Paediatric Investigation Plan (PIP) - CASRAI (2026)
A Paediatric Investigation Plan (PIP) is the development plan a sponsor must agree with the European Medicines Agency's Paediatric Committee (PDCO) before an EU marketing authorisation application (MAA) can be validated, under Regulation (EC) No 1901/2006. It sets out the studies, age-appropriate formulations, and timelines needed to support use of a medicine in children, and applies to new active substances and to new indications, pharmaceutical forms, or routes of administration for already-authorised products that are still under patent or supplementary protection certificate (SPC) protection. A product is only exempt from the PIP requirement if it has a PDCO-granted waiver (full or class), if it is a generic, well-established-use, homeopathic, or traditional-herbal application under Article 10 of Directive 2001/83/EC, or if all paediatric studies are formally deferred to a later stage of development while the PIP itself is still agreed and on file.
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Metadata - CASRAI (2026)
Structured information that describes, identifies, or explains a research output — most often a dataset — independent of the content itself, so that the output can be found, correctly interpreted, cited, and reused without the data (or document, sample, or instrument) having to be opened or examined directly. In research data management, metadata is what a repository, catalog, or search index actually reads to determine whether a record matches a query; the underlying data file is opaque to that process until metadata points to it.
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America Invents Act (AIA) - CASRAI (2026)
The America Invents Act (AIA) – formally the Leahy-Smith America Invents Act, Public Law 112-29 – is the 2011 U.S. patent reform statute that replaced the country's first-to-invent priority system with a first-inventor-to-file system for applications with an effective filing date on or after March 16, 2013. Under first-inventor-to-file, priority between two parties claiming the same invention goes to whoever files first at the USPTO, not whoever can prove they invented it first through lab notebooks and an interference proceeding. The AIA also broadened what counts as prior art to include public use, sale, or availability anywhere in the world (not just the U.S.), replaced interference proceedings with derivation proceedings, and created new post-grant review mechanisms (inter partes review, post-grant review, and the now-expired covered business method review) for challenging an issued patent's validity at the USPTO's Patent Trial and Appeal Board instead of only in federal court. For a technology transfer office (TTO), the operative consequence of the filing-date switch is that filing timing relative to any public disclosure – a conference talk, a preprint, a poster, a journal submission, even a sales conversation – became the single most consequential decision in the invention-disclosure-to-patent pipeline.
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Inventor - CASRAI (2026)
Under U.S. patent law, an inventor is a natural person who contributed to the conception of at least one claim of a patented (or claimed) invention, as governed by 35 U.S.C. § 116. Conception is the operative legal test, not construction, funding, supervision, or manuscript authorship: it is the formation, in that person's mind, of a definite and permanent idea of the complete and operative invention, later reduced to a form a person skilled in the art could reproduce without further inventive work. A person who only executes another's detailed instructions, provides routine technical assistance, funds the research, or supervises a lab does not become an inventor by virtue of that role alone. When two or more people jointly satisfy the conception standard, each is a joint inventor under § 116, even if they worked at different times, contributed unequally, did not work together physically, or each contributed to only some of the claims — provided each contributed to the conception of at least one claim in the resulting application. Inventorship is determined claim-by-claim and can change as claims are added, amended, or cancelled during prosecution, which is why university technology transfer offices (TTOs) routinely revisit the named-inventor list as a patent application matures.
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PCT Application - CASRAI (2026)
A PCT application (formally, an "international application" under the Patent Cooperation Treaty) is a single patent filing, administered by WIPO, that preserves an applicant's right to seek patent protection in some or all of the PCT's 158 Contracting States without having to file separately in each one at the outset. It does not itself result in a granted patent anywhere – grant authority stays with each national or regional patent office. For a university invention, something qualifies operationally as a PCT application if it is filed with a receiving office (typically the USPTO, for a US-origin invention) within 12 months of the earliest priority filing (usually a US provisional application), enters an international phase producing a search report and written opinion on patentability, and is then converted into individual national or regional applications – "national phase entry" – by the applicable deadline (30 months from priority under the PCT default, though several major offices set 31 months). A TTO's PCT decision is fundamentally a triage decision: it buys roughly 18 extra months, beyond the original 12-month priority year, to assess commercial interest (licensee engagement, industry validation, additional data) before committing to the far higher cost of national-phase filing in specific countries.
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Watermark Faculty Success (Digital Measures) - CASRAI (2026)
A commercial faculty activity reporting (FAR) and faculty-lifecycle management platform, owned by Watermark Insights, used by institutions to collect faculty teaching, research, and service activity data once and repurpose it into annual activity reports, CVs, promotion and tenure dossiers, accreditation reports, and public faculty profiles. It was originally sold as 'Digital Measures Activity Insight' before Watermark's 2018 acquisition and subsequent rebrand to 'Faculty Success.'
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Invention - CASRAI (2026)
In the university technology-transfer and Bayh-Dole context, an invention is a new and useful process, machine, manufacture, or composition of matter (or a new and useful improvement to one of those) that a researcher has conceived — formed a definite and permanent idea of the complete, operative thing in their mind, not merely identified a problem or a goal (35 U.S.C. § 101; conception standard confirmed under 35 U.S.C. § 116 joint-inventorship case law). An idea alone is not yet an invention in the legal sense used by a technology transfer office (TTO): it becomes one, for disclosure and patenting purposes, once conception is complete and can be documented — typically in a dated lab notebook entry or an invention disclosure — even before the invention has been built or tested ("reduced to practice"). Whether that invention is also a subject invention under the Bayh-Dole Act turns on funding: 35 U.S.C. § 201(e) defines a subject invention as any invention of a contractor (a university, other nonprofit, or small business) conceived or first actually reduced to practice in the performance of work under a federal funding agreement. Only subject inventions trigger Bayh-Dole's disclosure, election-of-title, and government-license obligations under 35 U.S.C. §§ 200–212; an invention made entirely on private, unrestricted funds is not a subject invention even though it may still be patentable.
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Independent Data Monitoring Committee (IDMC) - CASRAI (2026)
An Independent Data Monitoring Committee (IDMC) is an independent group of clinical, statistical, and (where relevant) bioethics experts, external to a trial's sponsor and investigators, that periodically reviews accumulating safety and efficacy data from an ongoing clinical trial and recommends to the sponsor whether the trial should continue, be modified, or stop. 'IDMC' is the term used in EMA's dedicated guideline on the subject and, as of the January 2025 finalization of ICH E6(R3), is also the term used in the current ICH Good Clinical Practice guideline itself. It describes the same underlying body and function as a Data Safety Monitoring Board (DSMB) – the two terms are not different oversight mechanisms but regional/institutional naming variants for one function, with IDMC more common in EU/EMA and ICH-referencing contexts and DSMB more common in NIH- and US-funded trial contexts.
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Sponsor-Investigator - CASRAI (2026)
A sponsor-investigator is a specific FDA regulatory designation (21 CFR 312.3 for drugs/biologics; 21 CFR 812.3 for devices) for an individual – never an institution, company, or group – who both initiates a clinical investigation and actually conducts it, personally directing the administration, dispensing, or use of the investigational product to subjects. Because one person occupies both roles, that individual must independently satisfy the full set of sponsor obligations (21 CFR 312.50-312.59) and the full set of investigator obligations (21 CFR 312.60-312.70) under the same IND or IDE – there is no reduced or merged standard for holding both roles at once.
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Basket Trial - CASRAI (2026)
A basket trial is a clinical trial design, formalized by FDA as one of three master-protocol types, that tests a single investigational drug (or drug combination) across multiple disease populations that are grouped not by their tissue of origin but by a shared molecular alteration or biomarker. In oncology, where the design is most established, a basket trial enrolls patients with different cancer types — lung, colorectal, melanoma, and others — into a common protocol as long as their tumors share a specified genomic alteration, and treats them with the same targeted therapy regardless of where the cancer originated. A study qualifies as a basket trial when three conditions hold together: (1) a single drug or drug combination is under evaluation, (2) enrollment is organized around a shared biomarker or molecular subtype rather than a single disease, and (3) the protocol spans what would otherwise be treated as separate diseases or histologies. Basket trials are typically single-arm and use overall response rate as the primary endpoint, since a shared, adequately characterized control group across multiple diseases is often impractical.
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arXiv Endorsement System - CASRAI (2026)
The arXiv endorsement system is the mechanism arXiv uses to confirm that a first-time submitter, or an existing author submitting to an arXiv subject category for the first time, is a legitimate participant in that field before their submission is accepted for processing. A submission is subject to endorsement whenever the submitting author has no prior accepted-and-announced papers in the specific endorsement domain they are submitting to. To satisfy the requirement, the author must be endorsed by an existing arXiv author (an 'endorser') who is themselves in good standing in that same endorsement domain, meaning the endorser has authored a sufficient number of papers in that domain within roughly the preceding five years (and at least three months old, so very recent authors cannot immediately endorse others). Endorsement confirms only that the submission is topically appropriate for the category and that the author appears to understand the field's basic conventions – arXiv is explicit that endorsement 'is not peer review' and endorsers are not vouching for scientific correctness. Endorsement is separate from arXiv moderation, the ongoing process by which category moderators can reclassify, hold, or (rarely) reject content after submission on subject-matter or scope grounds.
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Simultaneous Submission - CASRAI (2026)
Simultaneous submission (also called multiple or concurrent submission) occurs when an author submits the same manuscript, or manuscripts substantively reporting the same data or findings, to more than one journal at the same time, so that it is under active review at two or more venues simultaneously. It is prohibited by virtually all journal policies and by ICMJE's Recommendations, which state that authors 'should not submit the same manuscript, in the same or different languages, simultaneously to more than one journal.' A manuscript counts as under simultaneous submission from the point it is submitted to a second journal until it is formally withdrawn from, or rejected by, all but one of the venues. It is distinct from duplicate publication (also called redundant or self-plagiarized publication), which concerns a manuscript that substantially overlaps with work that has already been published, rather than work that is merely under review elsewhere at the same time.
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Medical Writing in Clinical Trials - CASRAI (2026)
Medical writing in clinical trials is the specialized discipline of drafting, editing, and maintaining the regulatory and clinical documents that a trial produces from protocol design through final reporting – protocols and protocol amendments, Investigator's Brochures (IB), informed consent forms (ICF), Clinical Study Reports (CSRs), the clinical sections of regulatory submissions (e.g. the Common Technical Document modules submitted to FDA, EMA, or other regulators), and trial-related publications such as journal manuscripts, congress abstracts, and plain-language summaries. A document counts as an instance of medical writing in this sense when (a) it is a formal, structured deliverable required or expected at a defined point in the trial lifecycle, (b) it must accurately represent clinical and statistical content that the writer did not personally generate, and (c) it is produced to a recognized structural or ethical standard – most commonly ICH E3 for CSRs, ICH E6 for protocol and consent-related content, and the Good Publication Practice (GPP 2022) guidelines for publication-related writing – rather than being general-purpose scientific or lay writing about a trial.
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Deferential Vulnerability (Research Ethics) - CASRAI (2026)
A type of research-subject vulnerability, identified in Kenneth Kipnis's taxonomy commissioned for the U.S. National Bioethics Advisory Commission (NBAC, 2000/2001), arising from a hierarchical or authority relationship between a prospective subject and the person recruiting or conducting the research – formal or, more often, informal (e.g., professor/student, employer/employee, treating physician/patient, military superior/subordinate) – in which the subject may feel unable to freely decline or withdraw from participation, whether from fear of offending the authority figure and incurring retribution or from a genuine desire to please a respected other. It is distinguished from juridic vulnerability (formal legal authority, as with incarceration) by the informality of the compelling relationship, and from population-based vulnerability categories (age, pregnancy, incarceration) by being relational and situational rather than a fixed characteristic of the subject.
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45 CFR 46 Subpart D (Additional Protections for Children in Research) - CASRAI (2026)
The section of the Common Rule (45 CFR 46, §§46.401-46.409) that governs HHS-conducted or HHS-funded research involving children as subjects. A protocol falls under Subpart D whenever its subjects have not attained the legal age for consent to the research procedures under the law of the jurisdiction where the research will be conducted (§46.402). The IRB must classify the protocol into one of four risk categories – no greater than minimal risk (§46.404), greater than minimal risk with prospect of direct benefit (§46.405), greater than minimal risk with no direct benefit but likely generalizable knowledge (§46.406), or research not otherwise approvable that HHS’s Secretary determines addresses a serious child-health problem (§46.407) – and must determine what combination of parental/guardian permission and child assent is required under §46.408 before approving it.
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Effort Certification - CASRAI (2026)
The process by which an individual with direct, first-hand knowledge of the work performed – historically the employee themselves or a person with suitable means of verification, such as a supervisor – attests, after the fact and typically on a periodic basis, that the percentage of salary charged to a sponsored award reasonably reflects the actual effort that person expended on that award during the certification period. Under 2 CFR 200.430 (the Uniform Guidance, effective December 26, 2014), effort certification is no longer a federally mandated, one-size-fits-all form – it is one acceptable method an institution may build into the 'system of internal control' the regulation actually requires, which must provide reasonable assurance that salary charges are accurate, allowable, and properly allocated, and must be based on records reflecting the total activity for which the employee is compensated (not exceeding 100 percent). Institutions may instead rely on budget estimates on an interim basis, provided the estimation process produces reasonable approximations of actual activity, significant changes in work distribution are documented promptly, and the internal-control system includes periodic after-the-fact review with adjustments where needed. A federal awarding agency retains the authority to require personnel activity reports or prescribed certifications from a specific recipient if that recipient's own internal controls fall short of the standard.
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ONIX (ONline Information eXchange) - CASRAI (2026)
An XML-based family of metadata standards, maintained internationally by EDItEUR (with regional groups Book Industry Communication/BIC in the UK and BISG in the US), used to exchange structured product and rights information across the publishing supply chain. A metadata record qualifies as ONIX when it validates against one of EDItEUR's published ONIX XML schemas/DTDs (the current major version for book-trade metadata is ONIX for Books 3.0, extended by 3.1) and carries the standard's defined composite structure, code lists, and identifiers rather than a proprietary or free-text feed.
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Wearable Devices and Digital Health Technologies (DHTs) in Clinical Trials - CASRAI (2026)
A digital health technology (DHT) is defined by FDA as a system that uses computing platforms, connectivity, software, and/or sensors for healthcare and related purposes, used to collect, store, and transmit health-related data. In a clinical trial, a device or software is functioning as a DHT specifically when it is used to remotely acquire data from or about a participant that will be used to support a trial endpoint or otherwise inform a regulatory decision — not merely as a convenience app or a participant engagement tool with no bearing on the data package submitted to a regulator. Wearables (heart rate trackers, actigraphy bands, continuous glucose monitors) are the most visible category, but the term also covers non-worn sensors, implantables, and participant-facing mobile apps that capture symptom or functional data, provided that data feeds into the trial's endpoints or safety monitoring. What distinguishes a DHT from an ordinary electronic data-capture tool is the verification and validation burden it creates: a sponsor must demonstrate the technology reliably captures the intended clinical event or physiological parameter, in the population and context of actual use, before that data can support a trial conclusion.
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TransCelerate GCP Mutual Recognition Program - CASRAI (2026)
The TransCelerate GCP Mutual Recognition Program is an industry framework, run by TransCelerate BioPharma (a nonprofit collaboration of biopharmaceutical sponsor companies), under which Good Clinical Practice (GCP) training completions from a recognized training provider are accepted by multiple participating sponsor companies rather than each sponsor requiring its own separate GCP training for the same investigator or site staff member. It sits within TransCelerate's Site Qualification and Training (SQT) initiative, which targets the duplicative questionnaires, forms, and training courses that clinical trial sites have historically had to complete separately for each sponsor and, in some cases, for each individual trial. A GCP training provider participates by self-attesting that its course meets minimum criteria aligned with ICH E6 Good Clinical Practice; providers that meet the criteria have their courses made available through TransCelerate's Shared Investigator Platform (SIP), where site staff can complete training once, upload the resulting certificate, and have participating sponsors retrieve and accept it during study start-up instead of re-verifying or re-issuing training separately. A record is a genuine instance of the program when the underlying GCP course completion was issued by a provider recognized under TransCelerate's mutual-recognition criteria and is being accepted, without separate re-training, by a second (or subsequent) participating sponsor company for a different trial or company relationship – not merely any GCP-aligned course completion in general.
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National AI Research Resource (NAIRR) - CASRAI (2026)
The National AI Research Resource (NAIRR) is a US federal initiative – currently operating as the NAIRR Pilot – that provides researchers, educators, and students with shared access to AI computational infrastructure (supercomputing and cloud allocations), AI-ready datasets, pretrained models, and educational resources, rather than direct cash funding. It is led by the National Science Foundation (NSF) in partnership with more than a dozen other federal agencies, including the Department of Energy (DOE) and National Institutes of Health (NIH), who co-lead a security-focused 'NAIRR Secure' track for sensitive data. Eligible US-based researchers, educators, and graduate students (with a faculty sponsor) apply for time-limited resource allocations – typically a 3-month Start-Up award or a 12-month Research award – through a competitive, proposal-based process rather than an open-access account. A project 'uses NAIRR' when it draws on the pilot's pooled portfolio of partner-provided compute, storage, or model resources under an awarded allocation; a project that purchases or funds its own AI hardware, or that uses a single university's internal HPC cluster with no NAIRR allocation, is not a NAIRR activity even if the research itself is AI-related.
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Medical Monitor (Clinical Trials) - CASRAI (2026)
A Medical Monitor is the physician (or other appropriately qualified clinician) designated by a clinical trial sponsor or its CRO to provide ongoing, cross-site medical and safety oversight: reviewing accumulating adverse events for causality and expectedness, answering investigators' medical eligibility and protocol-interpretation questions, and flagging safety signals for the sponsor or a DSMB. The role requires medical qualification, sponsor-side (not site-based) placement with no direct participant-care relationship, and cross-site safety-judgment scope — it is a de facto function of the sponsor's safety obligations under ICH E6 and 21 CFR 312.32 rather than a term either formally defines in its own glossary.
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Biosafety and Biosecurity - CASRAI (2026)
Biosafety and biosecurity are the two complementary risk-management frameworks that together govern institutional work with biological materials capable of causing harm. Biosafety is the set of containment practices, equipment, and facility design (see Biosafety Level (BSL)) intended to prevent accidental exposure of personnel or unintended release of a biological agent into the environment. Biosecurity is the set of physical security, access control, personnel-reliability, and material-accountability measures intended to prevent deliberate misuse, theft, loss, or diversion of biological agents or toxins – the concern is an intentional bad actor, not an accident. A given institutional program is a biosafety-and-biosecurity program only when it addresses both halves: containment/exposure-prevention controls administered through an Institutional Biosafety Committee (IBC) under the NIH Guidelines and the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual, and security/accountability controls administered through the Federal Select Agent Program (jointly run by CDC and USDA-APHIS) for any select agent or toxin on the HHS/USDA Select Agent List, plus Dual-Use Research of Concern (DURC) review where applicable. A program that only locks containment (biosafety) without inventory control and personnel vetting for regulated agents is not biosecure; a program with strict access control but inadequate containment practice is not biosafe. The two are reviewed together but are not interchangeable and are not satisfied by the same control.
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Research Integrity Officer (RIO) - CASRAI (2026)
The institutional official a research institution formally designates, per 42 CFR § 93.233, to administer its written research-misconduct policy: receiving allegations, conducting the initial assessment of whether they meet the fabrication/falsification/plagiarism definition and fall within institutional jurisdiction, deciding whether to open a formal inquiry, sequestering relevant research records, and appointing inquiry/investigation committees. Institutions that apply for or receive PHS support (NIH, CDC, FDA, and other Public Health Service funding) must designate an RIO as a condition of that support.
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Blinding and Masking in Clinical Trials - CASRAI (2026)
Blinding (or masking, the term FDA/ICH guidance now prefer) in a clinical trial is the procedure of keeping one or more trial parties – the participant, the investigator/care provider, the outcomes assessor, and/or the data analyst – unaware of which treatment arm a given participant was assigned to, from the point of randomization onward. It is recorded on ClinicalTrials.gov as the "Masking" data element with levels of None (open-label), Single, Double, Triple, or Quadruple, depending on how many of those roles are kept unaware. Masking is a distinct methodological safeguard from randomization and allocation concealment: it addresses performance bias (differential behavior or care from knowing the assignment) and detection/ascertainment bias (differential outcome judgment), not selection bias at enrollment.
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Inventor Recognition Program - CASRAI (2026)
An inventor recognition program is a formal, typically non-monetary or symbolic activity run by a university technology transfer office (TTO) or research office to publicly acknowledge faculty, staff, and student inventors for their contributions to invention disclosure, patenting, licensing, and commercialization. It is distinct from — and runs alongside — the financial royalty-sharing terms set out in the institution's intellectual property policy: a program counts as inventor recognition when its primary function is reputational and cultural (visibility, honor, institutional gratitude) rather than a payment obligation, even if it is announced at the same event where royalty distributions are discussed.
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15 CFR Part 734 (EAR — Scope and Definitions) - CASRAI (2026)
15 CFR Part 734, titled “Scope of the Export Administration Regulations,” is the part of the Export Administration Regulations (EAR) – the dual-use export control regime administered by the US Department of Commerce's Bureau of Industry and Security (BIS) – that establishes what the EAR applies to at all and supplies the controlling definitions used throughout the rest of the regulation (15 CFR Parts 730-774). Part 734 does not itself list controlled items – that is the Commerce Control List, Supplement No. 1 to 15 CFR Part 774 – instead it defines what is 'subject to the EAR' (15 CFR 734.2-734.3), sets the de minimis US-content threshold for foreign-made items (734.4), and supplies the definitions of 'export' (734.13), 'reexport' (734.14), 'release' (734.15), and 'transfer (in-country)' (734.16), including the deemed-export and deemed-reexport concepts built into those definitions and into the dedicated carve-outs at 734.18 and 734.20. It also states the fundamental research exclusion (734.8): technology or software that arises during, or results from, fundamental research and is intended for publication falls outside the EAR's scope entirely, not merely under a license exception. Because these definitions determine whether the EAR applies to a given item, transaction, or disclosure at all, a research institution's export-control determination almost always starts with a Part 734 definition rather than with a Commerce Control List entry.
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Data Safety Monitoring Plan (DSMP) - CASRAI (2026)
A Data Safety Monitoring Plan (DSMP) is the written document a study team develops – usually as part of a grant application or protocol package, before a trial opens – describing exactly how participant safety data will be monitored throughout the study: who will review the data, how often, what will be reviewed, the mechanism for reporting adverse events to the IRB, the funding agency, and (where applicable) the FDA, and the stopping rules that would trigger pausing or ending the trial. Every NIH-funded clinical trial must have a DSMP, scaled to the trial's size, complexity, and risk – but not every DSMP requires a full independent Data Safety Monitoring Board (DSMB). A DSMP is the plan document itself; a DSMB is one possible monitoring mechanism a DSMP can specify. For lower-risk trials, the DSMP more commonly designates the principal investigator or an independent safety monitor/medical monitor as the reviewer instead of convening a formal board.
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FAR 52.227-11 (Patent Rights — Ownership by the Contractor) - CASRAI (2026)
FAR 52.227-11, “Patent Rights—Ownership by the Contractor,” is the patent-rights clause the Federal Acquisition Regulation requires contracting officers to insert into federal procurement contracts awarded to small business firms and nonprofit organizations (including universities) for experimental, developmental, or research work. It is prescribed by FAR 27.303(b)(1) and is the FAR's own codification of the Bayh-Dole Act's contractor-ownership default — the contract-instrument counterpart to the 37 CFR 401.14 Standard Patent Rights Clause used in grants and cooperative agreements. A federally funded project is governed by 52.227-11, rather than 37 CFR 401.14, specifically because of which funding instrument was used (a procurement contract) rather than because the underlying substantive rights differ.
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Retraction vs. Redaction - CASRAI (2026)
Retraction and redaction are frequently confused because both involve a publisher acting on already-published content, but they answer different questions and have different consequences for the reader. A RETRACTION withdraws an entire published work from the reliable literature: the journal or publisher determines the findings are unreliable (due to error, misconduct, duplication, or other invalidating factors), issues a public retraction notice explaining why, and the article is prominently marked as retracted while typically remaining accessible for the scholarly record (per COPE's Retraction Guidelines). A REDACTION removes or obscures specific sensitive content within a document – personal data, classified or export-controlled information, or other legally protected material – while the document as a whole remains published and in circulation, usually with a note indicating that specific content has been withheld and why. Retraction is a judgment about the validity or integrity of the whole work; redaction is a targeted removal of particular information from an otherwise valid, still-published work. The two are not mutually exclusive: a paper can, in principle, be both redacted (to remove sensitive data) and later retracted (if a separate integrity issue emerges), but neither implies the other.
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NIGMS Payline - CASRAI (2026)
A NIGMS payline, as commonly asked about by analogy to other NIH institutes, does not refer to a published percentile-rank cutoff the way it does at NINDS, NHLBI, or NIAID – NIGMS is distinctive among NIH institutes for not publishing a fixed payline figure for its standard grant mechanisms. NIGMS has instead described its funding decisions as weighing an application's percentile score, assigned after peer review at an NIH study section, alongside factors including the investigator's current level of NIH support and the balance of NIGMS's overall funded research portfolio, rather than ranking applications strictly against a single published threshold. This is further complicated for NIGMS's flagship Maximizing Investigators' Research Award (MIRA, activity code R35), which consolidates an investigator's overall NIGMS-supported research program into one award and is reviewed on that basis rather than as a single discrete project, making a simple percentile payline concept fit even less naturally than it does for NIGMS's R01 funding generally. As of late 2025, NIH signaled that its payline-publishing institutes and centers would move toward a more holistic, portfolio-aware approach – directionally similar to how NIGMS has operated for years – rather than continuing to publish fixed percentile cutoffs; confirm current institute-specific practice against NIGMS's own current guidance rather than assuming a specific figure applies.
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eSource (Electronic Source Data) - CASRAI (2026)
Electronic source data (eSource) is clinical trial data that is first recorded in electronic form at the point of observation – typed directly into an electronic health record (EHR), an electronic patient-reported outcome (ePRO) or clinical outcome assessment (eCOA) device, or directly into an EDC system during a study visit – rather than being first written on paper (a clinic note, a lab printout, a paper diary) and later transcribed into an electronic system. The origination point, not the software used to store or display the data, is what makes a given data point eSource: the same EDC platform can hold both eSource data (entered live, not transcribed) and non-eSource data (transcribed from a paper source document) within the same study.
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National Research Act of 1974 - CASRAI (2026)
The National Research Act of 1974 (Public Law 93-348, signed July 12, 1974) is the U.S. federal statute that created the National Research Service Award (NRSA) training-grant program (Title I) and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, while separately requiring federally funded institutions to use an independent review board for human-subjects research (Title II). It is the statutory origin of the modern IRB requirement and the direct cause of the Belmont Report (1979) and the Common Rule (45 CFR 46).
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RTTP (Registered Technology Transfer Professional) and ATTP - CASRAI (2026)
RTTP (Registered Technology Transfer Professional) is an individual professional credential – awarded in three tiers (Candidate RTTP, RTTP, and RTTP Fellow) – that certifies a knowledge-exchange/technology-transfer (KE/TT) practitioner has met minimum thresholds of professional experience, continuing education, and demonstrated competency across six defined core competency areas. It is awarded exclusively by ATTP (the Alliance of Technology Transfer Professionals), a nonprofit standards body formed by a consortium of national and regional technology-transfer associations – including AUTM in North America – rather than by any single national association acting alone. An individual is RTTP-certified only after ATTP has reviewed and approved a formal application/portfolio; association membership, job title, or years of experience alone do not confer the designation.
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Researcher Development Concordat - CASRAI (2026)
The Researcher Development Concordat (formally the Concordat to Support the Career Development of Researchers) is a UK sector-wide agreement, first launched in 2008 and substantially revised in 2019, that sets out reciprocal commitments among research funders, research organizations (universities and institutes), and researchers themselves for improving the environment, employment conditions, and career development of researchers. An organization is treated as implementing the Concordat when it is a formal signatory, has published a public action plan addressing the Concordat's three principles, and reports progress against that plan on a defined cycle – not merely by stating general support for researcher development.
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IRB Coordinator - CASRAI (2026)
The IRB Coordinator (also called IRB Administrator, IRB Analyst, or Human Subjects Protection Coordinator, depending on the institution) is the staff role responsible for the administrative and operational running of an Institutional Review Board (IRB) office — protocol intake and completeness review, meeting scheduling and logistics, correspondence with investigators, tracking continuing-review and other regulatory deadlines, and maintaining the IRB's official records. It is a non-voting, non-determination-making role: the Coordinator supports the board's process but does not review protocols for approval, does not preside over convened meetings, and does not carry the IRB Chair's statutory authority to make or assign expedited-review determinations under 45 CFR 46.110 / 21 CFR 56.110.
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Clinical Trial Central Laboratory - CASRAI (2026)
A clinical trial central laboratory is a single designated laboratory, or a network of laboratories operating under one standardized protocol, contracted to perform sample testing (e.g., blood chemistry, hematology, biomarker assays, pharmacokinetic analysis) for every investigative site in a multi-site trial, rather than each site using its own local or institutional lab. A vendor relationship qualifies as a central laboratory arrangement when it provides all of: (1) a single set of standardized testing protocols, equipment, and reference ranges applied uniformly across every participating site; (2) site-facing logistics – specimen collection kits, labeled containers, and standardized courier/shipping arrangements – so specimens from geographically dispersed sites reach the same analytical instruments; and (3) pooled, harmonized result reporting back into the trial's data set, so that a lab value from Site A and the equivalent value from Site B were generated by the same method and are directly comparable without a site-specific correction factor.
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Journal Citation Indicator (JCI) - CASRAI (2026)
A journal's Journal Citation Indicator (JCI) is the field-normalized citation-impact score Clarivate calculates for it as part of each annual Journal Citation Reports (JCR) release. It measures the average citation impact of a journal's citable items published in the most recent three-year window, normalized against the average citation rate for all similarly-aged papers of the same document type in the same JCR subject category. A journal qualifies for a JCI if it is indexed in a JCR-eligible Web of Science Core Collection index (SCIE, SSCI, AHCI, or ESCI) with enough citable output in the relevant window for Clarivate to calculate a normalized rate. The score is a decimal where 1.0 equals the world average for that category and document type: a JCI of 1.5 means the journal's papers are cited 50% more than the world average for comparable papers in that field, and a JCI of 0.5 means cited half as often.
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IVD Clinical Trials (In Vitro Diagnostic Studies) - CASRAI (2026)
An IVD (in vitro diagnostic) clinical trial – more precisely termed a performance study or, in FDA IDE terminology when one is required, an IVD investigation – is a study that evaluates a diagnostic test's ability to detect, measure, or characterize a condition or analyte using specimens taken from the human body (blood, urine, tissue, swabs), rather than a study that administers a drug or activates a therapeutic device inside a patient. Because most IVD studies test specimens that have already been collected, or collect them through routine, minimally invasive means, they are regulated as a distinct category from both drug trials (governed in the US by the Investigational New Drug, or IND, pathway) and therapeutic device trials (governed by the Investigational Device Exemption, or IDE, pathway under 21 CFR Part 812). A study is an IVD clinical trial, in the sense this term is used on this site, when its object is establishing or confirming a diagnostic test's analytical performance (does the assay measure the analyte accurately and reproducibly) and/or clinical performance (does the result correlate with the clinical condition it claims to detect) – not when it evaluates a drug's or device's direct therapeutic effect on a patient.
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Technology Licensing Office (TLO) - CASRAI (2026)
A Technology Licensing Office (TLO) is the name a research institution gives to its intellectual-property-and-licensing office. Absent institution-specific information, an office named 'Technology Licensing Office' should be treated as performing the same core function as a 'Technology Transfer Office' (TTO) – receiving invention disclosures, deciding whether to pursue patent protection, and negotiating licenses with companies – under a different institutional naming convention, not a categorically different kind of office. Some institutions choose the 'TLO' label specifically to signal a renewed or narrower emphasis on the licensing/IP-protection function relative to the broader industry-engagement and sponsored-research-support activities a 'TTO' label can imply, but this is a per-institution branding choice, not a standardized, cross-institutional scope distinction – confirm actual scope from the specific office's own published mandate rather than inferring it from the name alone.
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Scite (Smart Citations) - CASRAI (2026)
Scite is a commercial citation-analysis platform whose core feature, Smart Citations, uses a trained natural-language-processing (deep learning) model to classify each individual citing statement of a paper as supporting, contrasting, or mentioning the claim it cites, and displays the actual citation-context sentence alongside that classification. A citation is a Scite Smart Citation, specifically, when it comes with (a) the excerpted sentence from the citing paper that references the cited work, and (b) a supporting/contrasting/mentioning label assigned to that specific citing statement – not just a tally of how many times the work has been cited.
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Commercial IRB - CASRAI (2026)
A commercial IRB (also called an independent IRB) is an Institutional Review Board that operates as a standalone, for-profit or non-profit business providing human-subjects ethics review as a paid, fee-for-service function – rather than as an internal department of the university, hospital, or research institution whose studies it reviews. It is registered with OHRP and, for FDA-regulated research, meets the same 21 CFR Part 56 requirements as any other IRB; the distinguishing feature is organizational independence and a client-billing relationship with the sites and sponsors it reviews for, not a lower regulatory bar. Commercial IRBs (WCG/WIRB and Advarra are the two largest in the U.S. market) are frequently designated as the single IRB (sIRB) of record for multi-site trials, but sites also route single-site industry-sponsored studies to a commercial IRB even when no sIRB mandate applies – typically because the sponsor requires it, the site has no local IRB, or the site's own IRB lacks capacity or relevant expertise for the study type.
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Link Resolver - CASRAI (2026)
A link resolver is OpenURL-based library-discovery software that accepts a context-sensitive citation link (from a database, discovery layer, or search engine), checks it against the library's knowledge base of current subscriptions and open-access holdings, and, if a match exists, routes the user to the specific full-text copy that institution has legitimate access to – rather than to a fixed, publisher-assigned location. It is the software behind a library's "Find It", "Get It", or "Get Full Text" button.
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Prior Inventions Disclosure - CASRAI (2026)
A prior inventions disclosure is the exhibit or schedule attached to an employment, consulting, or IP assignment agreement in which an individual lists every invention they created before the agreement's effective date, using an affirmative yes/no format, so that pre-existing IP is documented as excluded from the agreement's forward-looking assignment clause rather than left ambiguous.
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Cabells Predatory Reports - CASRAI (2026)
Cabells Predatory Reports (formerly Cabells' Blacklist, renamed in June 2020) is a commercial subscription database, published by the scholarly-analytics company Cabells, that lists journals its review team has determined exhibit deceptive or predatory editorial and publishing practices. A journal's inclusion is determined by evaluating it against a published, versioned set of behavioral indicators — v1.0 (2017) contained 64 criteria and v1.1 (2019) expanded to 74, organized by category (integrity, peer review, business practices, indexing claims, and similar) and by severity — rather than by a single reviewer's informal judgment. Unlike Beall's List, which is a static snapshot frozen in January 2017, Predatory Reports is actively maintained: journals are added, and the underlying criteria themselves have been revised, on an ongoing basis. Access is by paid subscription, typically arranged at the institutional level through a university library, either as a standalone product or bundled with Cabells' companion Journalytics subscription.
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Panel on Research Ethics (PRE) - CASRAI (2026)
The Panel on Research Ethics (PRE), formally the Interagency Advisory Panel on Research Ethics, is the body created jointly in 2001 by Canada's three federal research funding agencies (CIHR, NSERC, and SSHRC) to develop, interpret, and steward the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2) on the Agencies' behalf; it does not itself review or approve individual research protocols, which remains the role of institutional Research Ethics Boards (REBs).
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PRISMA-ScR (PRISMA Extension for Scoping Reviews) - CASRAI (2026)
A report is PRISMA-ScR compliant when it satisfies PRISMA-ScR's 20 essential reporting items (Tricco et al. 2018), frames its question in PCC (Population, Concept, Context) rather than PICO terms, and documents evidence "charting" and mapping rather than risk-of-bias-weighted synthesis – the checklist purpose-built for scoping reviews, distinct from the core 27-item PRISMA 2020 checklist used for systematic reviews of intervention effects.
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AUTM Licensing Activity Survey (LAS) - CASRAI (2026)
The AUTM Licensing Activity Survey (LAS) is AUTM's annual, voluntary, self-reported data-collection instrument that gathers standardized technology-transfer metrics – research funding administered, invention disclosures received, patent applications filed and patents issued, licenses and options executed, licensing income received, and startup companies formed – from participating U.S. and Canadian universities, academic medical centers, hospitals, and research institutions for a given fiscal year. A figure counts as LAS data specifically when it is drawn from an institution's own completed survey submission to AUTM (or from AUTM's aggregated published report or STATT database built from those submissions), not from an institution's separately published internal annual report or from an unrelated third-party estimate of technology-transfer activity.
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UPIRSO (Unanticipated Problem Involving Risks to Subjects or Others) - CASRAI (2026)
A UPIRSO is an incident, experience, or outcome in human subjects research that meets all three of OHRP’s reporting criteria: it is unexpected in nature, severity, or frequency given the protocol and subject population; it is related or possibly related to participation in the research; and it suggests subjects or others face greater risk of harm than was previously known. All three prongs must be met — an event failing any one of them is not a UPIRSO under OHRP guidance, even if it is still reportable under another category such as a routine adverse event or protocol deviation. The investigator reports a suspected UPIRSO promptly to the IRB per 21 CFR 56.108(b) (FDA-regulated research) and the institution’s Federalwide Assurance procedures (federally-supported research generally); the institution may then have a further obligation to report certain UPIRSOs to OHRP and the supporting federal agency, on a timeframe set by its own written policies rather than one fixed federal number of days.
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Product Development Agreement - CASRAI (2026)
A product development agreement (PDA) is a contract between a company and a university, research institution, or individual inventor to jointly develop a specific product or technology toward a commercial outcome, combining ongoing development work with pre-negotiated terms for how the resulting IP will be owned and eventually commercialized. An arrangement counts as a product development agreement, rather than one of the adjacent instruments it is routinely confused with, when three elements are present together: (1) the parties jointly perform development work aimed at a defined product or application – it is not a license of already-existing IP with no development obligation attached, and not open-ended research without a specific commercial product as the target; (2) it sets milestone-based development obligations (technical milestones, timelines, sometimes funding contributions) that both parties are bound to, rather than one party simply performing services for a fee; and (3) it addresses in advance how IP arising from the joint work – particularly improvements, modifications, or new inventions built on either party's background IP – will be owned, and how the finished product will ultimately be licensed or otherwise commercialized. A PDA is a general contracting concept, not a term of art created by a specific statute; its content is negotiated case by case, unlike a CRADA, which is a specific federal-laboratory mechanism created by statute.
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International Confidentiality Agreement - CASRAI (2026)
A confidentiality agreement (NDA) between parties in different countries, which requires provisions a purely domestic NDA does not: export-control screening of the disclosed information for deemed-export risk, a deliberately chosen governing-law/jurisdiction/dispute-resolution clause that will actually be enforceable across the relevant borders, and, when the confidential information includes personal data, transfer safeguards that satisfy the data-protection law of the disclosing party's jurisdiction (most commonly GDPR Chapter V).
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Model Clinical Trial Agreement (mCTA) - CASRAI (2026)
A Model Clinical Trial Agreement (mCTA) is a standardized, pre-negotiated template Clinical Trial Agreement published by a national body, funder, or multi-institutional consortium, and intended to be used with little or no clause-by-clause negotiation for each new trial. Adopting sponsors and sites fill in trial-specific variables (protocol reference, budget schedule, site details) against core legal language – indemnification, IP allocation, publication rights, data ownership – both sides have already pre-agreed is acceptable. It is defined by the contracting strategy (a fixed starting point institutions commit in advance to accept largely unmodified), not by any single clause, since CTA content itself varies by jurisdiction.
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Horizon Europe Article 19 (Ethics) - CASRAI (2026)
Article 19 of Regulation (EU) 2021/695 is the Horizon Europe framework Regulation's general ethics clause: it requires all Horizon Europe-funded actions to comply with ethical principles and applicable EU/national/international law, mandates a proposal-stage ethics self-assessment plus Commission screening and, where warranted, a formal ethics assessment (automatic for any action involving human embryonic stem cells or embryos), requires participating entities to hold and keep on file all required national/institutional ethics and data-protection approvals before starting the relevant activity, allows ethics checks during a project's lifetime, and excludes certain fields of research (human reproductive cloning, heritable germline genetic modification, and creating human embryos solely for research or stem-cell procurement) from funding altogether.
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Good Publication Practice (GPP) - CASRAI (2026)
Good Publication Practice (GPP) is a named, industry-authored set of ethics guidelines for planning, writing, and publishing company-sponsored biomedical research – primarily pharmaceutical, biotechnology, and medical-device studies. It is maintained by a GPP Steering Committee working with ISMPP (the International Society for Medical Publication Professionals) and published as a peer-reviewed article in Annals of Internal Medicine. The current version is GPP 2022, which superseded GPP3 (2015); GPP3 itself superseded the original GPP2 (2009) and GPP (2003). A study, manuscript, or publication process is GPP-compliant when: authorship is assigned strictly against ICMJE's four authorship criteria (not honorary, guest, or ghost authorship); the funding source and the sponsor's role in study design, analysis, and the decision to publish are disclosed; any professional medical writer's involvement is named and their support disclosed, typically in the acknowledgements; named authors have full access to the data (or a summary sufficient to vouch for it) and control over interpretation and the final decision to publish; and there is a documented intent to publish results regardless of outcome, including negative or inconclusive findings.
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Editorial Independence - CASRAI (2026)
Editorial independence is the principle, formalized by COPE (Committee on Publication Ethics), that a journal's editorial decisions – to accept, reject, or request revision of a manuscript – are made solely on scholarly merit and are insulated from influence by the journal's owner, publisher, advertisers, sponsors, or any other commercial or non-scientific interest. It requires that editors hold final, unoverridable authority over content decisions, that advertising/sponsorship functions operate organizationally separate from editorial functions, and that any relationship between the journal and a commercial or sponsoring party is governed by a declared, public policy rather than an informal arrangement.
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Horizon Europe Article 39 (Open Access) - CASRAI (2026)
Article 39 of Regulation (EU) 2021/695, the Horizon Europe framework regulation, is the legal provision that creates the programme's binding open science obligations for grant beneficiaries. It has two strands: (1) mandatory immediate open access to peer-reviewed scientific publications resulting from Horizon Europe funding, with no embargo period, licensed under the latest version of Creative Commons Attribution (CC BY) or an equivalent licence (a narrower exception permits CC BY-NC or CC BY-ND for monographs and other long-form outputs); and (2) responsible management of research data under the FAIR principles and the default that data should be 'as open as possible, as closed as necessary,' subject to documented, justified exceptions for IP, personal data, confidentiality, or security. Horizon Europe Grant Agreements incorporate both strands as binding funding conditions, not discretionary guidance.
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European Code of Conduct for Research Integrity - CASRAI (2026)
The European Code of Conduct for Research Integrity is a specific, named document — not a general principle or a professional network — published by ALLEA (All European Academies), the federation of European academies of sciences and humanities. First issued in 2011 (jointly with the European Science Foundation), it was revised in 2017 and again in 2023. It sets out four principles — reliability, honesty, respect, and accountability — and translates them into good research practices covering research design, data management, methodology, authorship, publication, and peer review, alongside a taxonomy of research misconduct and other research integrity violations. A document or practice is 'covered' by the Code when it is cited as the reference standard in a funding agreement, institutional policy, or national code — most consequentially, the European Commission recognises the Code as the primary research-integrity standard for Horizon Europe, and it is incorporated by reference in the Horizon Europe Model Grant Agreement, making adherence a binding condition of EU research funding rather than a voluntary aspiration.
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Horizon Europe Article 7: Gender Equality Plan (GEP) - CASRAI (2026)
Article 7 of the Horizon Europe framework regulation (Regulation (EU) 2021/695) makes gender equality a cross-cutting priority of the programme and is the legal basis for the Gender Equality Plan (GEP) eligibility criterion: for Horizon Europe calls with submission deadlines from 2022 onward, public bodies, higher education establishments, and research organisations established in an EU Member State or an Associated Country must have a GEP (or an equivalent gender equality strategy) in place to be eligible to receive funding. It is a legal entity-level eligibility check, not a proposal-evaluation criterion – an applicant either has a qualifying GEP on file or it does not, and non-compliant public-body, HEI, or research-organisation applicants are ineligible for that call regardless of the scientific merit of their proposal. Private, for-profit entities (companies, including SMEs) are exempt from the requirement.
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42 CFR Part 11 - CASRAI (2026)
42 CFR Part 11 is the federal regulation, titled "Clinical Trials Registration and Results Information Submission," that codifies the ClinicalTrials.gov registration and results-reporting requirements originally created by Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801). Issued by HHS as a Final Rule and effective 18 January 2017 (compliance expected by 18 April 2017), it converts FDAAA 801's statutory mandate into binding, enforceable regulatory text: who counts as the "responsible party" for a trial, which trials are "applicable clinical trials" (ACTs) subject to the rule, the specific data elements and deadlines for registration and results submission, and FDA's civil monetary penalty authority for noncompliance. A trial is governed by 42 CFR Part 11 only if it meets the regulation's ACT definition; broader definitions used by ICMJE or by NIH's own separate results-reporting policy can require registration or reporting for trials that fall outside Part 11's narrower scope.
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22 CFR Part 120 (ITAR — Purpose and Definitions) - CASRAI (2026)
22 CFR Part 120 is the opening part of the International Traffic in Arms Regulations (ITAR), the body of US federal regulations administered by the Department of State's Directorate of Defense Trade Controls (DDTC) that controls the export and temporary import of defense articles and defense services on the US Munitions List (USML). Part 120 does not itself list controlled items – that is Part 121 (the USML) – instead it states ITAR's statutory basis and purpose (Subpart A) and, in Subpart C (22 CFR 120.30-120.69), supplies the controlling definitions used throughout the rest of ITAR (22 CFR Parts 121-130), including 'defense article,' 'defense service,' 'technical data,' 'export,' 'US person,' and 'foreign person.' Because these definitions govern how every other ITAR part is read, a research institution's export-control determination for a given item, collaboration, or foreign national almost always traces back to a Part 120 definition rather than to a substantive control provision elsewhere in ITAR.
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Adverse Event of Special Interest (AESI) - CASRAI (2026)
An Adverse Event of Special Interest (AESI) is an adverse event (serious or non-serious) that a trial sponsor pre-identifies in the study protocol as being of scientific and medical concern specific to the investigational product or research programme, because there is a known or suspected mechanistic, class-effect, or prior-safety-signal reason to watch for it. Unlike a general Adverse Event (AE), which is simply any untoward medical occurrence observed during a trial, an AESI is defined in advance, by name, before the first participant is enrolled – the protocol (and often a companion safety monitoring plan) lists the specific event, the case definition or diagnostic criteria used to confirm it, and the enhanced procedures for capturing it (e.g. dedicated case report form fields, expedited investigator-to-sponsor reporting timelines, or independent adjudication by a clinical events committee). Because the AESI designation is about the *reason for watching*, not the event's clinical severity, an AESI can be non-serious under the ordinary ICH E2A seriousness criteria (death, life-threatening, hospitalization, persistent disability, congenital anomaly, or 'otherwise medically important') and still trigger the same rapid-reporting and characterization procedures a serious event would. This is the operational test for whether something is an AESI: was it named as a specific event of concern in the protocol/safety monitoring plan before enrollment began, for a documented scientific or regulatory reason – as opposed to emerging unexpectedly during the trial.
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Published Data - CASRAI (2026)
Data is 'published' when it has been formally released as a discrete, citable research output: deposited in a repository or registry that assigns it a persistent identifier (typically a DOI), described with metadata sufficient for independent discovery and reuse (at minimum the DataCite mandatory set – Identifier, Creator, Title, Publisher, PublicationYear, ResourceType), and made accessible under a stated licence. A dataset that is merely stored, backed up, or informally emailed to a collaborator is not 'published' in this sense, even if the underlying files are identical – publication is a formal act with a fixed citation form, not a description of where the bytes happen to live.
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Clinical Trial Protocol - CASRAI (2026)
A clinical trial protocol is the formal, version-controlled document that defines a study's rationale, objectives, design, methodology, statistical considerations, and organization – specifying eligibility criteria, interventions, assessments/procedures and their timing, endpoints, and the responsibilities of investigators and sponsors. Under ICH E6(R3), it is the controlling document that IRB/ethics committee review, investigator conduct, sponsor oversight, and (once locked) the statistical analysis all reference; any conduct outside its terms requires either an approved amendment or documented justification as an immediate-safety deviation.
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Microsoft Academic Graph (MAG) - CASRAI (2026)
A large-scale, free scholarly knowledge graph built and maintained by Microsoft Research — publications, authors, affiliations, venues, and a machine-generated fields-of-study taxonomy, linked by citation and authorship edges, and distributed via the Microsoft Academic website, the Microsoft Academic Knowledge API, and periodic bulk data dumps — that Microsoft fully retired on December 31, 2021, and no longer maintains, updates, or serves in any form.
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Beall’s List - CASRAI (2026)
Beall's List refers to the self-published blacklist of publishers and standalone journals that University of Colorado Denver librarian Jeffrey Beall judged to be "potential, possible, or probable" predatory open-access operations, posted on his blog Scholarly Open Access between 2008 and January 15, 2017. It was a single-author evaluation against Beall's own evolving criteria (fake or absent peer review, fabricated editorial boards, false indexing claims, deceptive fee disclosure, and similar red flags), not a criteria-based process run by a standards body, publisher coalition, or institution. Beall removed the entire site in January 2017 and it has not been updated since, so any reference to "Beall's List" today points to a frozen, decade-plus-old snapshot (or to one of several unofficial community mirrors of it) rather than to a live, current resource.
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Investigational New Drug (IND) - CASRAI (2026)
A drug or biologic that FDA has authorized, via an active IND application under 21 CFR Part 312, to be shipped and administered to human subjects in a clinical investigation before it has received marketing approval — or an already-approved drug being studied outside the bounds of its approved labeling in a way that meets the triggering criteria in 21 CFR 312.2(b). The term refers interchangeably to the drug's regulatory status, the sponsor's application establishing that status, and the FDA-assigned number the study operates under.
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Open Science Badges (Open Data, Open Materials, Preregistered) - CASRAI (2026)
The Open Science Badges are a set of journal-awarded visual icons, created and administered by the Center for Open Science (COS), that certify a published article met a disclosed openness standard for one of three practices: publicly posting the study's underlying data (Open Data), publicly posting the materials needed to reproduce the reported procedure and analysis (Open Materials), or registering the study design – and, for the Preregistered+Analysis Plan variant, the analysis plan – in a public registry before data collection began (Preregistered). A journal awards a badge either on a simple author self-disclosure statement or after independent editorial verification, and displays the badge icon alongside the article together with a link to the disclosed data, materials, or registration.
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Dual-Use Research of Concern (DURC) - CASRAI (2026)
Research is DURC only when it meets a two-part US Government test: it involves one of 15 enumerated select agents/toxins, AND it is reasonably anticipated to produce an outcome in one of seven defined categories of experimental concern (e.g., enhancing transmissibility/virulence, conferring resistance to countermeasures). DURC review by an institution's Institutional Review Entity/IBC is complementary to, not a substitute for, routine biosafety containment review.
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Research Animal - CASRAI (2026)
An animal that is used, or intended for use, in research, research training, testing, or experimentation, and that therefore falls under one or both of two overlapping US regulatory frameworks: the Animal Welfare Act (which reaches warm-blooded species other than purpose-bred rats, mice, and birds) and PHS Policy on Humane Care and Use of Laboratory Animals (which reaches any live vertebrate used in PHS/NIH-funded work, including species the AWA excludes). Whether a specific animal is a "research animal" for compliance purposes depends on which framework applies to it and to the funding/registration status of the institution using it.
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USPTO Office of Enrollment and Discipline (OED) - CASRAI (2026)
The Office of Enrollment and Discipline (OED) is the office within the U.S. Patent and Trademark Office's Office of the General Counsel that controls who may represent inventors and applicants before the USPTO in patent matters. It performs two distinct functions: (1) it administers registration – reviewing each applicant's scientific/technical qualifications, developing and administering the registration examination (the 'patent bar exam'), and maintaining the official roster of registered patent attorneys and patent agents – and (2) it investigates grievances and administers discipline (from a warning through suspension or exclusion) against practitioners who violate the USPTO Rules of Professional Conduct (37 CFR Part 11). An individual is a 'registered patent practitioner' only if OED has admitted them to practice and their name remains on the active roster; passing a state bar exam alone does not confer patent-prosecution authority, and OED registration alone does not confer authority to give general legal advice, draft licenses, or litigate – those require a state law license, which is why a registered practitioner is either a 'patent attorney' (also a licensed attorney) or a 'patent agent' (not a lawyer, authorized only to prosecute patent applications before the USPTO).
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Nuremberg Code - CASRAI (2026)
The Nuremberg Code is a ten-point statement of ethical principles for research involving human subjects, set out in the August 19, 1947 verdict of the U.S. military tribunal in United States v. Karl Brandt et al. (the 'Doctors' Trial') at Nuremberg. It is the operative reference point for a claim that a given human-subjects study meets the minimum ethical floor for legitimate research: the study is judged against the Code when its consent process, scientific justification, and risk controls are being assessed retrospectively as a historical or foundational benchmark, distinct from applying a current regulation such as the Common Rule or an IRB's own protocol-specific determination. Its first and most influential point establishes that the voluntary, informed consent of the human subject is 'absolutely essential' – the earliest internationally recognized statement of that requirement, and the direct conceptual ancestor of informed-consent requirements in every later research-ethics code and regulation.
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45 CFR 164.512(i) (HIPAA Uses and Disclosures for Research Purposes) - CASRAI (2026)
The provision of the HIPAA Privacy Rule, at 45 CFR 164.512(i), that permits a covered entity to use or disclose protected health information (PHI) for research without the individual's written authorization, through one of three specific pathways: (1) an Institutional Review Board (IRB) or Privacy Board has approved a waiver or alteration of authorization under the documented criteria at 164.512(i)(1)(i) and (i)(2); (2) the researcher represents the use is solely a review preparatory to research and no PHI will be removed from the covered entity; or (3) the researcher represents the use is solely for research on a decedent's information. A disclosure only qualifies under 164.512(i) if it fits one of these three pathways exactly as documented — it is not a general research exception.
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shortDOI - CASRAI (2026)
A shortDOI is a redirect alias, in the form 10/abcde, generated by the International DOI Foundation's shortDOI Service (shortdoi.org) for an existing, already-registered DOI name. It is not a separately registered persistent identifier: it resolves through the same DOI Handle System and https://doi.org/ resolver as the underlying DOI, is issued only once per DOI (requesting a shortDOI for a DOI that already has one returns the existing alias rather than minting a new one), and carries none of a DOI's registration guarantees on its own – the original DOI remains the identifier of record for citation, archiving, and metadata purposes.
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OAIS Reference Model (ISO 14721) - CASRAI (2026)
A conceptual framework, standardised as ISO 14721, that defines the functions, information packages, and terminology an archive needs to preserve digital (or physical) information and keep it accessible to a defined community over the long term, independent of the specific technology used to implement it.
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Risk-Benefit Analysis - CASRAI (2026)
Risk-benefit analysis is the determination an IRB or REC must make, under the Belmont Report's Beneficence principle and its codification at 45 CFR 46.111(a)(1)-(2), that (1) risks to research participants have been minimized through sound research design, and (2) the residual risks are reasonable in relation to the study's anticipated benefits to participants, if any, and the importance of the resulting knowledge. It is a mandatory precondition for IRB approval, made by the board itself before a study proceeds – distinct from informed consent, which discloses those already-evaluated risks and benefits to participants so each can decide individually whether to accept them.
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Data Transfer Agreement (DTA) - CASRAI (2026)
A contract governing the mechanics of transferring a dataset between institutions – authorised senders and recipients, transmission and security method, and destruction-or-return terms – distinct from a Data Use Agreement's downstream use restrictions and a Material Transfer Agreement's coverage of physical materials.
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Case Report Form (CRF) - CASRAI (2026)
A case report form (CRF) is the study-specific data-collection instrument – paper or electronic (eCRF) – through which a clinical trial's protocol-defined data points are recorded for each participant and transmitted to the sponsor or its designee for analysis. Its content is derived directly from the protocol and the Statistical Analysis Plan: every field on a CRF should map to a specified assessment, visit, or endpoint, and nothing should appear on a CRF that isn't required by the protocol. Data recorded on a CRF must be verifiable against source documents (the original records – clinic charts, lab reports, imaging, ECGs, patient diaries – where a data point was first captured), a process called source data verification (SDV). ICH E6(R2)/(R3) hold the CRF to the same data-integrity expectations that apply to source data generally, commonly summarized by the ALCOA+ attributes (attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, available); any correction made after initial entry must preserve an audit trail rather than overwrite the original value. CRF field design commonly follows CDISC's CDASH standard to ease downstream mapping to SDTM submission datasets. A CRF is a distinct concept from a published case report (a journal article type describing an unusual clinical case) despite the similar name.
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Crossref Simple Text Query - CASRAI (2026)
Crossref Simple Text Query is a free web-based matching tool at doi.crossref.org/simpleTextQuery that takes an unstructured reference or reference list — pasted as plain citation text, not structured fields — and returns the matching DOI for each item it can identify. A submission can hold up to 1,000 references, entered one per line or block, and the tool attempts to return exactly one best-match DOI per reference by default (an option to list all possible matches is available when a reference is ambiguous). No Crossref membership or account is required to use it, and there is no charge. The same underlying free-text matching is also exposed programmatically through the Crossref REST API's query.bibliographic parameter on the /works route (for example api.crossref.org/works?query.bibliographic=your+citation+string), which is the machine-actionable equivalent of pasting a citation into the web form — useful for batch reference-linking pipelines rather than one-off lookups.
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Last Author - CASRAI (2026)
The name occupying the final position in a scholarly work's byline. In contribution-ranked fields – most consistently biomedicine and the life sciences – this position conventionally signals the senior investigator or principal investigator who supervised the study and obtained funding, distinct from the first author who typically performed the primary hands-on work. Last-author position is not itself an ICMJE authorship criterion, and the convention does not apply uniformly: alphabetical-order fields (mathematics, particle physics, much of economics) carry no such signal, and last author is not automatically the same person as the corresponding author.
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ISRCTN - CASRAI (2026)
ISRCTN — originally an acronym for International Standard Randomised Controlled Trial Number, now used as the registry's own name — is a UK-based clinical study registry that assigns a permanent, unique identifier (an ISRCTN number) to a study at or before its start. A study qualifies as "ISRCTN-registered" when its investigator or sponsor has submitted the required minimum data set (design, intervention, population, primary/secondary outcomes, sponsor, funder) through isrctn.com, the entry has passed the registry's validation checks, and it has been assigned a permanent identifier in the format ISRCTN followed by an eight-digit number (for example, ISRCTN12345678). Unlike its original RCT-only scope, ISRCTN now accepts any study assessing the effect of a health intervention on a human population, including non-randomised interventional studies and some observational designs — the acronym is retained for historical/branding reasons but no longer describes the registry's actual scope.
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Research Transparency - CASRAI (2026)
Research transparency is the practice of making the specific decisions, materials, data, and code behind a study visible and checkable at the point they are used, not the broader movement to open up research outputs generally (that is open science). A study demonstrates research transparency to the degree it discloses, and ideally shares and cites, what it did: whether hypotheses and analysis plans were specified before or after seeing the data, where materials and data can be obtained, whether analytic code is available, and whether the design and reporting follow a recognized standard. The most widely adopted operational framework for this is the Transparency and Openness Promotion (TOP) Guidelines, published by the Center for Open Science (COS), which turns 'be transparent' into eight checkable standards — citation, data transparency, analytic methods (code) transparency, research materials transparency, design and analysis transparency, study preregistration, analysis plan preregistration, and replication — each ratable at one of three levels of stringency, from disclosure through requirement to independent verification.
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Nature Author Contributions - CASRAI (2026)
Nature's author contributions policy requires every submitted paper to include a free-text statement describing each author's role, built on authorship criteria drawn from McNutt et al. (2018) rather than ICMJE's four-part test, and without mandating the CRediT taxonomy for the statement itself. It also permits explicit "contributed equally" and "jointly supervised" co-author designations and prohibits authorship changes after acceptance.
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Research Data - CASRAI (2026)
Research data is the recorded, factual material generated or collected in the course of a research project that is needed to validate, reproduce, or build on that project's findings — raw measurements, observations, instrument readings, survey responses, code outputs, and other structured or unstructured records, regardless of medium or discipline. In U.S. federally funded research specifically, the term carries a narrower, load-bearing regulatory meaning under 2 CFR § 200.315(e)(3) (the Uniform Guidance, which consolidated and replaced the older OMB Circular A-110 in 2014): research data means 'the recorded factual material commonly accepted in the scientific community as necessary to validate research findings.' That specific definition is what determines what a federal award recipient must make available in response to a Freedom of Information Act (FOIA) request, and it is the baseline many institutions use to scope what a data management plan (DMP) is actually obligated to describe. Distinguishing 'research data' in this operational sense from the much larger set of everything a researcher produces during a project — drafts, correspondence, physical samples, unfinished analysis — is the first practical step in scoping a DMP, a repository deposit, or a records-retention schedule, and underpins research data management (RDM) practice generally.
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eConsent (Electronic Informed Consent) - CASRAI (2026)
eConsent (electronic informed consent) is the use of an electronic system, often incorporating multimedia such as video or interactive comprehension checks, to present IRB-approved informed consent information and capture a participant's electronic signature in place of a paper form. A process counts as eConsent when it delivers the required consent content electronically, preserves a genuine opportunity for the participant to ask questions before signing, captures an attributable electronic signature that is time-stamped and non-detachably linked to the specific document version reviewed, and provides the participant a copy of the signed consent. For FDA-regulated clinical investigations, the electronic signature must meet 21 CFR Part 11's criteria; FDA and OHRP's December 2016 joint guidance additionally recommends that IRBs review the electronic process and interface itself, not just the consent language.
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ICH Q1 (Stability Testing Guidance) - CASRAI (2026)
ICH Q1 is the International Council for Harmonisation's guideline series covering the stability testing that establishes a drug substance's or drug product's shelf-life (expiration dating period), retest period, and required storage/labeling conditions. The historical Q1 series — Q1A(R2) (stability testing of new drug substances and products, revised 2003), Q1B (photostability testing, 1996), Q1C (stability testing for new dosage forms, 1996), Q1D (bracketing and matrixing study designs, 2002), and Q1E (evaluation of stability data, 2003) — together with the biotechnology/biological product stability guideline Q5C (1995), remain the operative reference guidance as of this writing. ICH is consolidating the entire series (plus Q5C) into a single revised Q1 guideline, extended in scope to cover both synthetic and biological products; that consolidated draft reached ICH Step 2b (public consultation) on 11 April 2025 and has not yet reached Step 4 (final guideline) — until it does, and each region formally adopts it, the existing Q1A-Q1E/Q5C texts remain the applicable standard.
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PNAS Author Contributions - CASRAI (2026)
PNAS Author Contributions refers to the Proceedings of the National Academy of Sciences' requirement that every published paper carry a structured statement of who did what, plus a corresponding-author guarantor clause. PNAS pioneered this in 1995, using its own fixed checklist that predates CRediT (ANSI/NISO Z39.104-2022) by roughly two decades; current submissions are directed to the standard CRediT taxonomy while PNAS retains its guarantor requirement and adds a mandatory ORCID for the corresponding author.
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NSF CISE (Computer and Information Science and Engineering) - CASRAI (2026)
NSF CISE (the Directorate for Computer and Information Science and Engineering) is one of the National Science Foundation's major organizational directorates. It is a budgetary and administrative unit, not a single funding program or solicitation: CISE funds fundamental research and education across computer science, information science, and computer engineering, and proposals are routed to specific thematic program areas within it based on subject matter. Following NSF's agency-wide reorganization announced in December 2025, CISE's internal structure moved from its long-standing division model to six current thematic program areas.
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Editorial board - CASRAI (2026)
An editorial board is the named group of individuals — typically an editor-in-chief (or co-editors-in-chief), one or more associate/section/deputy editors, and a wider roster of board members — appointed by a journal or its publisher to set editorial policy, uphold publication ethics and peer-review integrity, and make or ratify final accept/reject decisions on submissions. Editorial board members are governance/oversight appointees, not, by default, the pool that performs first-pass external peer review of any given manuscript (that is typically done by invited subject-matter reviewers selected per submission, sometimes including board members but not limited to them). A journal without an identifiable editorial board is treated by indexing/vetting bodies (e.g. DOAJ) as a red flag for undisclosed or absent editorial oversight.
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FFATA Reporting - CASRAI (2026)
FFATA reporting is the mandatory disclosure of subaward and executive-compensation information required under the Federal Funding Accountability and Transparency Act of 2006. A prime recipient of a federal award (or a pass-through entity issuing subawards under it) must report each subaward action of $30,000 or more in federal funds through SAM.gov (successor to the retired FSRS.gov, migrated around March 2025), by the end of the month following the month in which the obligation was made. Recipients meeting a two-part revenue test must also report the compensation of their five most highly compensated executives. The reporting obligation sits with the pass-through entity, not the subrecipient, and the resulting data feeds USASpending.gov for public transparency.
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Administrative Metadata - CASRAI (2026)
Administrative metadata is the category of metadata used to manage a resource — as distinct from metadata used to describe or discover it. It typically covers four practical areas: rights and permissions (licensing, access restrictions), provenance and acquisition history (who deposited it, when, and how), technical/file-format details (file type, software/equipment used, checksums), and access-control information. NISO's standard three-way split names it alongside descriptive and structural metadata, and treats technical and preservation metadata as administrative subtypes — though usage varies slightly by standard: METS, for example, models technical, rights, provenance, and preservation information together under a single amdSec (administrative metadata section), sitting alongside — not nested inside — its descriptive metadata section (dmdSec).
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Tuskegee Syphilis Study - CASRAI (2026)
The Tuskegee Syphilis Study refers specifically to the U.S. Public Health Service's Study of Untreated Syphilis in the Negro Male, conducted in Macon County, Alabama from 1932 to 1972, in which roughly 600 Black men (399 with latent syphilis, 201 as an uninformed control group) were enrolled without being told their actual diagnosis or the study's purpose, and were denied treatment – including penicillin once it became the standard cure in the 1940s – so researchers could observe the untreated disease's natural progression. The term is invoked today as the specific, documented U.S. case of research conducted without informed consent, through active deception, targeting a vulnerable population defined by race, and involving the deliberate denial of available treatment; its 1972 public exposure is the direct legislative trigger for the National Research Act of 1974 and, through the National Commission it created, the 1979 Belmont Report.
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ICH E6(R2) (Good Clinical Practice, 2016 Addendum) - CASRAI (2026)
ICH E6(R2) is the 2016 integrated addendum to ICH's original E6(R1) (1996) Good Clinical Practice guideline, reaching ICH Step 4 on 9 November 2016 and adopted as final FDA guidance on 1 March 2018. It layers new provisions onto (not replacing) E6(R1): a new Section 5.0 (Quality Management, including risk-based quality management and quality tolerance limits) and a revised Section 5.18 (Monitoring, formally recognizing centralized and risk-based monitoring alongside traditional on-site visits). It was superseded as ICH's current core guideline by ICH E6(R3) (Principles + Annex 1 finalized January 2025), but remains the applicable GCP text for any trial, institution, or jurisdiction that has not transitioned to E6(R3), including many trials authorized and still running under it.
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NIH Genomic Data Sharing (GDS) Policy - CASRAI (2026)
A study falls under NIH's Genomic Data Sharing (GDS) Policy (2014) when it is NIH-funded and generates large-scale human or non-human genomic data (GWAS, SNP arrays, WGS/WES, transcriptomic, epigenomic, metagenomic, or gene-expression data). Covered human-data studies must use GDS-specific prospective informed consent language, obtain an Institutional Certification from the awardee institution (via its Signing Official, in coordination with the IRB) confirming consistency with participant consent, and submit data to an NIH-designated controlled-access repository – dbGaP for most human genomic data – under a Data Use Certification Agreement. The GDS Policy predates and operates alongside, not inside, the broader 2023 NIH Data Management and Sharing (DMS) Policy.
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Study Identifier - CASRAI (2026)
The unique code a registry assigns to identify a specific research study — a clinical trial, systematic review, or other registered research project — as that study itself, distinct from an identifier assigned to one of its resulting outputs (a DOI), its underlying dataset, or an individual researcher (an ORCID iD). A study identifier's format, prefix, and issuing authority are registry-specific: ClinicalTrials.gov assigns 'NCT' numbers, the ISRCTN registry assigns 'ISRCTN' numbers, and PROSPERO assigns 'CRD42' numbers. A single study can carry more than one study identifier if it is registered, or cross-registered, in more than one registry.
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Group Authorship - CASRAI (2026)
Group authorship (also called consortium authorship or collaborative-group authorship) is the practice of listing a named collaboration, consortium, or working group as an author entity on a publication's byline, rather than (or in addition to) listing only individual researchers. ICMJE's own wording is direct on this: "Some large multi-author groups designate authorship by a group name, with or without the names of individuals." Two configurations occur in practice: (1) the group name appears alongside a full list of individually named authors, functioning mainly as citation shorthand; or (2) the group name alone is the primary visible byline, with the full roster of individual contributors published separately (an appendix, supplementary file, or membership list). What qualifies a case as group authorship rather than an ordinary large-author paper is that the collaboration/consortium name itself functions as a citable author entity. Per ICMJE, this naming convention does not relax the underlying bar: every individual credited as an author within the group – whether visible on the byline or listed separately – must independently satisfy all four ICMJE authorship criteria (substantial contribution, drafting/critical revision, final approval, and accountability). This is distinct from ordinary multi-institutional co-authorship (many named individuals, no group entity name) and from an acknowledgments section (which by definition credits people or entities that do NOT meet authorship criteria).
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CIHR Catalyst Grant - CASRAI (2026)
A CIHR Catalyst Grant is a short-term (typically up to one year), relatively small (typically capped in the tens of thousands up to roughly CA$125,000 per award, set per competition) seed-funding mechanism issued periodically by the Canadian Institutes of Health Research under various themed funding opportunities, used to support planning, pilot work, feasibility testing, or generation of preliminary data as a first step toward a larger, longer operating grant such as the CIHR Project Grant.
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Technical Metadata - CASRAI (2026)
Technical metadata is the category of metadata that documents the digital characteristics of a resource needed to render, verify, and process it correctly over time: file format and version, the hardware and software environment used to create or read it, technical characteristics (size, encoding, resolution, compression), and a record of any technical processing or transformation events (format migration, compression, checksum regeneration) applied since creation. It answers 'what does a machine need to know to open, verify, and correctly interpret this file,' as distinct from what a resource is about (descriptive metadata) or who may use it and under what terms (administrative metadata, in the narrower rights/provenance/access-control sense). Some frameworks, including NISO's influential three-way split, treat technical metadata as a subtype nested under the broader administrative metadata category; others, including the METS schema's own internal structure, give it a distinct named subsection (techMD) alongside rights and provenance subsections rather than folding it into a single undifferentiated administrative bucket. Both framings agree on the underlying content – format, environment, and fixity information – they differ only in where they draw the taxonomy line.
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Mutual Support Authorship - CASRAI (2026)
An arrangement in which two or more researchers agree, explicitly or informally, to reciprocally list each other as authors on each other's papers regardless of whether each individual meets the substantive ICMJE authorship criteria, in order to inflate publication counts on both sides. Unlike gift authorship, which typically flows in one direction, mutual support authorship is a two-way trade of unearned credit.
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Metadata Format - CASRAI (2026)
A metadata format (also called a serialization format) is the concrete syntactic encoding used to write metadata values out as a machine-readable byte stream for storage, exchange, or transmission — for example XML, JSON, RDF/Turtle, or YAML. It answers 'how is this metadata physically written down,' which is a separate question from what a metadata schema answers: 'which fields exist and what do they mean.' A schema (Dublin Core, DataCite, Darwin Core, PROV-O) defines the field set and semantics; a format defines the byte-level syntax those fields get poured into. The same schema is routinely available in more than one format, and the same format is routinely used to carry many unrelated schemas — so 'metadata format' and 'metadata schema' are not interchangeable, even though the two terms get conflated constantly in casual usage.
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ISSN - CASRAI (2026)
An eight-digit identifier (ISO 3297), formatted NNNN-NNNC with a modulus-11 check digit as the final character, assigned to a continuing resource's TITLE — a journal, magazine, newspaper, or other serial published indefinitely over time, in print or online — by a national ISSN Centre under the coordination of the ISSN International Centre (CIEPS) in Paris. An ISSN identifies the serial as a whole, not any individual article, issue, or volume within it, and each distinct medium of the same title (print vs. online) is assigned its own ISSN, linked together via an ISSN-L.
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Knowledge-to-Action (KTA) Framework - CASRAI (2026)
The Knowledge-to-Action (KTA) Framework is a specific conceptual model for how research evidence moves into practice, developed by Ian Graham and colleagues (2006). A project, program, or funder policy is 'using the KTA Framework' when it explicitly structures knowledge translation work around the model's two linked components: (1) a Knowledge Creation funnel of three phases – knowledge inquiry, knowledge synthesis, and the creation of knowledge tools/products, each stage distilling and tailoring the evidence further – and (2) a seven-phase Action Cycle – identify the problem (or identify/select/review knowledge), adapt knowledge to the local context, assess barriers to knowledge use, select/tailor/implement interventions, monitor knowledge use, evaluate outcomes, and sustain knowledge use. The phases are not strictly sequential: they are dynamic and can proceed simultaneously or iterate, and a given initiative rarely needs all seven Action Cycle phases to count as KTA-based, though 'identify the problem' and 'sustain knowledge use' anchor the cycle's start and end. It is a narrower, named instance of the broader knowledge translation concept, not a synonym for it.
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AAHRPP (Association for the Accreditation of Human Research Protection Programs) - CASRAI (2026)
AAHRPP is an independent, non-profit accrediting body that reviews and certifies an institution's entire Human Research Protection Program (HRPP) – not an individual researcher, and not a single IRB committee in isolation, but the full organizational system of policies, procedures, and oversight structures that protects human research participants. Accreditation is voluntary and organizational-level: an institution (a university, hospital, independent IRB, government agency, or research organization) applies, undergoes a self-assessment against AAHRPP's published standards, and is then peer-reviewed by a site visit team of experienced research-protection professionals before AAHRPP's Council on Accreditation makes a determination. A program either holds current AAHRPP accreditation or it does not – there is no equivalent to an individual passing an exam. This is the key distinction from an individual credential such as CIP (Certified IRB Professional) or from completing required human-subjects training through a platform like CITI: those attach to a person; AAHRPP accreditation attaches to the institution's program as a whole.
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CRADA (Cooperative Research and Development Agreement) - CASRAI (2026)
A formal, written collaborative R&D agreement between one or more federal laboratories and one or more non-federal parties, authorized under the Federal Technology Transfer Act (15 U.S.C. 3710a), under which the federal laboratory may contribute personnel, services, facilities, equipment, or intellectual property (but never funds) while the non-federal partner may contribute funding, personnel, or other resources toward a jointly performed, mission-consistent research effort.
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T32 (NIH Institutional Research Training Grant) - CASRAI (2026)
A T32 is an NIH Ruth L. Kirschstein NRSA institutional research training grant: NIH funds a university department or program (not an individual) to run a structured predoctoral and/or postdoctoral research training program, and the program's PD/PI selects and appoints trainees into the grant's funded slots. It is distinct from an individual fellowship (F31/F32), where the trainee themselves applies and holds the award.
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Priority Review Voucher (PRV) - CASRAI (2026)
A priority review voucher (PRV) is a transferable FDA incentive awarded when a sponsor wins approval of a qualifying drug or biologic under the rare pediatric disease PRV program (FD&C Act section 529) or the tropical disease PRV program (FD&C Act section 524). The voucher lets its holder — the original sponsor or a company it is sold to — redeem it for priority review (a six-month FDA review goal) instead of standard review (a ten-month goal) on a different, later marketing application.
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Citation Impact - CASRAI (2026)
The extent to which a research output, researcher, or venue has been cited by later work, used as a proxy for scholarly influence and measured through a family of metrics that range from raw, unweighted citation counts to field-normalized indicators designed to correct for citation-rate differences across disciplines.
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Placebo-Controlled Study Design - CASRAI (2026)
A placebo-controlled study is an interventional design in which one or more comparator arms receive an inert or sham intervention (a placebo) instead of, or in addition to, the intervention under investigation, so that any outcome difference between arms can be attributed to the study intervention itself rather than to the act of receiving treatment, participant or investigator expectation, natural disease fluctuation, or regression to the mean. It is one of the standard concurrent-control-group categories set out in ICH E10, alongside no-treatment control, dose-response control, active (positive) control, and external/historical control, and it is most often paired with randomization and blinding so that neither participants nor assessors know which arm a given participant is in.
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Coercive Authorship - CASRAI (2026)
Coercive authorship occurs when a person with evaluative or supervisory authority over a researcher — typically a principal investigator, department chair, or thesis supervisor — uses that power imbalance to compel the inclusion of an undeserving author (often themselves) or the exclusion of a deserving one, rather than authorship being negotiated on the basis of ICMJE/CRediT contribution criteria. The defining feature is not the resulting byline, which can look identical to a gift-authorship byline, but the mechanism: the junior researcher's assent is not freely given, because dissent carries real, foreseeable career risk the senior party controls — a weaker reference, delayed degree progress, or reduced access to resources or future collaboration.
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Research (45 CFR 46.102(l)) - CASRAI (2026)
Under the Common Rule, "research" is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(l)). An activity is IRB-reviewable human-subjects research only if it meets this systematic-investigation/generalizable-knowledge test AND separately involves a "human subject" under 46.102(e); an activity can be highly systematic and still fall outside the definition if it isn't designed to produce generalizable knowledge (the basis for excluding most quality-improvement and program-evaluation work), or if it falls into one of four categories the regulation expressly deems not to be research: scholarly/journalistic activities, public health surveillance, criminal-justice data collection, and authorized national-security operations.
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MedDRA (Medical Dictionary for Regulatory Activities) - CASRAI (2026)
MedDRA (Medical Dictionary for Regulatory Activities) is the standardized, five-level hierarchical medical terminology – System Organ Class, High Level Group Term, High Level Term, Preferred Term, and Lowest Level Term – used to code adverse events, symptoms, diagnoses, and other clinical findings for entry into clinical trial databases and electronic submission to regulators. Developed under ICH and maintained by the MSSO, a MedDRA-coded term is required for electronic individual case safety report (ICSR) submission across ICH-region regulators.
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Journal Editor - CASRAI (2026)
A journal editor is a person holding operational editorial authority over a journal or over specific submissions to it: authority to select and manage peer reviewers, and to accept, reject, or request revision of a manuscript. This is distinct from serving on the journal's editorial board in a non-operational capacity, and from acting as an invited peer reviewer on a single manuscript. The role commonly splits into editor-in-chief (overall journal direction and final authority on contested decisions) and associate/handling/section editors (day-to-day management of individual submissions through peer review).
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NIST SP 800-171 - CASRAI (2026)
NIST SP 800-171 ("Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations") is a U.S. National Institute of Standards and Technology special publication that specifies the security requirements a nonfederal organization — including a university, hospital, or independent research institute — must implement to protect Controlled Unclassified Information (CUI) when that information resides in, or flows through, the organization's own IT systems rather than a federal government system. A document, dataset, or research record is 'in scope' for 800-171 when it (a) meets the definition of CUI under the NARA CUI Registry categories — commonly Export Controlled, Controlled Technical Information, or Privacy — and (b) is created, received, stored, or transmitted by a nonfederal entity under a federal contract, grant, or agreement that designates it as CUI. The most widely deployed version, Revision 2, organizes 110 security requirements into 14 requirement families: Access Control, Awareness and Training, Audit and Accountability, Configuration Management, Identification and Authentication, Incident Response, Maintenance, Media Protection, Personnel Security, Physical Protection, Risk Assessment, Security Assessment, System and Communications Protection, and System and Information Integrity. Each family groups related controls (e.g., multi-factor authentication and least-privilege access sit under Access Control) rather than prescribing a single monolithic checklist.
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Complete Response Letter (CRL) - CASRAI (2026)
A Complete Response Letter (CRL) is a formal notice FDA sends a sponsor, under 21 CFR 314.110, stating that a New Drug Application, Biologics License Application, or efficacy supplement will not be approved in its present form. It is distinct from a refusal to file (issued before review begins) and from an outright, final rejection: the sponsor may resubmit after addressing the cited deficiencies, withdraw the application, or request a hearing.
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Globus - CASRAI (2026)
A non-profit, hosted research data management service - built on GridFTP-based transfer technology and operated by the University of Chicago with Argonne National Laboratory - that provides high-performance, fault-tolerant file transfer, institutional 'endpoints' (via Globus Connect Server/Personal), and controlled sharing between research storage systems, HPC centers, and repositories.
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ORCID iD for NIH Senior/Key Personnel - CASRAI (2026)
The ORCID iD requirement for NIH Senior/Key Personnel means: every individual designated as Senior/Key Personnel on an NIH grant application — the Program Director/Principal Investigator (PD/PI) plus any other individual who contributes to the scientific development or execution of a project in a substantive, measurable way, regardless of whether they receive salary support from the award — must (1) hold a registered ORCID iD, (2) link it to their own eRA Commons Personal Profile account, an action NIH requires the individual to complete themselves rather than delegate to grants administration staff, and (3) have that iD populate correctly in the Persistent Identifier (PID) field of the NIH Common Form versions of the Biographical Sketch and Current and Pending (Other) Support documents, both generated through SciENcv. This applies to applications with due dates on or after January 25, 2026 (NIH Guide Notice NOT-OD-26-018). An application missing a required, correctly linked ORCID iD for any listed Senior/Key Personnel is not merely flagged — as of May 8, 2026, eRA Commons system validations treat this as a hard error that blocks submission outright (NOT-OD-26-079), after an initial warning-only enforcement period (extended once, via NOT-OD-26-033, through May 7, 2026).
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ARC Linkage Project - CASRAI (2026)
A grant awarded under the Australian Research Council's Linkage Program that funds collaborative research between a university-based team and at least one external Partner Organisation (industry, government, or community body), where the Partner Organisation(s) must contribute cash and/or in-kind resources whose combined value at least matches the funding requested from the ARC, with cash alone required to be at least 25% of the ARC request.
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CIHR Planning and Dissemination Grant - CASRAI (2026)
A CIHR Planning and Dissemination Grant is a small, short-duration award funded through CIHR's Institute/Initiative Community Support (ICS) mechanism to support planning activities (for example, convening partners to design a future research program or initiative) or dissemination events (for example, a workshop, symposium, or knowledge-translation event that communicates health research evidence to researcher or knowledge-user audiences). It is distinguished from CIHR's research-funding mechanisms by what it explicitly excludes: it does not fund the direct cost of research, including pilot projects, feasibility studies, primary data collection, or principal/co-investigator salaries. A given competition is 'in scope' for this grant type if its funds are being used to organize an event or plan a future initiative rather than to conduct or seed research itself.
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Australian Research Data Commons (ARDC) - CASRAI (2026)
The national research data infrastructure provider for Australia: a not-for-profit company, funded through the Australian Government's National Collaborative Research Infrastructure Strategy (NCRIS), that builds, operates, and stewards shared digital research infrastructure — including platforms, skills programs, and persistent-identifier services such as RAiD — for use across the Australian university and public-research sector rather than by any single institution.
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Clinical Research - CASRAI (2026)
Clinical research is the umbrella term for any systematic investigation involving human participants, or material of human origin traceable to a living individual, that is designed to generate generalizable knowledge about human health or disease. Per NIH's own definition, it spans three broad categories: (1) patient-oriented research, where an investigator directly interacts with human subjects to study disease mechanisms, therapeutic interventions, clinical trials, or new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. A clinical trial is only one subset within the first category — specifically, patient-oriented research in which participants are prospectively assigned to an intervention. Clinical research as a whole also includes purely observational studies (cohort, case-control, cross-sectional), registry-based research, and health-services/outcomes work where no intervention is assigned at all. It is distinct from basic (preclinical, bench-level) research, though the two are connected along a translational research spectrum.
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NIH Administrative Supplement - CASRAI (2026)
An NIH administrative supplement is non-competing supplemental funding added to the current budget period and project period of an already-active NIH grant or cooperative agreement, requested by that award's PI/PD, to cover unforeseen cost increases or add new research activities that stay within the scope NIH's peer reviewers already approved. It is evaluated administratively by NIH program/grants management staff, not through new scientific peer review, and cannot extend beyond the parent award's existing project period.
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ISO 16363 (Formal-Level Certification) - CASRAI (2026)
The Formal level of the three-tier trustworthy-repository certification framework: a repository is ISO 16363-certified only when an accredited external auditor (typically PTAB, accredited under ISO 17021/16919) has conducted a full audit against ISO 16363's evidence-based metrics and formally certified the result — distinct from CoreTrustSeal's and the nestor Seal's self-assessment models. Full title: Space data and information transfer systems — Audit and certification of trustworthy digital repositories. Descends from the 2007 TRAC (Trustworthy Repositories Audit & Certification) checklist published by RLG/NARA, formalised by CCSDS as ISO 16363:2012 and subsequently revised.
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TCPS2 Chapter 9 (Research Involving Indigenous Peoples) - CASRAI (2026)
TCPS2 Chapter 9 is the section of Canada's Tri-Council Policy Statement (TCPS 2, 2022) interpreting how the Policy's core ethical principles apply to research involving First Nations, Inuit, and Métis peoples: it calls for community engagement, a documented research agreement, and, where a recognized community authority exists, review at both the institutional REB and community level before recruitment or data collection begins.
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Warranties and Covenants - CASRAI (2026)
In a research agreement — a sponsored research agreement, grant or cooperative agreement terms and conditions, subaward, or license agreement — warranties and covenants are two distinct categories of contractual promise, each triggering different remedies if broken. A warranty is a party's assurance that a stated fact is (and, for a continuing warranty, will remain) true, functioning as a guarantee coupled with an implied right to a remedy if the assertion proves false; common research-agreement warranties include a recipient's authority to enter the agreement, its compliance capacity (e.g., having an active federalwide assurance or IRB/IACUC oversight in place), or a licensor's warranty regarding title to intellectual property. A covenant is a promise to do, or to refrain from doing, something in the future over the life of the agreement — for example, a covenant to submit progress reports on a defined schedule, to maintain effort-reporting records for the required retention period, or to obtain sponsor approval before a change in scope. Warranties are tested at a point in time (a warranty is either true or false when made, or when restated); covenants are tested by performance over the agreement's term. A clause labeled a 'representation' is a closely related third category — a statement of past or present fact made to induce the other party to sign — and research contracts frequently combine all three under a single 'Representations, Warranties, and Covenants' article, but the distinction still matters because remedies differ: breach of a warranty is a contract claim measured by the value of what was promised versus what was delivered, while breach of a covenant can, if material, excuse the other party's further performance or support injunctive relief/specific performance in addition to damages.
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Metadata enrichment - CASRAI (2026)
A record's metadata is enriched when new descriptive, administrative, or relational elements are added to it after initial deposit or harvest — typically by resolving free-text values (author names, affiliation strings, subject terms) against authority files and controlled vocabularies (ORCID, ROR, funder registries, subject-classification schemes), or by pulling additional attributes from an external API (citation counts, open-access status, computed topic classifications). It is distinct from correcting or normalizing values already present (data cleaning) and from the original act of depositing the baseline record (initial deposit) — enrichment specifically adds elements the record did not previously have.
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FORCE11 (Future of Research Communications and e-Scholarship) - CASRAI (2026)
FORCE11 (Future of Research Communications and e-Scholarship) is a global, member-driven nonprofit community of scholars, librarians, archivists, publishers, and research funders working to make scholarly communication more open, transparent, and reusable across every stage of the research lifecycle – not only the final journal article. An initiative qualifies as FORCE11's work if it was developed through one of its working groups or endorsed community declarations (for example the FAIR Guiding Principles, the Joint Declaration of Data Citation Principles, the Software Citation Principles, or the Resource Identification Initiative behind RRIDs) and carries FORCE11's name as convener or co-convener, as opposed to work that merely cites or is philosophically aligned with FORCE11's broader open-scholarship goals without having gone through its community process.
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Pre-AIA 35 U.S.C. § 102 - CASRAI (2026)
Pre-AIA 35 U.S.C. § 102 is the version of the U.S. patent novelty statute that governed patentability before the America Invents Act (AIA) took effect on March 16, 2013. It operated on a first-to-invent system: priority between competing claimants to the same invention was resolved by actual date of invention (conception plus reduction to practice, with diligence), not by who filed first, and disputes were resolved through an interference proceeding before the USPTO. It had seven prior-art/loss-of-right subsections, (a) through (g), several of which (abandonment, premature foreign patenting, derivation, and prior invention by another) were eliminated outright when the AIA replaced it with the current first-inventor-to-file version of § 102. Pre-AIA § 102 is not purely historical: under the AIA's transitional rule, any U.S. application that contains or ever contained a claim with an effective filing date before March 16, 2013 is examined in its entirety under pre-AIA §§ 102 and 103, so it still actively governs a real population of applications and issued patents today.
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21 CFR Part 50 (Protection of Human Subjects) - CASRAI (2026)
21 CFR Part 50 is the FDA's own human-subjects protection regulation. It applies to clinical investigations of products that fall under FDA's regulatory jurisdiction under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act – drugs, biologics, and medical devices for human use – regardless of who funds the study. It sets the informed-consent requirements FDA holds sponsors and investigators to (Subpart B), and adds extra safeguards when children are enrolled (Subpart D). A study triggers Part 50 when it is 'regulated by FDA' under sections 505(i) or 520(g) of the FD&C Act (i.e. it supports or could support an IND or IDE, or the drug/device is otherwise subject to FDA jurisdiction) – not because a federal agency is paying for it. That funding-vs-jurisdiction distinction is what separates Part 50 from 45 CFR 46 (the Common Rule), and many trials involving both a federal funder and an FDA-regulated product must satisfy both simultaneously.
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Patent Exhaustion Doctrine - CASRAI (2026)
Patent exhaustion (the patent first-sale doctrine) holds that once a patent owner, or someone the patent owner has authorized, sells a patented item, the patent owner's exclusive rights over that specific item are exhausted – the purchaser and any later owner may use, repair, or resell it without committing patent infringement, regardless of restrictions the patentee attaches to the sale. Under Impression Products, Inc. v. Lexmark International, Inc., 581 U.S. 360 (2017), this applies to authorized sales anywhere in the world, not just U.S. sales, and any post-sale restriction the patentee wants to enforce has to be pursued as a contract claim against the buyer, not a patent infringement claim.
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Grant-in-Aid - CASRAI (2026)
A grant-in-aid is a payment of funds from one level of government, a government department, or a funding body to another organization to support a defined activity, program, or body of ongoing operations, typically under conditions the recipient must satisfy (eligible use of funds, reporting, sometimes matching or cost-sharing). It is a broader, more programmatic category than a single research project grant: a grant-in-aid can fund an entire program area, an institution's core operations, or a recurring formula-based allocation, whereas a research/project grant funds one specific, time-bound piece of research with a defined scope of work. In UK and Commonwealth public finance, 'grant-in-aid' has a specific technical meaning: funding voted by Parliament (or the relevant legislature) and paid by a sponsoring government department to an arm's-length public body – most commonly a non-departmental public body – to finance that body's approved programs and net running costs, governed by the terms set out in the body's framework document. In US federal usage, 'grants-in-aid' is the umbrella term public-finance and public-administration literature uses for the whole family of federal transfers to state and local governments, which is further split into categorical grants (purpose-restricted, project or formula) and block grants (broad-purpose, high recipient discretion).
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P01 Grant (NIH Research Program Project Grant) - CASRAI (2026)
A P01 (Research Program Project Grant) is an NIH activity code funding one award that supports multiple independent but scientifically interrelated research projects unified by a single central theme, plus shared infrastructure (an Administrative Core and, often, additional scientific cores) that serves all of the projects. It is a grant (not a cooperative agreement), meaning NIH does not anticipate substantial involvement in directing the funded science, and it is distinguished from R01s by its multi-project, cross-project-synergy structure rather than by award size alone.
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Secure Data Enclave - CASRAI (2026)
A controlled-access computing environment in which approved researchers analyze restricted or sensitive data in place, without the ability to download, copy, or otherwise export the raw underlying records. Access is typically granted only after training, credentialing, and a signed data use agreement, computation happens on infrastructure the data steward controls (an on-site terminal room, a remote-access session, or an isolated cloud workspace), and only aggregate or disclosure-reviewed outputs — tables, statistics, model results — are allowed to leave the environment. The defining feature is not where the data sits but that raw data never crosses the boundary; only vetted outputs do.
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Research Council - CASRAI (2026)
A research council is a government-established public funding body — typically a national, arm's-length or quasi-autonomous statutory agency — whose core function is to award competitive, peer-reviewed research funding to external researchers and institutions rather than to conduct research itself. It sits between direct ministerial/departmental research funding, philanthropic foundation funding, and government mission agencies that both fund and directly perform research (e.g., NIH's intramural program). The name is a category of funding body, not a single organization: the UK's seven discipline research councils, Canada's NSERC/SSHRC/CIHR, and Australia's ARC/NHMRC are all specific instances of this same institutional model.
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Trial Master File (TMF) - CASRAI (2026)
The Trial Master File (TMF) is the complete, organized collection of essential documents that individually and collectively permit evaluation of the conduct of a clinical trial and the quality of the data it produced, as defined by ICH E6(R2) Section 8. A document belongs in the TMF if it is on the ICH E6 essential-documents list (or a sponsor's/site's approved TMF index derived from it) and falls into one of three time-based groupings: documents generated before the clinical phase begins (protocol, investigator's brochure, IRB/IEC approval, signed agreements), documents generated during the conduct of the trial (protocol amendments, monitoring visit reports, informed consent forms, drug/device accountability records, adverse event reports), and documents generated after the trial is completed or terminated (final study report, subject identification code list, audit certificate). A sponsor maintains a central TMF; each investigator site maintains a parallel Investigator Site File (ISF) covering the same essential-document categories at site level. Today the TMF is almost always maintained electronically as an eTMF, commonly organized using the TMF Reference Model's zone/section/artifact taxonomy rather than an ad hoc folder structure.
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IND-Enabling Studies - CASRAI (2026)
IND-enabling studies are the package of nonclinical (preclinical) pharmacology, pharmacokinetics/ADME, and toxicology studies a sponsor must complete before filing an Investigational New Drug (IND) application with FDA. Their purpose is narrow and specific: to generate the data supporting a reasonable expectation that the drug can be tested safely in humans at a defined starting dose, not to demonstrate efficacy or complete the full nonclinical program a marketing application will eventually require. The scope and design of the package is governed principally by ICH M3(R2), "Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals," which FDA has adopted as guidance. A study is IND-enabling if its data is used to support the safety rationale in an IND submission's pharmacology/toxicology section (21 CFR 312.23(a)(8)) — as distinct from later-stage nonclinical studies (e.g., carcinogenicity, reproductive toxicology at later phases) conducted after first-in-human dosing has already begun, which support later clinical phases or the eventual marketing application rather than the initial IND filing itself.
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Converis (Clarivate) - CASRAI (2026)
Converis is Clarivate's commercial CRIS (Current Research Information System) product: a configurable platform that ingests publication and bibliometric data (including from Web of Science and other sources), manages pre-award and post-award research-project workflows, and exposes a public research-portal layer for institutions, funders, and national research agencies. An institution's software counts as an instance of Converis specifically when it is the Clarivate-branded, vendor-hosted or vendor-configured platform – not merely any locally-built research-activity database with similar functions.
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NIH Payline - CASRAI (2026)
An NIH payline is the percentile-rank (occasionally priority-score) threshold that a given National Institutes of Health institute or center (IC) publishes for a fiscal year as its planning guideline for which peer-reviewed grant applications it expects to fund. It is set independently by each of NIH's 27 ICs – there is no single, NIH-wide payline – and is recalculated annually against that year's appropriation, application volume, and research priorities. A payline is a budgeting and planning benchmark, not a binding rule: ICs retain discretion to fund some applications scoring outside the published payline (commonly called "select pay" or "exception pay") and to decline some scoring inside it, based on advisory council input and program priorities. As of late 2025, NIH has directed its ICs to move away from publishing fixed paylines in favor of weighing peer-review scores against institute priorities and budget more holistically – treat any specific payline figure as time- and institute-bound, and confirm current practice against the awarding IC's own guidance.
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HHS Grants Policy Statement (HHS GPS) - CASRAI (2026)
The HHS Grants Policy Statement (HHS GPS) is the U.S. Department of Health and Human Services' department-wide reference document setting out the general terms and conditions that apply to HHS discretionary grant and cooperative agreement awards. It is issued and maintained by HHS's Division of Policy, Oversight, Evaluation, and Training (DPOET), within the Office of the Assistant Secretary for Financial Resources (ASFR), and is incorporated by reference into the Notice of Award for HHS discretionary awards it covers. Critically, the HHS GPS is not universal across every HHS component: the National Institutes of Health maintains its own, separate NIH Grants Policy Statement (NIH GPS), and NIH awards are governed by that document rather than the HHS GPS. Other HHS operating divisions – including CDC, HRSA, SAMHSA, AHRQ, and ACF – use the HHS GPS as their primary grants policy document, in each case supplementing it with their own agency-specific program guidance where needed.
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SciVal - CASRAI (2026)
A subscription research-analytics platform, owned and sold by Elsevier, built on Scopus abstract and citation data, that lets research institutions, funders and government bodies benchmark research performance, track collaboration, and analyse societal and funding impact at the level of a researcher, department, institution, country or custom peer group. It is a reporting and benchmarking layer on top of Scopus rather than a separate bibliographic database of its own – everything SciVal shows is ultimately traceable back to a Scopus record.
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FDA Adverse Event Reporting System (FAERS) - CASRAI (2026)
A post-marketing surveillance database maintained by the U.S. Food and Drug Administration that collects reports of adverse events and medication errors associated with drugs and biologics already on the U.S. market. FAERS is fed by two distinct report streams: mandatory reports that drug and biologic manufacturers (application holders) are legally required to submit under 21 CFR 314.80 and 21 CFR 600.80, and voluntary reports submitted through MedWatch, FDA's Safety Information and Adverse Event Reporting Program, by healthcare professionals, patients, and consumers. FAERS is scoped to drugs and biologics only: vaccine adverse events go to VAERS (co-managed by CDC and FDA), device events go to MAUDE, and the EU's structural counterpart is EudraVigilance. It is also operationally distinct from the pre-market Investigational New Drug (IND) safety reporting obligations under 21 CFR 312.32: FAERS covers a marketed product's real-world use after approval, not an investigational product still under a trial protocol.
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Active Substance Master File (ASMF) - CASRAI (2026)
An EU/EEA regulatory submission format for a single active substance's manufacturing and quality-control data, split into a non-confidential Applicant's Part (submitted as part of a marketing authorisation application or IMPD) and a confidential Restricted Part (submitted directly to the competent authority by the active-substance manufacturer), and referenced by — never substituting for — the medicinal-product submission it supports.
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FDA Recognized Consensus Standards - CASRAI (2026)
An FDA Recognized Consensus Standard is a voluntary standard developed by a recognized standards development organization (SDO) – such as ISO, ASTM International, AAMI, IEC, or CLSI – that FDA has formally reviewed and added to its 'Recognized Consensus Standards: Medical Devices' database. A standard qualifies as an instance of this category only once FDA has completed its own review and listed it (with a recognition number and a stated extent of recognition – full, partial, or recognized with FDA-identified deviations); merely being a published ISO/ASTM/AAMI standard, or being commonly cited in industry practice, is not sufficient on its own. Recognition lets a device manufacturer submit a Declaration of Conformity (DoC) to that standard in a premarket submission – attesting the device conforms (in full or with disclosed deviations) and providing a summary of test methods and results – rather than submitting the full underlying test data for independent FDA review. The legal basis is Section 514 of the Federal Food, Drug, and Cosmetic Act, as amended by the FDA Modernization Act of 1997 (FDAMA), which directed FDA to establish this recognition process specifically to reduce duplicative review burden for both industry and the agency. FDA can also withdraw or limit recognition (for example when a standard is superseded by a newer edition), so the database – not the standard's existence or prior use – is the authoritative, current record of what may be cited via a DoC at any given time.
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Safety Data Exchange Agreement (SDEA) - CASRAI (2026)
A Safety Data Exchange Agreement (SDEA) is a written contract between two or more legally distinct parties who share development, marketing, licensing, distribution, or co-promotion rights to the same medicinal product, defining how each party will exchange safety information – adverse event and adverse drug reaction reports, product complaints with a safety component, literature findings, and aggregate safety reports – so that each party can independently meet its own national and regional pharmacovigilance reporting obligations. An agreement qualifies as an SDEA (rather than some other contract) when it specifies, at minimum: which party holds which pharmacovigilance responsibilities (case intake, medical review, causality assessment, expedited and periodic reporting, literature surveillance, signal detection); the format and timelines for exchanging individual case safety reports (ICSRs) and aggregate reports such as PSURs between the parties, typically set tighter than the underlying regulatory deadlines to leave room for each party's own downstream submission; reconciliation procedures to confirm no cases were missed on either side; and named contacts, including each party's Qualified Person Responsible for Pharmacovigilance (QPPV) where EU obligations apply. SDEAs are prepared with reference to ICH E2A/E2B/E2D definitions and reporting standards and, in the EU, to the EMA's Good Pharmacovigilance Practices (GVP) modules; they can be bipartite (two parties) or tripartite (three, e.g. when a contract research organization or specialty distributor is also party to the arrangement).
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Repository Citation - CASRAI (2026)
A repository citation is the reference used to attribute and locate a dataset (or other research output such as software or a physical sample) deposited in a data repository, built around a persistent identifier — typically a DOI minted via DataCite — rather than around the journal, volume, and page numbers used for an article citation. A citation counts as a repository citation when it points directly to the deposited data object itself (resolving through its own persistent identifier to the repository landing page or the data), not to a journal article, data paper, or other publication that merely describes or analyzes that data.
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Limited Data Set (HIPAA) - CASRAI (2026)
A dataset qualifies as a HIPAA limited data set under 45 CFR 164.514(e) when a covered entity removes the 16 direct identifiers enumerated at 164.514(e)(2) (names, contact details, medical record/account/certificate numbers, device and biometric identifiers, full-face photos, and similar) while retaining permitted indirect identifiers – full dates and geographic subdivisions down to town, city, state, and zip code – and discloses the resulting dataset only for research, public health, or health care operations to a recipient who has signed a Data Use Agreement restricting its use, access, safeguarding, and redisclosure, and prohibiting re-identification attempts. It remains protected health information (PHI) and stays subject to the Privacy Rule, unlike data that has been fully de-identified under 164.514(a)-(b).
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R21 (NIH Exploratory/Developmental Research Grant) - CASRAI (2026)
An NIH R-series research grant activity code — Exploratory/Developmental Research Grant Award — that funds early-stage, high-risk research not yet ready for the scale and preliminary-data expectations of an R01. R21 support is capped NIH-wide at $275,000 in total direct costs over a project period of no more than two years, with no more than $200,000 in any single year; most R21 Funding Opportunity Announcements (FOAs) explicitly do not require preliminary data. An R21 can stand alone or serve as the first, exploratory phase of a milestone-gated two-phase award paired with an R33 (the combined "R21/R33" mechanism).
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Independent Ethics Committee (IEC) - CASRAI (2026)
An Independent Ethics Committee (IEC) is the international/non-US regulatory term for the independent body that reviews and approves a clinical trial's protocol, informed consent materials, investigator qualifications, and facilities before enrollment begins, and continues to oversee the trial's ethical conduct throughout its life, to protect the rights, safety, and wellbeing of trial participants. It performs the identical core function as a US Institutional Review Board (IRB): both are independent bodies of medical, scientific, and non-scientific members that review research involving human subjects against the same underlying principles in ICH E6 Good Clinical Practice (GCP). The two terms describe the same regulatory role arising from different national and regional legal traditions, not two different sets of responsibilities – which is why ICH E6(R2) and industry practice almost always write the pairing as a single unit, 'IRB/IEC.'
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New Approach Methodologies (NAMs) - CASRAI (2026)
A technology or method (in vitro assay, organ-on-chip/microphysiological system, in silico/computational model, or human-relevant cell-based model) developed or applied specifically to generate safety/efficacy data in place of, or alongside, an animal study a regulatory pathway would otherwise require or expect. The "new approach" framing is relative to the existing animal-testing default in a given regulatory pathway (principally FDA drug/biologic review), not a general claim of scientific novelty for the underlying technology itself.
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R25 Grant (NIH Education/Research-Related Grant) - CASRAI (2026)
An NIH activity code for a research-education award, not a research-project grant: R25 funds are used to develop and/or deliver educational activities – courses, curricula, mentored or short-term research experiences, and outreach or career-transition programs – intended to strengthen the biomedical, behavioral, or clinical research workforce, rather than to fund a PD/PI's own independent research program. A given award is an R25 if its Notice of Award activity code reads 'R25,' its Funding Opportunity Announcement was issued under the NIH Research Education Program mechanism (parent FOAs such as PAR-27-034), and its aims describe an education/training program rather than a hypothesis-driven research plan.
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Concordat on Open Research Data - CASRAI (2026)
The Concordat on Open Research Data is a UK sector-wide policy framework, published 28 July 2016 by the Higher Education Funding Council for England (HEFCE), Research Councils UK (RCUK, since absorbed into UK Research and Innovation, UKRI), Universities UK, and the Wellcome Trust, setting out ten principles for how researchers, research organisations, and funders should approach making research data openly available. It is not a regulation, mandate, or legal instrument: an institution, funder, or research group operationalises the Concordat when its research data policy, Data Management Plan (DMP) guidance, or grant terms explicitly build in the ten principles — for example, requiring a documented, case-by-case justification for any restriction on data openness (Principle 2), recognising a researcher's right to a reasonable first-use period before data must be shared (Principle 4), or expecting data underlying a publication to be accessible, citable via a persistent identifier, and retained for at least ten years from the publication date (Principle 8).
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ICH Q/S/E/M Guideline Categories (Quality, Safety, Efficacy, Multidisciplinary) - CASRAI (2026)
The four-letter taxonomy the International Council for Harmonisation (ICH) uses to organize every technical guideline it publishes: Quality (Q) guidelines cover pharmaceutical development, manufacturing, and stability; Safety (S) guidelines cover nonclinical (in vitro and animal) safety testing such as carcinogenicity, genotoxicity, and reprotoxicity studies; Efficacy (E) guidelines cover the design, conduct, safety reporting, and analysis of human clinical trials, including ICH E6 Good Clinical Practice; and Multidisciplinary (M) guidelines cover cross-cutting topics that don't fit uniquely under Q, S, or E, such as the Common Technical Document (CTD) submission format and MedDRA terminology. Each guideline within a category carries a sequential number (e.g. Q1, S1, E1, M1) and, when revised, a parenthetical revision marker (e.g. E6(R2), E6(R3)); a document isn't a true ICH guideline unless it has progressed through the ICH multi-step process to at least Step 4 adoption by the ICH Assembly.
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Self-Citation Rate - CASRAI (2026)
The self-citation rate is the proportion of an entity's total citations that point back to its own prior output. At the author level, it is the share of citations to a researcher's work that were made by that same researcher (in a later paper, citing an earlier one). At the journal level, it is the share of citations counted toward a journal's metrics (most visibly its Journal Impact Factor in Journal Citation Reports, or its CiteScore in Scopus) that come from articles published in that same journal. In both cases the rate is a simple ratio: self-citations divided by total citations received, usually expressed as a percentage over a defined citation window (JCR uses the same two- and five-year windows it uses for the Journal Impact Factor itself). A nonzero self-citation rate is normal and expected — researchers build on their own prior work, and journals publish follow-on articles in an ongoing research area. The metric becomes a research-integrity concern only when the rate is unusually high relative to field and venue norms, which is treated as a signal of possible citation manipulation rather than of an intrinsic quality problem.
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InCites - CASRAI (2026)
A subscription research-evaluation and benchmarking platform, owned and sold by Clarivate, built on Web of Science Core Collection publication and citation data, that lets research institutions, funders, publishers and government bodies benchmark research performance, track collaboration, and analyse impact at the level of a researcher, department, institution, country, journal or custom peer group. It is a reporting and benchmarking layer on top of Web of Science rather than a separate bibliographic database of its own – everything InCites shows is ultimately traceable back to a Web of Science record. It is Clarivate's direct counterpart to Elsevier's Scopus-based SciVal.
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Technology Transfer - CASRAI (2026)
Technology transfer is the formal process by which discoveries, inventions, data, and know-how created at a university, government laboratory, hospital, or other research institution move into practical, commercial use outside that institution – typically through patenting and licensing to an existing company, or through the formation of a new company (a spinout or startup) built around the technology. A given activity counts as technology transfer when three elements are present together: (1) an underlying research output capable of being protected or transferred (an invention disclosure, patentable invention, copyrighted software, biological material, or dataset), (2) a formal instrument moving rights or materials to an outside party (a license agreement, material transfer agreement, or equity/founding arrangement for a spinout), and (3) an institutional office or function – almost always a Technology Transfer Office (TTO), sometimes branded an Office of Technology Licensing or Innovation and Commercialization Office – that manages the disclosure, IP protection, and negotiation on the institution's behalf. In the United States, technology transfer involving federally funded research operates inside the framework set by the Bayh-Dole Act of 1980, which lets universities and other recipients elect to retain title to inventions made under federal funding, in exchange for specific obligations including timely disclosure, a preference for U.S. manufacturing, and government march-in rights.
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Clinical Trial Data - CASRAI (2026)
Clinical trial data is any information generated or recorded during the conduct of a clinical trial that documents what happened to a participant, what was measured, or how the trial was run – from a clinician's original observation through to the frozen dataset submitted to a regulator. A given piece of information qualifies as clinical trial data if it is (a) collected under the trial's protocol, from an enrolled participant or the trial process itself, and (b) subject to the trial's data-integrity and traceability controls (audit trail, source-to-database verification, applicable regulatory retention rules) rather than being incidental or off-protocol information. It is a category, not a single artifact: it spans source data (the first recording of an observation), the case report form (CRF) data derived from that source, and the coded, cleaned, and locked datasets used for statistical analysis and regulatory submission.
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Research Pharmacy (Investigational Drug Service, IDS) - CASRAI (2026)
A research pharmacy — also called an Investigational Drug Service (IDS) — is the specialized pharmacy unit responsible for the receipt, storage, accountability, preparation, dispensing, and (where applicable) return or destruction of investigational products used in clinical trials, operating under the protocol and Good Clinical Practice (GCP) rather than under routine hospital-formulary dispensing rules. A pharmacy operation qualifies as a research pharmacy when it (1) receives and stores investigational product under sponsor- and manufacturer-specified conditions separate from commercial stock, (2) maintains a full chain-of-custody accountability record for every unit from receipt through final disposition, (3) dispenses only against a valid protocol-specific order tied to subject eligibility and randomization assignment, and (4) where the trial is blinded, restricts access to the randomization code to designated unblinded staff who function independently of the study team members assessing outcomes.
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Simulation of Clinical Trials - CASRAI (2026)
Simulation of clinical trials is the use of computational and statistical models – built from preclinical, pharmacokinetic/pharmacodynamic (PK/PD), and prior clinical data – to predict how a proposed trial design will behave before a single participant is enrolled. A model of the drug, the disease, and the trial process is run many times (commonly via Monte Carlo methods) under different design assumptions to forecast outcomes such as statistical power at a given sample size, the probability of correctly selecting a dose, or the operating characteristics of an adaptive design's decision rules. An activity counts as clinical trial simulation when it (1) uses an explicit quantitative model rather than a rule-of-thumb or expert-opinion estimate, (2) is applied prospectively, during design, to a specific trial or program decision – not retrospectively to explain results already observed, and (3) produces a distribution of possible outcomes across repeated in-silico trials rather than a single point estimate, letting designers see the probability of success under uncertainty rather than one deterministic answer.
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FDA Form 356h - CASRAI (2026)
FDA Form 356h ("Application to Market a New or Abbreviated New Drug or Biologic for Human Use") is the standardized cover form an applicant files with a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA). It identifies the applicant and product, states the application type and submission type (original, resubmission, or supplement), indexes the enclosed technical sections, and carries the signed certification statements required for FDA to accept the submission for review. It applies only to drug/biologic marketing applications reviewed by CDER or CBER – it is not used for medical device submissions, which use a separate CDRH cover sheet (Form 3514).
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FDA Priority Review - CASRAI (2026)
FDA Priority Review is a designation FDA assigns to a marketing application (a New Drug Application, Biologics License Application, or efficacy supplement) for a drug or biologic that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition, compared with available therapy. A Priority Review designation sets FDA's internal review-clock goal at 6 months from the filing date for a first review cycle, instead of the 10-month goal that applies to a Standard Review application. It is one of FDA's four expedited programs for serious conditions, alongside Fast Track, Breakthrough Therapy designation, and Accelerated Approval, but unlike the other three it is a review-timeline classification tied to a completed application rather than a designation sponsors typically request earlier in development.
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IRB Chair - CASRAI (2026)
The IRB Chair is the IRB member designated to preside over the board's convened meetings and to personally conduct, or assign to an experienced board member, expedited-review determinations under 45 CFR 46.110 / 21 CFR 56.110 – distinct from a regular voting IRB member (no presiding or independent expedited-review authority) and from the institution's Designated Institutional Official / FWA-signing Institutional Official (an institution-wide compliance-commitment role, not a board-review role).
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Bring Your Own Device (BYOD) for Research Data Collection - CASRAI (2026)
In research data collection, BYOD (bring your own device) is a practice in which participants or researchers use their own personally-owned smartphone, tablet, or wearable – rather than a device supplied, configured, and owned by the study – to run a data-collection app or sensor. What makes an instance BYOD is device ownership and control: the hardware belongs to the participant or researcher, not the study team, so the study cannot fully standardize, lock down, or reclaim it, and must build its data-integrity and security controls around that constraint.
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PREMIS - CASRAI (2026)
A resource's metadata qualifies as PREMIS metadata when it is structured according to the PREMIS Data Dictionary for Preservation Metadata (currently version 3.0, maintained by the Library of Congress), populating semantic units under one or more of PREMIS's four in-scope entities — Object, Event, Agent, and Rights — to document what a digital object is, what has happened to it over time, who or what acted on it, and what permissions govern its preservation. PREMIS is a data dictionary, not a file format or package standard in the way METS is; it is most commonly implemented as an XML schema (premis.xsd) embedded inside a METS document's administrative metadata section, or serialized natively inside a repository's own preservation system.
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ECCN Determination Process - CASRAI (2026)
The process by which a specific item, technology, or piece of software is assigned an Export Control Classification Number (ECCN) under the US Export Administration Regulations (EAR, 15 CFR 730-774), determining whether and how it is controlled for export under the Commerce Control List (CCL) administered by the Department of Commerce's Bureau of Industry and Security (BIS). An item is either classified against a specific ECCN entry on the CCL, or, if it is subject to the EAR but matches no CCL entry, falls into the residual 'EAR99' catch-all category. Determination can be done in-house by self-classification against the CCL, or by requesting a formal, binding Commodity Classification from BIS (a Commodity Classification Automated Tracking System, or CCATS, determination). In a university research setting, the outcome of this determination is a prerequisite input to fundamental research exclusion analysis: the exclusion (rooted in NSDD-189, 1985) can remove a project's published *results* from EAR/ITAR control, but it does not retroactively declassify a controlled *item, software, or technical data set* used to get there – so export control offices classify the underlying technology first, independent of whether the surrounding research is intended for open publication.
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Inducements in Research (Undue Inducement) - CASRAI (2026)
An inducement is any payment, benefit, or opportunity a researcher offers to encourage a prospective participant to enroll in or remain in a study. Offering compensation is not itself a problem: the Belmont Report's respect-for-persons and beneficence principles, and their regulatory implementation at 45 CFR 46.116(a)(1) (Common Rule) and 21 CFR 50.20 (FDA), treat reasonable payment for time and burden as compatible with voluntary consent. An inducement becomes an undue inducement when its size or structure is large enough, or contingent enough, to impair a prospective participant's ability to weigh the study's risks and benefits rationally – functioning as pressure to enroll or stay enrolled rather than as compensation for burden. Under 45 CFR 46.111(b), an IRB must determine that consent will be sought under circumstances that minimize the possibility of coercion or undue influence; review of the payment plan (amount, schedule, and any completion contingency) is the concrete mechanism through which that determination gets made for offers of payment specifically.
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Risk Indicators and Risk Thresholds - CASRAI (2026)
A risk indicator is a specific, observable fact about an applicant, recipient, or subrecipient that correlates with an elevated likelihood of noncompliance, financial mismanagement, or poor performance on a federal award — for example, a prior single audit finding, financial instability, a new or first-time awardee with no federal-award history, or an irregular or unnegotiated F&A (indirect cost) rate. A risk threshold is the predetermined materiality level at which an accumulation or severity of risk indicators requires an awarding agency or pass-through entity to escalate its oversight response — from routine monitoring to enhanced monitoring, imposition of specific award conditions, or formal high-risk designation. Together they form the operating vocabulary of risk-based monitoring: instead of applying identical oversight to every award in a portfolio, an agency or institution calibrates monitoring intensity to where the indicators and thresholds say the actual risk is concentrated.
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Program Officer - CASRAI (2026)
A program officer (sometimes called a program director or program official, depending on the funder) is the funding-agency or foundation staff member who manages a defined portfolio of grants within a scientific, technical, or thematic program area and serves as the primary point of contact between the funder and applicants/awardees throughout the funding lifecycle — before submission (fit-to-program questions, letters of intent), during review (assembling panels, contextualizing scientific merit for funding decisions), and after award (progress-report monitoring, no-cost extensions, scope changes, and, at many agencies, the funder's side of pre-award and post-award programmatic decisions). A person or role counts as a program officer when three things are true together: they hold programmatic (not purely administrative/financial) authority over which proposals get recommended for funding within their portfolio; they are the named contact awardees are expected to reach for scientific or programmatic questions about an active or prospective award; and their responsibility is bounded to a defined subject area, directorate, or program rather than the funder's entire portfolio.
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Clinical Study Report (CSR) - CASRAI (2026)
A Clinical Study Report (CSR) is the comprehensive, standalone document summarizing the design, conduct, and results of a single clinical trial, prepared in the format defined by ICH E3 (Structure and Content of Clinical Study Reports) so that any ICH regulatory authority can evaluate the trial on its own terms. A document qualifies as a CSR, rather than a lesser trial-reporting artifact, when it (a) integrates the full trial narrative – objectives, methods, efficacy and safety results, and statistical analyses – into one report keyed to a specific protocol, and (b) is structured to ICH E3's numbered outline (title page; a roughly three-page synopsis; ethics; investigators; introduction; study objectives; investigational plan; study patients; efficacy and safety evaluation; discussion and conclusions; tables, figures, and appendices), whether or not every section header is used verbatim. A CSR is compiled after database lock, once the trial's data are final, and is submitted to regulators as part of a marketing application (e.g., an NDA, BLA, or MAA) rather than published as an independent research output.
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Washout Period - CASRAI (2026)
In a crossover clinical trial, a washout period is the interval deliberately built between two consecutive treatment periods during which no study intervention is administered, allowing the effects of the treatment given in the prior period to dissipate before the next treatment period begins. Its function is to prevent a carryover effect – a residual pharmacological, physiological, or symptomatic effect of the earlier treatment contaminating the outcome measurements taken during the following period. A washout period is only meaningful in designs where the same participant receives more than one treatment in sequence (crossover and N-of-1 designs); it has no equivalent in a parallel-group design, where each participant receives only one treatment for the trial's duration. The length of a washout period is a protocol-specified design parameter, not an incidental gap in scheduling: it is set during protocol development, justified in the statistical analysis plan, and reviewed by the IRB/ethics committee as part of the overall trial design.
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DDI Codebook - CASRAI (2026)
A metadata document is an instance of DDI Codebook (DDI-C) when it is a well-formed XML file rooted at the <codeBook> element and containing the DDI Alliance's standard sections for describing a single dataset: a study description (title, authors, abstract, methodology, sampling procedure), a file description of the physical data file, and a data description that documents each variable individually, including its name, label, question text, value labels, and universe. It is maintained by the DDI Alliance and versioned (current releases in the 2.x line, e.g. 2.5/2.6); it is the single-dataset-focused branch of DDI, distinct from the multi-wave/lifecycle-tracking DDI Lifecycle (DDI 3.x) specification.
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Clinical Trial Associate (CTA) - CASRAI (2026)
A Clinical Trial Associate (CTA) is an entry-level, sponsor- or CRO-side administrative and project-tracking support role for clinical trials. A CTA maintains the Trial Master File (TMF) and site regulatory documents, schedules meetings and site visits, tracks study timelines and action items, and supports the Clinical Research Associate (CRA)/monitor's workload – without independently conducting site monitoring visits or exercising the CRA's oversight authority over site conduct. Regardless of exact job title, a role counts as CTA-function work when it is administrative/logistical support performed on behalf of the sponsor or CRO team, not independent site oversight (that is the CRA function) and not day-to-day study conduct at the site itself (that is the Clinical Research Coordinator, or CRC, function).
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SCORE (Systematizing Confidence in Open Research and Evidence) - CASRAI (2026)
A DARPA-funded research program, run by DARPA's Defense Sciences Office from 2019 to roughly 2022, that tested whether quantitative 'confidence scores' – generated from human forecasting/prediction markets, expert surveys, and automated algorithms – could reliably estimate how likely a published social and behavioral science (SBS) claim was to replicate. The program sampled around 3,000 research claims from roughly 60 journals published between 2009 and 2018, had forecasters and algorithms score them before any new data collection, then commissioned independent replications on a subsample to check which forecasting method came closest to the actual outcome. It is now complete; DARPA lists it as inactive and retained for reference.
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CAP Biorepository Accreditation Program (CAP-BAP) - CASRAI (2026)
The CAP Biorepository Accreditation Program (CAP-BAP) is a voluntary, formal accreditation program run by the College of American Pathologists (CAP), established in 2012 as the first accreditation program specifically for biorepositories. A biorepository is accredited when it undergoes and passes an on-site peer-inspection assessment against a defined set of CAP accreditation checklists covering the Biorepository-specific checklist plus the shared Laboratory General, Director Assessment, and All Common checklists, is re-inspected on-site every two years, and completes a self-inspection using the same checklists in the intervening off-year. The checklists address consent and protection of research participants, specimen collection and chain of custody, institutional governance documents such as material transfer agreements, and long-term preservation infrastructure (equipment maintenance, temperature monitoring, backup systems). CAP-BAP draws on guidance from ISBER, the NCI, and the OECD in building its checklists but is itself a distinct, CAP-branded accreditation credential, not a re-badging of either.
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NNN Agreement (Non-Disclosure, Non-Use, Non-Circumvention Agreement) - CASRAI (2026)
A hybrid contract – combining non-disclosure, non-use, and non-circumvention clauses – used when a research institution or inventor discloses confidential technical information to a prospective foreign manufacturing or licensing partner, most commonly a China-based manufacturer, where a standalone confidentiality (NDA) clause is often difficult to enforce or insufficient in scope.
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ICF (Informed Consent Form) - CASRAI (2026)
The specific written document, IRB-approved before use, that restates a study's required disclosure elements (45 CFR 46.116(b)-(c); for FDA-regulated research, 21 CFR 50.25) for a prospective participant to read and sign. Distinct from the informed-consent process itself, which is documented separately under 45 CFR 46.117 / 21 CFR 50.27 and can, in limited cases (e.g. a documentation waiver, or the short-form pathway for non-English speakers), occur without a conventional long-form signed ICF.
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Phase 1 Trial - CASRAI (2026)
A Phase 1 trial is the first stage of human testing for an investigational drug or biologic under an IND (21 CFR 312.21), where the primary endpoints are safety, tolerability, pharmacokinetics/pharmacodynamics, and dosing rather than efficacy. It typically enrolls a small cohort (roughly 20-80 participants), advances doses through a pre-specified dose-escalation design (commonly 3+3 or rolling six) governed by dose-limiting toxicity (DLT) criteria, and concludes by establishing a maximum tolerated dose (MTD) and/or a recommended Phase 2 dose (RP2D) that later phases carry forward.
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Conflict of Commitment (COC) - CASRAI (2026)
A conflict of commitment (COC) exists when the time and effort a researcher or faculty member devotes to outside professional activities – consulting, a second job, board service, an external appointment, or a startup role – interferes with, or exceeds institutional limits on, the effort owed to their primary institutional obligations. It is a time-allocation problem, not a financial-bias problem: a COC can exist with no money involved (an unpaid but time-consuming board seat), and a significant financial conflict of interest can exist with no conflict of commitment at all (passive equity with no time commitment). Institutions typically manage COC through annual outside-activities disclosure, defined time caps, and cross-checking against sponsored-award effort reporting, distinct from the financial-disclosure process used for conflict of interest.
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eRA Commons ID - CASRAI (2026)
An eRA Commons ID (also called a Commons ID or Commons username) is the individual login credential issued within the National Institutes of Health’s Electronic Research Administration (eRA) system, required for any person who needs to be named on, or take action within, an NIH grant application or award. This includes the Program Director/Principal Investigator (PD/PI), every other Senior/Key Personnel and Other Significant Contributor named on an application, trainees on training and career-development awards, and the institutional Signing Officials and Account Administrators who manage the organization’s eRA profile. The same Commons ID is used across eRA Commons itself and the linked application/reporting modules — ASSIST (grant application preparation and submission), xTrain (trainee appointment and stipend management on T, F, and K training mechanisms), and RPPR (Research Performance Progress Report) — so a person keeps one Commons ID for their entire NIH-facing career rather than a new one per application, institution move, or award. A defining operational feature is that individuals cannot self-register for an eRA Commons ID. Only a Signing Official (the institution’s Authorized Organizational Representative) or an Account Administrator at an institution already registered in eRA Commons can create an account and issue a Commons ID to a PI, trainee, or other key personnel. A PD/PI cannot create their own account and must go through their institution’s Signing Official or Commons administrator to be registered. When a person moves institutions, their existing Commons ID is typically affiliated with the new institution rather than replaced, preserving continuity of their NIH grant history under one identifier.
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ISO 20387 (Biobanking) - CASRAI (2026)
ISO 20387:2018, Biotechnology — Biobanking — General requirements for biobanking, is the international standard specifying requirements for the competence, impartiality, and consistent operation of biobanks. It applies to organisations biobanking biological material and associated data from humans, animals, plants, fungi, and microorganisms for research and development, covering the full chain of collection, preparation, preservation, storage, and distribution of biospecimens. Structurally, it draws on the general competence requirements of ISO/IEC 17025 (testing and calibration laboratories) and the quality-management-system requirements of ISO 9001, adapted specifically for biobanking. A biobank meets ISO 20387 when a national accreditation body (for example UKAS in the UK or ANAB in the US, both operating under the same international accreditation framework as ISO/IEC 17025 labs) has formally assessed and accredited its quality management system, sample traceability, and impartiality — not merely when it follows informal best-practice guidance.
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Data Stewardship Wizard (DSW) - CASRAI (2026)
An open-source, self-hostable DMP-authoring platform that generates data management plans from versioned, branching questionnaire 'knowledge models' rather than static funder templates, developed and stewarded as an ELIXIR infrastructure tool and released under the Apache License 2.0.
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W3C DCAT (Data Catalog Vocabulary) - CASRAI (2026)
DCAT (Data Catalog Vocabulary) is a W3C Recommendation: an RDF vocabulary, published under the namespace http://www.w3.org/ns/dcat#, for describing datasets, dataset series, distributions, and data services within a data catalog so that catalogs published by different organizations can be harvested, aggregated, and searched interoperably. A metadata record qualifies as DCAT (rather than a merely similar, ad hoc catalog schema) when its fields map to DCAT's own RDF classes and properties – dcat:Catalog, dcat:Dataset, dcat:Distribution, dcat:DataService, dcat:DatasetSeries, and dcat:CatalogRecord, built on top of Dublin Core, FOAF, SKOS, and PROV-O terms rather than a locally invented field set – and is expressed (or losslessly convertible to) RDF, typically serialized as JSON-LD, Turtle, or RDF/XML.
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35 U.S.C. § 282 (Presumption of Patent Validity and Invalidity Defenses) - CASRAI (2026)
35 U.S.C. § 282 is the U.S. Patent Act provision that (a) presumes an issued patent, and each claim of it independently, to be valid, and places the burden of proving otherwise on the party asserting invalidity, and (b) lists the categories of defenses available to a defendant in a patent infringement action. A fact pattern is governed by § 282 whenever an issued U.S. patent's validity or enforceability is being contested in litigation — as opposed to during examination at the USPTO, where no presumption of validity yet applies because no patent has issued. Under § 282(a), the presumption attaches at issuance and survives even when the challenged claim relies on prior art the examiner never considered; it does not evaporate simply because a defendant produces new references. In Microsoft Corp. v. i4i Limited Partnership, 564 U.S. 91 (2011), the Supreme Court held that § 282's presumption requires invalidity to be proved by clear and convincing evidence — a heightened standard above the ordinary civil preponderance-of-the-evidence standard — and that this standard applies uniformly, including to prior art the USPTO never examined. § 282(b) enumerates the defenses a party may raise in a patent action: (1) noninfringement, absence of liability for infringement, or unenforceability; (2) invalidity of the patent or any claim on any ground specified in Part II of the Patent Act as a condition for patentability — in practice this reaches novelty (35 U.S.C. § 102), obviousness (35 U.S.C. § 103), and subject-matter eligibility (35 U.S.C. § 101); (3) invalidity for failure to comply with the specification, enablement, written-description, or definiteness requirements of 35 U.S.C. § 112, or of § 251 (reissue); and (4) any other fact or act made a defense by the Patent Act. Indefiniteness under § 112(b) and lack of enablement under § 112(a) are both raised as § 282(b)(3) defenses, distinct from the novelty and obviousness grounds raised under § 282(b)(2).
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MSCA Postdoctoral Fellowship - CASRAI (2026)
An MSCA Postdoctoral Fellowship is an individually held European Union research grant, funded under Horizon Europe's Marie Skłodowska-Curie Actions (MSCA), awarded jointly to a researcher who already holds a doctoral degree (or has defended a thesis, not yet formally awarded) and a host organisation that will supervise and train them. It is not a consortium grant: unlike MSCA Doctoral Networks, which fund multi-partner training partnerships for pre-PhD doctoral candidates, a Postdoctoral Fellowship is competed for and held by one named researcher at one host institution (with optional short secondments elsewhere). Eligibility is capped at a maximum of eight years of full-time-equivalent research experience since the award of the PhD, excluding documented career breaks, and subject to MSCA's standard mobility rule (the researcher must not have resided or carried out their main activity in the host country for more than 12 of the 36 months immediately before the call deadline). The action comes in two tracks – European Postdoctoral Fellowships (1-2 years, host in an EU Member State or Horizon Europe Associated Country, open to researchers of any nationality) and Global Postdoctoral Fellowships (2-3 years total: an outgoing phase of 1-2 years at a host in a non-associated Third Country, followed by a mandatory 1-year return phase at a European host, restricted to nationals or long-term residents of an EU Member State or Associated Country). Funding is paid as EU-wide unit costs – a living allowance, mobility allowance, and, where applicable, family, long-term leave, and special needs allowances, plus separate research/training/networking and management/indirect-cost contributions to the host – rather than as an institution-set salary. “MSCA Postdoctoral Fellowships” is the Horizon Europe (2021-2027) name for what was called “Individual Fellowships (IF)” under Horizon 2020; the underlying individually-held, PhD-holder-only mechanism carried over largely unchanged through the rename.
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File Wrapper (USPTO) - CASRAI (2026)
The file wrapper — also called the prosecution history or file history — is the complete official record the U.S. Patent and Trademark Office (USPTO) maintains for a patent application from filing through issuance (or abandonment) and any subsequent post-grant proceedings. It contains every document that passed between the applicant (or the applicant's patent attorney/agent) and the examiner: the application as originally filed, office actions (rejections and objections), applicant responses and claim amendments, examiner's amendments, interview summaries, information disclosure statements (IDS) citing prior art, terminal disclaimers, notices of allowance, and the issued patent itself. The term is a holdover from the paper era, when each application's papers were literally kept in a manila file wrapper; the record is now maintained and served digitally. A document set counts as part of the file wrapper if and only if it was formally entered into the application's official record by the USPTO — informal correspondence, examiner's personal notes not made of record, and an applicant's internal drafts never filed do not qualify, even if they discuss the same application.
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Shared Investigator Platform (SIP) - CASRAI (2026)
The Shared Investigator Platform (SIP) is an industry-wide technology platform, originally developed by TransCelerate BioPharma and now operated by Cognizant, that lets clinical investigators and site staff maintain a single reusable profile – credentials, training records, Good Clinical Practice (GCP) certifications, CVs, and facility/equipment information – and share it across multiple participating sponsors and CROs, instead of re-submitting the same regulatory and qualification documentation separately to every sponsor for every study. A site interaction counts as using SIP, as distinct from a sponsor's own proprietary site portal, when: (1) the site maintains one Facility Profile and individual user profiles through a single central platform account rather than a sponsor-specific login; (2) that profile data – training certificates, licenses, CVs, financial disclosure and other startup documents – is entered once and then made visible, on the site's authorization, to any participating sponsor running a study at that site; and (3) study start-up and conduct activities (document exchange, study-specific training assignment, communication) for a given trial route through the shared platform rather than a separate sponsor-built system. TransCelerate's own Shared Investigator Platform Initiative reached completion in 2020 – TransCelerate states no new deliverables or updates are planned by the organization – and the platform is now owned and operated by Cognizant; sponsor and CRO adoption is voluntary and platform use for a given study still depends on which sponsor is running it.
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FDA Biosimilars (351(k) Pathway) - CASRAI (2026)
An FDA biosimilar is a biological product approved under section 351(k) of the Public Health Service Act (42 U.S.C. § 262(k)) — an abbreviated licensure pathway, distinct from the standard 351(a) Biologics License Application (BLA) route, under which a sponsor relies on an existing FDA-licensed reference product rather than generating the full standalone clinical package a 351(a) BLA requires. A product qualifies as a biosimilar only when FDA determines, on the totality of the evidence, that it is highly similar to the reference product notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between the two products in terms of safety, purity, and potency. A biosimilar may additionally earn an interchangeable designation, a higher bar that permits pharmacy-level substitution for the reference product without the prescriber's intervention, subject to state pharmacy-substitution law.
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ISO 23081 (Records Management Processes — Metadata for Records) - CASRAI (2026)
ISO 23081 (Information and documentation — Records management processes — Metadata for records) is the ISO standard that defines the principles and framework governing the metadata records systems must capture so that records can be managed, retrieved, and trusted as evidence throughout their lifecycle. A metadata scheme qualifies as ISO 23081-aligned when it goes beyond simple descriptive metadata (title, creator, date) to capture recordkeeping context: the business process or mandate that created the record, the agents responsible for it, its relationships to other records and aggregations, and its retention/disposition authority. The standard is published in three parts: Part 1 sets out the principles underpinning records metadata; Part 2 gives conceptual and implementation guidance for building a metadata schema consistent with Part 1; Part 3, published as a Technical Report, provides a self-assessment method for evaluating an existing metadata schema against the standard. ISO 23081 was developed by ISO/TC 46/SC 11 as a companion to ISO 15489 (the core international records management standard), translating 15489's principles into a concrete metadata model that records-management systems, archives, and institutional repositories can actually implement.
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Peer Review - CASRAI (2026)
A work is peer reviewed when, before publication, an editor sends it to one or more independent experts in the same field (peer reviewers) who evaluate its methodology, validity, originality, and significance, and the editor uses that written feedback to decide whether to accept, reject, or require revisions. Three elements distinguish genuine peer review from ordinary editorial handling: (1) the reviewers are subject-matter experts external to the editorial staff, not merely copy-editors; (2) the review is documented (recorded reviewer reports, even if reviewer identity is withheld from the author); and (3) the outcome materially gates publication rather than serving as optional feedback offered after the fact. The specific procedure varies by venue — reviewer and author identities may or may not be disclosed to each other (single-anonymized, double-anonymized, or open review), and some venues review a study's protocol before results exist (registered reports) rather than only the finished manuscript — but the core requirement of independent expert gatekeeping prior to publication is common to all forms. A 'peer-reviewed journal' is simply a journal that applies this process, as a matter of documented policy, to the research articles it publishes.
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Development Safety Update Report (DSUR) - CASRAI (2026)
The ICH E2F-standardized annual aggregate safety report a sponsor prepares for an investigational product's whole development program as of a single yearly data-lock point, summarizing accumulated safety data across all its trials worldwide and assessing the product's evolving benefit-risk profile — distinct from the event-triggered expedited SUSAR reporting required under 21 CFR 312.32, and often submitted in place of the separate US IND annual report under 21 CFR 312.33.
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Google Scholar Metrics - CASRAI (2026)
Google Scholar Metrics is a free tool built into Google Scholar that ranks publication venues – journals, conference proceedings, and some preprint repositories – by an automatically-computed h5-index, rather than ranking individual authors. A source counts as covered by Google Scholar Metrics only once it clears fixed inclusion thresholds (at minimum roughly 100 articles published within the most recent five complete calendar years, with at least some citations to those articles); anything below that threshold simply does not appear, regardless of quality. It is a venue-level ranking feature, not an author-level metric – it should never be confused with an individual researcher's h-index or i10-index, which Google Scholar computes separately inside a personal Google Scholar Citations profile.
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EU AI Act Article 10 (Data and Data Governance) - CASRAI (2026)
Article 10 of the EU AI Act (Regulation (EU) 2024/1689), in Title III, Chapter 2, sets the data-quality and data-governance obligations for the training, validation, and testing datasets used to build high-risk AI systems. A system falls under Article 10 only after it has already met the Act's separate 'high-risk' classification test (an Annex III listed use case, or a safety component covered by Annex I sectoral product law). For a high-risk system built using techniques that involve training models on data, Article 10(2) requires documented data-governance practices covering collection and origin, preparation operations (annotation, labelling, cleaning, updating, enrichment), bias examination, bias-mitigation measures, and identification of data gaps; Article 10(3)-(4) require the training, validation, and testing datasets to be relevant, sufficiently representative, and to the best extent possible free of errors and complete for the system's intended purpose and deployment context. For a high-risk system that does not use such training techniques, Article 10(6) narrows the same requirements to the testing dataset only. Article 10(5) separately permits limited, safeguarded processing of special-category personal data solely to detect and correct bias. It does not apply to AI systems or models developed and used solely for scientific research and development prior to being placed on the market or put into service, per the Article 2(6)/2(8) research exemption.
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eCTD (Electronic Common Technical Document) - CASRAI (2026)
A regulatory submission qualifies as an eCTD only when its files are organized into the standardized five-module folder hierarchy (Module 1 region-specific administrative/prescribing information, Module 2 CTD summaries, Module 3 quality/CMC, Module 4 nonclinical study reports, Module 5 clinical study reports) AND wrapped in an XML backbone (index.xml) that assigns each file lifecycle-operation metadata (new, append, replace, delete) so a reviewer's system and the sponsor's own submission history can track changes across amendments to the same application. A folder of complete, correctly-labeled PDFs that lacks the XML backbone and Module 1-5 structure is not an eCTD, regardless of content completeness.
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Journal Article Reporting Standards (JARS) - CASRAI (2026)
Journal Article Reporting Standards (JARS) is the American Psychological Association's set of manuscript-section reporting requirements, published as part of APA Style and incorporated into the Publication Manual of the APA (7th edition). A manuscript is JARS-compliant when the author has followed the module matching its research design: JARS-Quant for quantitative studies (numerical data, statistical analysis), JARS-Qual for qualitative studies (natural-language, descriptive, or interview-based data), or JARS-Mixed for studies combining both. A cross-cutting fourth module, JARS-Race, Ethnicity, and Culture (JARS-REC), adds reporting expectations for how race, ethnicity, and culture are described and analyzed, and applies regardless of which core module a study uses. Each module specifies, section by section (title/abstract, introduction, method, results, discussion), the minimum information a submission must state – for example, JARS-Quant requires reporting exact sample-size determination and any data exclusions; JARS-Qual requires describing the researcher's own standpoint and role in relation to the data. JARS is APA's own umbrella framework and is distinct from discipline- or design-specific reporting guidelines such as PRISMA (systematic reviews), CONSORT (randomized trials), or COREQ/SRQR (qualitative research specifically) – a paper can be asked to satisfy JARS alongside one of those other checklists, not instead of it, since JARS covers general manuscript-section content while the others target a specific study design in more procedural depth.
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Good Clinical Laboratory Practice (GCLP) - CASRAI (2026)
Good Clinical Laboratory Practice (GCLP) is the quality standard governing laboratories that analyze human-derived samples from clinical trials – most centrally bioanalytical work such as pharmacokinetic (PK) sample analysis, biomarker assays, and other trial-support testing. It is a hybrid standard: it applies the study-control, quality-assurance, and data-integrity discipline of Good Laboratory Practice (GLP) – normally written for preclinical, non-human studies under 21 CFR Part 58 – to a clinical-trial, human-sample setting, while also incorporating the trial-conduct and subject-protection principles of Good Clinical Practice (GCP) (ICH E6). A laboratory qualifies as GCLP-compliant when it operates a documented quality management system covering facility/equipment qualification, personnel training records, standard operating procedures, sample chain-of-custody and traceability back to the clinical trial subject, method validation, raw-data integrity and retention, and independent quality assurance oversight – applied specifically to samples originating from a clinical trial rather than a preclinical study or routine diagnostic workload.
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GDPR Article 44 (International Data Transfers) - CASRAI (2026)
GDPR Article 44 is the opening provision of Chapter V of the EU General Data Protection Regulation, and states the general principle that governs every transfer of personal data out of the European Economic Area: a transfer to a third country or international organisation may only take place if the conditions in the rest of Chapter V are satisfied, and the level of protection guaranteed by the GDPR must not be undermined – including for onward transfers from the receiving third country to yet another third country. Article 44 does not itself supply a transfer mechanism; it is the trigger that makes Articles 45-49 mandatory whenever personal data (including pseudonymised research data that remains personal data, per GDPR Article 4(5)) leaves the EEA. For a research collaboration, that means every step of a project involving a non-EEA partner – shipping a dataset to a US co-investigator, hosting trial data on a non-EEA cloud region, or granting a non-EEA collaborator remote access to an EEA-hosted database – is a Chapter V transfer, whether or not it is described as a 'transfer' in the project's data management plan.
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Human Research Protection Program (HRPP) - CASRAI (2026)
A Human Research Protection Program (HRPP) is the complete organizational structure an institution operates to protect the rights and welfare of human research participants – not a single committee, but the full system of one or more Institutional Review Boards (IRBs), written policies and procedures, an institutional compliance/administrative office, researcher training requirements, conflict-of-interest management, and ongoing monitoring of active research, all operating under the institution's Federalwide Assurance (FWA) with HHS's Office for Human Research Protections (OHRP). The IRB is the HRPP's core review committee, not the whole program; AAHRPP is the external body that voluntarily accredits an institution's HRPP as a unit. An institution operates an HRPP whether or not it ever seeks AAHRPP accreditation – running a compliant HRPP under the Common Rule (45 CFR 46) and applicable FDA regulations is a baseline legal requirement for institutions conducting covered human-subjects research; AAHRPP accreditation is an optional, additional layer of external, third-party verification on top of it.
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U54 Grant (NIH Specialized Center Cooperative Agreement) - CASRAI (2026)
A U54 (Specialized Center Cooperative Agreement) is an NIH activity code for a single award that funds a multi-project, multidisciplinary research center built around one specific disease or biomedical problem area, funded as a cooperative agreement rather than a grant. That means NIH anticipates substantial, ongoing programmatic involvement in the funded center after award – NIH staff assist, guide, coordinate, or participate in center activities – distinguishing it from the P01 Research Program Project Grant, which funds a similarly multi-project, multi-core structure without that level of federal involvement.
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ANSI/NISO Z39.19 (Controlled Vocabularies and Thesauri) - CASRAI (2026)
A controlled vocabulary or thesaurus is constructed to ANSI/NISO Z39.19-2005 (R2010), "Guidelines for the Construction, Format, and Management of Monolingual Controlled Vocabularies," when it follows the standard's rules for term selection and form (preferring noun phrases, singular/plural conventions, avoiding ambiguous homographs without a qualifier), and when it displays the three relationship types Z39.19 defines between terms: equivalence relationships (USE/UF, linking a non-preferred synonym to its preferred term), hierarchical relationships (BT/NT, Broader Term/Narrower Term, for genus-species, whole-part, or instance relationships), and associative relationships (RT, Related Term, for terms that are conceptually related but not synonymous or hierarchical). The standard covers several vocabulary types along a spectrum of structural complexity – authority lists, synonym rings, taxonomies, and full thesauri – and specifies how each should be tested, formatted, and maintained over time (adding, deprecating, and merging terms as usage and the underlying domain evolve).
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Prior Approval - CASRAI (2026)
Prior approval (sometimes written “prior written approval”) is the requirement, under 2 CFR 200.407 of the OMB Uniform Guidance, that a federal grant recipient obtain the federal awarding agency’s written sign-off before taking a specified action, rather than proceeding and defending the decision after the fact. Something is genuinely a “prior approval” matter — as opposed to routine project management the recipient can handle on its own authority — only if it falls into one of the categories the regulation or the recipient’s own award terms specifically names. Section 200.407 lists sixteen such categories, including cost sharing (200.306), program income (200.307), revision of budget and program plans (200.308), fixed-amount subawards (200.333), compensation for personal services and fringe benefits (200.430–200.431), equipment and capital expenditures (200.439), exchange-rate losses (200.440), fines and penalties (200.441), fundraising costs (200.442), goods or services for personal use (200.445), insurance and indemnification (200.447), organization costs (200.455), pre-award costs (200.458), rearrangement and reconversion costs (200.462), and travel costs (200.475). The regulation is explicit that the absence of prior approval does not, by itself, make a cost unreasonable or unallocable unless prior approval is specifically required for that item — the requirement only bites where it is named. The most frequently triggered prior-approval events sit inside 2 CFR 200.308, “Revision of budget and program plans,” which requires a recipient to ask before: changing the scope or objective of the project (even without any budget change), changing key personnel identified by name or position in the award, a PD/PI disengaging from the project for more than three months or reducing time and effort on it by 25 percent or more, redirecting participant support costs to other budget categories, adding a subaward not proposed in the original application, changing the total approved cost-sharing amount, needing additional federal funds to complete the project, moving funds between construction and non-construction categories, or extending the project period beyond what the recipient’s own expanded/automatic authority already covers. Because 200.308’s list is itself an enumerated set — not a general “ask if unsure” standard — a change that doesn’t match one of its named triggers, or one of 200.407’s other named cost categories, does not require prior approval merely because it feels significant to the PI.
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Rigor and Transparency Index (RTI) - CASRAI (2026)
The Rigor and Transparency Index (RTI) is the average SciScore — an automated score of methods-rigor and resource-identification reporting — across a journal's or institution's articles in a given year, published by SciCrunch as a benchmarking metric for reporting quality. It is calculated independently of citation-based metrics such as Journal Impact Factor and is meant to be compared only within the same field or subfield.
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Patent Continuation Application - CASRAI (2026)
A patent continuation application is any of a family of U.S. nonprovisional applications – continuation, continuation-in-part (CIP), or divisional – filed while an earlier-filed 'parent' nonprovisional application is still pending (co-pending), that claims the benefit of the parent's filing date under 35 U.S.C. 120 or 121 and 37 CFR 1.78. What distinguishes the three types is what changes relative to the parent's disclosure and claims: a continuation carries forward the parent's disclosure exactly and pursues new or different claims to the same invention already disclosed; a continuation-in-part repeats a substantial part of the parent's disclosure but adds new matter not found in the parent (the new matter does not get the benefit of the parent's filing date); and a divisional carves out claims to an independent or distinct invention that the parent disclosed but did not claim, typically after the examiner issued a restriction requirement forcing the applicant to elect one invention to pursue in the parent.
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eRA Commons Roles - CASRAI (2026)
An eRA Commons role is the permission set assigned to an account within NIH's Electronic Research Administration (eRA) system that determines what actions that account can take inside eRA Commons and its connected modules (ASSIST, xTrain, RPPR, and others) – on behalf of an individual, or on behalf of an institution. Roles fall into two broad categories: institutional/administrative roles (Signing Official, Administrative Official, Business Official, Account Administrator), which carry authority to act for the recipient organization and vary in how much of that authority each one holds, and scientific/reporting roles (Principal Investigator, Assistant, trainee roles, Financial Status Reporter, Financial Conflict of Interest, Public Access Compliance Reporter, Internet Assisted Reviewer), which are scoped to a specific project, report, or review function. A role is distinct from the eRA Commons ID itself: the ID is the individual's persistent login credential, while the role determines what that credential is authorized to do, and only a Signing Official or Account Administrator at an already-registered institution can assign or change a role – individuals cannot self-assign a role.
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PHS Policy (Public Health Service Policy on Humane Care and Use of Laboratory Animals) - CASRAI (2026)
The binding NIH policy, administered by the Office of Laboratory Animal Welfare (OLAW) under the Health Research Extension Act of 1985 (42 U.S.C. section 289d), that requires any institution receiving Public Health Service (PHS) funding to hold a written Animal Welfare Assurance accepted by OLAW before conducting or supporting activities involving any live vertebrate animal. It requires the institution's IACUC to review protocols and inspect facilities as OLAW's agent, and requires the animal care program to be based on the Guide for the Care and Use of Laboratory Animals and to comply with USDA's Animal Welfare Regulations as an absolute minimum. It is distinct from the Animal Welfare Act (a separate, funding-independent federal statute with narrower species coverage) and from AAALAC accreditation (a voluntary, non-mandatory private accreditation that does not substitute for the Assurance).
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