries of a multi-partner grant, in addition to and subordinate to the Grant Agreement with the funder, that governs the internal relationship between partners: decision-making bodies, the coordinator's role, intellectual property allocation, access rights, liability for a defaulting partner, and dispute resolution. It binds the partners to each other, not to the funder.
Partner (grant consortium)
A non-coordinator beneficiary in a multi-partner grant consortium, responsible for an agreed share of the work and budget and party to the consortium agreement.
Coordinator (grant consortium)
The beneficiary in a multi-partner grant (especially Horizon Europe) that takes legal and administrative lead, acting as the single point of contact with the funder and coordinating consortium activities, reporting, and payments.
Beneficiary (Horizon Europe)
A legal entity that signs the Horizon Europe Grant Agreement and is directly accountable to the European Commission for delivery of an agreed share of the project's work and budget.
MTDC (Modified Total Direct Cost)
The base to which a US federal indirect cost rate is applied, equal to total direct costs minus excluded items (typically equipment over a threshold, capital expenditures, patient care, tuition remission, rental costs, scholarships, and the portion of each subaward exceeding $50,000 under 2 CFR 200.1 since October 1, 2024).
De minimis rate (NIH)
A federally permitted de minimis indirect cost rate that organisations without a negotiated F&A rate may elect to use on US federal awards, applied to modified total direct costs (MTDC). The government-wide ceiling under 2 CFR 200.414(f) is up to 15 percent for awards issued on or after October 1, 2024, raised from 10 percent; NIH reverted to 10 percent for its own awards via Notice NOT-OD-26-072 (April 20, 2026).
Indirect Cost Rate (F&A Rate)
Indirect cost rate (also called the F&A rate in US federal terminology): the negotiated or de-minimis percentage applied to a defined direct-cost base to recover an institution's facilities and administrative (overhead) costs on US federal grants and contracts — costs that support a sponsored project but cannot be attributed to it directly.
Indirect costs (overheads)
The costs an institution incurs for common or joint objectives that cannot be readily identified with a single federal award without disproportionate effort -- facilities, general administration, and similar shared infrastructure -- recovered through a negotiated or de minimis rate applied to a direct-cost base rather than charged to any one award directly.
Direct costs
A cost that can be identified specifically with a particular award, project, or activity with a high degree of accuracy, and is therefore charged directly to that award rather than recovered through an indirect-cost rate. Under 2 CFR 200.413, classification as direct or indirect turns on whether a cost is allocable to a specific cost objective, not on the type of expense itself -- the same expense category (e.g. administrative staff time) can be direct on one award and indirect on another depending on the actual relationship to project objectives.
Implementation science
The scientific study of methods and strategies for embedding evidence-based practices and interventions into real-world policy and practice settings, addressing the gap between 'what works' in a controlled study and its sustained real-world use.
Bench-to-bedside
A phrase used in biomedical research to describe the translation of laboratory ('bench') discoveries into clinical practice ('bedside'), encompassing the T1 stage of translational research.
Translational research
Research explicitly organised around moving findings from basic discovery through to clinical, practical, or population-level application, typically described through a staged (T0-T4) model of successive translation.
Action research
A research approach in which researchers and practitioners work together to investigate a practical problem and develop solutions through iterative cycles of planning, action, observation and reflection.
Community-based participatory research (CBPR)
A collaborative research approach that equitably involves community members, organisational representatives and researchers in all aspects of the research process, with shared decision-making and the aim of combining knowledge with action for social change.
Lived-experience expert
A person whose personal experience of a condition, situation or issue is recognised as a form of expertise that contributes meaningfully to research, policy or practice alongside professional and academic expertise.
Co-design (research)
The collaborative design of research studies, interventions, services or products with the people who will use them or be affected by them, integrating their knowledge and perspectives from the outset.
Co-production (research)
A research approach in which researchers and stakeholders share authority over the research question, design, conduct, analysis, and dissemination across the entire research lifecycle, not one phase of it.
Engagement metric
A quantitative or structured-qualitative indicator capturing the extent, depth, reach or quality of engagement between researchers and non-academic stakeholders or publics.
Responsible Research and Innovation (RRI)
A governance and research-practice framework asking researchers and innovators to anticipate, reflect on, and be responsive to the ethical, social and environmental implications of their work throughout the research process, rather than only after the fact.
Mission-oriented research
Research and innovation activity organised around explicit, bold, measurable, time-bound societal goals ('missions') that are broad and interdisciplinary in scope, rather than around a single discipline or open-ended discovery agenda.
SDG-Aligned Research
Research that is explicitly designed, framed or assessed in relation to specific Sustainable Development Goals and their targets, with the intent of contributing to their achievement.
SDG 17 (Partnerships)
The seventeenth Sustainable Development Goal: strengthen the means of implementation and revitalise the global partnership for sustainable development.
SDG 9 (Industry Innovation)
The ninth Sustainable Development Goal: build resilient infrastructure, promote inclusive and sustainable industrialisation and foster innovation.
SDG 4 (Quality Education)
The fourth Sustainable Development Goal: ensure inclusive and equitable quality education and promote lifelong learning opportunities for all.
SDG mapping (research output)
The practice of classifying research outputs, projects, or programmes against one or more Sustainable Development Goals or their underlying targets, typically using a keyword-based, citation-based, or machine-learning classification method.
Sustainable Development Goals (SDGs)
A set of 17 goals, adopted by UN member states in 2015 as part of the 2030 Agenda for Sustainable Development, that the research community increasingly uses to frame funding priorities, project design, and impact reporting.
ECSA (European Citizen Science Association)
A European network of citizen-science practitioners, researchers and project owners that promotes the practice, quality and recognition of citizen science across Europe and internationally.
Citizen science
A research method in which members of the public contribute directly to data collection, protocol design, or analysis -- not merely as subjects or an audience -- ranging from contributory through collaborative to co-created participation.
Patient partner
A patient, carer, or member of the public who contributes lived experience to shaping research design, conduct, analysis, or dissemination as an active collaborator -- involvement -- as distinct from a research participant (participation) or an engagement audience.
Patient and Public Involvement (PPI)
Research being carried out 'with' or 'by' members of the public rather than 'to', 'about' or 'for' them, as defined by INVOLVE (the UK national advisory group for PPI).
Public engagement with research (PER)
Engagement activity directly connected to a specific piece of research -- involving publics in shaping questions, dialogue during the work, or engagement with findings -- as distinct from broader public engagement with higher education or science that need not tie to any one project.
Public engagement (PE)
The myriad ways in which the activity and benefits of higher education and research can be shared with the public, often involving two-way interaction to generate mutual benefit, as defined by the National Co-ordinating Centre for Public Engagement (NCCPE).
Knowledge exchange (KE)
A two-way process through which knowledge, ideas and experiences are shared between researchers and non-academic partners (such as businesses, public services, third sector, communities) to mutual benefit.
Knowledge mobilisation (KMb)
The processes by which research evidence and other forms of knowledge are made accessible, useful and used by communities, practitioners, policymakers and other stakeholders to inform decisions and action.
Knowledge translation (KT)
The process of moving research knowledge into use -- synthesising, disseminating, exchanging and applying it -- to improve outcomes and strengthen practice or policy, anchored in CIHR's framework distinguishing end-of-grant KT from integrated KT.
Pathway to impact
A mandatory, standalone section of UKRI grant applications, required from 2009 and formally removed from March 2020, in which applicants identified likely beneficiaries, planned activities, and the mechanisms linking research outputs to societal effects. Historical, not a current requirement.
Theory of change
An explicit, testable map of how and why a research project, programme or intervention is expected to lead to specified outcomes, identifying the causal pathway and necessary intermediate conditions.
Impact evaluation
A systematic assessment of the effects a piece of research or a research programme has had -- often extending beyond its own stated objectives -- using methods such as counterfactual or comparison-group designs, contribution analysis, or theory-based evaluation. Typically conducted after project completion, sometimes at a portfolio level across many awards, and distinct from a single project's end-of-project review.
Impact case study (REF)
See 'REF impact case study' (responsible-assessment). A structured narrative documenting how specific research has produced effects beyond academia, submitted as part of UK Research Excellence Framework assessment.
Environmental impact
The environmental footprint generated by research activity itself — energy use, emissions, water use, waste, and procurement associated with laboratories, fieldwork, computing, and research travel — as distinct from a research project's findings contributing to environmental outcomes, or the UK REF's separate 'impact' assessment concept.
Cultural impact
Cultural impact is a category of non-academic research impact concerned with effects on museums, galleries, performance, broadcast media, creative practice, heritage conservation, and public understanding of history, identity, and the arts. It is distinguished from academic impact (effect on a field of scholarship, evidenced through citation and uptake by other researchers) and from economic impact (effect on commercial value, jobs, or productivity) by being evidenced through audience engagement, critical reception, and expert testimony rather than metrics or financial figures.
Policy impact
The contribution that research makes to the formulation, content or implementation of public policy at local, national or international levels.
Economic impact
A quantifiable financial or employment effect of research -- jobs, revenue, licensing income, cost savings, or spin-out value -- evidenced through economic modelling, payback methods, or documented case-based outcomes.
Societal impact
A documented change in public knowledge, attitudes, social practice, community wellbeing, or civil-society institutions attributable, at least in part, to research, typically evidenced through contribution analysis or structured case studies rather than a single metric.
Academic impact
The contribution that research makes to the advancement of scientific knowledge and to other research communities, typically evidenced through citations, methods uptake, theoretical influence and training of researchers.
Research impact
An effect on, change, or benefit to the economy, society, culture, public policy, services, health, environment, or quality of life that occurs beyond academia and can be attributed, at least in part, to a specific piece of research.
OA Monitoring Explained
The systematic measurement and reporting of open-access publication uptake, compliance with OA policies, and progression toward open scholarship goals at institutional, funder or national level.
Knowledge Equity Index
A composite measure or framework that quantifies how equitably knowledge production, dissemination and access are distributed across geographies, languages, disciplines, demographics or career stages.
Principles of Open Scholarly Infrastructure (POSI)
A set of principles published in 2015 (updated 2020) by Bilder, Lin and Neylon defining the governance, sustainability and insurance characteristics that scholarly infrastructure should have to be considered open and community-controlled.
Open infrastructure (POSI principles)
Scholarly infrastructure that is community-governed, financially sustainable, and operationally transparent, in alignment with the Principles of Open Scholarly Infrastructure (POSI).
Institutional Waiver Programme (APCs)
A structured arrangement by a publisher or institution that grants reductions or full waivers of article-processing or publication charges to authors who would otherwise face financial barriers to open-access publication.
Author Fee Equity in OA
The principle that author-side publication charges (APCs, page charges, submission fees) should not act as a barrier to publication, with equitable access ensured through waivers, transformative agreements, diamond OA alternatives or funder support.
Predatory journal
A journal that solicits and accepts manuscripts in exchange for fees without providing the editorial and peer-review services normally expected of a legitimate scholarly venue, often through deceptive marketing.
Multilingual Scholarship
Scholarly communication that recognises, supports and produces research outputs in multiple languages, in contrast to English-only norms that dominate international academic publishing.
Geographic Editorial Diversity
The presence on a journal's editorial board, reviewer pool and authorship of researchers from a wide range of countries, regions and institutional types, especially including the Global South.
Equitable Peer Review
Peer-review practice that actively addresses structural inequities in reviewer recruitment, manuscript handling, language fairness and decision-making, to ensure that authors from under-represented regions, languages and demographics receive fair evaluation.
Global-South Publishing
Scholarly publishing originating from, owned by or serving researchers and communities in Africa, Latin America, the Caribbean, Asia, the Pacific and other regions historically marginalised by Northern publishing infrastructures.
AfricArXiv
A community-led preprint repository for African researchers, established in 2018, providing a publishing venue for African scholarship in multiple African languages alongside English and French.
African Open Science Platform (concept)
The African Open Science Platform (AOSP) is a continental open-science infrastructure and policy initiative, originating from a 2016 CODATA-International Science Council pilot funded by South Africa’s National Research Foundation and now led into its second phase by the African Academy of Sciences, focused on FAIR data repositories, interoperability, training, and policy coherence across African Union member states.
AmeliCA (concept)
AmeliCA (Conocimiento Abierto para América Latina y el Sur Global) is a non-profit, academic-led open-access publishing infrastructure and advocacy initiative for Latin America, the Caribbean, Spain, and Portugal, built around a diamond-open-access model as an explicit alternative to article-processing-charge (APC) driven open-access reform.
SciELO (concept)
Scientific Electronic Library Online, an open-access publishing model and bibliographic database founded in Brazil in 1997, now a network of country collections across Latin America, the Caribbean, South Africa and beyond.
Redalyc: Open-Access Journal System
A non-profit scientific information system, launched in 2002 and operated by UAEM Mexico, that hosts and disseminates peer-reviewed open-access journals from Iberoamerica and beyond.
Latindex (concept)
A regional online information system for scientific journals from Latin America, the Caribbean, Spain and Portugal, established in 1997 and coordinated from UNAM, Mexico.
Bibliodiversity: The 2017 Jussieu Call
The principle that the global scholarly publishing ecosystem should support a plurality of languages, disciplines, geographies, business models and editorial communities, as articulated by initiatives such as DOAJ, AmeliCA, Redalyc and the Jussieu Call.
Pure publish agreement
A contract between an institution or consortium and a publisher that covers only the open-access publication of the institution's authors, without bundled subscription reading access.
Pure read agreement
A traditional subscription contract giving an institution access to read a publisher's content, with no open-access publishing component, in contrast to a transformative or pure publish agreement.
Transformative Agreement (TA) – Definition
A time-limited contract between an institution or consortium and a publisher designed to shift the financial flow from subscription-based payment for access to payment for open-access publication, with the intent of converting subscription journals to fully OA.
Read-and-Publish Agreement
An agreement between an institution or consortium and a publisher that bundles the costs of reading subscription content with the costs of open-access publishing by the institution's authors in the publisher's journals into a single negotiated price.
Subscribe-to-Open (S2O)
A business model in which a journal flips to open access for a given year if enough institutional subscribers renew their subscriptions, with the same subscription price funding open publication instead of access control.
Diamond Open Access
A publication model in which scholarly content is freely available to read with no charges to either readers or authors, typically supported by institutional, scholarly-society or public funding.
Plan U (Preprint)
Plan U is a 2019 proposal, not an adopted funder policy, that argues the simplest and lowest-cost route to immediate open access is for funders to require grantees to post a preprint — in an approved server such as bioRxiv, medRxiv, or arXiv — at or before the point of journal submission. It was set out in Richard Sever, Michael Eisen, and John Inglis, "Plan U: Universal access to scientific and medical research via funder preprint mandates," PLOS Biology , 4 June 2019 (DOI 10.1371/journal.pbio.3000273). Sever and Inglis co-founded the bioRxiv and medRxiv preprint servers
cOAlition S
An international consortium of research funders, launched in 2018 by Science Europe, that collectively implements Plan S and advocates for full and immediate open access to research publications.
Plan S Explained
An open-access publishing policy launched in September 2018 by cOAlition S requiring that, from January 2021, scholarly publications resulting from research funded by member organisations be made openly available immediately upon publication under an open licence.
Re-evaluation cycle
The interval and criteria on which a researcher's, unit's, or output's contribution is periodically reassessed for tenure, promotion, or funder track-record review.
Lifetime contribution lens
An assessment approach evaluating a researcher's career as a whole -- including non-traditional outputs, career breaks, and mentorship -- rather than a fixed recent window of journal articles, typically operationalised through a narrative CV.
Career diversity
Recognition, within research assessment, that researchers contribute through varied routes -- industry-to-academia moves, career breaks, part-time research, late entry, discipline shifts, international mobility -- rather than a single linear, full-time, uninterrupted trajectory.
Process diversity (in assessment)
Recognition in research assessment of the diverse research processes researchers contribute to, including teaching, mentoring, peer review, leadership, software engineering, data curation, public engagement and policy work.
Output diversification
The recognition, in assessment criteria and CV formats, of datasets, software, protocols, and other non-paper outputs as legitimate, citable evidence of research contribution.
Peer review (in assessment)
The use of expert qualitative judgement by a grant panel, REF sub-panel, or promotion committee to evaluate a researcher's, output's, or unit's overall contribution, as distinct from editorial peer review of a single manuscript.
Quantitative-qualitative balance
The deliberate combination of metrics and expert qualitative judgement within a single assessment process, so that neither substitutes entirely for the other.
Responsible metrics
An approach to using quantitative indicators in research assessment that emphasises robustness, humility, transparency, diversity and reflexivity, as articulated in the 2015 Metric Tide report.
Twitter mentions (concept)
An altmetric signal counting public posts on Twitter (rebranded to X in 2023) that include a link or identifier referring to a specific research output.
Mendeley readership
An altmetric signal derived from the count of users who have added a research article to their personal library in the Mendeley reference manager.
Relative Citation Ratio (RCR, NIH)
An article-level field-normalised citation metric developed by the US National Institutes of Health, expressing an article's citations per year relative to the median in the article's co-citation network, with a value of 1.0 corresponding to NIH-funded median performance.
Field-Weighted Citation Impact (FWCI)
An article-level citation indicator, published by Elsevier (SciVal/Scopus), that normalises an article's citation count against the average for outputs of the same publication year, document type and subject field, with 1.0 representing the world average.
Article-level metrics
Any impact or attention indicator reported at the level of an individual article rather than aggregated to its journal, including citation counts, downloads, and altmetric signals.
Altmetrics
A non-citation attention signal -- social-media mention, media coverage, policy citation, or reference-manager save -- used as one input alongside citation-based evidence, not a synonym for article-level metrics generally.
h-index
A researcher-level metric proposed by Jorge Hirsch in 2005, defined as the largest number h such that the researcher has published h papers each cited at least h times.
CiteScore
A journal-level metric published by Elsevier (Scopus) since 2016 that measures the average number of citations received in a given year by documents published in that journal during the previous four years.
Journal Impact Factor (JIF)
An annual journal-level metric, published by Clarivate in the Journal Citation Reports (JCR), equal to the average number of citations in a given year to articles published in that journal during the preceding two years.
Personal statement (research assessment)
A short narrative section in a researcher CV, grant application or assessment dossier in which the researcher explains, in their own voice, the context, motivation and significance of their work and contributions, evaluated against explicit assessment criteria.
Biosketch (NIH-style)
The structured biographical document every senior/key person on an NIH grant application must submit. For due dates on or after January 25, 2026, NIH requires it in a new two-part NIH Biographical Sketch Common Form (Professional Preparation, Appointments and Positions, Products) plus a separate NIH Biosketch Supplement (Personal Statement, Honors, Contributions to Science) -- both prepared in SciENcv -- replacing the narrative five-page Section A-D format used since 2015.
R4RI mandate (UKRI 2024)
The UK Research and Innovation policy, fully effective in 2024, requiring applicants and reviewers in most UKRI funding opportunities to use the R4RI-derived narrative CV ('Resume for Research and Innovation') instead of traditional academic CVs.
R4RI (Resume for Researchers / Royal Society narrative CV)
R4RI (Résumé for Research and Innovation, also called Resume for Researchers or the Royal Society narrative CV) is UKRI's specific, named narrative-CV template. It structures a researcher's self-description around four defined domains rather than open-ended prose, and has been mandatory across UKRI funding applications since January 2024.
REF 2029
The next planned cycle of the UK Research Excellence Framework, currently scheduled with a submission deadline in 2028 and results in 2029, with substantial design changes following the Future Research Assessment Programme.
REF 2021
The 2021 cycle of the UK Research Excellence Framework, whose results were published in May 2022, assessing research produced between 2014 and 2020. Now superseded by REF 2029.
REF impact case study
A structured, four-to-five-page narrative submission to the UK's Research Excellence Framework (REF), describing how research carried out at the submitting institution produced a demonstrable effect, change, or benefit beyond academia.
REF (Research Excellence Framework, UK)
The UK's national exercise for assessing the quality of research in higher education institutions, used to inform the selective allocation of quality-related (QR) research funding.
Metric Tide Review: Harnessing the Metric Tide (2022)
The 2022-2023 re-examination of the original Metric Tide report, also chaired by James Wilsdon for Research England, which reviewed how responsible-metrics principles had been implemented since 2015.
Metric Tide Report
The 2015 independent review of the role of metrics in UK research assessment, commissioned by HEFCE and chaired by James Wilsdon, which introduced the concept of 'responsible metrics'.
Leiden Manifesto
A 2015 set of ten principles for the responsible use of quantitative indicators in research evaluation, authored by Hicks, Wouters, Waltman, de Rijcke and Rafols and published in Nature.
Hong Kong Principles for Assessing Researchers
A set of five principles published in 2020 to guide the assessment of researchers in ways that reward research integrity and trustworthy practice rather than productivity alone.
CoARA Agreement
The 2022 Agreement on Reforming Research Assessment that sets out ten commitments members of CoARA undertake to implement in their evaluation policies and practices, plus four enabling commitments on the coalition's own operation.
CoARA (Coalition for Advancing Research Assessment)
A multi-stakeholder coalition launched in 2022 to coordinate the reform of research assessment across institutions, funders and learned societies, primarily in Europe but with global membership.
DORA signatory
An individual or organisation that has formally endorsed the San Francisco Declaration on Research Assessment by registering its commitment on the DORA website.
DORA (San Francisco Declaration on Research Assessment)
A 2012 declaration urging that research assessment stop relying on journal-based metrics, particularly the Journal Impact Factor, as proxies for the quality of individual research outputs or researchers.
Benefit-sharing agreement
A formal arrangement specifying how the benefits arising from research, use of Traditional Knowledge, or use of biocultural resources are shared with the communities from which the knowledge or resources originate.
Community-controlled research
Community-controlled research is a research model in which authority over a project — priorities, data rights, and use of findings — sits with the community being researched, rather than with the external research team.
Indigenous community review
Indigenous community review is a review of proposed or completed research by a body the community itself designates — such as an elders' council, community research ethics committee, or governance body — assessing alignment with community priorities and cultural protocols, separate from or alongside institutional ethics review.
Cultural protocol
The established practices, norms, and expectations of an Indigenous community governing engagement with the community, its members, its knowledge, and its territories.
Free Prior and Informed Consent (FPIC)
The right of Indigenous Peoples to give or withhold consent to actions affecting them, their territories, or their resources, where consent is freely given, sought sufficiently in advance, and based on full and accessible information about the proposed activity.
Biocultural labels
Community-controlled metadata labels developed within the Local Contexts framework to communicate Indigenous Peoples' interests, provenance, and protocols associated with biocultural and genetic data and specimens.
Local Contexts (concept)
A framework and supporting infrastructure that enables Indigenous communities to manage and communicate their cultural and intellectual property and provenance through Traditional Knowledge Labels, Biocultural Labels, and institutional Notices.
Traditional Knowledge Labels
Community-controlled metadata labels that communicate Indigenous community protocols, permissions, and expectations attached to Traditional Knowledge and associated data, developed through the Local Contexts initiative.
Traditional Knowledge (TK)
Knowledge, know-how, skills, innovations, and practices developed, sustained, and passed on within Indigenous and local communities, often forming part of their cultural and spiritual identity.
Matauranga Maori
Maori knowledge: the body of knowledge, ways of knowing, and practices held by Maori communities, encompassing language, customs, environmental knowledge, history, and worldview.
Maiam nayri Wingara
An Aboriginal and Torres Strait Islander data sovereignty collective in Australia, advocating for Indigenous Data Sovereignty principles in Australian data systems, research, and government.
Te Mana Raraunga
The Maori Data Sovereignty Network in Aotearoa New Zealand, advocating for Maori rights and interests in data and articulating principles of Maori Data Sovereignty grounded in Te Tiriti o Waitangi and tikanga.
OCAP Principles
The First Nations principles of Ownership, Control, Access, and Possession, asserting that First Nations have control over data collection processes and that they own and control how this information can be used, stewarded by FNIGC.
FNIGC (First Nations Information Governance Centre)
A First Nations-led non-profit organisation in Canada that asserts data sovereignty by promoting and supporting First Nations communities in stewarding information, and is the custodian and disseminator of the OCAP Principles.
Indigenous Data Governance
The principles, structures, mechanisms, and processes through which Indigenous Peoples exercise authority over the collection, access, use, and stewardship of data about themselves, their territories, resources, and ways of life.
GIDA (Global Indigenous Data Alliance)
An international network of Indigenous-led organisations and individuals advancing Indigenous Data Sovereignty and Indigenous Data Governance globally, and the source of the CARE Principles for Indigenous Data Governance.
Indigenous Data Sovereignty
The recognition of Indigenous Peoples' inherent and inalienable rights and interests relating to the collection, ownership, application, and stewardship of data about their peoples, lifeways, territories, and resources.
CARE Principles
A set of principles for Indigenous data governance articulated by the Global Indigenous Data Alliance in 2019, encompassing Collective Benefit, Authority to Control, Responsibility, and Ethics, intended to complement the FAIR data principles with people- and purpose-oriented obligations.
Open vs closed research
The open-versus-closed distinction in research security policy separates fundamental research, which is openly published and broadly shared, from closed research — classified work, work involving controlled unclassified information, export-controlled work, or work under contractual pre-publication restrictions — each of which carries different dissemination, access, and personnel controls.
Five Eyes alliance (research context)
The intelligence-sharing partnership between Australia, Canada, New Zealand, the United Kingdom, and the United States, increasingly invoked as a coordinating channel for aligned research security policies among the five countries.
JASON Report on research security
A 2019 report by the JASON advisory group, commissioned by the US National Science Foundation, analysing risks to fundamental research from foreign government influence and recommending a transparency-and-disclosure-based response rather than restrictive measures.
CHIPS and Science Act
A 2022 United States federal statute that authorises substantial public investment in semiconductor manufacturing and scientific research, and incorporates significant research security provisions affecting federally-funded researchers and institutions.
Trusted research framework (UK)
The Trusted Research framework is UK guidance, jointly published by the National Protective Security Authority (NPSA, formerly CPNI) and the National Cyber Security Centre (NCSC), helping universities, researchers and industry partners make risk-based decisions about international research collaboration to protect sensitive research and intellectual property.
Joint appointment (foreign)
A formal appointment in which a researcher holds simultaneous positions at their primary institution and a foreign institution, each with defined roles, time commitments, and supervisory relationships.
Visiting scholar agreement
A written agreement between a host institution and a visiting researcher (and frequently their home institution) defining the terms, duration, access, intellectual property, and compliance expectations of the visit.
Deemed export
The release of controlled US technology or source code to a foreign national, even within the United States, that is treated under export control regulations as an export to the foreign national's country of nationality.
Fundamental research exemption
A provision in US export control regulations exempting basic and applied research, conducted at accredited institutions of higher education, the results of which are ordinarily published and shared broadly within the scientific community, from many export licensing requirements. Rooted in NSDD-189, it is lost when publication, foreign-national access, or dissemination is contractually restricted.
Export-controlled research
Research subject to government regulations restricting the transfer of certain items, software, technologies, or technical data to foreign persons, foreign destinations, or end uses, regardless of whether transfer occurs domestically or internationally.
Controlled unclassified information (CUI)
United States government information that requires safeguarding or dissemination controls pursuant to law, regulation, or government-wide policy, but is not classified under Executive Order 13526 or the Atomic Energy Act.
Sensitive technology
Sensitive technology is research-security shorthand for a field a national government has formally flagged as warranting extra scrutiny of who is involved in it and how its outputs and collaborations are managed. The specific areas named vary by jurisdiction and change over time, but recurring categories include advanced semiconductors, quantum information science, advanced biotechnology, advanced materials, hypersonics, and certain artificial-intelligence applications. National authorities in the United States, United Kingdom, Canada, and Australia each maintain their own published list or fr
Undue foreign influence
The exertion of pressure, control, or hidden incentives by a foreign government or its proxies that distorts research conduct, integrity, or outputs to advance the interests of that foreign state at the expense of the funding country, host institution, or scientific community.
Foreign talent recruitment programme
A formal or informal arrangement sponsored, organised, or supported by a foreign state, instrumentality, or affiliated entity to recruit researchers based abroad, typically offering compensation, resources, or other benefits in exchange for affiliations, research outputs, or services.
In-kind contribution disclosure
The disclosure of non-monetary support provided in support of research, including access to laboratories, equipment, materials, personnel, data, or computational resources, regardless of whether a financial transaction occurs.
Pending grants disclosure
The disclosure of all research proposals submitted but not yet awarded or declined at the time of application, including those under review and those awaiting submission decision.
Active grants disclosure
The disclosure of all research grants currently providing financial or in-kind support to an investigator at the time of application or progress report.
Other support (NIH format)
The NIH-specific disclosure document listing all resources made available to a researcher in support of their research endeavours, including financial support and in-kind contributions, regardless of relevance to the NIH-funded project.
Current and pending support
A standardised disclosure of all current, pending, and in-kind sources of research support available to an investigator, regardless of monetary value, funding source, or relationship to the proposed work.
Foreign component disclosure
The disclosure of any significant scientific element or segment of a federally-funded research project performed outside the awardee country, including collaborators, resources, or activities conducted abroad.
Research security policy
An institutional or governmental policy framework that establishes safeguards, disclosures, and review processes intended to protect research integrity, intellectual property, sensitive data, and national interests from undue foreign influence or unauthorised transfer.
NSPM-33
United States National Security Presidential Memorandum 33, issued January 2021, directing federal research agencies to standardise disclosure requirements for researchers receiving federal funding and to strengthen protections against foreign government interference in the US research enterprise.
ICH GCP (Good Clinical Practice)
ICH GCP is the ICH-issued international standard (current core revision: E6(R3), finalized 6 January 2025) for the ethical and scientific conduct, recording, and reporting of interventional clinical trials involving human subjects, incorporated into FDA, EMA, MHRA, PMDA, and Health Canada regulatory frameworks.
Conflict of interest disclosure
The institutional process by which investigators report significant financial interests, fiduciary relationships, and other competing interests that could directly and significantly affect the design, conduct, or reporting of their research, enabling the institution to assess and manage, reduce, or eliminate identified conflicts.
Data processor
A natural or legal person, public authority, agency or other body that processes personal data on behalf of the controller, as defined in Article 4(8) of the GDPR, only on documented instructions from the controller and bound by a written contract meeting Article 28 requirements.
Data controller
The natural or legal person, public authority, agency or other body that, alone or jointly with others, determines the purposes and means of the processing of personal data, as defined in Article 4(7) of the GDPR.
Privacy by design
The obligation under Article 25 of the GDPR for a controller to implement appropriate technical and organisational measures at the time of determination of the means of processing and at the time of processing itself in order to implement data-protection principles effectively and integrate the necessary safeguards into the processing.
Data Protection Impact Assessment (DPIA)
A documented assessment required under Article 35 of the GDPR where a type of processing is likely to result in a high risk to the rights and freedoms of natural persons, describing the processing, assessing necessity, proportionality, and risks, and identifying mitigating measures.
Right to erasure
The right under Article 17 of the GDPR for a data subject to obtain from the controller the erasure of personal data concerning them without undue delay where one of the grounds in Article 17(1) applies and no exception in Article 17(3) operates.
Data subject rights (GDPR)
The collective set of rights conferred on identifiable individuals by Chapter III of the GDPR (Articles 12-22), including the rights to be informed, of access, to rectification, to erasure, to restriction of processing, to data portability, to object, and not to be subject to solely automated decision-making with legal or similarly significant effects.
Withdrawal of consent
The exercise by a research participant of the right to revoke their consent to ongoing participation in research, after which the investigator must cease prospective collection of data or biospecimens from that participant and apply the protocol-specified handling of data already collected.
Dynamic consent
A consent model implemented via a secure digital platform that enables participants to grant, modify, or withdraw consent for specific research uses over time and to receive ongoing communication about studies that use their data or samples.
Broad consent
A regulatory consent option introduced by the 2018 revised Common Rule at §46.116(d) by which a subject consents prospectively to the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens for future unspecified studies, subject to the elements enumerated in that paragraph.
Informed consent
The voluntary agreement of a prospective research participant, or their legally authorised representative, to take part in a specific research activity, given after disclosure of the information required by the applicable regulation and free from coercion or undue influence.
HIPAA Privacy Rule
The US federal regulation at 45 CFR Parts 160 and 164 Subparts A and E that establishes national standards for the protection of individually identifiable health information held or transmitted by covered entities and their business associates, requiring authorisation, a waiver, or another permitted basis for any use or disclosure for research.
GDPR (General Data Protection Regulation)
The European Union regulation that governs the processing of personal data of individuals in the EU, requiring a lawful basis for processing, transparency to data subjects, data-minimisation, security, and accountability, with extraterritorial application where data subjects in the EU are targeted or monitored.
Confidentiality agreement (NDA)
A contract by which one or more parties agree to keep specified non-public information in confidence and to use it only for a defined purpose for a defined period, typically as a precursor to scientific discussions or contract negotiations.
Data Sharing Agreement (DSA)
A contract between two or more parties that governs the bidirectional or multilateral exchange of data, allocating responsibilities for data quality, security, lawful basis, sub-processor use, and any controller-to-controller or joint-controller obligations.
Data Use Agreement (DUA)
A contractual instrument required before a recipient may access an identifiable, restricted, or limited dataset that defines permitted uses, security obligations, re-disclosure prohibitions, destruction requirements, and breach-notification duties.
Material Transfer Agreement (MTA)
A bilateral contract governing the transfer of tangible research materials between two institutions that defines permitted uses, ownership of the original material and derivatives, publication rights, liability, and onward-transfer restrictions.
Common Rule (45 CFR 46)
The US federal policy for the protection of human subjects codified at 45 CFR Part 46 Subpart A and adopted by twenty federal departments and agencies, which applies to all non-exempt human-subjects research conducted or supported by those agencies.
IACUC (Institutional Animal Care and Use Committee)
An institutionally appointed committee constituted under the US Animal Welfare Act regulations and the PHS Policy on Humane Care and Use of Laboratory Animals that reviews and approves all proposed activities involving vertebrate animals before such activities may begin.
REC (Research Ethics Committee)
A UK or EU committee constituted to provide an independent ethical opinion on a research proposal involving human participants, their tissue, or their identifiable data before the research may lawfully commence.
IRB (Institutional Review Board)
An institutionally designated committee constituted under 45 CFR 46.107 that reviews, approves, requires modification of, or disapproves research involving human subjects before any such research may be initiated at the institution. Depending on risk level, review proceeds through one of three pathways -- exempt, expedited, or full board -- and, for FDA-regulated research, the IRB also operates under the parallel 21 CFR Part 56 regulation.
Whistleblower (research)
A person who, in good faith, raises a concern about possible research misconduct, breach of research integrity, or other serious wrongdoing in a research context. The label applies when the concern is reported through a recognised channel and the reporter would benefit from protections against retaliation.
Expression of concern
An expression of concern (EoC) is a formal editorial notice, published by a journal and attached to a specific article, alerting readers to credible, unresolved doubts about the reliability of that article's data, methods, or conclusions. It is distinct from a retraction: an EoC does not remove the article's standing in the literature, and it is issued specifically when the available evidence does not (yet) meet the bar for retraction, or when conclusive evidence cannot be obtained within a reasonable time.
Correction (corrigendum)
A formal post-publication notice that amends an error in a published article without invalidating its overall conclusions. A correction is appropriate when the error is bounded and the central findings remain reliable; a retraction is appropriate when the conclusions are unreliable.
Retraction
The formal withdrawal of a published article from the literature by the journal, with a public retraction notice explaining the reason. An article is retracted when the journal determines that its findings are unreliable due to misconduct, honest error, or other invalidating factors.
Hong Kong Principles (2020)
Five principles for assessing researchers, articulated by Moher and colleagues at the 6th World Conference on Research Integrity in Hong Kong (2019) and published in 2020, designed to incentivise responsible research practices through hiring, promotion, and funding decisions. An institution adheres to the principles if its assessment processes embody all five.
Singapore Statement on Research Integrity (2010)
A short framework statement of four principles and fourteen responsibilities for the responsible conduct of research, adopted at the 2nd World Conference on Research Integrity in Singapore in 2010. It is referenced as a foundational global statement rather than a regulatory instrument.
ENRIO
The European Network of Research Integrity Offices, a network of national research-integrity bodies and offices across European countries that share practices, case experience, and policy positions. An organisation joins ENRIO by application from a national body with a research-integrity remit.
UKRIO
The UK Research Integrity Office, an independent advisory body providing confidential, expert advice on research integrity matters to UK research organisations and researchers. A query falls within UKRIO's remit if it concerns the conduct or governance of research in a UK context.
ORI (US Office of Research Integrity)
The US federal office within the Department of Health and Human Services that oversees and monitors investigations of research misconduct involving Public Health Service-funded research. A case is in ORI's jurisdiction if PHS funds (NIH, CDC, FDA, etc.) supported the research at issue.
COPE (Committee on Publication Ethics)
An international membership organisation providing standards, guidance, and case-by-case advice on publication ethics to editors and publishers across all research disciplines. A journal or publisher is a COPE member if it adheres to the COPE Core Practices and pays the membership fee; COPE itself does not certify, audit, or guarantee the ethical quality of a member's output.
Citation cartel
A group of authors, editors, or journals that systematically cite one another's work beyond what the underlying scholarship would independently warrant, in order to inflate citation-based metrics such as the Journal Impact Factor. A citation pattern is treated as cartel-like when the citation flows between the group's members are dramatically denser than the flows to comparable non-members, assessed through bibliometric network analysis — not merely because a group of researchers cite each other often.
Tortured phrases
Unusual paraphrases of established technical terminology that result from automated synonym substitution, often used to evade plagiarism detection. A phrase is tortured when a domain reader recognises it as a mangled rendition of a standard term.
Paper mill
A commercial operation that produces fabricated or low-effort manuscripts and sells authorship slots, or that brokers acceptance of such manuscripts into journals, typically at industrial scale. A submission is described as originating from a paper mill when the underlying research was not conducted by the named authors, was fabricated to order, or was assembled from a shared, reused template — an assessment made through pattern evidence and formal investigation, not a label to attach to an individual paper on suspicion alone.
Image duplication
The undisclosed reuse of an image, or portion of an image, to represent a different experimental condition, time point, or sample. Duplication is problematic when the figure legend implies the images are distinct sources.
Image manipulation
Adjustment of a research image (gel, blot, microscopy, etc.) in a way that misrepresents the underlying data or violates journal image-integrity policies. Manipulation is problematic when it changes the conclusion a reader would draw or when it would not survive disclosure.
Coercive citation
The practice by editors or reviewers of pressuring authors to add citations that are not scientifically warranted, typically to the journal or to the reviewer's own work, as a condition of acceptance. A request is coercive when no substantive scientific reason is given and the citations would not otherwise be added.
Gift authorship
The inclusion as an author of a person who did not meet the substantive authorship criteria, typically as a courtesy, in exchange for resources, or for prestige. An authorship is a gift when removing the named person would not require any change to the manuscript.
Ghost authorship
The undisclosed substantial contribution to a manuscript by a person not listed as an author or named in the acknowledgements. A contribution is ghost-written when, by ICMJE criteria, it would have warranted authorship had it been disclosed.
Authorship dispute
An authorship dispute is a disagreement among collaborators, or between collaborators and an institution or journal, over who should be listed as an author, in what order, or whether a listed individual actually met authorship criteria — resolved through a defined procedure (co-authors, then institution, then journal editor via COPE guidance) rather than a single fixed rule, since authorship criteria themselves require judgment.
Salami slicing
Salami slicing (salami publication) is dividing the results of a single coherent study or dataset into multiple separately submitted papers, each too fragmentary to represent the work fully, without disclosing the relationship to editors or readers.
Duplicate publication
Duplicate publication is publishing an article that substantially overlaps in hypothesis, data, discussion, and conclusions with a previously published article, presented as new, without disclosure to or agreement from the editors involved.
Self-plagiarism
Reusing substantial portions of one's own previously published work in a new publication without disclosure or appropriate citation, such that a reader is led to believe the material is new. Not generally illegal or copyright infringement (absent a prior copyright transfer to a publisher) and, in the US, excluded from the federal 42 CFR Part 93 research-misconduct definition of plagiarism — but treated as a publication-ethics and institutional-policy violation by COPE, journals, and most universities.
Plagiarism
Plagiarism is presenting another person's words, ideas, data, or unpublished material as one's own without appropriate attribution. The US Office of Research Integrity (ORI) formally splits it into plagiarism of text (copying or closely paraphrasing wording without credit) and plagiarism of ideas (using someone else's uncredited intellectual contribution, even when every word is rewritten). Whether a given instance rises to a misconduct finding depends on an institutional process, not on any single tool's output.
Falsification
Manipulating research materials, equipment, processes, or data such that the research record does not accurately represent the actual results. A modification qualifies if it is undisclosed and changes the conclusions a reader would draw.
Fabrication
Making up data or results and recording or reporting them as if real (42 CFR § 93.211). A finding is fabrication if no underlying experiment, observation, or measurement actually produced the reported result — distinct from falsification, where genuine data are altered.
Research misconduct
Fabrication, falsification, or plagiarism (FFP) in proposing, performing, or reviewing research, or in reporting research results. An act qualifies if it is a significant departure from accepted practices, committed intentionally, knowingly, or recklessly, and proven by a preponderance of evidence.
Research integrity
The umbrella construct covering accurate reporting, faithful data representation, fair attribution, conflict-of-interest declaration, humane treatment of subjects, and responsible resource stewardship, distinct from research ethics and research compliance.
Synthetic benchmark
A benchmark whose evaluation items are wholly or partially generated by another model or procedural method, rather than collected from natural human-produced sources, used to probe specific capabilities or to scale evaluation cheaply.
RLHF (Reinforcement Learning from Human Feedback)
A training methodology in which a language model is fine-tuned using a reward signal derived from human preferences over pairs (or larger sets) of candidate model outputs, typically by first training a reward model and then optimising the policy against it via PPO or a related algorithm.
Constitutional AI (concept)
A training methodology in which a model is trained to align its outputs with a written set of principles ('a constitution'), with the model itself used to critique and revise candidate responses against those principles in place of direct human feedback at scale.
Prompt injection
An attack where untrusted content -- supplied directly by an attacker or planted in data the model later retrieves -- causes an AI system to follow instructions its operator didn't intend, because the model can't reliably separate trusted instructions from untrusted data.
Jailbreak (LLM)
A prompt or interaction pattern that causes a language model to bypass its safety training and produce outputs the model was tuned to refuse, such as harmful instructions, restricted content, or violations of provider policy.
Red-teaming
Adversarial testing in which people or models deliberately try to make an AI system produce harmful, unsafe, or policy-violating output, surfacing failure modes that fixed benchmarks don't test for.
AI safety case
A structured, evidence-based argument that an AI system is acceptably safe to deploy in a defined context, modelled on safety cases from established engineering disciplines (nuclear, aviation, medical devices).
AI evaluation card
A structured documentation artefact specifically describing an evaluation of an AI system, separate from the model card, including the evaluation methodology, datasets, metrics, results, and known limitations of the evaluation itself.
Reproducible AI experiment
An AI experiment for which sufficient artefacts and metadata are released (data, code, seed, environment, hyperparameters, training procedure) that an independent investigator can re-run it and obtain numerically equivalent or statistically indistinguishable results.
Open-source model (criteria)
A model meeting the criteria articulated by the Open Source Initiative's Open Source AI Definition: open data information, open code, and open weights, with each released under terms compatible with the OSI's freedoms to use, study, modify, and share.
Open weights model
A model whose trained parameter values are publicly released and downloadable, typically under a named licence, distinct from but often described as 'open' even when training data and code are not released.
Model weight licence
A model-weight licence is the specific legal document governing use, modification, and redistribution of a released set of trained AI model parameters, distinct from any licence covering the training/inference code and from separate training-data licensing terms.
Model checkpoint
A saved snapshot of a model's parameters (and optionally optimiser state) at a specific point in training, identified by a step number or version tag and serialised to a file format such as safetensors or .pt.
Model evaluation suite
A defined collection of benchmarks, tasks, and metrics, with standardised prompting and decoding rules, used to characterise a model's capabilities and behaviour across a range of dimensions.
Model fine-tune lineage
The specific portion of model lineage that records the sequence of fine-tuning operations applied to a base model: dataset, method (SFT, DPO, RLHF, LoRA), hyperparameters, and resulting checkpoint identifier.
Model lineage
The chain of provenance for a model recording its base model, the fine-tuning datasets and procedures applied, and any further derivatives, such that any deployed model can be traced back to its constituent training operations.
Inference carbon footprint
The greenhouse-gas emissions associated with serving inference requests from a deployed model, typically expressed per-request (e.g., gCO2e per query) or in aggregate (kgCO2e per month).
Training carbon footprint
The total greenhouse-gas emissions, expressed in kilograms or tonnes of CO2-equivalent, attributable to training a machine-learning model, estimated from energy consumption and the carbon intensity of the electricity supply.
Compute (FLOPs estimate)
The total floating-point operations consumed by training a model, conventionally reported as a single number (e.g., 3.0 x 10^25 FLOPs) used as a regulatory and scientific proxy for training-run scale.
Training data composition
The actual makeup of a training corpus used to build an AI model -- the mix of languages, domains, source types (licensed, scraped, user-generated, synthetic), and demographic or geographic representation it contains -- as distinct from where that data came from (see training data provenance).
Parameter count
The total number of learnable scalar weights in a machine-learning model, conventionally reported as a count (e.g., 7B = 7 x 10^9 parameters) and disclosed as a basic model metadata field.
Mixture-of-experts (MoE)
A model architecture that replaces a single dense layer with many parallel expert sub-networks and a learned router that sends each input to only a small subset of experts, decoupling total parameter count from per-token compute cost.
Frontier model
A foundation model whose capabilities meet or exceed the most advanced publicly known systems at the time of training, often defined operationally by training-compute thresholds or by performance on canonical benchmarks.
Foundation model
A large machine-learning model trained on broad data at scale and adaptable to a wide range of downstream tasks through fine-tuning, prompting, or retrieval augmentation.
MMLU benchmark
The Massive Multitask Language Understanding benchmark, a 57-subject, 15,908-question multiple-choice test spanning elementary through professional-level knowledge, used to measure and compare broad-coverage language-model knowledge.
HELM benchmark
The Holistic Evaluation of Language Models benchmark, a multi-metric framework evaluating language models across accuracy, calibration, robustness, fairness, bias, toxicity, and efficiency on a fixed set of scenarios.
BIG-bench
The Beyond the Imitation Game benchmark, a community-contributed collection of more than 200 tasks designed to probe capabilities of large language models that may be missed by narrower benchmarks.
MLCommons benchmark
A benchmark published by the MLCommons consortium for measuring AI system performance under standardised workloads, datasets, and submission rules, with the principal suites being MLPerf Training, MLPerf Inference, and MLPerf HPC.
Hugging Face Hub (concept)
A web-based platform and ecosystem for sharing machine-learning models, datasets, and demonstration applications ('Spaces'), with conventions for model cards, dataset cards, and versioned repositories.
NIST AI RMF (Risk Management Framework)
The US National Institute of Standards and Technology's voluntary framework for managing risks associated with AI systems across the AI lifecycle, structured around the functions Govern, Map, Measure, and Manage.
ISO/IEC 42001 (AI management system)
An international standard, published in 2023, specifying requirements for establishing, implementing, maintaining, and continually improving an AI Management System within an organisation, structured analogously to ISO 9001 (quality) and ISO/IEC 27001 (information security).
AI conformance assessment
A formal evaluation, conducted by the AI system provider or a notified third-party body, demonstrating that an AI system meets the applicable regulatory or standard-based requirements before being placed on the market.
AI assurance
The process of measuring, evaluating, and communicating the trustworthiness of AI systems through evidence-based mechanisms such as audits, certifications, impact assessments, and conformity declarations.
Trustworthy AI
AI systems exhibiting properties (lawful, ethical, technically robust) that warrant the trust of users, affected parties, and society, as articulated in the EU High-Level Expert Group's framework and adopted in subsequent regulation.
Responsible AI
An umbrella term covering the design, development, deployment, and governance practices intended to ensure AI systems are ethical, fair, transparent, accountable, robust, secure, and respectful of privacy.
Use card
A documentation artefact recording an intended deployment context for a model or system, including the user population, the decisions the model informs, the supervision regime, and out-of-scope uses.
Algorithm card
A documentation artefact describing the algorithmic method or family (e.g., a particular gradient-boosting estimator, a clustering algorithm) independent of any particular trained instance, including inductive biases, assumptions, complexity, and intended use cases.
Bias audit (model)
A model audit scoped specifically to fairness and discrimination criteria: measuring quantitative fairness metrics and qualitative failure-mode patterns across pre-specified groups, often to satisfy a specific legal requirement.
Model audit
A structured assessment of a machine-learning model by an independent party against pre-specified criteria covering performance, robustness, fairness, security, privacy, and conformance with stated policy.
Data statement (NLP)
A standardised description of an NLP dataset covering curation rationale, language variety, speaker and annotator demographics, speech situation, text characteristics, and recording quality.
Datasheet for datasets
A structured document accompanying a machine-learning dataset that records its motivation, composition, collection process, pre-processing, intended uses, distribution, and maintenance, modelled on electronic-component datasheets.
System card
A documentation artefact describing an AI-enabled system in its production configuration, including the constituent models, the pre- and post-processing pipeline, safety filters, monitoring, and operational guardrails.
Model card
A short, structured document accompanying a machine-learning model that records its intended use, training data, evaluation methodology, performance characteristics across population sub-groups, and known limitations.
Scientific rigour
The strict application of the scientific method to ensure unbiased and well-controlled experimental design, methodology, analysis, interpretation, and reporting of results.
Authentication of key resources
The verification, by methods appropriate to the resource type, of the identity and integrity of biological and chemical materials used in research, including cell lines, antibodies, animal models, and specialty chemicals, as required by the NIH Rigor and Reproducibility policy for resources central to a proposed study.
NIH Rigor and Reproducibility policy
The set of US National Institutes of Health policies, effective from 2016, requiring applicants and grantees to address scientific premise, scientific rigour, biological variables (including sex as a biological variable), and authentication of key biological and chemical resources in grant applications.
STROBE
STROBE (STrengthening the Reporting of OBservational studies in Epidemiology) is a 22-item reporting checklist for observational study designs — cohort, case-control, and cross-sectional — published by von Elm et al. in 2007.
PRISMA 2020
The 2020 update of the Preferred Reporting Items for Systematic reviews and Meta-Analyses, a 27-item checklist with accompanying flow diagram for reporting systematic reviews.
CONSORT 2010
The 2010 edition of the Consolidated Standards of Reporting Trials, a 25-item checklist and participant-flow diagram covering items that should be reported in any randomised controlled trial publication.
ARRIVE 2.0
ARRIVE 2.0 is the 2020 revision of the ARRIVE (Animal Research: Reporting of In Vivo Experiments) reporting guideline, restructuring the original 2010 checklist into a 10-item "Essential 10" minimum-reporting set and an 11-item "Recommended Set" for animal research manuscripts.
TOP Guidelines
The Transparency and Openness Promotion Guidelines, an eight-standard framework for journal policies covering citation, data, materials, code, design, analysis, pre-registration, and replication.
Crowdsourced replication
A coordinated effort in which many independent laboratories or teams attempt to replicate the same set of studies under pre-specified protocols, in order to estimate field-wide replicability.
Many-analysts study
A many-analysts study is a research-methods design in which multiple independent teams are given the identical dataset and research question and asked to analyse it separately, used to directly measure how much a study’s conclusions vary purely as a function of analytic choices, holding the data and question constant.
Researcher degrees of freedom
The many individually defensible decision points in designing, running, analysing and reporting a study -- exclusions, covariates, outcome measures, stopping rules -- that collectively let a researcher reach a significant result far more easily than one pre-specified analysis would allow.
Garden of forking paths
The Gelman-Loken metaphor for the implicit, data-dependent multiplicity of analytical choices made in the course of an empirical study, even by analysts not engaged in explicit p-hacking.
Forking paths
The phenomenon by which the cumulative effect of many small, data-contingent analytical choices inflates false-positive rates even when each individual choice appears defensible.
HARKing (Hypothesising After Results are Known)
HARKing is presenting a post hoc, data-driven hypothesis in a paper's Introduction as though it were the a priori hypothesis that motivated the study's design, disguising exploratory findings as confirmatory ones.
P-hacking
P-hacking is the practice of exploiting flexibility in data collection, exclusion, or analysis choices — often unconsciously — to steer a result toward statistical significance, undisclosed in the final report as if the reported analysis were the only one that had been tried.
Reproducibility audit
A systematic, post-publication examination of whether a study's published results can be obtained from its deposited data and code, typically performed by an independent analyst.
Code review (research software)
Code review for research software is a check of analysis or research software code by someone other than its author, for correctness, clarity, and reproducibility, before or alongside publication of the results it produced.
FORCE11 Software Citation Principles
A citation practice satisfies the FORCE11 Software Citation Principles (Smith, Katz & Niemeyer, 2016, PeerJ Computer Science) to the extent it meets all six: Importance, Credit and Attribution, Unique Identification, Persistence, Accessibility, and Specificity (down to the exact version used). It is a standard for citing software, not for making software FAIR -- see the separate FAIR4RS Principles.
FAIR4RS (FAIR Principles for Research Software)
Software satisfies FAIR4RS to the extent it meets the four adapted FAIR categories -- Findable, Accessible, Interoperable, Reusable -- with sub-principles rewritten for software's executable, versioned, dependency-bound nature (RDA/FORCE11/ReSA, 2022, DOI 10.15497/RDA00068). It is a standard for making software FAIR, not for citing it -- see the separate FORCE11 Software Citation Principles.
Reproducible Research Practices (RRP)
Reproducible research practices are the concrete workflows a research team adopts — version-controlled code, pinned computational environments, data and code deposit, documented pipelines, pre-registration where applicable — that make a specific published result independently checkable.
Nextflow (concept)
A workflow orchestration system based on dataflow programming with a Groovy-based domain-specific language, designed for scalable, container-native, multi-platform execution of computational pipelines.
Snakemake (concept)
A Python-based workflow management system that expresses computational pipelines as rules with explicit inputs, outputs, and shell or script bodies, and infers a directed acyclic graph (DAG) of jobs from those rules.
Container image (Docker/Singularity/Apptainer)
A packaged, immutable filesystem and configuration that contains an application together with all its dependencies, runnable identically on any compatible container engine (Docker, Podman, Singularity, Apptainer). A Singularity container specifically refers to this artifact built or run via the Singularity/Apptainer engine -- a single portable .sif image file executed without a privileged daemon.
Workflow Language (CWL/WDL)
A declarative specification language for describing multi-step computational analyses such that the steps, their inputs and outputs, and their software dependencies are portable across compatible workflow execution engines.
Computational environment
The full software and hardware context in which an analysis runs, including operating system, language runtime, library versions, configuration, environment variables, and hardware-specific dependencies (e.g., GPU drivers).
Code Availability Statement
A statement in a published article describing where the source code used in the study can be obtained, under what licence, and at what version, typically required by journal policy.
Data availability statement
A data availability statement is a mandatory manuscript section, distinct from the paper's methods, that tells readers where and under what conditions the underlying research data can be obtained.
Open data
The practice of making research data freely available for any user to access, use, modify, and share, subject only to attribution requirements, typically through deposit in a public repository under an open licence.
Open materials
The release of the non-data, non-code materials used in a study (stimuli, survey instruments, experimental protocols, training materials, intervention manuals) such that future investigators can re-implement the procedure.
Open code
The practice of releasing the source code used in a study, under an open-source licence, alongside the publication, such that any reader may inspect, reuse, and re-execute the analysis.
Robustness check
An additional analysis, supplementary to the headline result, that varies one or more analytical choices in order to demonstrate that the main conclusion is not artefactual to those choices.
Multiverse analysis
An analytical approach in which all reasonable combinations of data-processing and modelling choices are executed, producing a distribution of results that displays the impact of researcher degrees of freedom on the conclusion.
Specification curve
An analytic and visual technique that plots the estimated effect across a large set of theoretically defensible model specifications, ordered by effect size, to convey the sensitivity of the result to analytical choices.
Pre-analysis plan
A detailed, time-stamped document specifying the statistical models, variable transformations, exclusion criteria, and inference rules to be applied to a dataset, lodged before the analyst sees the outcome data.
Pre-registration
The practice of publicly recording a study's hypotheses, design, sample, and analysis plan in a time-stamped registry before data collection or (in secondary-data work) before data access, in order to distinguish pre-specified from post-hoc analyses.
Reproducibility crisis
The widely reported finding that substantial proportions of published research, particularly in biomedical, psychological, and social sciences, fail to reproduce or replicate when re-tested.
Inferential reproducibility
Inferential reproducibility is when independent investigators, working from the same or comparable data, reach qualitatively similar scientific conclusions, even where their specific analytical choices differ — the highest of the three reproducibility types proposed by Goodman, Fanelli and Ioannidis (2016).
Results reproducibility
The narrow sense in which a study's reported quantitative results can be recreated from the deposited data using the deposited analysis procedures.
Methods reproducibility
The degree to which a study's methods are reported in sufficient detail that another investigator could re-implement them, independent of whether the same numerical or empirical results would follow.
Empirical reproducibility
The ability to obtain consistent observations when an empirical procedure (laboratory, field, or measurement) is independently repeated under matched conditions.
Computational reproducibility
The narrow technical sense of reproducibility: obtaining the same numerical outputs from the same data and code, on a comparable computational environment.
Generalisability
The extent to which a study's findings extend to populations, settings, or conditions other than those directly sampled.
Robustness
The property of a finding, estimate, model, or system remaining materially unchanged under defensible variation in analytic choices, input data, or operating conditions, rather than depending on one narrow configuration.
Replicability
The ability to obtain consistent results when an independent investigator collects new data using the same study design and analysis procedures.
Reproducibility
The ability to obtain consistent computational or analytical results when the same data and analysis procedures are applied by an independent investigator using the same code and tools.
Sensitive-data handling (in DMP)
Sensitive-data handling in a data management plan is the section documenting how personal, confidential, or culturally sensitive data will be classified, secured, and governed across the research lifecycle, including its legal basis and any Indigenous data governance commitments.
Sharing commitment (in DMP)
A statement in a DMP specifying which datasets will be shared, to whom, on what licence, with what timing relative to project end, and through which infrastructure.
Retention period (in DMP)
The minimum duration for which a specified dataset will be retained after project end, expressed as a calendar period and recorded as part of the DMP's preservation commitments.
Preservation commitment (in DMP)
A statement in a DMP specifying which datasets will be preserved beyond project end, in which repository, for how long, and under what conditions.
Cost element (in DMP)
A line item in a DMP describing a financial commitment associated with data management, such as repository deposit fees, long-term storage, data steward time, or anonymisation services.
Output management plan (OMP)
A broader successor concept to the DMP that covers all categories of research output (data, software, samples, protocols, models, publications) within a single management plan.
Software management plan (SMP)
A structured plan covering how research software will be developed, documented, licensed, tested, released, and maintained over a project's lifetime, increasingly required alongside or as an extension of a DMP.
Data steward role (in DMP)
A named individual or role accountable for the day-to-day execution of a DMP's commitments, typically distinct from the principal investigator and reported in the DMP's contributor metadata.
DMP component
A discrete, reusable section of a DMP corresponding to a logical entity (project, dataset, contributor, host, cost, security_and_privacy) as modelled in the RDA DMP Common Standard.
DMP compliance check
An automated or rules-based verification that a DMP satisfies the structural and policy requirements of a specific funder, institution, or standard, typically returning a binary or itemised pass/fail outcome.
DMP assessment
The structured rating of a DMP against a published rubric to produce a comparable score across plans, used in funder evaluation, institutional benchmarking, and capacity-building.
DMP review
A formal or informal evaluation of a DMP by a peer, data steward, librarian, or funder reviewer against quality criteria such as completeness, plausibility, and policy alignment.
Living DMP
A DMP that is versioned, citable, and intended to evolve over the life of the project, with each significant change captured as a new version of the plan.
Static DMP
A DMP that is produced at a single point in time (typically grant submission) and not subsequently updated, regardless of whether the project's data realities evolve.
Active DMP
A DMP that is actively maintained, updated, and queried during project execution, typically in machine-actionable form, in contrast to a one-off document filed at proposal stage.
DMP closeout phase
The final phase of the DMP lifecycle, at or after project end, when the plan is reconciled against actual outputs, preservation commitments are confirmed, and the DMP is archived as part of the project record.
DMP active phase
The phase of the DMP lifecycle during project execution, when the plan is iteratively updated as data are actually generated, processed, and deposited -- distinct from the award's own post-award phase, which it runs concurrently with but does not track.
DMP creation phase
The phase of the DMP lifecycle covering initial drafting, typically at grant-proposal stage, when data types, volumes, and intended sharing arrangements are projected rather than known.
DMP lifecycle
The set of phases through which a Data Management Plan passes from initial drafting at proposal stage, through active project execution, to project closeout and post-project preservation.
DMP RDA-JSON-LD
A JSON-LD context and ontology rendering of the RDA DMP Common Standard, enabling DMP graphs to be expressed as linked data and merged with other research-information graphs.
ezDMP
A funder-focused DMP creation service that guides researchers through funder-specific (originally US NSF directorates') requirements and produces both narrative and structured outputs.
DataDMP
A DMP authoring and management platform developed in Germany that implements the RDA DMP Common Standard and emphasises integration with institutional research-data infrastructures.
Argos (OpenAIRE)
OpenAIRE's open-source DMP authoring service, designed from the outset around the RDA DMP Common Standard and integrated with European Open Science Cloud (EOSC) and OpenAIRE Research Graph services.
DMPonline (DCC product)
The UK Digital Curation Centre's hosted instance of the DMPRoadmap platform, providing DMP authoring for UK and international institutions against funder-specific templates.
DMPRoadmap (DMP Tool)
An open-source Ruby on Rails platform for creating, reviewing, and exporting Data Management Plans, jointly developed by the UK Digital Curation Centre and the University of California Curation Center, and deployed under different brands (notably DMPonline and DMPTool).
DMP machine-readable expression
The structured serialisation of a DMP's content in a format (JSON, JSON-LD, XML) that conforming software can parse, validate, and act upon without human re-interpretation.
DMP narrative
The human-readable prose portion of a Data Management Plan, typically organised under the headings of the applicable funder or institutional template.
DMP template
A funder-, institution-, or community-specific structured set of questions and guidance used to elicit the content of a Data Management Plan from researchers.
RDA DMP Common Standard
A community-developed application profile, maintained by the Research Data Alliance DMP Common Standards Working Group, defining the core entities, properties, and JSON schema for expressing machine-actionable DMPs.
Machine-actionable DMP (maDMP)
A machine-actionable data management plan (maDMP) is a data management plan structured so that its content — identifiers, dates, cost lines, repository and licence choices — can be read, queried, and acted on by software, most commonly by conforming to the RDA DMP Common Standard, rather than existing only as free-text narrative in a PDF or Word document.
Data Management Plan (DMP)
A Data Management Plan (DMP) is a required condition of award at most major research funders and many institutions, setting out how a project's research data will be handled across its life: data types and volume, metadata standards, storage/security, access and sharing, and long-term preservation. It is the umbrella term for a family of more specific CASRAI entries covering the DMP active phase, machine-actionable DMP (maDMP) format, climate impact statements in a DMP, and sensitive-data handling in a DMP.
Aggregator service
A service that harvests, harmonises, and re-exposes metadata and (sometimes) content from many upstream sources, providing a unified search, browse, or query interface across the aggregated corpus; canonical examples include OpenAIRE, BASE, CORE, and OpenAlex.
Data safe haven
A secure data-handling environment that allows controlled, audited access to sensitive datasets for approved research, applying technical, physical, and procedural safeguards; effectively a synonym for trusted research environment (TRE) in much current usage, though the term has older roots in NHS information governance.
Five Safes framework
A framework for the safe use of sensitive data in research, articulated by the UK Office for National Statistics, that organises controls under five dimensions: Safe People, Safe Projects, Safe Settings, Safe Data, and Safe Outputs.
Trusted research environment
A secure computing environment — typically delivered as a remote-access workspace with controlled inbound/outbound data flows — that allows accredited researchers to analyse sensitive data in situ without exporting the data, supporting privacy-preserving secondary research use.
Sensitive-data repository
A repository specifically designed to hold sensitive research data — typically personal data, health data, criminal-justice data, commercially-confidential data, or culturally-sensitive Indigenous data — with enhanced access controls, audit logging, contractual access conditions, and (often) a secure analysis environment.
Persistent data identifier
A persistent identifier (typically a DataCite DOI, but also IGSN for samples, Handle, ARK, or other PID-scheme identifier) assigned to a research dataset to support stable citation, attribution, and resolution over the long term.
Dataset landing page
The human-readable web page that a dataset's persistent identifier (typically a DataCite DOI) resolves to, presenting the dataset's title, creators, description, identifiers, dates, version history, related works, access conditions, and a link to download or request the data.
Joint Declaration of Data Citation Principles
The Joint Declaration of Data Citation Principles is the specific 2014 FORCE11 document — produced by its Data Citation Synthesis Group, synthesising earlier statements from the US National Academies, DataCite, and the CODATA-ICSTI Task Group on Data Citation — that established the eight data citation principles as the field’s reference standard.
Data citation principle
The data citation principles are the eight normative rules — importance, credit and attribution, evidence, unique identification, access, persistence, specificity and verifiability, and interoperability — set out in FORCE11’s 2014 Joint Declaration of Data Citation Principles, defining what it means to cite a dataset properly rather than merely mentioning it in prose.
Data publication platform
A platform that supports the publication of research data as a citable artefact — assigning a persistent identifier, presenting a landing page, and applying review, curation, or peer-review processes — distinct from purely depositional storage.
Domain repository
A domain repository accepts data from a defined discipline or data type and builds its deposit workflow around that field's own metadata schema, controlled vocabularies, quality-control checks and reuse conventions — GenBank and SRA for sequence data, the Protein Data Bank for macromolecular structures, ICPSR for social-science survey microdata. It is distinguished from a generalist repository by subject-specific curation rather than uniform, discipline-agnostic deposit rules. A funder requiring deposit in an established discipline repository is referring to this type.
Generalist repository
A generalist repository accepts research outputs regardless of subject area or data type, applying uniform, discipline-agnostic deposit rules — a persistent identifier (typically a DataCite DOI), basic descriptive metadata and file-format flexibility — rather than the subject-specific metadata schemas, controlled vocabularies and curation workflows a domain repository builds around one data type. Zenodo, Figshare, Dryad and OSF are instances. A generalist repository typically satisfies a funder's data-availability requirement only where no established domain repository exists for that data type.
Discipline-specific repository
A repository whose scope is bounded to a particular research discipline or sub-discipline, with curation practices, metadata schemas, and community standards tailored to that domain's data types, terminologies, and norms.
FAIRsharing (concept)
A curated, community-driven registry of databases, standards (metadata, identifiers, formats, terminologies), and data policies relevant to research data, maintained at the University of Oxford with linkage to funders, journals, and standards organisations.
Re3data (concept)
Registry of Research Data Repositories: a global registry, operated by DataCite and partner institutions, that lists research data repositories worldwide with descriptive metadata about their disciplines, content types, access conditions, and policies, helping researchers locate suitable repositories for deposit and discovery.
UK Data Service (concept)
The UK Data Service is the UK's principal social and economic data infrastructure, funded by the Economic and Social Research Council (ESRC). It holds the UK's major government and academic survey data (including Understanding Society), census microdata, a qualitative data archive and international macro-data resources, and is the UK's principal node within CESSDA. It is distinguished from a general deposit service by operating tiered access — open, safeguarded and controlled — governed by the Five Safes framework rather than a single access condition.
ICPSR (concept)
Inter-university Consortium for Political and Social Research: a consortium-membership-funded data archive based at the University of Michigan that holds and curates over 10,000 social-science research datasets, providing access to member institutions worldwide.
Harvard Dataverse (concept)
A free research-data repository operated by Harvard University on the open-source Dataverse software platform, accepting datasets from researchers worldwide, minting DataCite DOIs, and serving as the flagship instance of the global Dataverse network.
Dryad (concept)
A non-profit generalist research data repository operated by Dryad Data Inc. (in partnership with the California Digital Library) that publishes peer-reviewed-paper-linked datasets, mints DataCite DOIs, and applies curation review before publication.
Figshare (concept)
Figshare is a concrete instance of the generalist repository type rather than a category of its own: like Zenodo, Dryad or OSF it accepts research outputs across disciplines and data types under a single deposit workflow, rather than applying the subject-specific curation a domain repository builds around one data type. It was founded in 2011 and has been commercially backed by Digital Science since a January 2012 relaunch.
Zenodo (concept)
A free generalist research repository operated by CERN and developed under OpenAIRE that accepts deposits of datasets, software, publications, presentations, posters, and other research artefacts, minting DataCite DOIs and providing free preservation up to a per-record size limit.
GitHub mirror
A copy of a Git repository (or set of repositories) hosted on GitHub that tracks an upstream source repository elsewhere, typically maintained for redundancy, visibility, or community-engagement reasons rather than as the canonical primary copy.
Software Heritage archive
A non-profit international initiative based at Inria that systematically crawls, archives, and preserves the world's publicly available source code, including its full version-control history, and issues persistent identifiers (Software Hash Identifiers, SWHIDs) to every archived artefact.
Code repository
A version-controlled storage location for source code, typically operated on top of a distributed version-control system such as Git, exposing the code's full revision history, branches, tags, and (often) collaboration features such as issues, pull requests, and code review.
Tissue bank
A specific kind of biobank focused on the collection, processing, storage, and distribution of human tissue samples (typically solid tissue specimens from surgical or post-mortem sources), governed under tissue-banking regulation in the relevant jurisdiction.
Sample repository
A repository for physical research samples — geological, environmental, biological, or material — that catalogues, stores, and provides access to samples for downstream analysis, often issuing persistent identifiers (IGSN, DataCite DOI) for citation and provenance tracking.
Biorepository
A facility or organisation that collects, processes, stores, and distributes biological materials and their associated data for research, encompassing both human and non-human samples, distinguished from a 'biobank' by usage in some communities to denote broader scope or specific research projects.
Biobank
An organised collection of biological samples (typically human samples such as blood, tissue, DNA, urine) together with their associated clinical, demographic, and lifestyle data, governed for use in biomedical research.
National data infrastructure
A coordinated, nationally-scoped programme and set of services for the storage, sharing, and reuse of research data within a country, typically combining funding policy, technical infrastructure (repositories, compute, federation), training, and governance.
Data hub
A central node in a data ecosystem that aggregates, harmonises, and brokers access to data from multiple upstream sources, exposing the harmonised data to downstream consumers via curated APIs, query interfaces, or download endpoints.
Federated data infrastructure
A data infrastructure in which data, services, and access controls remain distributed across multiple independent nodes (typically operated by different organisations) but are made discoverable, queryable, and usable as a unified resource through shared protocols, vocabularies, and identity-federation.
Data warehouse
A central repository of structured data, integrated from multiple operational sources, modelled for analytical querying (typically with a star or snowflake schema), and optimised for read-heavy workloads supporting reporting and decision-making.
Data lake
A storage repository that holds large volumes of structured, semi-structured, and unstructured data in their native formats, deferring schema-on-write requirements so that data can be ingested cheaply and only structured at the time of read or analysis.
Data commons
A shared data resource — often combined with shared computing and analysis tools — governed by a community under defined access and contribution rules, designed to enable many users to use and add to the resource for collective benefit.
Data Trust
A legal and organisational structure in which a fiduciary intermediary holds, governs, and brokers access to a body of data on behalf of its contributors and beneficiaries, applying agreed terms of access, use, and accountability.
World Data System certification
World Data System certification refers to two different things depending on the period. Before 2017 the World Data System ran its own certification process for its Regular and Network Members, evaluating the operations of scientific-data centres directly. From 2017 WDS folded that certification function into the merged CoreTrustSeal scheme, formed jointly with the Data Seal of Approval. A repository described as WDS-certified on the basis of an assessment after 2017 therefore holds CoreTrustSeal, not a separate WDS credential.
CoreTrustSeal
CoreTrustSeal is the entry-level, community-run certification for trustworthy digital repositories. It emerged in 2017 from the merger of two previously separate schemes, the Data Seal of Approval (DSA) and the ICSU World Data System (WDS) certification, which combined their requirements into a single set rather than continuing to run parallel, only partly compatible certifications. It is distinguished from higher-tier schemes by scope and depth of assessment rather than by subject coverage.
Trusted digital repository
A digital repository whose mission, governance, technical infrastructure, and procedures have been independently assessed against a recognised standard (e.g. CoreTrustSeal, nestor seal, ISO 16363) and judged trustworthy to preserve digital content over the long term.
EOSC Federation
The architectural model adopted by EOSC for federating heterogeneous national, thematic, and pan-European research-data infrastructures into a single user-facing layer, with shared identity and access management, monitoring, accounting, helpdesk, and service onboarding.
EOSC Marketplace
The EOSC Marketplace is the discovery and access catalogue for services within the European Open Science Cloud (EOSC) — data sources, computing, processing, networking, security, sharing and discovery, and training services from providers across the EOSC Federation. It is not a repository or preservation service in its own right, and listing or access through the Marketplace does not by itself satisfy a funder's data-deposit requirement.
Crossref deposit XML
The XML schema family maintained by Crossref that publishers and content-registration members use to submit metadata when minting Crossref DOIs, with distinct sub-schemas for journals, books, conference proceedings, preprints, peer reviews, grants, and standards.
DataCite Metadata Schema
The XML/JSON schema (current version 4.x) maintained by the DataCite Metadata Working Group that defines the mandatory, recommended, and optional metadata properties to be supplied when registering a DOI through DataCite.
RIOXX
Research Outputs Information Exchange XML (RIOXX): a UK-originated application profile for institutional-repository metadata, layered on Dublin Core, designed to capture funder, project, and licence information for OA-compliance reporting, currently maintained at v3.0.
MODS
Metadata Object Description Schema: a Library of Congress XML schema for descriptive bibliographic metadata, designed as a richer alternative to Dublin Core and a more flexible alternative to MARC for library, archive, and repository contexts.
METS
Metadata Encoding and Transmission Standard: a Library of Congress-maintained XML schema for encoding descriptive, administrative, and structural metadata for digital library objects, providing a wrapper around content files and metadata sections.
RDF triple store
A database management system specialised for storing and querying RDF (Resource Description Framework) statements — subject-predicate-object triples (or named-graph quads) — typically with a SPARQL query engine on top.
SPARQL endpoint
An HTTP endpoint that accepts SPARQL queries (the W3C-standard query language for RDF) against an RDF dataset and returns results in standard formats (XML, JSON, CSV, TSV), implementing the SPARQL 1.1 Protocol.
Linked Data Fragments
A family of Web interfaces for publishing RDF data — ranging from data dumps through SPARQL endpoints to lightweight Triple Pattern Fragments — designed to allow clients to query large RDF datasets without overloading the server.
ResourceSync
ANSI/NISO Z39.99: a framework for synchronising resources between a source server and one or more destination servers using Web-based sitemaps with extensions for change lists, incremental updates, and push notifications.
OAI-ORE
Open Archives Initiative Object Reuse and Exchange: a set of specifications, complementary to OAI-PMH, that define how to describe and exchange aggregations of Web resources (a 'compound digital object') using standard Web Architecture and Linked Data principles.
JATS XML
Journal Article Tag Suite (ANSI/NISO Z39.96): an XML vocabulary for describing the textual content and metadata of scholarly journal articles, comprising tag sets for archival (Green), publishing (Blue), and authoring (Pumpkin) use cases.
OAI-PMH
Open Archives Initiative Protocol for Metadata Harvesting: a low-barrier HTTP/XML protocol that allows a 'data provider' system (typically a repository or CRIS) to expose its metadata records for incremental harvesting by 'service providers' (aggregators, search services, national portals).
CRIS interoperability
The capacity of CRIS systems to exchange data with each other and with adjacent systems (repositories, funders, publishers, aggregators) through shared data models, schemas, protocols, and persistent identifiers — most prominently CERIF, OAI-PMH, the OpenAIRE Guidelines, and PID-based joins.
Affiliation (CRIS)
In CRIS terminology, a time-bounded relationship between a Person record and an Organization Unit, capturing the role (employee, visitor, honorary, student), start and end dates, employment fraction, and other contextual attributes of the association.
Organization unit
In CRIS terminology, an entity representing a structural component of a research organisation — a faculty, school, department, institute, centre, lab, or research group — with its own identifier, name, parent and child relationships, type, start and end dates, and links to People, Projects, and Outputs.
Person record (CRIS)
In CRIS terminology, the entity representing an individual person involved in research — researcher, RA, PhD candidate, or other contributor — with metadata including names (preferred and historical), identifiers (ORCID iD, ISNI, local HR ID), employments, qualifications, and links to outputs, projects, and organisational units.
Project (CRIS)
In CRIS terminology, an entity representing a discrete research project with a defined scope, time period, participating people and organisations, funding source(s), and intended or actual outputs — typically the central organising entity for activity-level reporting.
Funding entity
In CRIS terminology, an entity representing a specific award or funding instance — its funder, award number, amount, currency, start and end dates, and the project and people it supports — distinct from the abstract Funder organisation and from the project itself.
Research output (CRIS)
In CRIS terminology, an entity representing a discrete product of research — a publication, dataset, software release, patent, performance, exhibition, or other recognised output — recorded with its own identifier, type, date, contributors, and relationships to people, organisations, and projects.
Research activity (CRIS)
In CRIS terminology, an entity representing a research undertaking — typically a project, programme, or organised research effort — with its own start and end dates, participants, funding sources, outputs, and host organisation, around which CRIS data accretes over the activity's lifetime.
Research entity (CRIS)
A first-class object in a CRIS data model — typically Person, Project, Publication, Organisation Unit, Funding, Equipment, or Activity — that has its own identifier, metadata schema, and relationships to other entities, and that can be managed and reported on independently.
EOSC
European Open Science Cloud: an EU-led initiative and emerging federation of research data infrastructures intended to provide European researchers with seamless, cross-border, cross-discipline access to data, services, and computational resources under FAIR and open-science principles.
OpenAIRE Nexus
An OpenAIRE-led Horizon-Europe-funded initiative (2021-2024) that bundles OpenAIRE services and tools into a coherent service portfolio for delivery through the European Open Science Cloud (EOSC), targeting researchers, content providers, research communities, funders, and policy makers.
OpenAIRE EXPLORE
The end-user-facing discovery service of OpenAIRE that allows researchers, funders, and the public to search and browse the OpenAIRE Graph by publications, datasets, software, projects, organisations, and funders.
OpenAIRE Graph
An open scholarly knowledge graph maintained by OpenAIRE that aggregates and links publications, datasets, software, projects, organisations, and people harvested from thousands of repositories, journals, and CRIS systems across Europe and globally, with deduplication, enrichment, and link inference applied.
DSpace-CRIS
An open-source extension of the DSpace repository platform, developed by 4Science and the DSpace community, that adds CRIS-style entity management for researchers, projects, organisational units, journals, and other research-information entities alongside the existing repository content.
VIVO
An open-source semantic-web application and ontology developed by the VIVO community (initially at Cornell University, now under DuraSpace/LYRASIS) that publishes information about researchers, departments, publications, grants, and courses as linked open data and as a navigable web interface.
Elements (Symplectic)
A commercial CRIS product developed by Symplectic (part of Digital Science) that automates the discovery, capture, and management of research outputs and activities for individual researchers and institutional reporting workflows, with strong emphasis on researcher-facing workflows.
Pure
A commercial CRIS product, originally developed by Atira A/S in Denmark and now owned by Elsevier, used by universities and research organisations to manage publications, projects, people, organisational units, awards, equipment, and external engagement, and to expose this information through a configurable public 'research portal'.
CERIF
Common European Research Information Format: an EU-recommended data model and exchange schema for research information, developed and maintained by euroCRIS, that defines core entities (Person, Project, Publication, OrgUnit, Funding, Equipment) and the relationships among them with explicit role-and-time semantics.
RIM
Research Information Management: the organisational practice and the supporting systems and processes by which a university or research organisation collects, manages, and uses information about its research activities, encompassing both the technical CRIS layer and the people and policies around it.
CRIS
Current Research Information System: an enterprise-class software system that aggregates, stores, and publishes information about a research organisation's activities — its researchers, publications, projects, funding, equipment, collaborations, and outputs — and exposes that information to internal management and external reporting consumers.
Identifier crosswalk
A mapping or correspondence table between identifiers in different schemes that refer to the same real-world entity, allowing a system holding one scheme's identifier to find the equivalent identifier in another scheme.
DOI tombstone
A tombstone page served at the resolved URL of a DOI after the underlying resource has been withdrawn, providing withdrawal information and metadata while ensuring the DOI itself continues to resolve.
DOI suffix
The portion of a DOI after the first forward slash, assigned by the registrant within their issued DOI prefix, identifying the specific object; can contain any Unicode characters with the case-insensitivity rule applied during comparison.
DOI prefix
The leading portion of a DOI before the first forward slash, of the form 10.NNNN, where 10 is the directory indicator for the DOI system under the Handle System and NNNN is a string assigned by a DOI Registration Agency to a specific registrant.
Tombstone page
A landing page served at a persistent identifier's resolved URL after the underlying resource has been withdrawn, retracted, or made permanently unavailable, providing metadata describing the former resource, the reason for its absence, and (where applicable) a successor identifier.
Identifier syntax
The formal grammar that constrains the textual form of identifiers in a given scheme — what character sets, lengths, prefixes, separators, and check digits are allowed — typically expressed as a regular expression or BNF grammar in the scheme's specification.
Identifier scheme
A named, formally-defined system for constructing, issuing, and resolving identifiers, typically defined by a syntax, an authority structure (who can mint), a metadata schema, and a resolution policy.
PID resolution
The process by which a persistent identifier is looked up through its scheme's resolution infrastructure and returned either as an HTTP redirect to the current resource location or as metadata about the resource, depending on the request and the scheme's policy.
PID minting
The act of generating a new persistent identifier in a registered scheme and registering it, with associated metadata, at the appropriate PID provider so that it becomes resolvable and discoverable.
PID metadata
The descriptive metadata registered with a PID provider at the time of identifier minting, and updated thereafter, that describes the identified entity — its title, creators, dates, types, related identifiers, and so on — and that is exposed by the provider's APIs alongside the identifier itself.
Funder ID
An identifier from the Crossref Funder Registry (formerly FundRef), a curated, open registry of funder names and identifiers used by publishers to tag deposited works with the funders that supported them.
Curated org record (ROR)
An entry in the ROR registry that has been reviewed and approved by ROR curators against the published inclusion criteria, carrying a stable ROR ID and metadata including names, types, country, geographic location, parent/child/related/successor/predecessor relationships, and crosswalks.
ROR Curation
The community-driven process by which the Research Organization Registry receives, reviews, and acts on requests to add new organisations, update existing records, merge duplicates, or split records, governed by a published curation policy and managed by ROR's curation team.
PID graph
A graph data structure in which persistent identifiers (ORCID iDs, DOIs, ROR IDs, RAiDs, IGSNs, etc.) are nodes and the metadata relationships among them (creator-of, affiliated-with, funded-by, derived-from) are edges, allowing federated queries across multiple PID-provider registries.
PID consortium
A grouping of PID-provider member organisations, typically at national or regional scale, formed to share infrastructure, contracts, and support around one or more persistent identifier schemes such as DOI, ORCID, or ROR.
PID provider
An organisation that issues persistent identifiers from one or more PID schemes, operates (or contracts) the resolution infrastructure for those identifiers, and makes long-term commitments about the maintenance of the identifiers and their metadata.
Resolution service
A networked service that, given a persistent identifier, returns the current location of the named resource (typically by HTTP redirect) or returns its metadata, allowing the identifier itself to remain stable while the resource's location changes.
Persistent URL
An HTTP(S) URL that an issuing organisation commits to maintain unchanged over time so that links continue to resolve correctly even as the underlying resource is moved, renamed, or migrated between systems.
w3id.org PURL
A persistent URL hosted on the w3id.org domain by the W3C Permanent Identifier Community Group, providing a community-maintained redirect under https://w3id.org/<namespace> to ontologies, vocabularies, and standards documents that may move between hosting providers over time.
PURL
Persistent Uniform Resource Locator, a URL maintained by a PURL service that redirects (typically via HTTP 302) to the current location of the named resource, allowing the persistent URL to remain stable as the underlying resource location changes.
URN
Uniform Resource Name (RFC 8141), a URI of the form urn:NID:NSS where NID is a registered Namespace Identifier and NSS is the namespace-specific string, intended to denote a resource persistently and independently of any particular resolution mechanism.
Handle
An identifier in the CNRI Handle System (RFC 3650-3652), of the form Prefix/Suffix (e.g. 20.500.12345/abcd), resolved by a distributed system of Handle servers that map the identifier to one or more current URLs or other typed data values.
ARK inflection rules
A convention of the ARK identifier scheme whereby appending a single '?' to an ARK URL yields the object's descriptive metadata and appending '??' yields a 'commitment statement' describing the issuing institution's persistence policy for that ARK.
ARK
Archival Resource Key, a persistent identifier scheme for information objects of any type, in the form ark:/NAAN/Name[Qualifier], where NAAN is a Name Assigning Authority Number and Name is the local identifier; resolvable through any cooperating ARK resolver.
UUID
Universally Unique Identifier (RFC 4122 / ISO/IEC 9834-8), a 128-bit value rendered as 32 hexadecimal digits in 8-4-4-4-12 grouping, generated such that the probability of collision across independent generators is negligible.
GUID
A GUID is Microsoft's term for a 128-bit globally unique identifier that is structurally identical to a Variant-2 UUID (RFC 4122); in research-information contexts it is also used loosely for any system-generated opaque identifier that is NOT a registered persistent identifier such as a DOI, ORCID iD, or ROR ID.
PIDINST
A persistent identifier for a research instrument, minted under a DataCite DOI or Handle, conforming to the PIDINST metadata schema developed by an RDA Working Group, that enables citation of and provenance back to the instrument that produced data.
IGSN
International Geo Sample Number, a globally unique persistent identifier for physical samples (geological, environmental, biological) that supports tracking and citation of the sample through subsequent analyses, publications, and derived data.
RAiD
Research Activity Identifier, an ISO-standardised persistent identifier (ISO 23527) for a research project or activity, providing a stable handle around which related people, organisations, outputs, instruments, and funding can be linked over the activity's lifetime.
DataCite consortium
A national or regional grouping of DataCite member organisations led by a 'Consortium Lead' that holds the master agreement with DataCite, allowing member institutions to mint DOIs under a shared fee structure and shared support model.
DataCite DOI
A DOI registered through DataCite, the DOI Registration Agency that serves research data, software, samples, dissertations, instruments, and other non-article research outputs, accompanied by metadata in the DataCite Metadata Schema.
Crossref DOI
A DOI registered through Crossref, the DOI Registration Agency for scholarly publications (journals, books, conference proceedings, preprints, peer reviews, grants), accompanied by metadata deposited in Crossref's XML schema.
DOI
Digital Object Identifier (ISO 26324), a persistent identifier for an entity (typically a research output) consisting of a prefix assigned to a registrant by a DOI Registration Agency and a suffix assigned by the registrant, resolvable as an HTTPS URI under https://doi.org/.
ISNI
International Standard Name Identifier (ISO 27729), a 16-digit identifier for the public identity of a person or organisation involved in the creation, production, management, or distribution of content, administered by the ISNI International Agency.
GRID
Global Research Identifier Database: a retired legacy identifier and registry of research organisations originally operated by Digital Science, frozen to new records in 2021 and superseded by ROR, which was seeded from a deduplicated GRID snapshot and carries a crosswalk back to legacy GRID identifiers.
ROR ID
A persistent identifier for research organisations issued by the Research Organization Registry (ROR), expressed as an HTTPS URI of the form https://ror.org/0xxxxxxxx where the final nine-character path component is a base32-encoded random value with a check digit.
ORCID education
An affiliation item in an ORCID record asserting that the iD holder undertook formal, degree-granting study at a named organisation, including degree or qualification, department, start and end dates, and the organisation's disambiguated identifier.
ORCID employment
An affiliation item in an ORCID record asserting that the iD holder is or was employed by a named organisation, with start date, optional end date, department, role title, and the organisation's disambiguated identifier (typically a ROR ID).
ORCID work assertion
A claim, recorded in an ORCID record, that a particular research output (journal article, book chapter, dataset, software, etc.) is associated with the iD holder, with metadata fields including title, type, publication year, external identifiers (DOI, ISBN, PMID), and contributor role.
ORCID record permissions
The three-level visibility setting attached to each item in an ORCID record — public, trusted parties only, or private — which the record holder applies individually to names, employments, works, fundings, and other assertions.
ORCID consortium
A national or regional grouping of ORCID member organisations that share a single membership agreement and a lead organisation, in order to coordinate ORCID adoption, training, and policy advocacy within a country or region.
ORCID API
The two-tier REST application programming interface (Public API and Member API) operated by ORCID that allows systems to read public ORCID record data and, with researcher authorisation, to read restricted data or write trusted-party assertions to records.
ORCID record
The structured profile maintained at orcid.org for an individual ORCID iD, containing assertions about the person's names, employments, educations, funding, works, peer reviews, and service activities, each with a visibility setting and a source attribution.
ORCID iD
A 16-digit persistent identifier, expressed as four hyphen-separated blocks (e.g. 0000-0002-1825-0097) and resolvable as an HTTPS URI under https://orcid.org/, that uniquely identifies an individual researcher across publications, datasets, grants, employments, and peer-review activity.
Container image (as output)
A reproducibility-supporting container image (Docker, Singularity/Apptainer, OCI) packaging a complete computational environment — operating system, dependencies, software, configuration — deposited in a container registry with a persistent identifier and treated as a citable research output.
Workflow (as output)
A computational workflow — a structured description of a multi-step analysis pipeline, expressed in a workflow language (Nextflow, Snakemake, CWL, WDL) or platform-specific format, with dependencies, parameters, and provenance — deposited in a repository with a persistent identifier as a citable research output.
Model (as output)
A trained machine-learning model — including its weights, architecture, training metadata, and accompanying model card — deposited in a model repository (Hugging Face, Zenodo) with a persistent identifier, treated as a citable scholarly output independent of any paper that may describe it.
Dataset (as output)
A research dataset deposited in a FAIR-aligned repository with a persistent identifier (typically a DataCite DOI), metadata, licence, and access conditions, treated as a citable scholarly output in its own right rather than only as supporting material for a paper.
Translation (work)
A scholarly publication that renders a previously-published work from one natural language into another, with the translator(s) credited and the original work referenced, treated as a distinct research output for purposes of credit, citation, and intellectual contribution.
White paper
An authoritative document — published by a government, industry body, or research organisation — that provides analysis and recommendations on a specific issue, typically intended to inform a policy decision, state the issuing body's position, or guide implementation, with a more formal and longer treatment than a policy brief and a policy/decision-maker audience rather than a technical-practitioner one.
Technical report
A scholarly document published by a research-performing organisation (a laboratory, government agency, or company) reporting technical work in detail — full methods, data, and often extensive appendices — typically not peer-reviewed in the journal sense but vetted internally, bearing an institutional report number for citation, and aimed primarily at a technical-practitioner audience rather than a policy or decision-maker one.
Policy brief
A short document — typically 2-8 pages — synthesising research evidence for a policy-maker audience, with explicit policy implications or recommendations, structured for accessibility rather than for academic readers, and issued by research institutions, NGOs, or government-aligned bodies.
Discussion paper
A scholarly document — published by institutions, learned societies, think-tanks, or government bodies — that presents an argued perspective, policy proposal, or position for community deliberation, sometimes formally inviting a structured response, rather than reporting original empirical research findings for the first time.
Working paper
A scholarly document circulated through an institutional working-paper series (such as NBER, IZA, or CEPR), an academic website, or a repository, presenting research in progress for community feedback prior to — or sometimes instead of — formal peer review and journal publication. The defining feature is dissemination through an established institutional series with its own numbering and identity, distinct from a one-off self-posted draft.
Conference abstract
A short summary of research findings or planned work submitted to a conference for selection of oral or poster presentation, published in a conference abstract book or supplement, citable as a publication but typically lacking full peer review of the underlying research.
Conference proceeding
A peer-reviewed scholarly publication appearing in the published proceedings of a conference, workshop, or symposium, typically representing original research presented at the meeting, with a citation that includes the conference name, date, and proceedings location.
Null result publication
A peer-reviewed publication reporting that a study's primary analysis returned results statistically consistent with no effect (or, in equivalence/non-inferiority designs, consistent with no clinically meaningful difference), explicitly framed and interpreted as informative about the absence of effect.
Negative result paper
A peer-reviewed publication whose primary finding is that a tested hypothesis was not supported, an intervention did not produce the predicted effect, or an expected relationship was not observed, framed as a contribution to evidence rather than as a failure.
Electronic Lab Notebook (ELN)
An electronic lab notebook (ELN) is software that replaces the paper laboratory notebook as the primary record of experimental work. An entry qualifies as ELN record-keeping when it is timestamped and attributed at the moment of creation, when edits are versioned rather than overwritten (so a full history remains retrievable), and when the record is structured enough to be searched, exported in a non-proprietary format, and -- increasingly -- assigned a DOI and deposited as a citable research output.
Living systematic review
A systematic review that is continuously updated — typically by re-running the registered search, screening newly-identified studies, and incorporating eligible ones into the synthesis — with explicit triggers for major versus minor updates and a publicly maintained version history.
Living review
A review article — systematic or otherwise — that is continuously or periodically updated as new evidence emerges, maintained as a single citable resource with version history rather than being supplanted by a fresh standalone review on each update.
Narrative review
A literature review that synthesises existing scholarship on a topic through expert judgement and discursive argument, without using the pre-specified protocols, reproducible search strategies, or formal quality-appraisal frameworks that characterise systematic and scoping reviews. Search is selective and purposive (focused on what the author judges to be the significant work in the field) rather than exhaustive, and the output is typically a conceptual synthesis or argued perspective rather than a protocol-governed answer to a narrowly defined question.
Meta-analysis
A quantitative synthesis of effect estimates from multiple studies on a common question, using statistical methods (typically random-effects models) to compute a pooled estimate with confidence interval and heterogeneity diagnostics.
Scoping review
A literature review that maps the breadth and nature of evidence on a broad topic — characterising what exists, where, and in what form — using systematic search methods but without typically appraising study quality or synthesising effect estimates, following PRISMA-ScR.
Systematic review
A literature review that follows a pre-specified, registered protocol to systematically identify, appraise, and synthesise all evidence relevant to a focused research question, using reproducible methods for searching, screening, data extraction, and quality assessment.
Case report
A peer-reviewed publication describing in detail one or a small number of individual cases — typically clinical, sometimes legal or social — for educational, hypothesis-generating, or rare-presentation-documenting purposes, structured according to discipline-specific reporting standards (e.g., CARE guidelines for clinical cases).
Brief report
A peer-reviewed publication format for compact original research findings, particularly in clinical and applied fields, with tight word and figure limits, used for results that warrant rapid or focused communication of a single result or small study.
Short communication
A peer-reviewed publication format for compact original research findings, typically with word limits below those of full original articles (2,000-3,000 words) but greater than letters or research letters, used for results meriting publication but not requiring full-article treatment.
Research letter
A short, peer-reviewed publication presenting original research findings in a compressed format — typically under 1,000 words with limited tables/figures and abbreviated methods — used by a journal as a formally categorised publication type for results that warrant rapid or concise communication rather than a full-length original article.
Letter to editor
A short scholarly communication submitted to a journal in response to a previously-published article in that journal, raising questions, corrections, alternative interpretations, or additional evidence, typically published with a reply from the original authors.
Commentary
A short scholarly publication that responds to, contextualises, or critiques other recently-published work or a current development in the field, presenting an argued perspective rather than original empirical findings.
Methods paper
A peer-reviewed publication whose primary subject is a research methodology — a new analytic technique, experimental procedure, instrumentation approach, or computational method — described in sufficient detail for independent reuse by other researchers, sometimes with worked examples or benchmarking against existing techniques. The method itself, not a specific planned study using it, is the paper's contribution.
Protocol paper
A peer-reviewed publication that fully describes the methodology of a planned or ongoing research study (clinical trial, systematic review, cohort study, laboratory protocol) prior to or alongside execution, sufficient to enable replication and to fix the methods against post-hoc revision.
Software paper
A peer-reviewed scholarly publication whose primary subject is a research software package — describing its functionality, architecture, dependencies, testing, and intended uses — published in a venue that issues this format (JOSS, SoftwareX), accompanying the software release in a citable repository.
Data paper
A data paper (or data descriptor) is a peer-reviewed publication describing a dataset — its collection methods, structure, and quality — rather than presenting novel scientific analysis or findings from that data, giving citable scholarly credit for the work of producing a reusable dataset.
Replication study
A replication study is a new study that repeats the design and procedures of a prior study, using an independently collected sample, to test whether the original result recurs.
Stage-2 results paper
The completed registered report submitted after data collection, containing the results, discussion, and any exploratory (clearly labelled) analyses beyond the pre-registered plan, peer-reviewed only for adherence to the Stage 1 protocol and quality of conclusions — not for the direction of findings.
Stage-1 protocol
The introduction, methods, and analysis plan submitted as the first of two stages of a registered report, peer-reviewed for theoretical motivation, design adequacy, and analytic appropriateness, and (if accepted) granted in-principle acceptance for publication.
Registered Report
A publication format in which peer review of a study's rationale, hypotheses, and methodology happens before data collection (or before outcomes are known). If reviewers judge the protocol sound, the journal grants in-principle acceptance (IPA) — a binding editorial commitment to publish the completed study once it is executed as approved, regardless of whether the results are statistically significant or match the original hypotheses.
Version of record (VoR)
The final, formally published version of a scholarly work as issued by the publisher — including typesetting, pagination, copy-editing, and an assigned bibliographic citation — which is the canonical citable form of the work absent subsequent corrections.
Postprint
The author-accepted version of a manuscript after peer review and editorial decision of acceptance but before publisher typesetting and final layout — synonymous with 'author-accepted manuscript' (AAM) in many usage contexts.
Preprint
A scholarly manuscript posted to a public preprint server prior to formal peer review and journal publication, made openly accessible, citable via a persistent identifier (typically a DOI), and bearing a clearly identified version state.
Mentoring agreement
A mentoring agreement is a short written document, agreed jointly by a mentor and mentee at the start of a formal mentoring relationship, that records the pair's shared expectations: meeting frequency, the goals of the relationship, confidentiality boundaries, and how either party can end the arrangement. It is what turns an informal pairing into a documented one — a relationship without any such record, however regular, is informal mentoring rather than an agreement-governed one.
Sponsorship relationship
A career-development relationship in which a senior researcher (sponsor) uses their social and political capital actively on behalf of a more junior researcher's career advancement — through nomination, recommendation, public advocacy, or introductions — going beyond the advisory dyad of mentorship.
Two-page narrative
A two-page narrative is the short, fixed-length format convention used by R4RI and comparable narrative-CV schemes: applicants complete their contribution narrative within a hard length constraint (commonly rendered as roughly two sides of the template, though the operative limit is usually set as a word count by the specific funding opportunity) rather than writing an open-ended CV.
Diversity statement
A document — typically 1-2 pages — in which a researcher articulates their contributions to and plans for promoting diversity, equity, and inclusion in research and teaching, increasingly required in US faculty job applications and some research-funding contexts.
Teaching statement
A teaching statement is a US academic job-market document, typically 1-2 pages, in which a candidate for a faculty position describes their pedagogical approach: teaching philosophy, methods, and evidence of impact on student learning. It is a companion document to the research statement, addressing teaching rather than research, and some institutions require a separate, related teaching-diversity statement alongside it.
Research statement
A research statement is a US academic job-market document, typically 1-3 pages, in which a candidate for a faculty or tenure-track position describes their research program: past achievements framed as a coherent intellectual narrative and, critically, a forward-looking agenda for what they plan to investigate next. It is written for a hiring or tenure committee, not for a funder, and is distinct from both a publication list and from funder narrative-CV formats like R4RI.
Personal statement
A short narrative section within a researcher's CV, biosketch, or grant application, in which the researcher explains -- in their own voice -- why they are qualified to undertake the proposed work, their career trajectory, and any contextual factors relevant to how the application should be assessed.
Biosketch
A short, structured biographical document used in US federal research grant applications (most notably NIH and NSF) summarising a researcher's qualifications, positions, contributions, and a curated subset of their outputs, in a tightly page-limited format.
Narrative CV
A narrative CV is a researcher self-description format built around free-text, qualitative narrative sections (contribution to knowledge, to colleagues, to the wider community) rather than a chronological list of publications, positions, and metrics. It is the general practice/movement in responsible research assessment; specific implementations of it include the UK's R4RI, the Dutch Recognition & Rewards programme's narrative formats, narrative sections within the NIH Biosketch, and the Swiss National Science Foundation's format.
Resume for Researchers (R4RI)
A structured narrative-CV format developed by the Royal Society (UK) which asks researchers to describe their contributions under four headings: contributions to knowledge generation; contributions to development of individuals; contributions to the wider research community; and contributions to broader society.
Career interruption
A near-synonym of career break used by some funders (notably the Royal Society and ERC) to denote a period of reduced or absent research activity due to defined personal circumstances; sometimes also used to include reduced-fraction working (less than full-time) rather than complete absence.
Career break
A documented absence from active research work of at least three months' duration arising from parental leave, caring responsibilities, illness, disability, military service, or other personal circumstances, recognised by funders as extending early-career-researcher eligibility windows pro-rata.
Supervisor (doctoral)
The academic appointed by an institution to guide a doctoral candidate's research, with formal responsibility for the academic quality of supervision, progress monitoring, ethical conduct of the research, and recommendation for examination, in accordance with the institution's doctoral regulations.
Sponsor (career)
A senior researcher or leader who actively advocates for a more junior researcher's career advancement — nominating them for opportunities, opening doors, vouching for them in evaluations — distinct from a mentor (who advises) by the action of using social and political capital on the mentee's behalf.
Mentee
A researcher (typically more junior) who receives career, intellectual, or professional guidance from a mentor in a defined or recognised mentoring relationship, distinct from a supervisee in that the relationship lacks formal evaluative authority.
Mentor
An experienced researcher who provides career, intellectual, or professional guidance to a less experienced researcher (the mentee), distinct from a formal supervisor in that the mentoring relationship is typically chosen rather than assigned, may cross institutional lines, and does not carry formal evaluative authority.
Co-investigator
A named investigator on a research grant, contract, or protocol other than the lead PI, who contributes substantive scientific expertise and shares responsibility for portions of the work, typically with a defined role in the proposal and a named budget allocation.
Principal investigator (PI)
The named individual on a research grant, contract, or protocol who is formally accountable for the scientific direction, ethical conduct, financial stewardship, and reporting of the research, typically holding a continuing academic or research-leader position at the host institution.
Research associate
A research associate is a fixed-term, PI-directed contract researcher role, typically held by someone with a completed or near-complete PhD, employed on a specific grant or project rather than in a permanent post. The term is a formal grading category in UK higher education (distinct from, and one grade above, research assistant) and functions in grant administration primarily as a staffing/costing category rather than a strict career-stage label.
Research assistant
A staff member employed to provide research support — data collection, literature search, analysis, administration — to a research project under the direction of a more senior researcher, typically without independent design authority over the project.
Master’s-level researcher
A researcher whose highest qualification is a master's degree (MSc, MA, MRes, MPhil, etc.) engaged in research work in a role appropriate to that qualification, distinct from doctoral candidates and from those with bachelor's-only qualifications.
Pre-doctoral researcher
A researcher engaged in research work prior to commencing a doctoral programme, typically in roles such as research assistant, lab technician, or research associate at the master's-equivalent level, where the position involves substantive research rather than only support tasks.
Doctoral candidate
A student enrolled in a doctoral degree programme (PhD, DPhil, EdD, EngD, MD, etc.) who is undertaking original research toward a thesis or equivalent capstone, under the supervision of one or more academic supervisors.
Postdoctoral researcher
A person who holds a doctoral degree (PhD or equivalent research/clinical doctorate) and is engaged in a temporary, full-time, mentored research or scholarly-training position -- commonly one to five years, most often two to four -- undertaken specifically to build an independent publication record, grant history, and research skillset before moving into a permanent faculty, industry, or other independent research role. What separates a postdoc from an ordinary staff researcher is this combination: doctorate already in hand, a defined non-permanent term, and an explicit developmental/mentored purpose rather than an open-ended production role.
Senior researcher
A researcher at an advanced career stage (typically 15+ years post-PhD) with a sustained record of independent research leadership, mentoring of multiple researchers to independence, substantial competitive funding history, and recognised disciplinary contribution.
Mid-career researcher
A mid-career researcher is a career-stage category, used mainly by funders and institutions to scope eligibility for specific grant schemes, denoting a researcher who is no longer eligible for early-career-researcher (ECR) or first-grant schemes but who is not yet in a senior or established-leader category. There is no single field-wide definition of the stage's boundaries; each funder that uses the category sets its own eligibility window, most commonly expressed as a range of years since PhD award.
Early-career researcher (ECR)
A researcher within a defined number of years (typically 5-8) of their first doctoral degree, or — for researchers without a doctorate — within an equivalent period of full-time research practice, accounting for career breaks and part-time work.
Co-corresponding author convention
The practice of designating two or more authors as jointly corresponding on a published work, each taking responsibility for post-publication communication, editorial liaison, and queries about the work, with all co-corresponding authors typically marked by a symbol in the byline.
Reviewer role typology
A controlled vocabulary for distinguishing types of peer-review activity — e.g., manuscript peer reviewer, grant reviewer, conference programme committee member, data peer reviewer, software peer reviewer, reproducibility reviewer — used to give differentiated credit for review work.
“Degree of contribution” qualifier (lead/equal/supporting)
The optional CRediT modifier that may be applied to any of the 14 CRediT roles to indicate the relative magnitude of a contributor's input: 'lead' (primary responsibility), 'equal' (co-equal with one or more others), or 'supporting' (contributed but did not lead).
Conceptualization lead vs supporting
Under the CRediT taxonomy, the distinction between the contributor who led the formulation of the overarching research question, aims, or ideas for a project (Conceptualization: lead) and those who contributed to but did not originate the conceptual framing (Conceptualization: supporting).
Funding-acquisition lead vs supporting
Under the CRediT taxonomy, the distinction between the contributor who led the funding acquisition for a research project (typically the named principal investigator on the grant) and contributors who supported but did not lead the proposal (co-investigators, named collaborators).
Methodology consultant
A specialist who provides substantive advice on research methodology — study design, sampling, instrument selection, analytic strategy, or implementation approach — to a research project on which they are not a primary investigator.
Data validator
A contributor whose role is to check the integrity, accuracy, completeness, and conformance to schema of a dataset before its use, deposit, or publication — including range checks, plausibility tests, cross-source comparison, and metadata verification.
Reproducibility reviewer
A reviewer whose specific role is to verify that the computational, analytic, or experimental procedures reported in a manuscript can be re-executed by another party using the provided code, data, and instructions, distinct from a content peer reviewer.
Domain expert advisor
A subject-matter expert (clinical, technical, policy, lived-experience) who advises a research project on questions within their expertise — typically through formal advisory boards, steering committees, or focused consultations — distinct from co-authorship or formal investigator roles.
Indigenous-knowledge holder contribution
Substantive contribution to research from Indigenous knowledge keepers, elders, or community members who hold and share traditional knowledge, ecological observations, language, or cultural expertise relevant to the research, in accordance with CARE Principles for Indigenous Data Governance.
Citizen-scientist contribution
Substantive contribution to research by members of the public participating as volunteers in data collection, classification, observation, analysis, or interpretation, distinct from being a study subject and distinct from professional research staff.
Patient-partner contribution (PPI)
Substantive input from patients, service users, carers, or members of the public into the design, conduct, analysis, or dissemination of health and care research — as partners in the research process rather than as study participants.
Lab leadership (supervision extension)
Substantive oversight of a research team or laboratory by a principal investigator or group leader, including scientific direction, resource allocation, mentoring, and accountability for research conduct, recognised under CRediT 'Supervision' and increasingly through narrative-CV team-leadership categories.
Equipment provision (resources extension)
The provision of specialised equipment, reagents, materials, animals, samples, or computational infrastructure that materially enabled a research output, captured under CRediT 'Resources' or in acknowledgements when the contribution does not include intellectual input on the work itself.
Open-software contribution
The development, documentation, packaging, testing, or maintenance of research software released under an open-source licence, including authoring new code, contributing to existing projects, releasing reusable libraries, or operating long-term maintenance.
Open-data contribution
The substantive work of preparing, documenting, depositing, and maintaining a research dataset in a FAIR-aligned open repository under a permissive licence, distinct from the original data collection.
Medical writer contribution
Professional writing assistance to drafting a biomedical manuscript by a person whose primary role is writing rather than research — including drafting, restructuring, language polishing, and preparing submission — disclosed transparently per Good Publication Practice (GPP) guidelines.
Statistical consultancy
Substantive statistical advice or analysis provided by a statistician to a research project — including study design, sample-size calculation, analytic plan, model selection, code, or interpretation — that materially shapes the research's quantitative findings.
Translator contribution
The intellectual work of converting a scholarly work from one natural language to another while preserving meaning, register, and technical accuracy, including the translator's own scholarly judgement on terminology, idiom, and disciplinary convention.
Mentorship contribution
Career, intellectual, or methodological guidance provided to a researcher (typically more junior) that shapes the conduct or development of their research, distinct from formal supervision (which has institutional authority) and from co-authorship (which requires direct work on the output).
Pre-submission feedback contribution
Substantive intellectual input — comments, critique, suggested revisions, or methodological advice — provided by a colleague on a draft manuscript or proposal before it is submitted to a journal or funder, recognised in acknowledgements rather than as authorship.
Editorial contribution
Intellectual work performed in the role of editor for a scholarly venue — including soliciting submissions, selecting reviewers, synthesising review feedback, making accept/reject/revise decisions, and shaping the venue's scope and standards.
Peer reviewer contribution
The intellectual labour of evaluating a scholarly submission's validity, originality, significance, and clarity for a journal, funder, or conference, distinct from authorship and from editorial decision-making.
Technical staff contribution
Substantive technical work — laboratory technique, instrument operation, data acquisition, sample preparation, software engineering, or facility operation — performed by research-support staff (technicians, engineers, lab managers) that materially enables a research output.
Non-author contributor
An individual who made a meaningful contribution to a research output but is not listed in the author byline, typically because the contribution is partial (does not meet all authorship criteria) or because they declined authorship.
Acknowledged contributor
An individual whose contribution to a research output is recognised in the acknowledgements section rather than by authorship, typically because their contribution does not meet all four ICMJE authorship criteria but is substantive enough to warrant named credit.
Model versioning
The practice of identifying a specific revision of an AI model by name, version number, release date, or content hash, sufficient to uniquely distinguish it from earlier or later revisions that may behave differently on the same input.
Inference
The process of generating outputs from a trained AI model in response to inputs at runtime, distinct from training (which updates model parameters); for LLMs, inference is the production of completions from prompts.
Fine-tuning
The process of further training a pre-trained foundation model on a smaller, task-specific or domain-specific dataset, updating some or all parameters, to specialise its behaviour while retaining general capability.
Retrieval-augmented generation (RAG)
An AI architecture in which an LLM is augmented at inference time with documents retrieved from an external corpus (often via vector similarity search), so that the model's outputs are grounded in retrieved evidence rather than relying solely on parametric knowledge.
AI in literature search
The use of AI-powered discovery and retrieval tools (e.g. Elicit, Consensus, Scite, Undermind, Semantic Scholar's semantic-search features, or a general-purpose LLM queried directly) to identify, rank, filter, or synthesise relevant scholarly literature, as distinct from using AI to condense text a researcher has already found.
AI in qualitative coding
The use of an LLM or other AI tool to assign codes, categories, or themes to qualitative data -- interview transcripts, open-ended survey responses, field notes -- either as a first-pass triage that a human coder then reviews, or, more controversially, as a sole or primary coder alongside or instead of a human.
AI image generation
The underlying technical capability of a generative AI system to produce novel images from a text prompt or other input (text-to-image synthesis), as distinct from the separate question of whether a specific generated image is being used appropriately -- disclosed and illustrative, versus undisclosed and presented as a real research result (see synthetic image).
AI summarisation
The use of a generative AI system to condense a longer text -- a paper, dataset documentation, meeting notes, or a set of retrieved sources -- into a shorter form, typically preserving what the tool judges to be the key points while omitting detail, qualification, and nuance.
AI translation
The use of an AI system -- most commonly a neural machine translation model or a general-purpose LLM used for translation -- to convert text from one natural language into another, applied to manuscripts, participant-facing materials, survey instruments, or informed consent documents.
AI in editorial decisions
The use of AI or generative AI tools by a journal editor in the process of managing or deciding on a submitted manuscript -- including drafting decision letters, summarising reviewer reports, or (in the position no major publisher currently permits) using AI output to make or substantially inform the accept/reject/revise judgment itself.
AI in peer review
The use of generative AI by a peer reviewer in the process of evaluating a submitted manuscript, most consequentially by uploading manuscript text (in whole or part) to a third-party AI tool -- an act that most major publishers now explicitly prohibit because the manuscript is confidential, unpublished material.
Generative-AI disclosure statement
A dedicated section in a manuscript — typically headed 'Use of Generative AI' or similar — that consolidates all disclosures of AI tool use across the work, including tools used, versions, sections affected, and the human authors' verification process.
AI co-authorship rejection (ICMJE 2023)
The 2023 update to ICMJE's Recommendations stating explicitly that chatbots and generative AI systems cannot be listed as authors because they cannot satisfy any of the four ICMJE authorship criteria, in particular the requirement to be accountable for the work and to approve the version to be published.
Author responsibility (for AI use)
The principle that human authors retain full responsibility for the accuracy, integrity, originality, ethical sourcing, and lack of plagiarism of all content in a scholarly work, regardless of which portions were drafted, suggested, or generated by an AI tool.
Acknowledgement (vs authorship for AI)
The convention, codified by ICMJE and COPE (2023), that AI tool use must be disclosed in the methods or acknowledgements section of a scholarly work rather than via the author byline or CRediT contributor list, because AI cannot satisfy authorship's accountability requirements.
Training data provenance
A documented record of where an AI model's training data came from -- source, licensing basis, collection method, and chain of custody -- as distinct from what the data actually contains (see training data composition) and from labelling the origin of a specific piece of AI-generated output (see AI provenance / C2PA).
Data leakage (training)
Contamination of an AI model's training corpus with data that should have remained held out for evaluation -- most consequentially, public benchmark questions, answers, or test sets -- which inflates the model's reported performance on that benchmark relative to its true generalisation ability.
AI fairness
A contested normative criterion for evaluating whether an AI system's treatment of different groups or individuals is acceptable -- not a single measurable property, but a family of mutually incompatible formal definitions (e.g. demographic parity, equalised odds, predictive parity/calibration) among which a system generally cannot satisfy more than one simultaneously whenever base rates differ across groups.
AI bias
A measurable, descriptive property of an AI system's outputs: a systematic skew that produces unjustified differences in accuracy, treatment, or representation across groups, tasks, or contexts, arising from training data composition, algorithmic design choices, or deployment context -- distinct from ai-fairness, a contested normative judgment about which disparities are acceptable.
Detection tool (AI-generated)
A software system that estimates the probability that a given piece of content -- typically text, sometimes images -- was produced by a generative AI system, usually by statistically analysing patterns in the content itself without any cooperation from or signal embedded by the original generator, as distinct from watermarking, which requires generator-side cooperation at the point of creation.
AI provenance
The general practice of tracking and documenting the origin of AI-related content across the AI pipeline -- covering both an AI system's inputs (see training data provenance) and the origin of a specific generated output (which model, version, and generation event produced it) -- as distinct from any single concrete technical mechanism for asserting that origin.
Watermarking (AI output)
The embedding of a statistical, cryptographic, or visible signal into AI-generated content at the moment of generation, allowing later identification of that content as AI-produced -- a proactive, generator-side mechanism, as distinct from a detection tool that infers AI origin after the fact without the generator's cooperation.
Synthetic image
An AI-generated or otherwise artificially fabricated image presented within a research context -- most consequentially, an image standing in for genuine experimental or observational data in a publication (e.g. microscopy, blots, clinical imaging) without disclosure, which most journals now treat as a serious integrity breach distinct from disclosed, clearly-labelled illustrative use.
Synthetic data
Data generated artificially -- via simulation, statistical modelling, or a generative AI system -- to mimic the statistical properties of real data without any of its records corresponding to a real individual observation, used for privacy-preserving research, method testing, training-set augmentation, or teaching.
Hallucination
An output from a generative AI system that is presented confidently and fluently but is factually incorrect, fabricated, or unsupported by the input data or any verifiable source — including invented citations, non-existent authors, false statistics, and incorrect quotations.
System prompt
A instruction set or context injected by an AI platform or application developer before any end-user input, configuring a model's persona, constraints, or behaviour for an entire session or deployment -- typically invisible to and not authored by the end user, as distinct from prompt engineering, the user's own iterative practice of crafting their own input.
Prompt engineering
The practice of designing, refining, and structuring the input text (prompt) given to a generative AI system to elicit a specific desired output -- including techniques such as role assignment, few-shot examples, chain-of-thought scaffolding, and output-format specification -- considered here specifically for its reproducibility implications in research work, as distinct from system prompt, the separate, developer-set instruction layer a deploying application configures independently of the end user.
Generative AI
Artificial intelligence systems whose primary output is novel content (text, images, audio, video, code, or structured data) produced by sampling from a learned distribution, as distinct from discriminative AI systems whose output is a classification, score, or decision over existing inputs.
Large language model (LLM)
A neural-network model trained on large text corpora using self-supervised next-token prediction (or analogous objective), with parameter counts typically in the billions, capable of generating coherent text and performing a broad range of natural-language tasks without task-specific training.
AI tool disclosure
A statement within a scholarly work that identifies which generative AI tools were used, the version, the scope of use (e.g., language editing, code generation, figure creation), and which sections were affected, sufficient for a reader to assess the AI's role.
AI as author
The disallowed practice of listing a generative AI system (e.g., ChatGPT, Claude) in the author byline or contributor list of a scholarly work, on the rationale that AI cannot meet authorship criteria requiring accountability, agreement, and the capacity to take public responsibility.
AI-generated content
Text, images, code, or other artefacts produced substantively by a generative AI system in response to a prompt, where the AI is the proximate source of the content rather than a tool refining human-authored material.
AI-assisted writing
The use of a generative AI tool by a human author to draft, edit, paraphrase, summarise, or stylistically revise text where the human retains final editorial control and authorship responsibility.
Submission fee
Charge levied on author(s) upon submission of a manuscript to a journal, sometimes referred to as administrative or handling charges.
Subject repository
"Subject repository" is a synonym for domain repository: a repository organised by discipline or subject area rather than institutional affiliation. See the canonical domain repository entry for the full treatment.
Sharing
The extent to which a work, such as a publication, dataset, or other research output, can be discovered, accessed, and reused by people other than its author(s).
Reuse license
A set of terms and conditions that facilitates the reuse of published information.
Researcher webpage
A webpage featuring a researcher's profile, which possibly may also provide links to their publications.
Research funder
An organisation providing financial support for research activity. May be governmental, charitable or commercial. Such an organisation determines how funding is allocated for research and may have requirements for how the results of research are published, including open access (OA).
Repository
Repositories preserve, manage, and provide access to many types of digital materials in a variety of formats.
Read only
Online content or a system that can be viewed or downloaded by a user but not edited, modified, or deleted by them.
Pure gold journal
A pure gold journal is a scholarly journal in which every published article is open access from the moment of publication, with no subscription-only content or paywalled archive, distinguishing it from a hybrid journal (which mixes subscription and paid-open articles in the same title).
Publishing agreement
A legal contract between publisher and author(s) to publish written material by the author(s). This may involve a single written work, or a series of works.
Publish
A broad process or system that involves, at minimum, scholarship and writing, certification (most commonly via peer review), registration (commonly formal publishing in a journal or some other version of record), dissemination (awareness, making accessible, distribution), and archiving.
Publication permission
The circumstances under which copyright material may be used and where permission must be sought from the copyright holder.
Press embargo
A request by a source that the information or news provided by that source not be published until a certain date or certain conditions have been met.
Pre-print
"Pre-print" is a hyphenated spelling variant of preprint: a manuscript draft shared before formal peer review. See the canonical preprint entry for the full treatment.
Post-print
A manuscript draft after it has been peer reviewed.
Page charge
One of a number of supplementary charges imposed by some journals to cover the cost of publishing, and charged in addition to article processing charges (APCs).
Open archive
A repository that is compliant with the Open Archives Initiative Protocol for Metadata Harvesting (OAI-PMH) and therefore facilitates the sharing of metadata for a variety of purposes, most notably the compilation tasks performed by aggregator databases.
Open access
Making peer reviewed scholarly content freely available via the Internet.
Open access mandate
A policy requiring publication of research in an open access format. The research author's institution, research funder or government may impose a mandate.
Open access journal
A journal that makes its articles immediately available online to the reader without financial, legal, or technical barriers other than those inseparable from gaining access to the internet itself. All the articles in the journal are available open access.
Licence
In scholarly publishing, the legal terms under which a work — an article, dataset, preprint, or other output — may be reused, redistributed, or built upon, typically expressed as a Creative Commons licence attached at the point of publication or deposit.
Institutional webpage
A page hosted on an institution's own website, such as a departmental staff listing, research-group page, or faculty profile on the university's domain, that documents an author's affiliation with that institution.
Institutional repository
An online, digital collection of research outputs (see Repository) that are connected by their affiliation with a specific institution. Institutional repositories are most commonly associated with universities and other academic organisations, and so the contents of a single institutional repository may therefore cover a range of disciplines. An institutional repository may often be managed as part of a wider suite of services supporting scholarly communication, Open Access and Open Education.
Hybrid journal
A subscription journal in which some of the articles are open access at point of publication. This status typically requires the payment of a specific publication fee (also called an article processing charge or APC) to the publisher.
Green open access
A type of open access where a version of a publication is freely available via an institutional or subject repository, or other web-accessible digital archive, that is compliant with the Open Archives Initiative Protocol for Metadata Harvesting (OAI-PMH).
Gold open access
The publisher version of a publication is immediately and permanently freely available for anyone with internet access to read or download from the publisher site at the point of publication.
Free to read
Free to read (gratis open access) means the full text of a published article can be read online at no cost to the reader, with no requirement that it also carry an open license permitting reuse — a narrower guarantee than open access under a Creative Commons license.
Fee waiver
Full or partial waiver for article processing charges (APCs) offered by some publishers to authors based in selected developing countries or low-income economies.
Embargo
Restriction of access to the content of a copy of a work for a defined period of time.
Document version
During the development of a document there are usually several iterations of the work. There are periods along the authoring process that can be identified as a specific identifiable point where the work can be identified as a specific version of the work.
Deposit
The action of uploading a digital copy of a work into a digital repository or similar service by the author(s) or their agent, together with metadata that, ideally, supports FAIR principles (Findable; Accessible; Interoperable; Re-usable).
Date of start of embargo
The date that an embargo comes into force and from whence the length of the embargo period is counted. The start date of a period during which access to a document or file or record is restricted. This could be: “date of online publication” or “publication date” or “date of online availability” or “date of deposit”. This date and the triggering event to start the embargo are defined by the copyright holder or the repository governance or the law.
Date of publication
The date the work is made available to the public by a publisher, including by means of an electronic retrieval system; the earliest date the final version of record is made available on the publisher's website.
Date of online publication
The date that a work was first published on an online publishing platform. This may be before or after the publication date of the print version.
Date of online availability
The date that a work was first made available online. This may be before or after the publication date.
Date of first open access
The date that a work was first made publicly available on an Open Access (OA) basis. For example, this could be the date that a copy of the work was made live (discoverable) on an OA basis on a repository or may be triggered when an embargo period expires. It could also be when an work was available on a publisher web site, or elsewhere, on an OA basis.
Date of end of embargo
Date after which deposited items become available to read and download on the web. The date of the last day of an embargo period.
Date of deposit
Date on which a copy of a version of a work and its metadata is deposited in a repository (or equivalent). Not necessarily the same as the date that the work becomes discoverable. A period of time may elapse after deposit, but before the record is made publicly available during which the record may be checked for accuracy and compliance by repository administration staff and an embargo may be applied.
Date of compliant deposit
Date on which a copy of a version of a work and its metadata is in a repository (or equivalent) and meets the requirements of a mandate, policy, piece of legislation etc.
Date of acceptance
The day on which the publisher or evaluation institution or committee confirms formally that the article has been received from the author and no substantial changes to the content are required. Also the date on which the publisher tells the author that the article will be published and the article is ready to be processed for publication.
Copyright
A legal right created by the law of a country that grants the creator of an original work exclusive rights for its use and distribution.
Copyright transfer agreement
A legal document containing provisions for the conveyance of full or partial copyright from the rights owner to another party.
Closed access
Restricting access to Internet content via a paid subscription; is often called a paywall.
Born open access
Commercial or non-profit publishers established for the sole purpose of publishing Open Access (OA) journals. They normally make use of the Creative Commons Attribution License for their publications. Authors usually retain their copyrights and users are needed to acknowledge and cite the authors in future references.
Author accepted manuscript
The version of a manuscript that has been peer reviewed and accepted by a publisher for publication, but has not yet been typeset, copy-edited, or assigned final pagination.
Article publication charge
An article publication charge (APC) is a fee levied by a publisher on an author, their funder, or their institution to publish an article, most commonly to fund open-access publication under an open license.
Article processing charge
Fee paid to journals to publish an article as open access.
Access
The continued, available for use, ongoing usability of a digital resource, retaining all qualities of authenticity, accuracy and functionality deemed to be essential for the purposes the digital material was created and/or acquired for. Users who have access can retrieve, manipulate, copy, and store copies on a wide range of hard drives and external devices.
Reviewer Roles
Review Types
Research Classification
Person ID Types
Output Types
Output ID Types
Org ID Types
Licence Types
Field of Application
Contributor Roles
Working Paper
Website
Web Address
Visual Artwork
Video Recording
Translation
Topic
Theatric
Text Interview
Test
Technical Standard
Team Capacity
Supervised Student Publication
Standard or Policy
Spin Off Company
Sound Design
Signature
Short Fiction
Set Design
Script
Reviewer
Reviewer Suggestion
Review
Review Subject
Research-based Degree Supervision
Research Tool
Research Technique
Research Location
Research Dataset
Research Dataset Contributor
Report
Registered Copyright
Reference
Radio-TV Program
Promotion-Tenure Assessment
Project
Project Risk
Project Partner
Project Participant
Project Overview
Project Milestone
Project Info
Project HQP Training
Project Budget
Program Developed
Professional Leave of Absence
Professional Designation
Principal Investigator
Phone Number
Personal Leave of Absence
Person Info
Performance Art
Patent
Other Study
Online Resource
Office Held
Non-research Presentation
Non HE Employment
Newspaper Article
Newsletter Article
Musical Performance
Musical Composition
Mentoring
Membership
Manual
Mailing Address
Magazine Article
Litigation
Light Design
License
Language Competency
Journal Reviewing-Refereeing
Journal Issue
Journal Article
Internal OA Cost Application
Institutional Review
In-kind Funding
HE Institution Employment
Grant
Grant Application Assessment
Graduate Examination
Funds Request
Expert Witness
Exhibition Catalogue
Event Participation
Event Administration
Encyclopedia Entry
Employee Supervision
Editorial
Edited Book
E-mail
Distinction
Dissertation
Disclosure
Dictionary Entry
Degree
Data Set
Curatorial-Museum Exhibition