CASRAI Dictionary - CASRAI (2026)
Version v2026.1, CC-BY 4.0

Generative AI use and disclosure - CASRAI (2026)
Vocabulary for human–AI collaboration on research outputs and the disclosure required.
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CRediT extensions and adjacent contribution vocabularies - CASRAI (2026)
Extending CRediT to acknowledged contributors, peer reviewers, technical staff.
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Mentorship, training, and career stages - CASRAI (2026)
Career-stage terms underpinning narrative CVs and mentorship recognition.
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Research outputs (expanded) - CASRAI (2026)
Modern outputs taxonomy beyond articles — preprints, datasets, models, protocols, more.
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Scholarly publishing - CASRAI (2026)
Vocabulary bridging dictionary entries to the scholarly-literature and editorial ecosystem.
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The persistent identifier ecosystem - CASRAI (2026)
ORCID, ROR, RAiD, IGSN, PIDINST, DOIs — the PID landscape.
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Research-information systems and integration - CASRAI (2026)
CRIS, RIM, CERIF, OpenAIRE, JATS — vendor-neutral terms.
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Research data infrastructure - CASRAI (2026)
Trusted repositories, EOSC, biobanks, data trusts, federated infrastructure.
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Machine-actionable data management plans - CASRAI (2026)
RDA DMP Common Standard and the ecosystem of maDMP tools.
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Reproducibility and computational research - CASRAI (2026)
Workflows, containers, FAIR4RS, Software Heritage, computational reproducibility.
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AI and ML research outputs - CASRAI (2026)
Model cards, system cards, datasheets, benchmarks, evaluation suites.
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Research integrity and misconduct - CASRAI (2026)
FFP, paper mills, retractions, COPE / ORI / UKRIO frameworks.
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Compliance and regulatory - CASRAI (2026)
IRB/REC, IACUC, GDPR, MTAs, EAR/ITAR — the compliance lattice.
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Research security - CASRAI (2026)
NSPM-33, foreign component, DURC, dual-use research.
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Indigenous data governance — CARE principles - CASRAI (2026)
CARE alongside FAIR; TK labels, FPIC, GIDA.
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Clinical research and clinical trials - CASRAI (2026)
Clinical trial protocols, IND/IDE filings, case report forms, and HIPAA research-disclosure rules.
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Consent, privacy, and regulatory disclosure - CASRAI (2026)
GDPR/data-protection sections, the EU AI Act, informed-consent waivers, financial-interest and covered-species disclosure rules.
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Responsible research assessment - CASRAI (2026)
DORA, COARA, R4RI, narrative CVs.
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Knowledge equity, diversity, global-south inclusion - CASRAI (2026)
Diamond OA, APC waivers, Plan S, bibliodiversity.
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Engagement, impact, and SDG alignment - CASRAI (2026)
REF Impact, PPI, citizen science, SDGs.
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Sustainable research and laboratory operations - CASRAI (2026)
LEAF, My Green Lab, carbon footprint of research.
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Funding lifecycle and financial vocabulary - CASRAI (2026)
Calls, NCE, indirect costs, biosketch, current & pending.
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Grants management and sponsor compliance - CASRAI (2026)
Award administration vocabulary — supplements, FFATA reporting, warranties and covenants, funder-specific terms.
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Research lifecycle stages and project metadata - CASRAI (2026)
RAiD-anchored project lifecycle, phases, milestones.
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Technology transfer and commercialization - CASRAI (2026)
Patents, licensing agreements, IP disclosures, and university–industry deal terms.
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Life sciences and biology - CASRAI (2026)
Vocabulary anchored in biological and life-sciences research disciplines.
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Earth, environmental, and marine sciences - CASRAI (2026)
Vocabulary anchored in earth, environmental, and marine-science research disciplines.
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Space and planetary sciences - CASRAI (2026)
Vocabulary anchored in space and planetary-science research disciplines.
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Physical sciences and materials - CASRAI (2026)
Vocabulary anchored in physical-science and materials-research disciplines.
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Conceptualization - CASRAI (2026)
Ideas; formulation or evolution of overarching research goals and aims.
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Methodology - CASRAI (2026)
Development or design of methodology; creation of models.
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Software - CASRAI (2026)
Programming, software development; designing computer programs; implementation of the computer code and supporting algorithms; testing of existing code components.
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Validation - CASRAI (2026)
Verification, whether as a part of the activity or separate, of the overall replication/reproducibility of results/experiments and other research outputs.
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Formal analysis - CASRAI (2026)
Application of statistical, mathematical, computational, or other formal techniques to analyse or synthesise study data.
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Investigation - CASRAI (2026)
Conducting a research and investigation process, specifically performing the experiments, or data/evidence collection.
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Resources - CASRAI (2026)
Provision of study materials, reagents, materials, patients, laboratory samples, animals, instrumentation, computing resources, or other analysis tools.
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Data curation - CASRAI (2026)
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.
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Writing — original draft - CASRAI (2026)
Preparation, creation and/or presentation of the published work, specifically writing the initial draft (including substantive translation).
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Writing — review & editing - CASRAI (2026)
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.
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Visualization - CASRAI (2026)
Preparation, creation and/or presentation of the published work, specifically visualization / data presentation.
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Supervision - CASRAI (2026)
Oversight and leadership responsibility for the research activity planning and execution, including mentorship external to the core team.
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Project administration - CASRAI (2026)
Management and coordination responsibility for the research activity planning and execution.
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Funding acquisition - CASRAI (2026)
Acquisition of the financial support for the project leading to this publication.
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CONSORT Flow Diagram for Randomised Trials - CASRAI (2026)
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Human Cell Atlas (HCA) - CASRAI (2026)
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.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Reverse Causality - CASRAI (2026)
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.
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Vivli (concept) - CASRAI (2026)
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.
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PharmGKB (Now ClinPGx): The Pharmacogenomics Knowledgebase - CASRAI (2026)
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.
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Authorised Prescriber (AP) Scheme (TGA, Australia) - CASRAI (2026)
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.
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Office of the Gene Technology Regulator (OGTR) - CASRAI (2026)
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.
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Composite Endpoint - CASRAI (2026)
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.
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Health Canada Special Access Program (SAP) - CASRAI (2026)
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.
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Negative Predictive Value (NPV) - CASRAI (2026)
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.
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Number Needed to Harm (NNH) - CASRAI (2026)
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.
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Ensembl (Genome Browser) - CASRAI (2026)
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).
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Odds Ratio (OR) - CASRAI (2026)
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.
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STRING (Protein-Protein Interaction Networks) - CASRAI (2026)
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.
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Reactome - CASRAI (2026)
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.
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Relative Risk (RR) - CASRAI (2026)
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.
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KEGG (Kyoto Encyclopedia of Genes and Genomes) - CASRAI (2026)
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.
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UK Stem Cell Bank (UKSCB) - CASRAI (2026)
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.
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ChEMBL - CASRAI (2026)
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.
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Health Technology Assessment (HTA) - CASRAI (2026)
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.
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Cost-Utility Analysis (CUA) - CASRAI (2026)
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.
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Cost-Effectiveness Analysis (CEA) - CASRAI (2026)
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.
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BioSample - CASRAI (2026)
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.
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ENCODE (Encyclopedia of DNA Elements) - CASRAI (2026)
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.
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Human Fertilisation and Embryology Authority (HFEA) - CASRAI (2026)
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.
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Human Fertilisation and Embryology Act (HFE Act) - CASRAI (2026)
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.
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ICER (Incremental Cost-Effectiveness Ratio) - CASRAI (2026)
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.
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QALY (Quality-Adjusted Life Year) - CASRAI (2026)
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.
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Pending IRG Review - CASRAI (2026)
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.
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Hierarchy of Controls (NIOSH) - CASRAI (2026)
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.
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Person-Time - CASRAI (2026)
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.
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Case Fatality Rate (CFR) - CASRAI (2026)
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.
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Attack Rate - CASRAI (2026)
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.
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CCRC (Certified Clinical Research Coordinator) - CASRAI (2026)
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.
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CCRP (Certified Clinical Research Professional) - CASRAI (2026)
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.
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CIP (Certified IRB Professional) - CASRAI (2026)
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.
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dbSNP - CASRAI (2026)
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.
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Sequence Read Archive (SRA) - CASRAI (2026)
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.
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1000 Genomes Project - CASRAI (2026)
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.
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All of Us Research Program - CASRAI (2026)
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.
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The Cancer Genome Atlas (TCGA) - CASRAI (2026)
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.
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gnomAD (Genome Aggregation Database) - CASRAI (2026)
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.
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Positive Predictive Value (PPV) - CASRAI (2026)
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.
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StarLIMS - CASRAI (2026)
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.
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jamovi - CASRAI (2026)
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.
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Labguru - CASRAI (2026)
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.
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Citavi - CASRAI (2026)
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.
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Limited IRB Review - CASRAI (2026)
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.
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IRB Administrator - CASRAI (2026)
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.
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Comparative Effectiveness Research (CER) - CASRAI (2026)
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).
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CPIA (Certified Professional in IACUC Administration) - CASRAI (2026)
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.
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GISAID - CASRAI (2026)
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.
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ClinVar - CASRAI (2026)
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.
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Genomic Data Commons (GDC) - CASRAI (2026)
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.
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Mental Capacity Act 2005: The Consultee Model for Research - CASRAI (2026)
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.
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Strategy for Patient-Oriented Research (SPOR) - CASRAI (2026)
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.
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ResearchNet (CIHR) - CASRAI (2026)
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.
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Special Access Scheme (SAS) - CASRAI (2026)
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.
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Cincinnati Radiation Experiments - CASRAI (2026)
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.
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Nuremberg Doctors’ Trial - CASRAI (2026)
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.
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Jesse Gelsinger Case - CASRAI (2026)
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.
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Genome Canada - CASRAI (2026)
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.
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Declaration of Geneva - CASRAI (2026)
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.
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Therapeutic Misconception - CASRAI (2026)
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.
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Guatemala Syphilis Experiments - CASRAI (2026)
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.
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Cooperative Research Centres (CRC) Program - CASRAI (2026)
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.
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ARC LIEF (Linkage Infrastructure, Equipment and Facilities) - CASRAI (2026)
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.
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National Clinical Trials Governance Framework (NCTGF) - CASRAI (2026)
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.
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NHMRC Partnership Project - CASRAI (2026)
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.
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Ethics Review Manager (ERM) - CASRAI (2026)
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.
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NCRIS (National Collaborative Research Infrastructure Strategy) - CASRAI (2026)
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.
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Willowbrook Hepatitis Study - CASRAI (2026)
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.
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Research Councils UK (RCUK) - CASRAI (2026)
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.
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National Mutual Acceptance (NMA) Scheme - CASRAI (2026)
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.
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ARC Centres of Excellence - CASRAI (2026)
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.
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HREA (Human Research Ethics Application) - CASRAI (2026)
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.
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ARC DECRA (Discovery Early Career Researcher Award) - CASRAI (2026)
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.
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PHIPA (Personal Health Information Protection Act) - CASRAI (2026)
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.
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Best Evidence Synthesis (BES) - CASRAI (2026)
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.
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Meta-Synthesis - CASRAI (2026)
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.
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Health Data Research UK (HDR UK) - CASRAI (2026)
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.
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Health and Care Research Wales (HCRW) - CASRAI (2026)
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).
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CCAC (Canadian Council on Animal Care) - CASRAI (2026)
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).
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Health Research Authority (HRA) - CASRAI (2026)
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.
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ANZCCART (Australian & New Zealand Council for the Care of Animals in Research and Teaching) - CASRAI (2026)
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.
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Omitted Variable Bias - CASRAI (2026)
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.
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ICH Q8 (Pharmaceutical Development) - CASRAI (2026)
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.
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Amendment Clauses: Why Verbal Changes to a Vendor Contract Usually Don’t Count - CASRAI (2026)
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.
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Entire Agreement (Integration) Clauses in Vendor Contracts - CASRAI (2026)
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.
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Waiver Clause: Why Excusing One Breach Doesn’t Waive Future Enforcement Rights - CASRAI (2026)
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).
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Non-Solicitation Clauses in Vendor Contracts - CASRAI (2026)
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.
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Notice Requirements in Vendor Contracts: How and Where Notice Must Be Delivered - CASRAI (2026)
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.
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Severability Clauses in Vendor Contracts - CASRAI (2026)
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.
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Cure Period: How Long a Vendor Gets to Fix a Breach Before Termination - CASRAI (2026)
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.
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MFN (Most-Favored-Nation) Pricing Clauses in Vendor Contracts - CASRAI (2026)
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.
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Consignment Inventory Pricing: How a Consignment Fee Structure Actually Works - CASRAI (2026)
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.
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Minimum Advertised Price (MAP) Policy in Medical Distribution - CASRAI (2026)
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.
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Supplier Diversity Certifications: MBE, WBE, VOSB and What They Mean for Institutional Buyers - CASRAI (2026)
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.
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BBB Rating Scale: What A+ Actually Means - CASRAI (2026)
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.
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DSCSA Compliance: What It Requires of a Distributor - CASRAI (2026)
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.
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FDA Registered Establishment: What It Means and Doesn’t Mean - CASRAI (2026)
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.
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Backhaul Freight - CASRAI (2026)
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.
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Contract Price vs. List Price on a Distributor Price List - CASRAI (2026)
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.
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Cross-Docking - CASRAI (2026)
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.
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Chargeback in Medical Distribution Pricing - CASRAI (2026)
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.
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Electronic Data Interchange (EDI) in Medical Supply Procurement - CASRAI (2026)
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.
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Net-30 Payment Terms and Vendor Account Verification - CASRAI (2026)
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.
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Backorder vs. Discontinued: Reading Medical Supply Vendor Status Codes - CASRAI (2026)
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.
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Par Level (Inventory) in Clinical Supply Management - CASRAI (2026)
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.
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Group Purchasing Organization (GPO) - CASRAI (2026)
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.
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Minimum Order Quantity (MOQ) in Medical Supply Procurement - CASRAI (2026)
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.
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Vendor-Managed Inventory (VMI) - CASRAI (2026)
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.
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Total Cost of Ownership (TCO) in Medical Equipment Purchasing - CASRAI (2026)
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.
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Newcastle-Ottawa Scale (NOS) - CASRAI (2026)
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).
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Digital Curation Centre (DCC) - CASRAI (2026)
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.
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STTR (Small Business Technology Transfer) - CASRAI (2026)
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.
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SNIP (Source Normalized Impact per Paper) - CASRAI (2026)
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.
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ChiCTR (Chinese Clinical Trial Registry) - CASRAI (2026)
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.
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CTRI (Clinical Trials Registry – India) - CASRAI (2026)
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.
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FDA De Novo Classification - CASRAI (2026)
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).
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FDA Breakthrough Device Designation - CASRAI (2026)
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.
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U01 (NIH Research Project Cooperative Agreement) - CASRAI (2026)
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.
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K99/R00 (Pathway to Independence Award) - CASRAI (2026)
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.
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Phase 4 Trial - CASRAI (2026)
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.
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Phase 3 Trial - CASRAI (2026)
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.
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Phase 2 Trial - CASRAI (2026)
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.
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Phase 0 Trial - CASRAI (2026)
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.
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R01 (NIH Research Project Grant) - CASRAI (2026)
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.
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FDA Fast Track Designation - CASRAI (2026)
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.
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NSF CAREER Award (Faculty Early Career Development Program) - CASRAI (2026)
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.
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Plant Patent - CASRAI (2026)
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.
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Defined Daily Dose (DDD) - CASRAI (2026)
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.
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New Chemical Entity (NCE) - CASRAI (2026)
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.
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New Molecular Entity (NME) - CASRAI (2026)
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.
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Observer Bias - CASRAI (2026)
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.
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Regression to the Mean - CASRAI (2026)
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.
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Standardized Infection Ratio (SIR) - CASRAI (2026)
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.
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Beyond-Use Date (BUD) - CASRAI (2026)
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.
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EU AI Act - CASRAI (2026)
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.
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CSE (Council of Science Editors) - CASRAI (2026)
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.
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Research Support Services - CASRAI (2026)
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.
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Request for Proposal (RFP) - CASRAI (2026)
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.
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Jussieu Call for Open Science and Bibliodiversity - CASRAI (2026)
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.
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Helsinki Initiative on Multilingualism in Scholarly Communication - CASRAI (2026)
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.
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DuraSpace - CASRAI (2026)
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.
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ORCID Peer Review Record - CASRAI (2026)
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.
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GRADE (Evidence Certainty Rating) - CASRAI (2026)
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.
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Crossref REST API - CASRAI (2026)
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.'
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AI Literacy (EU AI Act Article 4) - CASRAI (2026)
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.
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Fundamental Rights Impact Assessment (FRIA) - CASRAI (2026)
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.
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European AI Office - CASRAI (2026)
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.
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WAME (World Association of Medical Editors) - CASRAI (2026)
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.
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Guarantor of a Paper - CASRAI (2026)
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.
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STAR Methods - CASRAI (2026)
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.
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Grant DOI - CASRAI (2026)
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.
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RDA FAIR Data Maturity Model - CASRAI (2026)
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.
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