Freedom to Operate (FTO) Analysis - CASRAI (2026)
A freedom to operate (FTO) analysis determines whether making, using, selling, offering to sell, or importing a specific product or process would infringe any granted, in-force third-party patent claim in the jurisdiction(s) where that activity will occur. It is distinct from a patentability (prior art) search: patentability asks whether an applicant's own invention is novel and non-obvious enough to be patented; FTO asks whether commercializing a specific product infringes patents already held by others, regardless of whether the product's own contribution is itself patentable. FTO is jurisdiction-specific (patent rights are territorial) and time-bound (it cannot detect unpublished pending applications), so it is typically re-run before entering a new market or launching a materially redesigned product.
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FDA Form 3454 (Certification: Financial Interests and Arrangements of Clinical Investigators) - CASRAI (2026)
FDA Form 3454 ('Certification: Financial Interests and Arrangements of Clinical Investigators') is the form a marketing-application sponsor submits to FDA to certify – rather than disclose – that no clinical investigator (or subinvestigator, and no covered spouse or dependent child) who participated in a covered clinical study has any of the disclosable financial interests or arrangements defined at 21 CFR Part 54. It is used only when the sponsor's inquiry into each investigator's financial interests comes back clean; if any investigator has a reportable interest or arrangement, the sponsor files the counterpart form, FDA Form 3455, disclosing it instead. The form must be dated and signed by the applicant's chief financial officer or other responsible corporate official, and it is submitted with the marketing application it supports (an NDA, ANDA, BLA, or PMA/510(k) as applicable) rather than at the start of the trial.
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Expedited Review (IRB) - CASRAI (2026)
Expedited review is an IRB review pathway, available only when a proposed research activity (or a minor change to already-approved research) presents no more than minimal risk to participants and falls into one of the categories on OHRP's expedited-review category list. Instead of going to a convened meeting of the full board, it is reviewed by the IRB Chairperson personally, or by one or more experienced reviewers the Chairperson designates from the board's membership, under 45 CFR 46.110 (and the parallel FDA provision, 21 CFR 56.110). An expedited reviewer may exercise all the authorities of the full IRB except one: they may not disapprove the research – a study can only be disapproved through full-board review at a convened meeting. ’Expedited’ describes who conducts the review (chair or designee, not the full board), not a guaranteed fast turnaround.
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FDA Process Validation - CASRAI (2026)
FDA Process Validation refers to the FDA's January 2011 guidance document "Process Validation: General Principles and Practices" (issued by CDER in cooperation with CBER, ORA, and CVM, superseding the agency's 1987 process-validation guideline), and to the three-stage lifecycle framework it establishes for demonstrating that a pharmaceutical or biologic manufacturing process consistently produces a product meeting its predetermined quality attributes. A manufacturing process is treated as "validated" under this framework only when all three stages have been satisfied: Stage 1 (Process Design), in which the commercial process is defined based on knowledge gained through development and scale-up activities; Stage 2 (Process Qualification), in which the process design is evaluated to confirm the process is capable of reproducible commercial manufacturing, including facility/utility/equipment qualification and Process Performance Qualification (PPQ) runs; and Stage 3 (Continued Process Verification, or CPV), an ongoing program of collecting and statistically trending process and product data during routine commercial production to confirm the process remains in a state of control. This is distinct from clinical-trial protocol validation or software/computer-system validation – the term specifically denotes manufacturing-process validation for drug substances, drug products, and biologics under current Good Manufacturing Practice (CGMP).
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21 CFR Part 56 (Institutional Review Boards) - CASRAI (2026)
21 CFR Part 56 is FDA's own regulation governing Institutional Review Board (IRB) review of clinical investigations that fall under FDA's product-jurisdiction authority — chiefly studies conducted under an Investigational New Drug (IND) application (21 CFR Part 312), an Investigational Device Exemption (IDE) (21 CFR Part 812), or otherwise submitted to FDA in support of a research or marketing permit (21 CFR Part 813). Per 21 CFR 56.103, any such clinical investigation must receive IRB approval before it may begin and must remain subject to continuing IRB review for its duration; FDA may refuse to rely on data from an investigation that lacked this initial and continuing IRB oversight. Part 56's trigger is the product/application jurisdiction of the study, not its funding source — it applies whether or not any federal grant money is involved, which is the structural feature that distinguishes it from the Common Rule (45 CFR 46), whose trigger is federal funding or conduct. A single trial can therefore fall under the Common Rule only, Part 56 only, or both at once (for example, an NIH-funded IND drug trial), in which case both regulatory tracks' IRB-review and informed-consent requirements must independently be satisfied.
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Biosafety Level 1 (BSL-1) - CASRAI (2026)
The CDC/NIH BMBL laboratory-containment tier assigned to a protocol when the biological agent(s) involved are well-characterized and not known to consistently cause disease in healthy adults, and pose minimal potential hazard to laboratory personnel and the environment. An instance of BSL-1 is basic, open-bench microbiological work performed with standard microbiological practices (handwashing, no eating/drinking/mouth pipetting, decontamination of work surfaces) and no specialized primary containment equipment such as a biosafety cabinet, in a laboratory that is not required to be separated from general building traffic.
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Unliquidated Obligations (ULO) - CASRAI (2026)
An unliquidated obligation (ULO) is the portion of a federal award's obligated funds that has been legally committed through an obligating action – such as a purchase order, contract, or subaward agreement – but for which payment has not yet been made (on a cash-basis report) or the corresponding expenditure has not yet been recorded (on an accrual-basis report). Under 2 CFR 200.1, a 'financial obligation' is created by orders placed for property and services, contracts and subawards made, and similar transactions requiring payment under a Federal award. An 'unliquidated financial obligation' is that same committed amount before it is liquidated – i.e., before the recipient or subrecipient actually pays it (cash basis) or records the expenditure (accrual basis). A dollar only becomes a ULO once an obligating action has occurred; funds that are merely available but not yet committed to any specific order, contract, or subaward are instead part of the award's unobligated balance, not a ULO.
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VC Term Sheet - CASRAI (2026)
A VC term sheet is a short, non-binding document, proposed by a venture capital investor and negotiated with a company's founders, that lays out the key economic and control terms of a proposed equity investment before the parties draft the full, binding financing documents (a stock purchase agreement, an amended certificate of incorporation, an investors' rights agreement, and related ancillary documents). A document qualifies as a VC term sheet if it specifies, at minimum, the round's valuation (pre-money and post-money) and the resulting price per share, the class of stock being issued (almost always preferred stock rather than common), the size of the investment, and the investor's proposed rights over the company post-closing – typically including a liquidation preference, anti-dilution protection, board composition, and pro-rata (or preemptive) rights for future rounds. Because it is explicitly non-binding on the substantive deal terms (most term sheets carry binding provisions only for a narrow set of housekeeping clauses – confidentiality, exclusivity/no-shop, and governing law – while everything else is subject to definitive documentation and due diligence), signing one commits a founder to negotiate on the stated terms in good faith, not to close the round on those terms.
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NIH Research Security Training (RST) - CASRAI (2026)
NIH's Research Security Training (RST) requirement, established under NIH Guide Notice NOT-OD-26-017, requires every 'covered individual' – meaning every senior/key person listed on an NIH grant application – to complete research security training within the 12 months before the application's due date. Compliance is evidenced through a dual certification: an institutional certification by the Authorized Organizational Representative (AOR) on the SF424 R&R face page, and an individual certification captured through the person's NIH Biographical Sketch in SciENcv. It applies to applications with due dates on or after May 25, 2026.
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License Agreement - CASRAI (2026)
A license agreement is a contract in which the owner of intellectual property (IP) – a patent, copyright, trademark, or trade secret – (the licensor) grants another party (the licensee) permission to exercise specified rights in that IP, in exchange for agreed-upon consideration, without transferring ownership of the underlying IP itself. A given arrangement counts as a license agreement, rather than some other transaction, when three elements are present together: (1) the licensor retains title to the IP throughout the term of the agreement, (2) the grant is bounded – limited by scope (which rights: make, use, sell, reproduce, display, etc.), field of use, territory, and/or duration – rather than an unrestricted, permanent transfer of all rights, and (3) the agreement specifies the consideration and other obligations attached to the grant, typically royalties, an upfront or milestone fee, sublicensing terms, reporting requirements, and termination conditions. Because the licensor keeps ownership, a license agreement is legally distinct from an assignment, which transfers ownership of the IP itself to the assignee; the underlying grant can also be exclusive (only the licensee may exercise the granted rights, even excluding the licensor) or non-exclusive (the licensor may grant the same rights to other parties in parallel).
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NIH Financial Conflict of Interest (FCOI) Policy - CASRAI (2026)
The federal regulatory framework (42 CFR Part 50, Subpart F for PHS grants/cooperative agreements; 45 CFR Part 94 for PHS contracts) requiring any institution receiving Public Health Service or NIH funding to maintain a written FCOI policy, collect financial disclosures from every Investigator on a covered project, have a designated official review and manage any identified conflict, and report it to the funding agency before award funds are expended.
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USPTO Power of Attorney - CASRAI (2026)
A USPTO power of attorney is the written document by which a patent applicant or patent owner appoints one or more registered patent practitioners — a patent attorney or patent agent registered under 37 CFR 11.6 — to prosecute a patent application on their behalf before the U.S. Patent and Trademark Office. It is governed by 37 CFR 1.32 and, for applications filed on or after September 16, 2012, is typically executed on Form PTO/AIA/82. Under 37 CFR 1.32(b), a valid power of attorney must be in writing, name one or more representatives who qualify under 37 CFR 1.32(c) (joint inventors, practitioners associated with a Customer Number, or up to ten individually named practitioners with registration numbers), give that representative the power to act on the principal's behalf, and be signed by the applicant or patent owner. Only a registered patent attorney or patent agent — not a general power-of-attorney holder, and not an unregistered representative — may be appointed to prosecute a utility or plant application; practitioners registered for design patents only under 37 CFR 11.6(d) may act solely in design matters.
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Site Initiation Visit (SIV) - CASRAI (2026)
A Site Initiation Visit (SIV) is the visit – conducted on-site or remotely by a sponsor or CRO monitor (typically a Clinical Research Associate) – that formally activates an investigational site for a specific clinical trial, immediately before enrollment may begin. A visit counts as an SIV, regardless of format, when it verifies that all site-activation prerequisites are simultaneously in place: current IRB/IEC approval of the protocol and informed consent form, completed staff training (protocol-specific and Good Clinical Practice) for every individual on the delegation-of-authority log, a complete regulatory/essential-document binder per ICH E6(R2) Section 8, receipt and accountability procedures for investigational product and study supplies, and a working understanding among site staff of source documentation and data-entry (EDC) procedures. A visit is NOT an SIV if it occurs before the site has been contracted and IRB-approved (that is a site-selection/pre-study visit) or after the site has already begun enrolling participants (that is a routine/interim monitoring visit or a close-out visit).
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Full Economic Costing (fEC) - CASRAI (2026)
Full economic costing (fEC) is the UK methodology, calculated via the Transparent Approach to Costing (TRAC), that institutions must use to cost UKRI grant applications. It sums directly incurred costs, directly allocated costs, and indirect (estates/overhead) costs to state a project's true full cost; UKRI Research Council grants then fund 80% of that fEC figure, with the institution finding the remaining share elsewhere – in England, substantially via Research England's QR block grant.
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AAALAC International - CASRAI (2026)
A private, nonprofit accrediting body (founded 1965, headquartered in Frederick, Maryland) that grants voluntary, triennial peer-review accreditation to animal research, teaching, and testing programs worldwide against three primary standards (the Guide, the Ag Guide, and ETS 123), confirming a program meets or exceeds legally required animal-welfare standards – distinct from the mandatory Animal Welfare Act (USDA-enforced statute) and PHS Policy (NIH funding condition), neither of which AAALAC accreditation replaces or is required by.
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ARC Industry Fellowships - CASRAI (2026)
A fellowship funded under the Australian Research Council's Linkage Program that provides salary and project-cost support for an individual researcher to work across the academia-industry boundary – either an academic researcher taking up a placement with an industry Partner Organisation, or an industry-based researcher taking up a placement at a university – rather than funding a defined project team as an ARC Linkage Project does. The scheme comprises three career-stage streams (Early Career, Mid-Career, and Industry Laureate Industry Fellowships), each with its own salary contribution, duration, and project-cost allowance.
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ARMA, EARMA, and INORMS: International Research Management Associations - CASRAI (2026)
ARMA (the Association of Research Managers and Administrators), EARMA (the European Association of Research Managers and Administrators), and INORMS (the International Network of Research Management Societies) are three related but distinct professional bodies serving people who manage and administer research rather than conduct it. ARMA is the national professional association for research management in the UK, incorporated in 2006, with roughly 3,800 members. EARMA is the regional professional association for the same profession across Europe, formed in 1994, open to research managers and administrators working in academia, industry, and the public and private sectors. INORMS is not a membership body for individuals at all – it is an umbrella federation of national and regional research-management societies, founded in 2001, whose own members are organizations such as ARMA, EARMA, and the US-based National Council of University Research Administrators (NCURA) and Society of Research Administrators International (SRAI), alongside other national societies around the world. An individual research administrator typically joins their applicable national or regional body directly (ARMA if UK-based, EARMA if Europe-based, NCURA or SRAI if US-based, and so on); they do not join INORMS directly, because INORMS's own members are the societies themselves, not individual practitioners.
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Electronic Trial Master File (eTMF) - CASRAI (2026)
An eTMF is a software system – standalone or a CTMS module – used to create, store, version-control, quality-check, and track the real-time completeness of a clinical trial’s Trial Master File (TMF) electronically, structured against a reference taxonomy such as the TMF Reference Model and, for FDA-regulated trials, generally within the scope of 21 CFR Part 11.
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March-In Rights - CASRAI (2026)
March-in rights are the authority under 35 U.S.C. § 203 letting a federal funding agency require the holder of a patent on a federally funded “subject invention” to grant additional licenses to a responsible third party – or grant one itself – when the holder isn't achieving practical application, isn't meeting unmet health/safety needs, isn't satisfying regulation-specified public-use requirements, or hasn't met the Section 204 U.S.-manufacturing agreement. Title is not transferred or revoked; only additional licensing is compelled, and only at the funding agency's discretion after a petition and agency review.
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NINDS Payline - CASRAI (2026)
A NINDS payline is the percentile-rank threshold that the National Institute of Neurological Disorders and Stroke publishes for a given fiscal year and grant mechanism as its planning guideline for which peer-reviewed applications it expects to fund. It is NINDS's own institute-specific application of the general NIH payline mechanism, set independently of every other NIH institute or center against NINDS's own appropriation, application volume, and research priorities. NINDS also publishes a separate, more generous extended payline for Early Stage Investigators, aimed at giving early-career researchers a comparable success rate to established investigators applying for the same mechanism. A NINDS payline is a budgeting and planning benchmark, not a binding rule: NINDS retains discretion to fund some applications scoring outside its published payline (select pay / exception pay) and to decline some scoring inside it, based on advisory council input and program priorities. As of late 2025, NIH signaled its institutes and centers would move away from publishing fixed paylines in favor of weighing peer-review scores against institute priorities and budget more holistically – confirm current NINDS practice against its own current guidance rather than assuming a specific figure still applies.
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Patent Eligibility Restoration Act (PERA) - CASRAI (2026)
The Patent Eligibility Restoration Act (PERA) is proposed U.S. federal legislation — not current law — that would rewrite 35 U.S.C. § 101 to replace the judge-made "abstract idea" and "law of nature" exceptions with a shorter, closed list of statutory exclusions. It has been introduced, in varying forms, across the 116th, 118th, and 119th Congresses without being enacted. The current version, S. 1546 (119th Congress, 2025–2026), was reintroduced on May 1, 2025 by Senators Thom Tillis (R-NC) and Chris Coons (D-DE) and Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA). The Senate Judiciary Subcommittee on Intellectual Property held a hearing on the bill on October 8, 2025; as of this writing it has not been marked up by the full committee, passed by either chamber, or signed into law. A page that treats PERA as settled law would be factually wrong — its defining characteristic, for research-administration purposes, is that it is a live legislative proposal responding to an unresolved doctrinal problem, not a rule anyone can rely on yet. The problem PERA is written to address Under current § 101 doctrine, the Supreme Court's Mayo Collaborative Services v. Prometheus Laboratories (2012) and Alice Corp. v. CLS Bank International (2014) decisions established a two-step framework (often called the "Alice/Mayo test" or, in USPTO examination guidance, "Step 2A/Step 2B") that lets an examiner or court invalidate a claim as directed to an unpatentable "abstract idea," "law of nature," or "natural phenomenon" even though those categories appear nowhere in the patent statute itself — they are judicial exceptions layered on top of § 101's text. See CASRAI's 35 U.S.C. § 101: Patentable Subject Matter and the Alice/Mayo Eligibility Test for the current test as it actually operates today. Critics across the patent bar, technology-transfer offices, and biotech/software industry groups argue the resulting case law is inconsistent and hard to predict at the claim-drafting stage, disproportionately affecting diagnostic methods, software and AI-related inventions, and certain life-sciences discoveries — exactly the categories a university technology transfer office most often needs to protect before licensing. What PERA proposes to change Rather than amending the Alice/Mayo case-law test directly, PERA's approach is to eliminate judicially-created exceptions from § 101 entirely and substitute a short, enumerated list of statutory exclusions from eligibility (categories such as claims to an unmodified human gene as it exists in the human body, or to a mathematical formula standing alone, are the kind of exclusion prior versions of the bill have specified) while otherwise stating that a claimed invention is eligible if it falls within one of the statute's existing categories (process, machine, manufacture, or composition of matter) and is not excluded. Sponsors describe the goal as restoring eligibility for practical, real-world applications in fields like AI, biotechnology, and diagnostics without reopening genuinely abstract claims to patenting. Because PERA has been revised between reintroductions, the exact exclusion list and definitions in the live S. 1546 text should be checked directly against the bill text on congress.gov rather than assumed to match an earlier version. Why this matters for university tech transfer specifically A technology transfer office evaluating whether to patent a faculty invention has to make a § 101 eligibility judgment long before litigation is ever a possibility — at invention-disclosure triage, at the provisional-filing decision, and again when licensing counsel diligence the claims. Diagnostic-method inventions (a correlation between a biomarker and a disease state) and software/AI inventions (a novel algorithm or model architecture) are the two categories most exposed to Alice/Mayo rejections today, which in turn affects a TTO's practical calculus on whether patenting is worth the cost relative to protecting the same invention as a trade secret or relying on a first-mover/know-how advantage instead. PERA, if enacted, would not retroactively revive an invention a TTO already declined to patent under current doctrine — patentability is assessed as of filing — but it would change the eligibility calculus for inventions disclosed and filed after any effective date, and could affect prosecution strategy for pending applications depending on the bill's final transition provisions. None of that is triggered by introduction or a committee hearing; only enactment would change what is patentable.
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Desk Rejection - CASRAI (2026)
A desk rejection is an editorial decision made by the handling editor (or an in-house editorial team) to decline a submitted manuscript before it is sent out for external peer review. It is issued at the initial screening stage, prior to any reviewer being invited, and is typically driven by one or more of: a scope mismatch with the journal's aims, insufficient apparent novelty or significance for the target venue, failure to meet basic formatting, language-quality, or file-completeness requirements, or failure to meet the journal's baseline reporting standards (missing ethics statements, required disclosures, or a data-availability statement, for example). Because no reviewer has evaluated the manuscript's methods or findings, a desk rejection reflects a judgment about fit and readiness, not a verdict on scientific merit. Some journals and publishers report a desk rejection rate – the share of submissions declined at this screening stage – though the figure varies enormously by journal prestige and field and has no universal benchmark.
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xTrain - CASRAI (2026)
xTrain is the electronic module within NIH's eRA Commons system used to prepare, submit, and track the paperwork that appoints a trainee to, and later terminates a trainee from, an NIH-supported training or fellowship award. Something qualifies as an xTrain transaction if it involves one of two specific forms: the PHS 2271 Statement of Appointment (used for a new appointment, a re-appointment into a subsequent budget period, or an amendment to an existing appointment) or the PHS 416-7 Termination Notice (used when a trainee's participation on the award ends, whether by completing the training period or leaving early). xTrain covers institutional research training grants (T32 and related T-series mechanisms, with the documented exception of T34), institutional career development awards, individual Kirschstein-NRSA fellowships (F30, F31, F32, F33), and research education awards – it does not cover research grants that carry no trainee-appointment obligation, and it is not itself a funding mechanism, only the submission system for the appointment/termination paperwork a mechanism like T32 or F31/F32 requires.
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FDA FOIA Request - CASRAI (2026)
A written request filed under 5 U.S.C. § 552 and FDA's implementing regulation, 21 CFR Part 20, submitted to FDA's Division of Freedom of Information asking the agency to release records it holds but has not proactively published — most commonly the narrative text of a Form FDA-483, the fuller Establishment Inspection Report, warning letters, or IND/NDA/BLA correspondence not already in a public FDA database.
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Accelerated Approval - CASRAI (2026)
Accelerated Approval is an FDA regulatory pathway that lets the agency approve a drug or biologic for a serious or life-threatening condition on the basis of an effect on a surrogate endpoint, or an intermediate clinical endpoint, that is reasonably likely to predict the product's actual clinical benefit – rather than waiting for a completed trial to show that benefit directly. It is authorized under 21 CFR Part 314 Subpart H (drugs, 21 CFR 314.500-314.560) and 21 CFR Part 601 Subpart E (biologics, 21 CFR 601.40-601.46). Approval is conditional: the sponsor must conduct a post-approval confirmatory trial to verify the predicted clinical benefit, and, under the Food and Drug Omnibus Reform Act of 2022 (FDORA, part of the Consolidated Appropriations Act, 2023), FDA can now require that confirmatory trial be underway – not merely committed to – at the time of approval or shortly after. If the confirmatory trial fails to verify clinical benefit, or other evidence shows the product isn't safe or effective, FDA can withdraw the approval through an expedited withdrawal procedure that FDORA also created.
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35 U.S.C. § 154 (Patent Term) - CASRAI (2026)
35 U.S.C. § 154 is the U.S. Patent Act provision that (a) defines the substantive right a patent grants – the right to exclude others from making, using, offering for sale, or selling the invention throughout the United States, or importing it into the United States (and, for a process patent, the right to exclude others from using, offering for sale, or selling products made by that process) – and states the length of that grant, and (b) authorizes patent term adjustment (PTA), which lengthens a patent's term to compensate for certain USPTO examination delays. A fact pattern is governed by § 154 whenever the question is how long an issued utility or plant patent's exclusionary term runs, or whether USPTO delay during prosecution entitles the applicant to extra term – as distinct from patent eligibility (35 U.S.C. § 101), novelty (§ 102), the specification requirements (§ 112), or the presumption of validity in litigation (§ 282), each governed by its own provision.
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SBIR/STTR Data Rights - CASRAI (2026)
The specific FAR/DFARS data-rights clause package (FAR 52.227-20 for civilian agencies, DFARS 252.227-7018 for DoD) that attaches automatically to SBIR/STTR-funded contracts and grants, giving the small-business or STTR awardee exclusive control over the technical data and computer software it generates under the award. During a 20-year protection period running from the date of award (per SBA's SBIR/STTR Policy Directive and, for DoD, DFARS 252.227-7018 effective January 17, 2025), the government may use that data only for internal government purposes and cannot release or disclose it to a third party – including a competing contractor bidding on follow-on work – without the awardee's permission. This is a distinct protection from patent rights: it applies to the data/software deliverables themselves, not the underlying invention, and does not require a patent to be filed at all.
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Prescription Drug User Fee Act (PDUFA) - CASRAI (2026)
The Prescription Drug User Fee Act (PDUFA) is the 1992 U.S. federal law authorizing FDA to collect user fees from companies that submit certain human drug and biologic applications for review, or that are named as sponsors of certain approved prescription drug products. In exchange for these fees, FDA commits to specific performance goals – most visibly, review-time targets such as the 10-month goal for a Standard Review application and the 6-month goal for a Priority Review application – set out in a negotiated agreement between FDA and industry that Congress reauthorizes roughly every five years. PDUFA is the funding and accountability mechanism underlying FDA's human drug review program; it is distinct from the individual expedited-review pathways (Priority Review, Breakthrough Therapy, Fast Track, Accelerated Approval) that operate within the review process it funds.
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OSF Preprints - CASRAI (2026)
A work counts as an OSF Preprints deposit if it is hosted on the preprint infrastructure built and operated by the Center for Open Science (COS) – either on the generalist osf.io/preprints server itself, or on one of the branded, discipline-specific community servers (PsyArXiv, SocArXiv, EarthArXiv, and others) that run on the same underlying OSF backend but carry their own name, editorial moderators, and disciplinary scope. It is distinct from an OSF project (the private/public research-management workspace) and from OSF Registries (preregistrations): a preprint is a discrete, versioned, publicly posted manuscript that receives its own Crossref-registered DOI, separate from any OSF project it may have originated in.
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ARC Discovery Project - CASRAI (2026)
An ARC Discovery Project is a competitively awarded research grant funded under the Australian Research Council's Discovery Program, one of the two programs that make up the ARC's National Competitive Grants Program (NCGP) (the other being the Linkage Program). Discovery Projects fund investigator-driven basic, strategic basic, and applied research across all disciplines except clinical and other medical research (which sits with Australia's National Health and Medical Research Council, NHMRC). Funding runs at $30,000 to $500,000 per year, for project durations of one to five years, administered through the ARC's Research Management System (RMS). Unlike the ARC's dedicated fellowship schemes – the Discovery Early Career Researcher Award (DECRA) and the ARC Future Fellowship – a Discovery Project grant is not restricted to a particular career stage: it can be held by an individual researcher or, more commonly, a team of investigators spanning early-career to senior levels, and the grant funds a defined research project rather than a single person's salaried fellowship. This is the defining operational distinction: DECRA and Future Fellowship exist to support a person at a specific career point; a Discovery Project exists to fund a specific piece of research, regardless of who on the team is at what career stage.
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Data Curation Network (DCN) - CASRAI (2026)
The Data Curation Network (DCN) is a membership consortium of academic and non-profit research-data repositories that pools trained data curators across member institutions so that any participating library can call on specialist review for a dataset, rather than each institution having to hire full curation expertise for every data type it receives. It is distinct from 'data curation' the generic activity and 'data curator' the generic role: DCN is a specific, named organization, hosted administratively by the University of Minnesota Libraries, that operationalizes those generic concepts as a shared-staffing service across its member institutions.
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CIHR Postdoctoral Fellowship - CASRAI (2026)
The CIHR Postdoctoral Fellowship was the Canadian Institutes of Health Research's individually held, individually competed award funding up to two years of mentored postdoctoral research in a health-research field within CIHR's mandate, providing the fellow with a stipend (most recently harmonized at $70,000 per year) portable to an eligible Canadian or international host institution. CIHR has discontinued this standalone program: it has been folded, together with NSERC's and SSHRC's equivalent individual postdoctoral fellowship programs, into the jointly administered Canada Postdoctoral Research Award (CPRA) – part of the Tri-Agency's Canada Research Training Awards Suite (CRTAS), which also replaces the three councils' separate master's and doctoral scholarship programs. A researcher researching 'CIHR Postdoctoral Fellowship' or 'CIHR Fellowship' today needs the CPRA application process, applied for through CIHR for health-research proposals.
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Special Category Data (GDPR Article 9) - CASRAI (2026)
Personal data that GDPR Article 9(1) singles out for heightened protection because of its sensitivity — data revealing racial or ethnic origin, political opinions, religious or philosophical beliefs, or trade union membership, plus genetic data, biometric data used to uniquely identify a person, health data, and data concerning sex life or sexual orientation. Processing any of these categories is prohibited by default; a research controller needs both an Article 6 lawful basis and a separate Article 9(2) condition before touching the data at all, and for most academic and clinical research that second condition is Article 9(2)(j), the research/archiving/statistics derogation.
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Discretionary Grant - CASRAI (2026)
A federal award in which the awarding agency exercises statutory judgment ('discretion') in selecting the recipient and/or setting the funding amount, typically through a competitive, merit-reviewed process, as distinguished from a mandatory (formula) grant, where funds are allocated automatically to every entity meeting predetermined statutory eligibility criteria with no agency selection judgment involved.
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NSF Merit Review Panel - CASRAI (2026)
An NSF merit review panel is the group of external subject-matter experts (or, for ad hoc/mail review, individual experts working independently) that the National Science Foundation convenes under PAPPG Chapter III to evaluate a proposal against the two NSB-mandated criteria, Intellectual Merit and Broader Impacts, producing individual Excellent-to-Poor ratings and written reviews that an NSF program officer weighs, alongside program-level considerations and Division Director concurrence, when recommending a funding decision.
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AUTM Better World Project - CASRAI (2026)
The AUTM Better World Project is a public storytelling and awards initiative run by the Association of University Technology Managers (AUTM) that collects curated case studies of specific inventions, born from federally funded or institutional research, that were licensed and commercialized into products, services, or companies with a documented real-world benefit. An item qualifies as a Better World Project 'story' when it names a specific technology, traces it back to a specific research institution's technology transfer office, and narrates the licensing/commercialization path in lay terms aimed at a public or policymaker audience – not when it is simply an internal TTO metric or a generic description of what technology transfer does.
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ISO 14155 (Clinical Investigation of Medical Devices for Human Subjects — GCP) - CASRAI (2026)
ISO 14155:2020, ‘Clinical investigation of medical devices for human subjects — Good clinical practice,’ is the ISO standard defining GCP requirements — protocol design, informed consent, investigator qualification, sponsor monitoring, adverse-event/device-deficiency reporting, and reporting — for clinical investigations of medical devices in human subjects. It is the device-industry counterpart to ICH E6 for drug and biologic trials.
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KBART (Knowledge Bases And Related Tools) - CASRAI (2026)
A NISO Recommended Practice (currently RP-9-2014, KBART Phase II) that defines a common tab-delimited data format and field set for content providers to supply title-level holdings metadata — title, ISSN/ISBN, coverage dates, embargo, and URL — to knowledge-base vendors, so that link resolvers and discovery services can accurately determine and display full-text availability.
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Altmetric Explorer - CASRAI (2026)
Altmetric Explorer (formally 'Altmetric Explorer for Institutions,' with a separate 'Explorer for Publishers' edition) is Altmetric's paid, subscription-only dashboard application: a searchable, filterable web tool that lets a research office, library, or communications team browse, analyze, benchmark, and report on the online attention – news coverage, policy-document citations, social media mentions, blog posts, Wikipedia references, and other sources – that Altmetric has captured for research outputs. A product/page qualifies as Altmetric Explorer, rather than the free Altmetric Attention Score badge or browser bookmarklet, specifically because it is the paid, institution-wide reporting and analysis layer built on top of Altmetric's underlying attention data and Attention Score – not the score itself. The Attention Score and the free bookmarklet/journal-embedded badge are available to view for any individual research output without a subscription; Explorer, by contrast, only exists as a licensed institutional (or publisher) account with login-gated search, department/author-level views, benchmarking, and export/reporting functionality layered on top of that same underlying dataset.
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Library Publishing Coalition (LPC) - CASRAI (2026)
The Library Publishing Coalition (LPC) is an independent, community-led membership association of academic and research libraries and library consortia that operate or are developing scholarly publishing programs – library presses, journal-hosting platforms, open monograph publishing, and related services. It was formed between January 2013 and December 2014 when 61 academic libraries, working with the Educopia Institute, organized around a shared professional forum for developing best practices and shared expertise in library-based publishing; the founding conversation originated among Purdue University, the University of North Texas, and Virginia Tech, building on an earlier IMLS-funded planning project. LPC is not a publisher, a certification body, or a standards-setting organization in the way NISO or DOAJ are – it is a community of practice: a membership association whose value is peer knowledge-sharing, an annual member directory, a professional development curriculum, and an annual forum, run day-to-day through Educopia Institute (Atlanta, Georgia), which provides LPC's operational and staff support.
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Erratum - CASRAI (2026)
An erratum is a formal, published correction notice that a journal or publisher issues to fix a factual error introduced during the publication process itself (e.g. a typesetting mistake, a mislabeled figure, an author name spelled wrong, a column transposed in a table) rather than an error in the authors' own research, analysis, or reporting. It is linked bidirectionally to the original article's metadata (Crossref lists 'erratum' as one of its enumerated update types) so that the correction is discoverable wherever the article is indexed or cited. An erratum does not withdraw or invalidate the article's findings – by definition, the underlying science is not in question, only how it was rendered in print or online.
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Evaluation Agreement - CASRAI (2026)
An evaluation agreement (sometimes called an evaluation license) is a short-term, narrowly-scoped contract that a university or research institution's technology transfer office (TTO) uses to let a prospective licensee test a specific technology — a device, material, dataset, or piece of software — before either party commits to a full commercial license negotiation. What makes an agreement an evaluation agreement, rather than something else, is the combination of: (1) a limited internal-use-only purpose (testing, benchmarking, or feasibility assessment — not manufacturing, sale, sublicensing, or use in a marketed product); (2) a short, fixed term (commonly 90 days to one year, sometimes renewable once); (3) non-exclusivity as the default, since the institution is not yet committing the technology to any one party; and (4) little or no financial consideration, since the point is to let the evaluator decide whether the technology is worth licensing at all, not to monetize use during the trial itself. Many evaluation agreements also include, or are paired with, confidentiality terms and a right of first negotiation or option period for a subsequent full license.
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Race Equality Charter (REC) - CASRAI (2026)
The Race Equality Charter (REC) is an award-mark scheme run by Advance HE, the UK sector body for higher education and research quality, that recognises universities and research institutes for identifying and addressing structural barriers to race equality among staff and students. Modelled on the same self-assessment/award-mark structure as Advance HE's Athena SWAN gender-equality charter, REC requires a member institution to convene a self-assessment team, analyse ethnicity-disaggregated staff and student data across recruitment, promotion, pay and attrition, gather qualitative evidence of lived experience, and submit an application with a costed, time-bound action plan for independent peer review by an Advance HE panel. Institutions that meet the bar receive a Bronze or Silver award (there is no Gold tier, unlike Athena SWAN) tied to delivering that action plan.
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For-Cause Audit - CASRAI (2026)
A for-cause audit (or for-cause inspection) is a compliance review triggered by a specific, identified finding, complaint, safety signal, or concern – as distinguished from a routine, scheduled, or directed audit conducted on a periodic or pre-planned basis regardless of any known issue. The defining test is the presence of a triggering event: a monitoring visit report flagging a serious deviation, an adverse-event or safety-reporting concern, a whistleblower complaint, evidence of possible data integrity problems, or a pattern of findings from a prior routine audit. Two related but distinct uses of the term appear in clinical research: (1) an FDA Bioresearch Monitoring (BIMO) for-cause inspection, opened by the agency's field-investigation function in response to a specific complaint, required report, or safety signal, and which may be unannounced; and (2) a sponsor-, CRO-, or IRB-initiated for-cause audit of a trial site, investigator, or vendor, opened internally in response to a monitoring red flag or reported concern rather than as part of the organization's standard audit schedule.
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Scholarly Literature - CASRAI (2026)
Scholarly literature is the body of research output produced by subject-matter experts, evaluated through a formal quality-control process (typically peer review or editorial vetting by a scholarly body), and published with the primary purpose of advancing a field's knowledge base rather than generating commercial revenue or informing a general audience. A work qualifies as scholarly literature when it satisfies three conditions together: (1) authorship by researchers writing within their area of expertise, usually with an institutional or disciplinary affiliation; (2) formal vetting before or as a condition of publication – peer review for journal articles, editorial/academic-board review for monographs, programme-committee review for conference proceedings, or committee examination for dissertations and theses; and (3) a citation apparatus (references, methods, data availability) that lets other researchers verify, build on, or reproduce the work. The main forms are peer-reviewed journal articles, scholarly monographs, conference proceedings, and dissertations/theses; preprints and working papers are usually treated as scholarly literature in a provisional, not-yet-vetted form pending peer review.
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Knowledge Exchange Framework (KEF) - CASRAI (2026)
Research England's national exercise for assessing and benchmarking how English higher education providers perform knowledge exchange activity – reported across seven perspectives and scored in quintiles relative to a peer cluster, rather than as research quality (REF) or teaching quality (TEF).
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Conference Proceedings - CASRAI (2026)
Conference proceedings are the published collection of papers, abstracts, or extended abstracts presented at an academic or professional conference, typically compiled and released around the time of the event by the organizing society, a commercial publisher, or the conference itself. They are a distinct scholarly-output type from the journal article, the scholarly monograph, and the preprint: a proceedings paper is tied to a specific dated event and its program committee, not to a journal's rolling editorial process, and unlike a preprint it has already been through whatever acceptance process that specific conference uses – which ranges from rigorous full-paper peer review to a light abstract screen, depending entirely on the venue.
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Person Months (Horizon Europe) - CASRAI (2026)
In Horizon Europe, a person-month is the unit used in a proposal's work plan (Gantt chart and effort tables) to show how much staff time each beneficiary allocates to a work package or task. It is an estimation and planning unit, not the basis the European Commission actually pays on — that is a distinct point of confusion with NIH's identically-named unit. Actual personnel costs at reporting time are calculated in person-days against a capped standard number of working days per year, not directly in person-months, and beneficiaries using the Commission's average personnel cost (unit-cost) option may not need to track individual days at all. The European Commission's own indicative conversion, used for translating between days and months at proposal stage, is 220 working days per year = 12 person-months (so 1 person-month ≈ 18.3 working days). This 220-day planning figure is different from the 215 working days per year figure that is the operative ceiling for actual-cost personnel reporting under the Horizon Europe Annotated Model Grant Agreement (AGA), Article 6.2.A — the maximum number of day-equivalents a beneficiary may charge to the action in a given period is calculated as (215 ÷ 12) × number of months in the reporting period, pro-rated by a working-time (FTE) factor for part-time staff. The 220 and 215 figures serve different purposes (proposal planning vs. reporting ceiling) and should not be interchanged.
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Clinical Trial Agreement (CTA) - CASRAI (2026)
A Clinical Trial Agreement (CTA) is the legally binding contract between a study sponsor (or a Contract Research Organization acting for the sponsor) and the institution/site conducting the trial (and, typically, the Principal Investigator as a party or signatory) that sets the business and legal terms under which the trial will be performed at that site. A document qualifies as a CTA – as distinct from the protocol, the informed consent form (ICF), or a data/material-transfer agreement – when it governs the commercial and risk-allocation terms of the relationship rather than the scientific conduct of the study itself: per-subject and milestone budget and payment schedule, indemnification and insurance (including coverage for trial-related subject injury), intellectual property ownership (background vs. foreground), publication and disclosure rights, data ownership and confidentiality, regulatory-compliance representations, and termination and record-retention terms. The protocol defines what will be done scientifically; the ICF discloses risks and obtains a subject's voluntary participation; the CTA is the separate contract that lets the institution and sponsor actually transact – get paid, allocate liability, and agree who owns and can publish what comes out of the trial.
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IND Annual Report - CASRAI (2026)
A comprehensive, once-a-year progress summary that a sponsor holding an active Investigational New Drug (IND) application must submit to FDA under 21 CFR 312.33, due within 60 days of the anniversary date the IND went into effect. It covers every study conducted under the IND during the preceding year (status, enrollment, and completion), a summary of IND Safety Reports and subject deaths/dropouts, preclinical findings, manufacturing or microbiological changes, any Investigator's Brochure revisions, Phase 1 protocol modifications, the sponsor's investigational plan for the coming year, and foreign marketing developments. It continues annually for as long as the IND remains active, independent of whether any individual study is enrolling.
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Letter of Credit Drawdown - CASRAI (2026)
A letter of credit drawdown is the cash-management method under which a recipient institution draws federal grant funds from a Treasury-administered payment system — most commonly the HHS Payment Management System (PMS), but also agency-specific systems used by NSF, USAID, and others — only in the amount needed to cover actual, imminent disbursements, rather than receiving a lump-sum advance at the start of the award. It qualifies as an instance of this method when three conditions hold: (1) the institution holds standing drawdown authority against a Treasury-linked account tied to a specific award or pooled by awarding agency, not a one-time advance payment; (2) each individual drawdown request is sized to actual, immediate cash need rather than banked ahead of spending; and (3) the timing is governed by 2 CFR §200.305, the Uniform Guidance payment section, which requires non-State recipients to minimize the time elapsing between the transfer of funds from the federal awarding agency and the recipient's actual disbursement of those funds, regardless of whether the transfer happens by electronic funds transfer or another means. This distinguishes drawdown from a periodic reimbursement method, where the institution spends its own cash first and is paid back afterward (subject to a 30-calendar-day agency payment window under the same section), and from a single upfront advance payment covering an entire budget period.
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Audit Corrective Action Plan (Grants) - CASRAI (2026)
An audit corrective action plan is the document a grantee institution (the auditee) prepares under 2 CFR 200.511(c) responding to each finding in its Single Audit's Schedule of Findings and Questioned Costs. For every current-year finding, it must name the contact person(s) responsible for the corrective action, describe the corrective action to be taken, and give the anticipated completion date; if the auditee disagrees with a finding, it must instead include a detailed explanation of the reasons for disagreement. It is prepared by the auditee, not the auditor, and is submitted as a required component of the Single Audit reporting package – distinct from the auditor's own findings and from a clinical-research quality-system CAPA.
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Continuing Review (IRB) - CASRAI (2026)
Continuing review is the periodic re-review an IRB conducts of previously approved, ongoing research to decide whether approval should continue. Under 45 CFR 46.109(e), an IRB must conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, and not less than once per year, except for the limited categories the revised Common Rule exempts from continuing review entirely under 46.109(f) (research eligible for expedited review, research receiving limited IRB review under certain exemptions, and research that has closed to enrollment and moved solely into data analysis or long-term follow-up using standard-of-care procedures). FDA's parallel provision, 21 CFR 56.109(f), requires continuing review of FDA-regulated research at intervals appropriate to the degree of risk and not less than annually, and does not carry the same 2018 Common Rule exceptions. The operative distinction for a study posing greater than minimal risk: continuing review of that research cannot be conducted through the expedited procedure, because expedited review (whether at initial approval or at a continuing-review interval) is only available for research that is no more than minimal risk. A greater-than-minimal-risk study must therefore go before the full convened IRB, with a quorum present and a majority vote, at every continuing-review interval for as long as the study remains open to enrollment or active intervention – not just at initial approval.
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IACUC Semiannual Program Review and Facility Inspection - CASRAI (2026)
The PHS-Policy-mandated recurring self-governance duties every Institutional Animal Care and Use Committee (IACUC) must perform on its own institution: reviewing the entire animal care and use program at least once every six months against the Guide for the Care and Use of Laboratory Animals, inspecting all of the institution's animal facilities on that same six-month cycle, and preparing and submitting a signed written report of the review and inspection to the Institutional Official that classifies any deficiencies as significant or minor and sets a correction plan and schedule.
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Scholarly Monograph - CASRAI (2026)
A scholarly monograph is a book-length, single-authored (occasionally co-authored, rarely multi-contributor) work that presents an original, sustained scholarly argument or body of research on one subject, published by an academic or university press after external peer review of the proposal and, typically, the full manuscript. An output counts as a scholarly monograph, rather than a textbook, trade book, or edited volume, only if all of the following hold: (1) it advances a new argument or original research contribution rather than synthesizing existing knowledge for instructional use; (2) it is reviewed by independent subject-matter experts external to the press, evaluating the manuscript or proposal as a coherent scholarly work, not by press editorial staff alone; (3) it is the product of one sustained authorial voice across the whole book (co-authored monographs still meet this test; a collection of separately authored chapters compiled by an editor does not, and is instead an edited volume); and (4) it is published by a press with an identifiable scholarly-monograph series or list, typically a university press or a recognized academic imprint of a commercial publisher.
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NIH Shared Instrumentation Grant (S10) - CASRAI (2026)
The NIH Shared Instrumentation Grant (SIG) is a National Institutes of Health funding mechanism, identified by activity code S10, that pays for a single high-cost, commercially available scientific instrument (or integrated instrumentation system) for shared use by a group of NIH-funded investigators at one institution – it is not a project grant to any individual principal investigator. An award counts as an S10/SIG (rather than some other equipment line item) when: the institution, not an individual researcher, is the formal applicant; the requested instrument costs between $50,000 and $750,000; the application documents a defined 'Group of Major Users' of at least three investigators, each the PD/PI of a distinct, active NIH research award with a demonstrated need for the instrument; and the group's combined projected use meets NIH's Accessible Usage Time thresholds. A companion, higher-cost mechanism – the High-End Instrumentation (HEI) Grant, also under the S10 activity code – covers the $750,001 to $2,000,000 range using the same group-application model. Both are administered by NIH's Office of Research Infrastructure Programs (ORIP), part of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI).
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21 CFR 312.60 (General Responsibilities of Investigators) - CASRAI (2026)
21 CFR 312.60 is the FDA regulation establishing that an investigator conducting an IND-regulated clinical investigation is responsible for: conducting the study according to the signed investigator statement (Form FDA-1572) and the investigational plan/protocol; protecting the rights, safety, and welfare of subjects under the investigator's care; and controlling drugs under investigation, including obtaining informed consent under 21 CFR Part 50 and complying with IRB requirements under 21 CFR Part 56.
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PlumX Metrics - CASRAI (2026)
A proprietary altmetrics product, owned and operated by Elsevier (built on the Plum Analytics platform, acquired by Elsevier in February 2017), that qualifies as PlumX Metrics data specifically when it reports engagement for a research output as five distinct, non-aggregated category counts – Citations, Usage, Captures, Mentions, and Social Media – rather than combining those signals into one overall composite score; the category structure itself, not just the presence of altmetrics-style tracking, is what distinguishes it from single-score competitors.
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Pharmacovigilance System Master File (PSMF) - CASRAI (2026)
The Pharmacovigilance System Master File (PSMF) is the single, maintained regulatory document in which an EU marketing-authorisation holder (MAH) describes its ENTIRE pharmacovigilance system – not one product's safety data, but the organisational structure, processes, and quality system the MAH uses to detect, assess, and manage the safety of all the medicinal products it covers under that system. Required under GVP Module II (itself issued under the EU's 2010 pharmacovigilance legislation and Directive 2001/83/EC as amended), the PSMF must be kept permanently up to date and made available to EU national competent authorities and the European Medicines Agency (EMA) on request. A document is a PSMF, as opposed to some other pharmacovigilance record, if it (a) is maintained by or on behalf of a specific MAH, (b) describes the pharmacovigilance system as a whole – covering organisational structure, the Qualified Person Responsible for Pharmacovigilance (QPPV) and their responsibilities, data sources, IT systems, and the quality system that supports the whole – rather than a single case, study, or product, and (c) has a PSMF location and reference number that the MAH's marketing-authorisation dossiers reference back to, with QPPV and PSMF-location contact details held in the EMA database described in Article 57 of Regulation (EC) No 726/2004.
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Maintenance of Effort (MOE) - CASRAI (2026)
Maintenance of Effort (MOE) is a condition attached to certain federal (and some state) grant programs requiring a recipient to sustain its own non-federal financial or programmatic effort in a defined area at or above a documented baseline level – typically the prior year's expenditure, or an average of recent years – as a continuing condition of eligibility for the federal award, independent of whether the federal funds themselves are spent correctly. Unlike a one-time eligibility test, MOE is assessed on a recurring basis (usually annually) by comparing current-year non-federal spending or effort against the baseline; falling short constitutes an MOE violation even if every dollar of the federal award was used appropriately.
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Industry Affiliates Program - CASRAI (2026)
A standing, fee-based membership arrangement in which a company pays a recurring (typically annual) membership fee to a university lab, center, or department for a bundle of ongoing benefits – ordinarily early or preferred access to a defined stream of the center's research output, participation in an advisory or steering committee that helps set the research agenda, invitations to networking and research-showcase events, and access to a student recruiting pipeline – rather than funding a specific, deliverable-bound project. Membership is typically structured to grant a non-exclusive, use-only license to the resulting research output, not ownership or exclusive rights, which preserves the pre-competitive, multi-member model the program depends on.
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NIH Priority Score - CASRAI (2026)
An NIH priority score (overall impact score) is the numerical merit rating – 10 (best) to 90 (worst) – that a study section assigns a discussed grant application, calculated by averaging each voting reviewer's independent 1.0-9.0 overall impact rating and multiplying by 10. Where percentiling applies, that score is further converted into a percentile rank comparing the application against others reviewed by the same or a related study section over its three most recent meetings. Applications a study section does not select for full discussion (typically those projected to fall in the lower half of the range) receive no overall impact score. Not every scored application is percentiled – some mechanisms and small comparison groups are scored but not percentiled by policy. The priority score and percentile feed into, but do not by themselves determine, the funding institute's payline-based funding decision.
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Fake Citation - CASRAI (2026)
A fake citation (also called a fabricated citation or, when the source is a paper never written at all, a phantom reference) is a reference that does not correspond to a real, findable publication – an invented author, title, journal, DOI, or page range, or some combination of these, presented as if it points to an actual source. It also covers the narrower case of a citation to a real work that is misrepresented: the cited paper exists, but it does not say, show, or support what the citing text claims it does. A citation is operationally 'fake' if a reader who tries to locate and check it cannot verify that the source exists as described, or finds that the source exists but does not support the claim attached to it – as opposed to an honest error (a typo in a volume number, a wrong year) that still resolves to the intended real work.
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TMF Reference Model - CASRAI (2026)
The TMF Reference Model is a harmonized, industry-developed taxonomy for organizing Trial Master File (TMF) content into a predictable three-tier hierarchy of Zones, Sections, and Artifacts (with a fourth, more granular Sub-Artifact tier), each artifact carrying a unique ID, a written purpose/definition, and expected trial-phase metadata. A TMF or eTMF is properly described as 'built on' or 'mapped to' the TMF Reference Model when its filing structure and document types trace back to this defined Zone/Section/Artifact scheme rather than an organization's own bespoke folder taxonomy – it is a classification standard layered on top of the general TMF/eTMF concept, not a synonym for it.
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21 CFR Part 314 (Applications for FDA Approval to Market a New Drug) - CASRAI (2026)
21 CFR Part 314, "Applications for FDA Approval to Market a New Drug," is the FDA regulation establishing the entire New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) framework: the content and format an application must have (Subpart B, chiefly 314.50), the abbreviated pathway for generics relying on bioequivalence to an already-approved drug (Subpart C), FDA's review process including the filing decision, approval standard, and Complete Response Letter mechanism (Subpart D, 314.101/314.105/314.110), administrative hearing procedures (Subpart E), confidentiality provisions (Subpart G), accelerated approval based on a surrogate endpoint (Subpart H), and approval without human efficacy studies when unethical or infeasible, the "Animal Rule" (Subpart I). It governs a drug from the point a sponsor seeks marketing approval onward, picking up where 21 CFR Part 312 (Investigational New Drug) leaves off at the end of clinical investigation. Two individual Part 314 sections have their own dedicated CASRAI entries: 314.70 (post-approval changes) and 314.80 (postmarketing adverse event reporting), both within Subpart B.
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Delegation of Authority (DoA) Log - CASRAI (2026)
A Delegation of Authority (DoA) Log is the site-level record, maintained for each clinical trial at each investigator site, that documents which specific trial-related tasks the Principal Investigator (PI) has authorized named study-team members to perform, together with each person's qualifications, their signature or initials, and the exact date range during which that authorization was in effect. It answers one question for anyone reviewing the trial afterward — a monitor, an auditor, or an FDA inspector: was the person who performed this specific task actually authorized to perform it, on the date they performed it? A document set qualifies as a compliant DoA log when it names every individual (co-investigator, sub-investigator, clinical research coordinator, research nurse, research pharmacist, or other delegated staff) who performed a trial-related procedure or made a trial-related judgment; lists the specific tasks delegated to that person, not a generic job title; is signed or initialed by both the delegate and the PI; states the start date (and end date, once applicable) of each delegation; and is kept current as staff join, leave, or take on new responsibilities throughout the trial. Under ICH E6(R2) Section 4.1.5, the investigator must maintain a list of appropriately qualified persons to whom significant trial-related duties have been delegated; the DoA log is the standard operational instrument sites use to satisfy that requirement and to demonstrate it during inspection.
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MEDLINE Database - CASRAI (2026)
MEDLINE is the U.S. National Library of Medicine's core bibliographic database of biomedical and life-sciences journal literature: a curated set of article citations, indexed with MeSH controlled-vocabulary terms, drawn only from journals that have individually passed NLM's formal journal-selection review. It is distinct from PubMed (NCBI's free search interface, which includes MEDLINE plus some non-MEDLINE records) and from PubMed Central/PMC (NLM's separate full-text repository, with its own, less restrictive inclusion criteria).
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Ethical Violation - CASRAI (2026)
An ethical violation in research is any act or omission that breaches an accepted professional, institutional, or regulatory research-ethics norm, whether or not it meets the narrower threshold for formal 'research misconduct.' In the US federal system, research misconduct is legally defined by 42 CFR Part 93 as fabrication, falsification, or plagiarism (FFP) only, and explicitly excludes honest error, good-faith disagreement, and behaviors 'not unique to research' such as harassment or grant-management violations. 'Ethical violation' is the broader umbrella: it covers FFP, but also questionable research practices (QRPs), authorship abuse (ghost, guest, or gift authorship; denying deserved credit), undisclosed conflicts of interest, human- or animal-subjects protection breaches (e.g., proceeding without IRB/IACUC approval, exceeding approved protocol scope), peer-review misconduct (manipulating or leaking a manuscript under review), duplicate or salami-slicing publication, and mentorship or supervisory abuse. Whether a specific act rises to the level of an actionable 'ethical violation' is determined by the applicable code of conduct: an institution's own policy, a funder's terms and conditions, a journal's editorial policy (e.g. via COPE), or a national/international integrity code (e.g. ALLEA's European Code of Conduct for Research Integrity, or the UK's UKRIO framework), each of which sets its own scope and remedies.
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Investigator Site File (ISF) - CASRAI (2026)
A document or record belongs in an Investigator Site File (ISF) if it demonstrates something only the trial site itself can attest to under ICH E6(R2)'s essential-documents framework – delegation of authority, site-specific IRB/IEC oversight, staff qualifications, signed informed consent, and site-level investigational-product accountability – created and maintained by the site itself (not the sponsor or CRO) throughout the trial and kept available for monitoring and inspection.
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FDA BIMO (Bioresearch Monitoring) Program - CASRAI (2026)
FDA's Bioresearch Monitoring (BIMO) Program is the umbrella FDA inspection and data-audit program covering clinical investigators, sponsors/monitors/CROs, IRBs, nonclinical (GLP) laboratories, in vivo bioequivalence facilities, and several narrower tracks (RDRC, PADE, REMS reporting). It exists to verify the quality and integrity of data submitted in support of FDA product approvals and to protect the rights, safety, and welfare of human subjects and animals involved in the underlying research. BIMO inspections can be routine/surveillance, directed data audits, for-cause, or compliance follow-up, and each closed inspection resolves to one of three classifications: No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI).
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Site Management Organization (SMO) - CASRAI (2026)
A Site Management Organization (SMO) is a company that provides staff, infrastructure, and administrative support directly to clinical trial sites – as distinct from a Contract Research Organization (CRO), which contracts with the sponsor to manage a trial across multiple sites. An SMO's contractual relationship typically runs to the investigator or site, not the sponsor: it supplies clinical research coordinators (CRCs), regulatory-documentation support, patient-recruitment assistance, and study start-up help to one or more physical sites, and in many cases owns or directly operates a network of sites itself. Unlike the CRO, which is explicitly defined in ICH E6(R2) Section 5.2 and (for FDA-regulated drug trials) 21 CFR 312.52, an SMO has no equivalent formal regulatory definition – it is an industry business-model term, not a regulatory delegation category.
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Stevenson-Wydler Technology Innovation Act - CASRAI (2026)
A 1980 federal statute (Public Law 96-480, codified at 15 U.S.C. Chapter 63, Sections 3701 et seq.) that made technology transfer an explicit mission of every federal laboratory, requiring labs to actively work to transfer federally developed technology to state and local governments and the private sector – as distinct from Bayh-Dole, enacted the same year, which governs patent title for inventions made by universities, nonprofits, and small businesses under federal funding agreements, not the labs' own technology-transfer obligations.
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Sole Authorship - CASRAI (2026)
The condition of a scholarly or scientific work having exactly one author: a single named individual who alone satisfies the full authorship criteria a publisher or field applies (most commonly the ICMJE's four-part test – substantial contribution to conception or design, drafting or critically revising the work, final approval of the published version, and accountability for its accuracy and integrity), with no co-authors to share credit, order, or accountability with. Because there is only one contributor, none of the coordination questions that dominate multi-author authorship management – author order, corresponding-author designation, CRediT role-splitting, gift or ghost authorship, or authorship disputes – apply: the sole author is, by definition, first author, last author, and corresponding author simultaneously, and carries full responsibility for the entire work rather than a delineated share of it.
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Lead Author - CASRAI (2026)
A person is called a "lead author" in one of two distinct senses. Most commonly, it is an informal synonym for first author: the name listed first in a scholarly work's byline, conventionally read (in contribution-ranked fields) as the person who did the largest share of the practical work, and used interchangeably with "first author" especially in press releases, journalism, and general prose. Separately, in large team-authored scientific assessment reports (most visibly the IPCC), "Lead Author" is a formal, nominated role responsible for drafting a designated section of a chapter as part of a team, alongside Coordinating Lead Authors – a role defined by section-writing and coordination responsibility, not by contribution-ranked byline position, and with no single "first author" slot at all.
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Period of Performance - CASRAI (2026)
Period of performance is the specific time interval – defined at 2 CFR 200.1 as "the time interval between the start and end date of a Federal award, which may include one or more budget periods" – during which a recipient or subrecipient is authorized to incur allowable costs and carry out the substantive programmatic work of a federal award. Under 2 CFR 200.309, a non-Federal entity may charge to the award only costs incurred within this window, plus any pre-award costs specifically authorized in advance by the Federal awarding agency or pass-through entity, and a narrow publication/printing-cost exception at 2 CFR 200.461. Costs incurred before the start date or after the end date are not allowable charges to the award outside those exceptions. A multi-year award's single period of performance may be divided into one or more budget periods (annual funding increments, also defined at 2 CFR 200.1), and the period of performance's end date can be modified – most commonly extended – through a No-Cost Extension under 2 CFR 200.308(d)(2).
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R15 (NIH Academic Research Enhancement Award / AREA) - CASRAI (2026)
The R15 Research Enhancement Award (activity code R15, most commonly encountered via its Academic Research Enhancement Award / AREA sub-program, or its REAP sub-program for health professional and graduate schools) is an NIH grant mechanism restricted to institutions that have NOT been major recipients of NIH research funding: a qualifying institution (or its relevant non-health-professional components) must have received no more than $6 million per year in total NIH support in 4 of the last 7 fiscal years. It is designed to fund meritorious research at smaller, teaching-focused institutions while requiring that the research team be composed primarily of students, with a capped budget (currently up to $375,000 in direct costs) over a project period of up to 3 years.
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Supplanting - CASRAI (2026)
Supplanting is the use of federal grant funds to replace non-federal funds a recipient would otherwise have spent on the same activity, position, or service, rather than using the federal award to add new or expanded effort. It is the prohibited counterpart to the "supplement, not supplant" condition attached to many federal grant programs, and is assessed by comparing the funded level of activity against a documented non-federal spending baseline.
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NIH Prior Approval - CASRAI (2026)
A post-award change on an NIH grant or cooperative agreement requires NIH prior approval when it falls into one of the categories the NIH Grants Policy Statement (NIH GPS) Section 8.1.2 designates as requiring the awarding Institute or Center's written sign-off before the recipient implements it – rather than a change the recipient may make unilaterally and simply report after the fact. The request must be submitted by the institution's Authorized Organization Representative/Signing Official (not the PD/PI directly) through the eRA Commons Prior Approval module, or by email to the assigned Grants Management Specialist where the module does not yet cover a given request type, and NIH's practice is to expect submission at least 30 days before the proposed change and to target a response within 30 days of a complete request. Acting on one of these changes without approval is not merely a paperwork lapse: it converts an otherwise defensible administrative decision into a potential audit finding or disallowed cost.
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Final Invention Statement & Certification - CASRAI (2026)
The Final Invention Statement and Certification (HHS Form 568) is the grant-closeout document by which a federal award recipient certifies, to the funding agency, either a complete list of every subject invention conceived or first actually reduced to practice under the award, or an affirmative statement that no subject invention was made. It is a closeout-stage compliance filing required by NIH and other Public Health Service (PHS) awarding components under the Bayh-Dole Act's standard patent rights clause (37 CFR 401.14), submitted through the Interagency Edison (iEdison) system, and is distinct from the earlier, ongoing obligation to disclose each individual subject invention to the funding agency as it is made.
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F&A Waiver - CASRAI (2026)
An F&A waiver (indirect cost rate waiver) is an institution's agreement to recover indirect costs on a specific award at less than its full federally negotiated F&A rate – ranging from a partial reduction to a full waiver to 0%. It is an exception applied award-by-award, not a change to the institution's underlying Negotiated Indirect Cost Rate Agreement (NICRA), which continues to state the institution's full rate for every other award. A waiver is distinct from the de minimis rate (a flat substitute for organizations that have never negotiated a rate at all) and from a sponsor's own published rate cap, though a sponsor cap is the single most common reason institutions grant one.
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Risk-Based Quality Management (RBQM) - CASRAI (2026)
Risk-Based Quality Management (RBQM) is the quality-by-design framework ICH E6(R2) introduced in its Section 5.0 (2016) and ICH E6(R3) generalized further: sponsors identify and prioritize risks to critical-to-quality trial data and processes starting at protocol design (E6(R2) Section 5.0.1), set predefined quality tolerance limits (QTLs, Section 5.0.4) for a small number of trial-critical parameters, and use centralized statistical monitoring and risk-proportionate on-site/remote monitoring (Section 5.18.3) to detect and correct deviations. RBQM is the overarching quality-management framework; risk-based monitoring (RBM) is one operational technique within it, not a synonym for it.
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Clinical Trials Office (CTO) - CASRAI (2026)
A Clinical Trials Office (CTO) is the institutional unit – typically housed within an academic medical center, hospital, or university health science center – that provides centralized administrative, regulatory, and financial support to investigators conducting clinical trials at that institution. A unit qualifies as a CTO when it performs some combination of budget development and sponsor rate negotiation, clinical trial agreement (CTA) review and negotiation, regulatory-submission support (IRB liaison, FDA correspondence support), coverage-analysis and Medicare Clinical Trial Policy (NCD 310.1) billing-compliance review, and study feasibility/start-up coordination specifically for interventional or observational human-subjects trials – as distinct from a general Sponsored Programs Office (which administers the institution's full grants and contracts portfolio across all disciplines) and distinct from a Contract Research Organization (an external commercial vendor a sponsor hires to run trial operations, not an internal institutional support office).
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Person Months - CASRAI (2026)
Person months is NIH's standard unit for expressing the effort a PD/PI, faculty member, or other senior/key personnel devotes to a specific project. It is calculated by multiplying the percentage of a person's total professional effort committed to the project by the number of months in that person's appointment type: calendar year (CY, 12 months), academic year (AY, the institution's defined academic-year length – commonly 9 months, sometimes 9.5 or 10), or summer term (SM, the institution's defined summer period, commonly 2-3 months). The figure appears in the Senior/Key Person Profile of an NIH budget, in Other Support disclosures, and in the annual Research Performance Progress Report (RPPR), and it must reflect a genuine share of total professional effort – not clock hours worked or a share of a 40-hour week.
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Clinical Operations - CASRAI (2026)
Clinical operations (often shortened to "clin ops") is the organizational function responsible for the logistical and operational execution of a clinical trial once it has been designed and funded: selecting and activating sites, staffing and managing the monitoring function, overseeing clinical data management systems, coordinating investigational-product supply, managing third-party vendors (labs, imaging cores, IRT/RTSM providers), and tracking trial progress against timeline and budget. A function is properly described as clinical operations when its output is the trial actually running – sites open, participants enrolled, data flowing, product supplied – rather than deciding what the trial should study (clinical development) or generating the wider evidence base a study contributes to (clinical research).
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NSF GRFP (Graduate Research Fellowship Program) - CASRAI (2026)
The NSF Graduate Research Fellowship Program (GRFP) is a competitively awarded, individually-held fellowship funding three years of graduate study and research (within a five-year eligibility window) for early-career graduate students – and eligible undergraduate seniors applying in advance – pursuing full-time, research-based STEM or STEM-education master's or doctoral study. It provides a $37,000 annual stipend to the fellow plus a separate $16,000 Cost of Education allowance paid to the fellow's institution. Eligibility is restricted to U.S. citizens, U.S. nationals, and U.S. permanent residents; applicants must not already hold a doctoral or equivalent terminal degree.
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Cost Transfer - CASRAI (2026)
A cost transfer is the reassignment of an expense already posted to one sponsored project ledger to a different sponsored project (or from a non-sponsored account onto a sponsored one) after the original transaction has occurred. It is distinct from an initial charge decision made at the time an expense is incurred: a cost transfer is always a correction or reclassification made after the fact, moving a real, previously-recorded cost rather than authorizing a new one. Under the allowability and allocability standards at 2 CFR 200.403 and 200.405, every transferred cost must independently satisfy the same tests an original charge would – necessary, reasonable, allocable to the receiving award in proportion to the benefit it provides, and consistently treated – a transfer does not get a lower bar just because the underlying expense was legitimate somewhere. Most research institutions require transfers to be processed within a defined window, commonly 90 calendar days from the date the original charge posted, submitted with documentation specific enough that an independent reviewer, such as an auditor, could understand how the error occurred and confirm the new charge is correct – a generic note that a transfer corrects "a posting error" or moves a cost "to the correct project" does not meet that bar on its own.
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Biosafety Level 5 (BSL-5) - CASRAI (2026)
There is no “Biosafety Level 5” (BSL-5) in the biosafety containment framework used in the United States. The CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (BMBL, 6th edition, 2020) — the primary US reference for laboratory biosafety practice, and the framework incorporated by reference into the NIH Guidelines and the Federal Select Agent Program — defines exactly four cumulative containment levels, BSL-1 through BSL-4. BSL-4 is explicitly the maximum standard containment level: it is reserved for agents that pose a high risk of life-threatening disease, have no routinely available vaccine or treatment, and carry a realistic risk of aerosol transmission (for example Ebola, Marburg, and Variola/smallpox virus). No recognized national or international biosafety framework — including the frameworks referenced by WHO or by other countries’ biosafety authorities — defines a fifth, more stringent numbered tier above BSL-4. A search for “BSL-5” or “Biosafety Level 5” almost always reflects one of three things: (1) a misremembering or misreading of BSL-4 as if the numbering continued further; (2) informal or journalistic usage describing an especially dangerous, BSL-4-level pathogen as needing “level 5” containment for emphasis, with no formal designation behind the phrase; or (3) conflation of BSL-4’s two distinct primary-containment approaches — cabinet laboratories and suit laboratories — or of facility-specific “enhanced” protocols layered on top of baseline BSL-4 for a small number of especially high-consequence agents, as if these were a separate, higher-numbered level rather than variations within BSL-4 itself.
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Research Administrator Day - CASRAI (2026)
Research Administrator Day is an annual U.S. professional-recognition observance held on September 25, established in 2015 by the National Council of University Research Administrators (NCURA) and formally proclaimed through National Day Calendar. It is dedicated to recognizing the staff who manage the pre-award and post-award work of securing and administering sponsored research funding – grants specialists, sponsored-programs officers, compliance staff, and departmental research administrators. The Society of Research Administrators International (SRAI) also promotes the day to its own membership under the same September 25 date, so in practice it functions as a shared, sector-wide observance rather than one sponsored by a single body. It is not a federal holiday and carries no legal or regulatory status; observance is voluntary and institution-by-institution.
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NIH Guide for Grants and Contracts - CASRAI (2026)
The NIH Guide for Grants and Contracts (grants.nih.gov/guide) is NIH's official publication of record for grants-related announcements: every NIH Institute, Center, and Office is required to publish its official Notices there, each assigned a unique NOT-prefixed number, and a weekly Table of Contents lists everything posted that week. Before FY2026 it was also the official channel for Notices of Funding Opportunity (NOFOs, formerly FOAs) themselves; since FY2026, per NOT-OD-25-143, new NOFOs are posted on Grants.gov instead, while the Guide continues to carry every other Notice type – policy changes, administrative supplements, requests for information, correction notices, and pre-application announcements.
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ESRC Postdoctoral Fellowship - CASRAI (2026)
An ESRC Postdoctoral Fellowship is a UK Research and Innovation (UKRI) award, funded through the Economic and Social Research Council (ESRC) but applied for and administered through an ESRC-recognised Doctoral Training Partnership (DTP), not directly through ESRC or UKRI's central funding service. It supports a single named early-career researcher for up to nine months full-time (or up to 18 months part-time, pro-rated) immediately after completing a UK-based PhD, covering the fellow's salary plus additional funds for research and training costs. Eligibility is tightly bounded: the applicant's PhD must have been undertaken at a research organisation inside the ESRC doctoral training network, and no more than 15 months of active postdoctoral experience (full-time equivalent, measured from the viva to the competition closing date) can have elapsed. Fellowship activity must sit at least 50% within the social sciences even where the underlying research is genuinely interdisciplinary, and an applicant may submit to only one DTP per competition round.
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ICH Q10 (Pharmaceutical Quality System) - CASRAI (2026)
ICH Q10 (Pharmaceutical Quality System) is the ICH Quality-series guideline that defines a model pharmaceutical quality system (PQS) spanning a product's entire life cycle – pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. A quality system meets ICH Q10 when it (1) sits on top of applicable Good Manufacturing Practice (GMP/ICH Q7) requirements and incorporates ISO 9001 quality-management-system principles, (2) applies the risk-based tools of ICH Q9 (Quality Risk Management) to prioritize and scope quality decisions, (3) uses the science- and risk-based product/process understanding built during development under ICH Q8 (Pharmaceutical Development), and (4) operates four specific management enablers – a Process Performance and Product Quality Monitoring System, a Corrective and Preventive Action (CAPA) system, a Change Management System, and Management Review – under documented senior-management responsibility and a stated commitment to continual improvement.
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Select Agent List - CASRAI (2026)
The Select Agent List is the HHS/USDA-maintained roster (42 CFR Part 73, 7 CFR Part 331, 9 CFR Part 121) of specific biological agents and toxins determined to pose a severe threat to human, animal, or plant health. Any entity possessing, using, or transferring a listed agent above regulatory exclusion thresholds must register with the Federal Select Agent Program (jointly run by CDC and USDA/APHIS), designate a Responsible Official, and ensure every individual with access clears an FBI Security Risk Assessment; a smaller Tier 1 subset carries additional security and suitability-monitoring requirements.
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Institutional Base Salary (IBS) - CASRAI (2026)
The annual compensation an institution itself pays a faculty or staff member for the appointment covering their full professional effort – whatever mix of research, teaching, clinical, administrative, or other institutional duties that appointment involves – regardless of how many separate funding sources (federal, non-federal, institutional) ultimately pay portions of it. Per the NIH Grants Policy Statement (Section 12.8.1, Salaries and Fringe Benefits), IBS excludes any income an individual is permitted to earn outside their duties to the institution (e.g., outside consulting, honoraria, board fees) and excludes discretionary items such as bonuses or incentive pay that are not a fixed part of the base appointment. IBS cannot be inflated after the fact by substituting grant funds for institutional salary funds. IBS is the institution's own determination – there is no federal formula for calculating it – but once set, it becomes the base figure federal sponsors require for two distinct purposes: (1) as the denominator for converting a person's percentage of effort on a project into a dollar salary request, and (2) as the figure against which a cap such as the NIH salary limitation is applied, when one exists.
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Declaration of Helsinki - CASRAI (2026)
The Declaration of Helsinki is the World Medical Association's statement of ethical principles for medical research involving human participants, first adopted in 1964 (Helsinki) and revised at WMA General Assemblies through the most recent revision, adopted October 19, 2024. It is the operative ethical reference a physician-investigator, sponsor, or ethics committee cites specifically for physician-conducted medical research – distinct from the Nuremberg Code (a fixed 1947 tribunal judgment) and the Belmont Report (a US-specific 1979 national-commission document underlying the Common Rule) – and it is the ethical source ICH E6 Good Clinical Practice cites as the origin of its own principles. A study or protocol is judged against the Declaration when the question is whether independent ethics-committee review occurred, informed consent was genuinely obtained, any placebo/no-treatment control arm was ethically justified, and results-transparency obligations were met.
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Source Documentation (Source Documents / Source Data) - CASRAI (2026)
Source documentation is the body of original records – medical charts, laboratory reports, imaging studies, pharmacy dispensing logs, subject diaries, correspondence, and automated instrument printouts – in which clinical findings, observations, or other trial-related activities are first captured, at the point and time they occur. The information those records contain is source data; the records themselves are source documents. A record only counts as a source document for a given data point if it is where that data point was originally recorded – a transcription onto a separate worksheet or data-collection tool is not itself a source document unless no earlier original record exists. Per ICH E6(R2) Section 1.51, source data is 'all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial'; Section 1.52 defines source documents as the original documents, data, and records containing that information. To be inspection-ready and support reconstruction of the trial, source documentation must satisfy the ALCOA-C principles: Attributable (identifies who recorded it and when), Legible, Contemporaneous (recorded at the time of the observation, not backfilled), Original (the first record, or a verified certified copy), Accurate, and Complete.
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CAPA (Corrective and Preventive Action) - CASRAI (2026)
CAPA (Corrective and Preventive Action) is the formal quality-system process an organization uses to investigate a finding – an audit observation, a protocol deviation, an FDA Form 483 observation, or any other nonconformity – determine its root cause, implement a correction and corrective action to eliminate that cause, take preventive action to stop the same or a similar problem recurring elsewhere in the system, and verify afterward that those actions actually worked.
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ANZCTR (Australian New Zealand Clinical Trials Registry) - CASRAI (2026)
The Australian New Zealand Clinical Trials Registry (ANZCTR) is the primary online registry for clinical trials conducted in Australia and New Zealand, distinguished from clinical trial registration generally by being the specific bi-national system, housed and managed by the NHMRC Clinical Trials Centre at the University of Sydney since 2005, that assigns every registered study a unique ACTRN (Australian Clinical Trial Registration Number) and was, in 2007, one of the first three registries the World Health Organization recognized as a Primary Registry under its International Clinical Trials Registry Platform (WHO ICTRP).
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Consensus (AI Academic Search Engine) - CASRAI (2026)
Consensus is a named AI-powered academic search engine (built by the company Consensus, at consensus.app) that retrieves peer-reviewed papers relevant to a natural-language research question and generates a synthesis of what the retrieved literature says, rather than returning a plain ranked list of results. For questions phrased as a yes/no/maybe claim, it additionally displays a 'Consensus Meter' – a visual indicator of how the retrieved papers' findings line up (agree, disagree, or mixed) on that specific claim, generated from the paper set Consensus itself retrieved and summarized. It is a specific product in the 'literature summarization and evidence-synthesis' category, distinct from general-purpose AI chatbots (which do not search a dedicated indexed academic corpus or cite retrieved papers by default) and from citation-graph or general-purpose scholarly search tools such as Semantic Scholar (which surface and rank papers but do not generate a claim-level agreement synthesis across them).
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Medical Device Amendments of 1976 - CASRAI (2026)
The Medical Device Amendments of 1976 (Pub. L. 94-295) is the U.S. federal statute, signed by President Gerald Ford on May 28, 1976, that amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to create the modern medical device regulatory framework. Before 1976, FDA had essentially no premarket authority over devices – only the FD&C Act's general adulteration and misbranding provisions applied, the same standard used for drugs since 1938 but poorly suited to the mechanical, electrical, and implantable nature of devices. The Amendments added Section 513 to the FD&C Act, establishing a risk-based, three-tier classification system (Class I, II, III) and, for the first time, two premarket regulatory pathways keyed to that classification: premarket notification (what the statute's own section number gave us as the now-familiar '510(k)') and premarket approval (PMA) for the highest-risk devices. Devices already legally on the U.S. market when the law took effect were not retroactively required to prove safety and effectiveness from scratch; they were classified based on their existing marketing history, and later devices could establish 510(k) eligibility by claiming 'substantial equivalence' to one of these pre-1976 devices or to a device subsequently cleared through that same route – the origin of the 'predicate device' concept that still anchors the 510(k) pathway today.
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Software export controls - CASRAI (2026)
The application of US export control regulations, principally the Export Administration Regulations (EAR, 15 CFR 730-774), to software source code, object code, and related technical data, addressing three issues distinct from general item/equipment export control: (1) whether the software qualifies as 'published' and therefore outside EAR jurisdiction under 15 CFR 734.7 (or fundamental-research-excluded under 734.8), based on whether it was released without restriction on further dissemination; (2) whether the software has cryptographic functionality subject to the separate Category 5 Part 2 encryption controls (ECCNs 5A002/5D002/5E002) and associated License Exception ENC or self-classification requirements; and (3) whether granting a foreign national visual, electronic, or repository access to controlled, non-published source code constitutes a deemed export under 15 CFR 734.13, independent of whether any file is physically transmitted abroad.
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Je-S (Joint Electronic Submission) - CASRAI (2026)
Je-S (Joint Electronic Submission), hosted at je-s.rcuk.ac.uk, is UK Research and Innovation's (UKRI) legacy online system for submitting grant applications and administering research council awards. UKRI's seven research councils used Je-S for close to two decades before progressively replacing it with the UKRI Funding Service (funding-service.ukri.org) from 2023 onward. A form, account, or award is 'in Je-S' when it was created on, or is still being administered through, that older platform rather than the current Funding Service.
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IND Exemption (21 CFR 312.2(b)) - CASRAI (2026)
The regulatory determination, made by a sponsor under 21 CFR 312.2(b), that a clinical investigation of a drug already lawfully marketed in the United States does not require an Investigational New Drug (IND) application because the study meets all five conditions in the rule: it is not intended to support a new indication or a significant labeling/advertising change, it does not significantly increase the risk (or decrease the acceptability of risk) associated with the drug's approved use, it is conducted in compliance with IRB review (21 CFR Part 56) and informed consent (21 CFR Part 50) requirements, it is not intended to promote the drug for an unapproved use, and it does not involve a route of administration, dosage level, patient population, or other factor that significantly increases the risks associated with the drug's approved use. All conditions must be met simultaneously; failing any one of them means the study needs a full IND regardless of how the others resolve.
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21 CFR 314.70 (Changes to an Approved NDA or ANDA) - CASRAI (2026)
21 CFR 314.70 is the FDA regulation ("Supplements and other changes to an approved NDA," applied to ANDAs via 21 CFR 314.97) that requires the holder of an approved New Drug Application or Abbreviated New Drug Application to classify every post-approval change to the product, its manufacturing, or its labeling into one of four reporting tracks based on the change’s potential to adversely affect identity, strength, quality, purity, or potency: a Prior Approval Supplement (PAS) for major changes, requiring FDA approval before distribution of product made using the change; a Changes Being Effected in 30 Days supplement (CBE-30) for moderate-risk changes, permitting distribution 30 days after FDA receives the supplement absent an FDA objection; a Changes Being Effected in 0 Days supplement (CBE-0) for a narrower, FDA-designated set of lower-risk changes (most notably certain safety labeling updates), permitting distribution immediately upon FDA’s receipt; and the Annual Report track for minor changes, which are simply documented in the applicant’s next annual report rather than submitted as a standalone supplement. The applicable category is determined by the nature of the specific change, not by applicant discretion.
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ePRO (Electronic Patient-Reported Outcomes) - CASRAI (2026)
ePRO is the electronic capture of a Patient-Reported Outcome (PRO) directly from a clinical trial participant – via a provisioned or patient-owned (BYOD) device, app, wearable, or web portal – without amendment or interpretation by site staff. A data point qualifies as ePRO only when three conditions hold together: (1) the underlying instrument is a validated PRO measure with a defined concept of interest and context of use; (2) the response is entered by the patient at the point of report, not transcribed later by a coordinator or clinician; and (3) the capture system produces a timestamped, attributable, auditable electronic record sufficient to serve as source data for FDA inspection. It is distinguished from Clinician-Reported Outcome (ClinRO) data entered into the trial's eCRF by a site investigator, and from a paper PRO diary that a coordinator later keys into an EDC system – both of those break the direct-from-patient chain that defines a PRO in the first place.
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Medical Device Reporting (MDR) - CASRAI (2026)
Medical Device Reporting (MDR) is FDA's mandatory adverse-event reporting system under 21 CFR Part 803, requiring device manufacturers, importers, and device user facilities (hospitals, nursing homes, outpatient facilities) to notify FDA when they become aware that a device may have caused or contributed to a death or serious injury, or has malfunctioned in a way that would likely cause death or serious injury if the malfunction recurred. It is distinct from the EU's 'MDR' (Regulation (EU) 2017/745, the Medical Device Regulation governing premarket CE marking and market access) – the two share only an acronym, not a regulatory function.
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IND Safety Report - CASRAI (2026)
A written or electronic notification that a sponsor holding an active Investigational New Drug (IND) application must submit to FDA, and to every participating investigator, under 21 CFR 312.32, whenever the sponsor determines there is reasonable possibility that the investigational drug caused a serious and unexpected adverse event (i.e., the event qualifies as a suspected unexpected serious adverse reaction, or SUSAR). It is distinct from routine investigator-to-sponsor adverse event reporting, from the IND annual report, and from post-marketing adverse-event reporting under 21 CFR 314.80, which applies only after a drug is approved.
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NSF AI Institutes (National AI Research Institutes) - CASRAI (2026)
The NSF AI Institutes – formally the National Artificial Intelligence Research Institutes – are a cohort of large, multi-year, multi-institution research centers funded through cooperative agreements led by the U.S. National Science Foundation (NSF), typically in partnership with one or more other federal agencies or private-sector funders. An award qualifies as one of these institutes if it (1) was made under an NSF AI Institutes solicitation (the program has issued several since its first, NSF 20-503, in 2019-2020), (2) funds a single institute at roughly $20 million over a five-year period of performance, (3) spans multiple partner institutions organized around a lead awardee, and (4) is scoped around foundational AI research paired with a specific application domain (e.g., agriculture, astronomy, education, cybersecurity, weather) rather than AI research in the abstract. It is administratively distinct from a standard NSF research grant (see NSF PAPPG) both in award mechanism (cooperative agreement, which gives NSF a more active oversight role than a standard grant) and in scale.
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Standard Operating Procedure (SOP) - CASRAI (2026)
In a research context, a Standard Operating Procedure (SOP) is a written, controlled, step-by-step instruction for performing a specific recurring task the same way every time it is performed, regardless of who performs it – distinct from a protocol, which specifies what a particular study will do, and from a policy, which states an institution's general position or requirement. A document counts as a research SOP only if it is: (1) task- or process-specific rather than study-specific (e.g. "how this laboratory calibrates a balance" or "how this site receives and stores investigational product," not "what Study ABC-123 will test"); (2) formally approved and version-controlled, with an identifiable author, approver, effective date, and version/revision history; (3) written in enough procedural detail that a trained staff member unfamiliar with that specific instance of the task could follow it and produce a consistent, auditable result; and (4) actually followed and enforced in practice, with deviations documented – an unused or unenforced document is not functioning as an SOP even if it is labeled one.
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Proof-of-Concept Funding - CASRAI (2026)
Proof-of-concept (PoC) funding is a category of small, milestone-based, non-dilutive awards used to test and demonstrate the technical and/or commercial feasibility of a discovery that has already been made – bridging the gap between a research finding and a patentable, licensable, or investable technology. It is distinguished from earlier-stage seed funding by its purpose and starting point: PoC funding assumes a specific invention or result already exists (often already the subject of an invention disclosure or provisional patent filing) and uses the award to move that specific result forward – validating a prototype, running freedom-to-operate or IP-strategy work, generating the data needed for a licensing conversation, or engaging early industry/investor interest – rather than to generate the preliminary data needed to justify a larger research grant in the first place. PoC funding is typically administered by, or run in close coordination with, a university technology-transfer office (TTO), a national/regional funder's dedicated PoC scheme, or a translational funding agency, and award activity is usually reported against a technology readiness level (TRL) or an equivalent milestone framework rather than conventional research-progress metrics.
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Altmetric Attention Score - CASRAI (2026)
A proprietary, automatically calculated weighted count – produced by the company Altmetric (a Digital Science business) – of the online attention a specific research output has received across tracked sources, where a mention counts toward the score only if it is captured by Altmetric's tracking and is attributable to a source type in its weighting model (news outlets, blogs, policy documents, Wikipedia, post-publication peer review platforms, X/social media, and others); it is a measure of the volume and reach of attention, not of scholarly quality or citation impact.
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Pragmatic Trial - CASRAI (2026)
A pragmatic (clinical) trial is a randomized controlled trial designed to measure an intervention's effectiveness under conditions that resemble routine, real-world care, rather than its efficacy under tightly controlled, ideal conditions. It is still an experimental, randomized design – what distinguishes it from an explanatory trial is a cluster of protocol choices: broad eligibility criteria that mirror the population who would actually receive the intervention, delivery in usual-care settings by usual-care staff, flexible (rather than rigidly standardized) treatment protocols, a usual-care or standard-of-care comparator instead of placebo, and outcomes that matter to patients and decision-makers (e.g., hospitalization, function, quality of life) rather than surrogate or mechanistic endpoints. No trial is purely pragmatic or purely explanatory; every trial sits somewhere on a continuum between the two, and the PRECIS-2 (PRagmatic-Explanatory Continuum Indicator Summary-2) tool is the standard instrument for locating a given trial's design on that continuum, domain by domain, rather than as a single binary label.
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DoD Indirect Cost Rate: ONR/DCAA Process - CASRAI (2026)
For institutions whose cognizant federal agency for indirect costs is the Department of Defense (assigned via the Office of Naval Research (ONR) under 2 CFR 200 Appendix III), the standard NICRA negotiation process contains one distinct extra step not present for HHS-cognizant institutions: rather than the cognizant agency's own cost-allocation staff reviewing the university's indirect cost rate proposal in-house, ONR contracts that technical review out to the Defense Contract Audit Agency (DCAA), which independently audits the proposal under DCAA Contract Audit Manual (DCAAM) Chapter 13 – the chapter specifically covering audits at educational institutions, nonprofit organizations, and FFRDCs – and returns an audit report to ONR, which ONR then uses as the basis for negotiating the final F&A rate with the institution. The resulting agreement is still an ordinary NICRA under 2 CFR 200 Appendix III; the difference is confined to who performs the underlying audit before negotiation, not to a separate rate instrument or rate structure.
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Indirect Cost Rate Proposal - CASRAI (2026)
An indirect cost rate proposal is the documentation package an institution of higher education compiles and submits to its cognizant federal agency for indirect costs, under 2 CFR Part 200 Appendix III, to support negotiation of an indirect (F&A) cost rate. It identifies and assigns indirect costs to defined cost pools, selects an allocation base for each pool (or, for small institutions using the simplified method, a single base for total indirect costs), calculates proposed rates, and includes a signed Certificate of Indirect (F&A) Costs. The proposal is the institution's submitted request; the resulting signed document the cognizant agency issues after negotiation is the Indirect Cost Rate Agreement (NICRA), a distinct artifact.
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Condition Code 30 - CASRAI (2026)
Condition Code 30 is the two-digit value ("30 – Qualifying Clinical Trial") entered in the condition codes field of an institutional Medicare claim (UB-04 / CMS-1450, or the equivalent field on the electronic 837I transaction) to flag that the claim includes items or services furnished in connection with a qualifying clinical trial under Medicare's Clinical Trial Policy (National Coverage Determination 310.1). A claim requires Condition Code 30 when the trial meets NCD 310.1's qualifying criteria (falls within a Medicare benefit category, has therapeutic intent, and satisfies one of the NCD's deeming criteria — including NIH, FDA IND, or VA/DOD/CDC/AHRQ/CMS-funded/-supported studies) and the provider is billing Medicare for routine patient-care costs alongside the trial. It is reported on ALL clinical-trial-related institutional claims from a qualifying study, whether or not every line item on that particular claim is trial-related, and is submitted together with ICD-10 diagnosis code Z00.6 (encounter for examination for normal comparison and control in clinical research) and the trial's eight-digit National Clinical Trial (NCT) number — reported as UB-04 value code D4, or in loop 2300, REF02 (REF01 = P4) on the 837I. It functions purely as a claims-processing flag: it does not itself create coverage, it tells the Medicare Administrative Contractor (MAC) which coverage rules to apply to the claim.
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SF-424 (Application for Federal Assistance) - CASRAI (2026)
The SF-424, "Application for Federal Assistance," is the standard cover-sheet form used to open nearly every application for federal grant or cooperative-agreement funding submitted through Grants.gov. A submission qualifies as using "the SF-424" when it supplies the form's core identifying and administrative data — applicant legal name and Unique Entity Identifier (UEI), type of applicant, funding opportunity number, congressional districts, project title, proposed period of performance, requested federal and non-federal funding amounts, and the Authorized Organization Representative's certification — as the umbrella cover page bundled with program-specific forms in a single Grants.gov Workspace submission package. The base SF-424 (OMB Number 4040-0004) is one member of a wider "SF-424 family": SF-424A (Budget Information for Non-Construction Programs, OMB 4040-0006) and SF-424B (Assurances for Non-Construction Programs) are commonly paired with it, SF-424C/D cover construction programs, and a distinct variant, SF-424 R&R ("Research and Related"), is used by NIH, NSF, and other research-funding agencies in place of the base non-research SF-424. A document is NOT "the SF-424" merely because it is a federal grant application — the term refers specifically to this standardized cover form, not to the full application package, the budget narrative, or agency-specific supplemental forms bundled alongside it.
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Central IRB / Single IRB (sIRB) - CASRAI (2026)
The model in which one IRB of record – rather than each participating site's local IRB – conducts the ethical review for a multi-site human-subjects study under a single approved protocol, with all other participating sites relying on that review through a documented reliance arrangement (typically an IRB Authorization Agreement) instead of each convening a duplicate local review.
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NIDA GCP Training - CASRAI (2026)
NIDA GCP Training refers to the Good Clinical Practice training course developed and administered by NIDA's Center for the Clinical Trials Network (CCTN), the coordinating body for the National Institute on Drug Abuse's Clinical Trials Network (CTN) – a network of research sites and community treatment programs that conducts multisite trials on substance use disorder treatments. The course is not a separate regulatory standard: its content is built on the same underlying framework as ICH E6 Good Clinical Practice and applicable U.S. Code of Federal Regulations (CFR) provisions for human subjects research, but it is packaged, delivered, and administered specifically by NIDA/CCTN rather than by a third-party provider such as the CITI Program. A record is a genuine instance of 'NIDA GCP Training' when the completion certificate was issued through NIDA's own training platform (gcp.nidatraining.org) rather than through a different GCP course that merely also references ICH GCP.
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Letter of Intent (NIH) - CASRAI (2026)
An NIH Letter of Intent (LOI) was a short, non-binding, typically one-page pre-application notice – naming the PI, participating institution(s), and the funding opportunity number/title – that some (not all) NIH funding opportunity announcements asked prospective applicants to submit, generally around 30 days before the application due date, so NIH staff could estimate peer-review workload and recruit reviewers. It never obligated the sender to apply, was never scored or considered in peer review, and never counted against the application's own page limits. Effective December 3, 2025, NIH discontinued the LOI process NIH-wide via Guide Notice NOT-OD-26-019: NIH no longer requests or accepts letters of intent as part of the standard application process.
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ERC Proof of Concept Grant - CASRAI (2026)
An ERC Proof of Concept (PoC) Grant is a European Research Council top-up funding scheme, not a standalone competitive research grant. It is open only to principal investigators (PIs) who currently hold, or have held, one of the four ERC frontier-research grants (Starting, Consolidator, Advanced, or Synergy Grant). Its purpose is to help those researchers explore the commercial or societal application potential of results already generated under their ERC-funded project — testing a concept, validating an idea, addressing a technical bottleneck, clarifying an intellectual-property strategy, or engaging early with potential users, licensees, or investors. It is not a mechanism for funding new, unrelated research: the PI must be able to demonstrate a direct link between the proposed PoC activity and the frontier-research project it draws on. For the 2026 ERC Work Programme, PoC Grants are awarded as a lump sum of €150,000 for up to 18 months. Eligible applicants are PIs on an ongoing ERC main grant, or on a main grant that ended on or after 1 January 2025 — the ERC periodically shifts this eligibility window between Work Programme years, so applicants should always confirm the exact cut-off date against the current year's call documents rather than assume it carries over unchanged. Each PI may submit only one PoC application per call, and a single main grant project may receive a maximum of three PoC awards over its lifetime (six for Synergy Grant projects, reflecting their multi-PI structure). Evaluation is single-stage and assessed on breakthrough innovation potential, feasibility of the proposed approach, and the PI's strategic leadership — there is no separate peer-review panel structure comparable to the main schemes' two-stage process.
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Protocol Amendment - CASRAI (2026)
A protocol amendment is a written, sponsor-initiated description of a change to, or formal clarification of, an already IRB/IEC-approved research protocol. Under ICH E6(R2) Section 1.60, that is the formal definition. An amendment is planned and prospective: it must be submitted to and reviewed by the IRB/IEC (and, for FDA-regulated drug trials, separately reported to FDA under 21 CFR 312.30) and receive documented approval before the changed procedures take effect, with two narrow exceptions – a change made to eliminate an immediate hazard to subjects, and a change that is purely logistical or administrative (e.g., a monitor's phone number) and does not affect subject safety, rights, welfare, or the scientific integrity of the study. This prospective-approval requirement is what separates an amendment from a protocol deviation, which is an unplanned departure discovered and documented after the fact.
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FDA Form 3926 - CASRAI (2026)
FDA Form 3926, officially the "Individual Patient Expanded Access Investigational New Drug Application," is the streamlined form a treating physician uses to request FDA authorization for a single named patient to receive an investigational drug – or an approved drug whose availability is restricted by a Risk Evaluation and Mitigation Strategy (REMS) – outside a clinical trial, under the individual-patient category of FDA's expanded access ("compassionate use") pathway codified at 21 CFR Part 312, Subpart I. A request counts as a Form 3926 submission when: (1) the treating physician (not the manufacturer) files it with the relevant FDA review division, or in a genuine emergency initiates the request by phone/other rapid means and completes the form afterward; (2) the manufacturer/sponsor has agreed, generally via a Letter of Authorization, to supply the product for this specific patient; (3) the physician has documented the patient's brief clinical history, prior therapy, and treatment plan (dose, route, schedule, duration, monitoring) in the form's required sections; and (4) FDA has not objected within the applicable waiting period. Form 3926 is FDA's purpose-built, physician-oriented alternative to filing a full commercial IND application on Form FDA 1571 – it is not used for multi-patient or sponsor-initiated expanded access categories, and it is not part of the separate Right to Try Act pathway.
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RTSM (Randomization and Trial Supply Management) - CASRAI (2026)
A system counts as RTSM (Randomization and Trial Supply Management) – also called IRT (Interactive Response Technology) – if, within a single platform used by trial sites, it performs at least one of: (1) subject randomization to a treatment arm per the protocol's randomization scheme at enrollment, with blind maintenance and an auditable emergency-unblinding path where the trial is blinded; or (2) trial-supply management – real-time kit- or dose-level inventory tracking and automatic resupply triggering to sites or depots. Most production RTSM/IRT platforms do both together. A platform that only captures clinical data (an EDC) or only manages site financial, regulatory, and monitoring workflow (a CTMS) is not RTSM/IRT, even though all three are routinely used side by side, and sometimes integrated, on the same trial.
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PsyArXiv - CASRAI (2026)
PsyArXiv is a free, open-access preprint repository for psychology and related behavioral-science research. It was created by the Society for the Improvement of Psychological Science (SIPS) and is hosted on the Open Science Framework (OSF), the infrastructure built and maintained by the Center for Open Science (COS). A PsyArXiv Scientific Advisory Board oversees policy, and the service is funded by contributions from member institution libraries rather than author or reader fees. Authors upload working papers, preprints, registered reports, and author copies of accepted journal articles covering any area of psychology — clinical, cognitive, developmental, social, and beyond — without going through the peer review a journal would require before an editor even sees the manuscript. Accepted submissions receive a persistent DOI, making the preprint citable on its own before, or independent of, eventual journal publication. Operational definition A deposit is properly identified as a "PsyArXiv preprint" if it meets all of the following: It was submitted through the PsyArXiv service on OSF (osf.io/preprints/psyarxiv), not simply cross-listed or mirrored from another preprint server. It falls within psychology or a closely related behavioral/social-science discipline, per PsyArXiv's scope. Since PsyArXiv moved from post-moderation to pre-moderation in August 2025, it has passed moderator screening confirming the work is scholarly, psychology-focused, and internally consistent (matching author names, titles, and abstracts across the uploaded documents) — moderators do not evaluate scientific merit or methodology, only these threshold, non-substantive criteria. It has not been withdrawn; a withdrawn preprint is replaced by a "tombstone" page that preserves the metadata and DOI but removes the full text. What PsyArXiv is not PsyArXiv posting is explicitly not peer review. A preprint deposited there has not been evaluated by independent subject-matter reviewers the way a journal submission is — pre-moderation checks scope and completeness, not scientific validity. It is also distinct from a journal's own author-manuscript archive: PsyArXiv is a standalone, discipline-specific repository within OSF's family of subject-area preprint servers (alongside services such as SocArXiv for sociology and EdArXiv for education), not a publisher. Examples A cognitive psychology lab posts a working paper on PsyArXiv ahead of journal submission so collaborators and the field can cite and comment on it via its DOI while formal peer review is still underway elsewhere. A research team deposits a registered report's Stage 1 protocol on PsyArXiv as part of an open-science workflow, alongside data and materials hosted in a linked OSF project. Counter-examples Describing a PsyArXiv preprint as "peer reviewed" based on its presence on the server — pre-moderation screens for scope and completeness, not for methodological or scientific rigor, which only happens if and when the manuscript goes through a journal's own review process. Treating a preprint that was later formally published in a journal as unchanged from its PsyArXiv version — journal peer review frequently produces revisions between the preprint and the version of record, so the two should not be cited interchangeably without checking which version is being referenced.
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Clinical Data Abstraction - CASRAI (2026)
Clinical data abstraction is the process by which a trained abstractor reads unstructured or semi-structured source documents — electronic health record (EHR) notes, paper charts, radiology reports, pathology reports, discharge summaries, operative notes — and extracts, interprets, and re-enters the relevant data points into a structured study database according to a written abstraction protocol and predefined data dictionary. It is distinguished from prospective data entry in two ways: the source material is not a study-specific form filled out by the person generating the data, and abstraction always involves a human judgment step (locating the relevant fact inside free text and mapping it to the correct structured field) rather than transcription of an already-structured value. A process counts as clinical data abstraction, as opposed to routine data entry, when all of the following hold: (1) the source document was created for clinical care or another non-research purpose, not for the study itself; (2) an abstractor applies a documented protocol and coding conventions to decide what counts as a positive/negative finding, which date or value to use when a chart contains conflicting entries, and how to handle missing or ambiguous information; and (3) the resulting structured value is auditable back to a specific location in the source document (a practice generally called source traceability or query-back-to-source).
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Institutional Biosafety Committee (IBC) - CASRAI (2026)
A standing institutional committee, registered with the NIH Office of Science Policy under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, that reviews, approves, and provides ongoing oversight of research involving recombinant or synthetic nucleic acid molecules before such research may begin.
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ICH Q9 (Quality Risk Management) - CASRAI (2026)
ICH Q9 (Quality Risk Management) is the ICH guideline establishing a systematic process — risk assessment, risk control, risk communication, and risk review — for evaluating, controlling, and communicating risks to pharmaceutical quality across a product's lifecycle. A quality decision follows ICH Q9 when it (1) is grounded in scientific and clinical knowledge ultimately linked to patient protection, (2) applies effort and documentation proportionate to the level of risk involved, and (3) uses a structured method — such as FMEA, FMECA, or HACCP — rather than an ad hoc or purely subjective judgment.
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Crossover Study Design - CASRAI (2026)
A crossover study is a trial design in which each participant receives two or more of the interventions under comparison in a randomized sequence, separated by a washout period, so that within-participant outcomes on each intervention can be directly compared. It differs from a parallel-group design (one arm per participant, between-group comparison) and from an N-of-1 trial (identical within-subject logic applied to a single patient rather than a cohort, for an individual rather than a population-level conclusion).
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Protocol Deviation - CASRAI (2026)
A protocol deviation is any unplanned departure – by the investigator, study staff, or a subject – from the procedures, visit schedule, eligibility criteria, or other requirements set out in the IRB/IEC-approved clinical trial protocol, made without prior sponsor agreement and prior IRB/IEC approval. It is distinct from a protocol amendment, which is a formal, prospectively reviewed and approved change to the protocol itself. Deviations are typically classified by severity – commonly as minor/administrative versus important (also called major or significant) – based on whether they affect subject rights, safety, or well-being, or the completeness, accuracy, or reliability of study data.
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University Intellectual Property (IP) Policy - CASRAI (2026)
A university intellectual property (IP) policy is the formal, institution-wide governing document – adopted by a board of trustees or regents – that establishes ownership of IP created by faculty, staff, and students using university resources, the obligation to disclose inventions, how resulting revenue is shared with inventors, and how those rules differ for federally sponsored, industry-sponsored, and unsponsored research.
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TRAC (Transparent Approach to Costing) - CASRAI (2026)
TRAC (Transparent Approach to Costing) is the sector-wide activity-based costing methodology UK higher education providers are required to operate to calculate, on a consistent and auditable basis, what their teaching, research, and other activities actually cost to deliver. It is the named system and annual reporting process – not a single number – and it produces several distinct outputs: the Annual TRAC return (institution-wide cost and sustainability data submitted to the Office for Students and, for research, to UKRI/Research England), TRAC for research (the basis for Full Economic Costing, fEC, used on individual grant applications), and TRAC(T) (TRAC for Teaching, used to inform teaching funding). A costing exercise is a genuine TRAC exercise only if it follows the published TRAC methodology and guidance and feeds the institution's formal annual return; an internal cost estimate that isn't built on TRAC-derived rates and doesn't feed that return is not TRAC, whatever else it resembles.
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Senior Author - CASRAI (2026)
The senior author is the byline position – conventionally the last-listed author in fields that use a contribution-ranked author list, most consistently biomedicine and the life sciences – understood to signal the person who supervised the research, secured its funding, and takes overall responsibility for the work's integrity, typically the laboratory head or principal investigator, as distinct from the first author, who is understood to have carried out the largest share of the hands-on experimental or analytical work. Like first-author position, senior-author position is a convention read from byline placement, not a formal authorship criterion: everyone in the position still has to independently satisfy the applicable authorship test (most commonly the ICMJE's four-part test) on the same terms as every other listed author. The convention does not apply in fields with alphabetical byline order (mathematics, economics, parts of theoretical physics), where last position carries no seniority or supervisory signal at all, and it does not automatically confer the corresponding-author role, though the two are often – not always – held by the same person.
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SAM.gov (System for Award Management) - CASRAI (2026)
SAM.gov is the U.S. federal government's official, GSA-operated registration and data system for organizations and individuals doing business with the federal government, including recipients of federal financial assistance. An organization is not eligible to receive a federal grant, cooperative agreement, or contract until it has an active SAM.gov entity registration and a valid Unique Entity Identifier (UEI) – registration is a precondition for award, not a paperwork step that can be completed afterward, and it must be renewed at least every 12 months to stay active.
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Collaborative Research Agreement (CRA) - CASRAI (2026)
A Collaborative Research Agreement (CRA) is the umbrella contract that governs a joint research project between two or more independent parties – typically universities, non-profit research institutes, hospitals, and/or companies – none of which is a federal laboratory acting under statutory authority. A CRA is the instance of this instrument whenever the document (regardless of its exact title, which varies by institution – 'Collaborative Research Agreement,' 'Joint Research Agreement,' 'Research Collaboration Agreement,' or 'Consortium Agreement' for 3+ parties) sets out, for a defined project and term: (1) a scope of work and each party's respective research contributions (personnel, facilities, funding, data, or existing background IP); (2) ownership and licensing of resulting (foreground) IP, including how jointly-made inventions are handled; (3) publication rights, including any sponsor/partner review period before a paper is submitted; and (4) confidentiality obligations covering information shared in the course of the collaboration. It is the parent agreement under which narrower, single-purpose instruments – a Material Transfer Agreement (MTA) for a specific biological or physical material, a Confidential Disclosure Agreement (CDA/NDA) for pre-agreement or ancillary confidentiality, or a Data Use Agreement (DUA) for a specific dataset – are frequently executed as subordinate or referenced agreements for one particular exchange within the larger project.
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NHMRC Personnel Support Package (PSP) - CASRAI (2026)
A Personnel Support Package (PSP) is the fixed, banded salary-and-on-cost rate that Australia's National Health and Medical Research Council (NHMRC) sets for specified categories of research personnel — technical support staff, research assistants, and junior postdoctoral researchers — employed on NHMRC Research Support-type grants (such as Ideas Grants and other project-based schemes). Rather than reimbursing an institution's actual salary cost for a named staff member, NHMRC pays a fixed rate tied to the role's level (PSP1, PSP2, PSP3, and so on), published in an annual PSP rate table and indexed periodically. A cost is a PSP, rather than some other NHMRC budget line, when it is (a) salary for personnel other than a named Chief Investigator A on an Investigator Grant, and (b) claimed at NHMRC's published fixed band rate for that role rather than the individual's actual on-costed salary.
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Catalog of Federal Domestic Assistance (CFDA) - CASRAI (2026)
The Catalog of Federal Domestic Assistance (CFDA) was the government-wide, program-by-program listing of every US federal grant, loan, and other domestic assistance program, established under the Federal Program Information Act of 1977 and maintained by the General Services Administration (GSA). Each program was assigned a unique identifying number in the format XX.XXX – a two-digit federal agency code followed by a three-digit program code. In June 2021, GSA retired the standalone CFDA.gov site and the CFDA name, moving the same program listing to SAM.gov under the new name 'Assistance Listings.' The XX.XXX numbering scheme itself did not change – only the label did – so the legacy CFDA number and the current Assistance Listing Number (ALN) identify exactly the same program-level number, and the two terms are used interchangeably in practice, including in current federal regulation.
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Indirect Cost Rate Agreement (NICRA) - CASRAI (2026)
An Indirect Cost Rate Agreement – commonly called a NICRA (Negotiated Indirect Cost Rate Agreement) – is the formal document issued by an organization's cognizant federal agency under 2 CFR 200.414 and its supporting appendices, setting out the specific indirect cost (F&A) rate(s), the distribution base each rate applies to, the rate type (provisional, predetermined, fixed, or final), and the period for which each rate is authorized for use on federal awards.
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NIAID Payline - CASRAI (2026)
A NIAID payline is the percentile-rank threshold that the National Institute of Allergy and Infectious Diseases (NIAID), one of NIH's 27 institutes and centers, sets for a fiscal year and grant mechanism as its planning guideline for which peer-reviewed applications it expects to fund. It is NIAID's own institute-specific application of the general NIH payline mechanism, set independently of every other NIH institute or center against NIAID's own appropriation, application volume, and research priorities – so a NIAID figure should never be assumed to match NINDS's, NHLBI's, or any other institute's figure for the same fiscal year and mechanism. NIAID historically published interim paylines early in the fiscal year, updated them as budget and application volume became clearer, and set a more generous extended payline for Early Stage Investigators. Following NIH's November 2025 Unified Funding Strategy announcement, NIAID's own paylines page has been retitled to reflect a shift away from a single published percentile cutoff toward weighing peer-review scores against institute priorities and budget more holistically – confirm current NIAID practice against its own current guidance rather than assuming a specific figure or format still applies.
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Preclinical Development - CASRAI (2026)
Preclinical development (or nonclinical development) is the drug/biologic development stage between candidate selection and the filing of an Investigational New Drug (IND) application, during which a sponsor generates the animal and in vitro pharmacology, toxicology, and pharmacokinetic (ADME) data — chiefly under Good Laboratory Practice, 21 CFR Part 58, for pivotal safety studies — needed to establish a reasonable basis for testing the candidate safely in humans, alongside early formulation and manufacturing (CMC) work. It does not involve human participants and is therefore distinct from a clinical trial; the common phrase “preclinical trials” is a misnomer — the correct terms are preclinical or nonclinical studies.
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Chemistry, Manufacturing, and Controls (CMC) - CASRAI (2026)
A regulatory submission qualifies as containing CMC information when it documents, for a specific drug substance and/or drug product, the identity, composition, and manufacturing process used to produce it; the in-process controls and specifications (analytical test methods and acceptance criteria) used to confirm its strength, quality, and purity at each stage; and the stability data supporting the proposed container closure system and shelf life. In an eCTD-formatted submission to FDA or another ICH-aligned regulator, this material is filed as Module 3 (Quality) – CMC is the informal, universally-used shorthand for that module's content, not a separate submission or a formal ICH-defined term itself. A document that describes only the clinical protocol, nonclinical toxicology, or regulatory administrative forms, with no data on how the product is made, tested, or controlled, does not constitute CMC information regardless of how complete it is on those other dimensions.
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EU Clinical Trials Regulation (CTR) & CTIS - CASRAI (2026)
A clinical trial is governed by the EU Clinical Trials Regulation (Regulation (EU) No 536/2014, the "CTR") – and therefore must be authorised and registered through the EU's Clinical Trials Information System (CTIS) – when it (1) is an interventional trial (not a purely observational/non-interventional study), (2) tests a medicinal product for human use (not a medical device, which falls under the MDR/IVDR instead), and (3) includes at least one trial site in an EU/EEA member state. Since CTIS became the sole authorisation and registration route on 31 January 2025 – completing a three-year transition away from the prior Clinical Trials Directive 2001/20/EC and the EudraCT/EU Clinical Trials Register it used – this applies whether the trial runs in a single member state or spans multiple countries via one application, one Reporting Member State (RMS), and any number of other Member States Concerned (MSC).
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Plant Variety Protection Act (PVPA) - CASRAI (2026)
The Plant Variety Protection Act (PVPA), 7 U.S.C. §§ 2321-2582, is a U.S. federal law, enacted in 1970, that gives plant breeders a certificate-based intellectual-property right in a new, distinct plant variety. It is administered not by the USPTO but by the Plant Variety Protection Office (PVPO), part of USDA's Agricultural Marketing Service. A PVP certificate covers a specific reproducible variety – as bred, not an underlying gene, trait, or breeding method – that is new, distinct from existing varieties, and genetically uniform and stable across generations. Originally limited to sexually reproduced (grown from seed) and tuber-propagated varieties, the Agricultural Improvement Act of 2018 (the 2018 Farm Bill) extended PVPA eligibility to asexually reproduced varieties as well, creating overlap with the older plant-patent system for the first time.
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Conflict of Interest in Human Subjects Research - CASRAI (2026)
A conflict of interest in human subjects research exists when an investigator's, institution's, or IRB member's financial or personal interest could compromise – or reasonably appear to compromise – the design, conduct, oversight, or reporting of a study involving human participants. Unlike the general research-COI concept, review here is tied directly to the IRB approval decision: federal guidance and institutional policy require that a significant financial conflict be evaluated and, where warranted, managed under a documented plan before the IRB may approve the protocol, and require any IRB member with a conflicting interest in a specific protocol to recuse from reviewing or voting on it.
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21 CFR 314.80 (Postmarketing Reporting of Adverse Drug Experiences) - CASRAI (2026)
The FDA regulation (21 CFR Part 314, Subpart B) requiring holders of an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), and nonapplicant manufacturers/packers/distributors named on the drug's label, to surveil for, evaluate, and report postmarketing adverse drug experiences to FDA. It defines what makes an event "serious" (death, life-threatening, hospitalization, persistent disability, congenital anomaly, or an important medical event requiring intervention) and "unexpected" (not described in the drug's current approved labeling), and sets three reporting tracks: 15-day Alert reports for events that are both serious and unexpected, quarterly periodic reports for the first 3 years post-approval, and annual reports thereafter. It is the regulatory mechanism that populates the FDA Adverse Event Reporting System (FAERS) with mandatory manufacturer reports, distinct from FAERS's voluntary MedWatch stream and from pre-market IND safety reporting under 21 CFR 312.32.
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OIG Work Plan - CASRAI (2026)
An OIG Work Plan is the forward-looking list an agency's Office of Inspector General maintains of audits, evaluations, and inspections it has planned or has underway for the coming period. Unlike an OIG report, which documents a completed piece of work and its findings, a Work Plan entry is a statement of intent – it names a program area, population, or compliance topic the OIG has decided to examine, before the examination has produced any findings. For research administrators, the Work Plan is the single clearest public signal of where a funding agency's oversight attention is headed next, which is why sponsored-programs and compliance offices routinely cross-check active Work Plan items against their own institution's award portfolio.
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21 CFR Part 54 (Financial Disclosure by Clinical Investigators) - CASRAI (2026)
21 CFR Part 54 is the FDA regulation requiring sponsors of a covered clinical study to obtain, and FDA to evaluate, information about certain financial interests and arrangements held by the clinical investigators who conducted the study. It applies to any 'covered clinical study' – a study in humans that a marketing applicant or FDA relies on to establish a product's effectiveness (including a study demonstrating equivalence to an approved product), or a study in which a single investigator's data makes a significant contribution to the demonstration of safety – submitted in support of an NDA, ANDA, BLA, or a device marketing application (PMA or certain 510(k)s). Rather than banning financially interested investigators from participating, Part 54 requires the sponsor to certify (via FDA Form 3454) that no covered investigator has a disclosable financial interest, or to disclose (via FDA Form 3455) any that exist, so FDA can factor that information into its evaluation of the study's reliability. Sections 54.5 and 54.6 – FDA's authority to act on disclosed interests and the sponsor's recordkeeping obligation – are part of Part 54 itself but are not addressed by either form.
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FDA Form 3455 (Disclosure: Financial Interests and Arrangements of Clinical Investigators) - CASRAI (2026)
FDA Form 3455 ('Disclosure: Financial Interests and Arrangements of Clinical Investigators') is the form a marketing-application sponsor files with FDA when its financial-interest review, conducted under 21 CFR Part 54, finds that one or more clinical investigators (or a subinvestigator, spouse, or dependent child) participating in a covered clinical study has a disclosable financial interest or arrangement – e.g. compensation tied to study outcome, equity in the sponsor exceeding the regulatory thresholds, a proprietary interest in the tested product, or significant payments beyond direct study costs. Rather than certifying the interests' absence (the role of the counterpart form, FDA Form 3454), Form 3455 requires the sponsor to disclose the interest completely and accurately – its nature and, where applicable, its value – and, per 21 CFR 54.4(a)(3), describe what steps, if any, were taken to minimize its potential to bias the study's design, conduct, or reporting. It is submitted with the marketing application the covered study supports.
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Low- and Middle-Income Countries (LMIC) - CASRAI (2026)
LMIC is a World Bank income-classification category, combining the low-income, lower-middle-income, and upper-middle-income groups, used as a proxy for national economic development level. The World Bank sorts every economy into one of four groups (low-income, lower-middle-income, upper-middle-income, high-income) once a year, effective every 1 July, based on Gross National Income (GNI) per capita for the prior calendar year, converted to US dollars using the Atlas method. 'LMIC' is shorthand for the three non-high-income groups combined. In research administration, LMIC status determines eligibility for a large number of funder schemes, informs risk and vulnerability considerations in ethics review, and is used as a proxy variable in equity-in-research-participation and authorship analyses. A country's classification can and does change from year to year as its GNI per capita moves relative to the thresholds, so an eligibility list or dataset citing 'LMIC' status should always specify the fiscal year it draws on.
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Corporate Authorship - CASRAI (2026)
Corporate authorship is the practice of naming an organizational or collective entity – a consortium, study group, working group, network, or corporate body – as the author of record on a byline, in place of (or alongside) individually named researchers. It is distinguished from co-authorship by what appears on the byline itself: co-authorship is two or more named individuals who each independently meet the authorship criteria for the work, while corporate authorship substitutes or supplements those individual names with a group name that stands for the collective. The individuals who did the work still have to be identifiable and accountable – ICMJE guidance requires the corresponding author to specify the group name and clearly identify which group members can take credit and responsibility as authors – but the byline itself reads as the entity, not the roster.
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Open Science Framework (OSF) - CASRAI (2026)
A free, open-source web platform operated by the nonprofit Center for Open Science (COS) that lets a research team manage a project's full lifecycle from one persistent, citable project page: file storage and version control, collaborator permissions, preregistration of hypotheses and analysis plans, and public archiving with a DOI. 'Open Science Framework' is often shortened or misremembered as 'Open Science Foundation' — the organization that builds and runs OSF is the Center for Open Science, not an 'Open Science Foundation'; no organization by that name operates this infrastructure.
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UKRI PhD Stipend - CASRAI (2026)
The UKRI minimum doctoral stipend is the annual, tax-free subsistence allowance UK Research and Innovation sets each year as the floor payment for students on a UKRI-funded PhD studentship, applied uniformly across all seven research councils, with a fixed £2,000/year supplement for London-based host institutions; it is set centrally by UKRI, reviewed roughly annually, and takes effect each 1 October.
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ORCID Featured Works - CASRAI (2026)
A record is using ORCID Featured Works when the iD holder has designated one or more of their public works (up to a maximum of five) to appear in a dedicated "Featured" section at the top of the Works list on their ORCID record, each marked with a star icon. Featuring is a curation layer applied on top of an already-public work: only works whose visibility is already set to "Everyone" are eligible to be featured, and a work is automatically removed from the Featured list the moment its visibility is changed away from public. As of verification, the feature applies to the Works section only — there is no equivalent "Featured" mechanic for Employment, Education, Funding, Peer Review, or Distinctions entries on the record.
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Clinical Equipoise - CASRAI (2026)
Clinical equipoise is the state of genuine uncertainty, held within the expert medical community as a whole (not necessarily by any one investigator), about the comparative therapeutic merit of a randomized controlled trial's arms. It is the ethical precondition that justifies randomizing participants to a control or comparator arm rather than assigning known-superior treatment to everyone; it is disturbed, and randomization becomes unethical, once credible evidence resolves that community-wide uncertainty toward one arm.
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Electronic Batch Record (EBR) - CASRAI (2026)
An Electronic Batch Record (EBR) is the electronic-system equivalent of a paper batch record in GMP-regulated manufacturing: the record documenting, for one specific manufactured batch, that each step of the validated Master Production Record was performed – by whom or by which qualified automated equipment, when, with what materials and quantities, and with what in-process results – retained in a system meeting 21 CFR Part 11 controls (validation, independent audit trail, access control, attributable electronic signatures) because it is the electronic record being used to satisfy the GMP predicate requirement at 21 CFR 211.188. A record only functions as an EBR, rather than a digitized image of a paper record, if the generating system itself is validated and Part-11-compliant.
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SSHRC Partnership Grant - CASRAI (2026)
An SSHRC Partnership Grant is the largest and longest-running funding instrument in the Social Sciences and Humanities Research Council of Canada's partnership-funding stream: a two-stage, competitively adjudicated award of up to $2.5 million over 4 to 7 years, supporting a formal, already-substantiated research partnership between an academic team and one or more non-academic partner organizations. What distinguishes it operationally from SSHRC's smaller partnership instruments (Partnership Engage Grants, Partnership Development Grants) is scale and maturity: a Partnership Grant funds an established collaborative governance structure – shared intellectual leadership, a defined program of research, training, and knowledge-mobilization activities, and a mandatory minimum cash/in-kind contribution from partners – rather than a first-time or exploratory partnership still being tested or built.
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Real-World Evidence (RWE) - CASRAI (2026)
Real-World Evidence (RWE) is clinical evidence about the usage, benefits, or risks of a medical product derived from the analysis of Real-World Data (RWD) – data relating to patient health status and/or care delivery that is routinely collected outside the controlled setting of a randomized controlled trial (RCT). RWD sources include electronic health records (EHRs), medical claims and billing data, product and disease registries, and data from digital health technologies or patient-generated sources. RWE becomes regulatory-grade evidence only after the underlying RWD has been assessed as fit for use – relevant, reliable, and sufficiently complete for the specific question being asked – and the study design (e.g., pragmatic trial, prospective registry study, or retrospective database analysis) adequately addresses confounding and bias, since RWE studies typically lack the randomization and blinding that isolate causal effect in a traditional RCT.
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ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) - CASRAI (2026)
ICH Q7 ("Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients") is the International Council for Harmonisation's harmonized GMP guideline governing the manufacture of active pharmaceutical ingredients (APIs) – from starting materials through the finished API – as distinct from finished-dosage-form manufacturing (governed by 21 CFR 210/211 or EudraLex Volume 4 Part I). FDA adopted it as guidance (originally "Q7A," effective September 25, 2001, later recodified to Q7); it also forms the basis of EudraLex Volume 4, Part II in the EU.
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Persistent Identifier (PID) - CASRAI (2026)
A unique, actionable, long-term identifier assigned to a single entity in the research ecosystem – a work, a person, an organisation, a piece of equipment, a project, or a dataset – that is registered with a scheme-specific provider, stays associated with that entity even as its location or attributes change, resolves (typically over HTTP) to current metadata or the resource itself, and is designed to remain valid for decades, well beyond the lifetime of any one repository, publisher, or institutional system.
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Author Affiliation - CASRAI (2026)
The institutional identifier attached to a specific named author on a scholarly output, stating the organization the author was formally associated with while doing the reported work (conventionally at the time of the research, not necessarily the author's current employer), carried as structured byline metadata distinct from corresponding-author contact details or an internal CRIS affiliation record.
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Metadata Schema - CASRAI (2026)
A defined, published set of descriptive fields (elements or properties) — each with a name, definition, expected data type or controlled vocabulary, and obligation/cardinality rules — used to describe a resource consistently enough for people and systems to find, cite, exchange, and reuse it. Distinct from a metadata record, which is one specific instance of data filled into that specification.
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Fair Information Practice Principles (FIPPs) - CASRAI (2026)
Fair Information Practice Principles (FIPPs) are a U.S.-originated framework of privacy norms governing how organizations collect, use, disclose, and secure personal information. First articulated in the 1973 HEW report Records, Computers, and the Rights of Citizens, they underpin the Privacy Act of 1974 and were later reflected in the OECD's 1980 Guidelines on the Protection of Privacy. A dataset-handling or systems practice qualifies as FIPPs-aligned when it addresses, at minimum: transparency/notice about what personal data is collected and why; purpose specification and use limitation (data used only for stated, compatible purposes); data minimization (collecting no more than necessary); individual participation (the ability to access, correct, or contest one's own records); data quality and integrity; security safeguards; and accountability for compliance. There is no single canonical numbered list — the original HEW report set out five principles, the Privacy Act of 1974 codified eight statutory safeguards, and later agency restatements (for example the U.S. Department of Homeland Security's widely cited 2008 formulation) group them into eight principles: Transparency, Individual Participation, Purpose Specification, Data Minimization, Use Limitation, Data Quality and Integrity, Security, and Accountability and Auditing. FIPPs is a governance framework, not itself a statute — it becomes binding only where a specific law (such as the Privacy Act of 1974 for federal agency records, or a sector law like the Family Educational Rights and Privacy Act) incorporates it.
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SSHRC Postdoctoral Fellowship - CASRAI (2026)
The SSHRC Postdoctoral Fellowship was the Social Sciences and Humanities Research Council of Canada's individually held, individually competed award funding mentored postdoctoral research in the social sciences and humanities. Like its counterparts at Canada's other two federal research funders, SSHRC has discontinued this standalone program: it has been folded, together with the equivalent individual postdoctoral fellowship programs previously run separately by the Natural Sciences and Engineering Research Council (NSERC) and the Canadian Institutes of Health Research (CIHR), into the jointly administered Canada Postdoctoral Research Award (CPRA) – part of the Tri-Agency's new Canada Research Training Awards Suite (CRTAS), which also replaces the three councils' separate master's and doctoral scholarship programs. A researcher researching 'SSHRC Postdoctoral Fellowship' today needs the CPRA application process, applied for through whichever of the three agencies best matches the proposed research area – SSHRC for the social sciences and humanities.
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NSF Postdoctoral Fellowship - CASRAI (2026)
There is no single 'NSF Postdoctoral Fellowship' program at the U.S. National Science Foundation. NSF funds postdoctoral researchers through a family of separately named, directorate- or division-specific fellowship competitions – each with its own NSF publication number, solicitation, eligibility rules, term length, and stipend – rather than one central award a researcher applies to directly. Current examples include the Postdoctoral Research Fellowships in Biology (PRFB, NSF 26-504), the Mathematical and Physical Sciences Ascending Postdoctoral Research Fellowships (MPS-Ascend), the Mathematical Sciences Postdoctoral Research Fellowships (MSPRF), the SBE Postdoctoral Research Fellowships (SPRF), the NSF Astronomy and Astrophysics Postdoctoral Fellowships (AAPF), the Atmospheric and Geospace Sciences Postdoctoral Research Fellowships (AGS-PF), an Engineering Directorate postdoctoral fellowship, and the Innovative Postdoctoral Entrepreneurial Research Fellowship (I-PERF). All are individually held, individually competed awards – the fellow, not their host institution, is the recipient – which is the trait that distinguishes any of them from a postdoctoral researcher paid as staff out of a principal investigator's NSF research grant.
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Researcher Identifier - CASRAI (2026)
A persistent, unique digital identifier assigned to an individual person – as distinct from an identifier for a work, an institution, or a grant – that disambiguates that researcher across name variants, career moves, and multiple scholarly systems, and that is designed to stay resolvable and machine-readable for the researcher's whole career.
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Data Dredging - CASRAI (2026)
Searching a dataset for statistically significant relationships across many variables, subgroups, or model specifications without a hypothesis specified in advance, then reporting whichever pattern crosses a significance threshold as if it had been the study’s pre-specified object of investigation, without correcting for the number of comparisons actually performed.
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Medical Research Future Fund (MRFF) - CASRAI (2026)
The Medical Research Future Fund (MRFF) is the Australian Government's dedicated long-term financing vehicle for health and medical research and innovation, established under the Medical Research Future Fund Act 2015. A grant is an MRFF grant when its funding is drawn from the investment earnings of the MRFF's invested capital (rather than from annual Budget appropriations, as with most NHMRC National Competitive Grants Program funding) and is disbursed against a specific MRFF grant opportunity listed on GrantConnect, typically under one of the MRFF's Research Missions or the broader MRFF Strategy and Priorities set by the Australian Medical Research Advisory Board (AMRAB) — even where the grant opportunity is administered day-to-day by NHMRC, a Business Grants Hub, or another delegated body on the Department of Health, Disability and Ageing's behalf.
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NSERC Postdoctoral Fellowship - CASRAI (2026)
The NSERC Postdoctoral Fellowship was the Natural Sciences and Engineering Research Council of Canada's individually held, individually competed award funding two years of mentored postdoctoral research in the natural sciences and engineering, providing the fellow with a stipend (most recently $70,000 per year) portable to an eligible Canadian or international host institution. NSERC has discontinued this standalone program: it has been folded, together with CIHR's and SSHRC's equivalent individual postdoctoral fellowship programs, into the jointly administered Canada Postdoctoral Research Award (CPRA) – part of the Tri-Agency's new Canada Research Training Awards Suite (CRTAS), which also replaces the three councils' separate master's and doctoral scholarship programs. A researcher researching 'NSERC Postdoctoral Fellowship' today needs the CPRA application process, applied for through whichever of the three agencies best matches the proposed research area.
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Human Research Participant (Human Subject) - CASRAI (2026)
A human research participant (the regulatory term is "human subject") is a living individual about whom an investigator conducting research either obtains information or biospecimens through intervention or interaction, or obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens (45 CFR 46.102(e)). "Subject" is the term used in the Common Rule and IRB paperwork; "participant" is the term preferred by APA style and many journals for manuscript prose. Both refer to the same regulatory category of person.
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Scopus Author ID: What It Is and How It’s Assigned - CASRAI (2026)
A Scopus Author ID is a numeric identifier that Elsevier's Scopus database automatically generates and attaches to a researcher's profile once that researcher has two or more documents indexed in Scopus — it is algorithmically assigned from article metadata (name variants, affiliation, subject area, co-authors, citation patterns), not requested or self-registered by the researcher, and a given person can end up with more than one Scopus Author ID if the algorithm fails to match all of their work to a single profile.
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National Health and Medical Research Council (NHMRC) - CASRAI (2026)
The National Health and Medical Research Council (NHMRC) is the Australian Government's independent statutory authority for health and medical research funding, research translation, and health/medical research ethics guidance, established under the National Health and Medical Research Council Act 1992. A grant, ethics guideline, or research-translation activity falls within NHMRC's remit when it concerns health or medical research — the causes, treatment, diagnosis, monitoring, management, or prevention of human disease — administered through NHMRC's own National Competitive Grants Program (via its Sapphire platform) or through NHMRC's ethics-guidance function (e.g. the National Statement on Ethical Conduct in Human Research), rather than through the Australian Research Council's (ARC) National Competitive Grants Program, which covers all other fields of research.
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Non-Interventional Study - CASRAI (2026)
A non-interventional study is a clinical study of a medicinal product in which treatment assignment is not decided in advance by a protocol, prescribing and enrollment decisions are kept separate, and no diagnostic or monitoring procedures beyond normal clinical practice are imposed. Under EU Regulation (EU) No 536/2014, Article 2(2)(4), it is defined directly as any clinical study that is not a clinical trial. The classification determines whether a study needs prior competent-authority/ethics approval under the EU Clinical Trials Regulation, whether it triggers an FDA IND, and which registration/reporting regime applies.
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Investigational Device - CASRAI (2026)
A device is an "investigational device" under FDA's IDE regulation (21 CFR 812.3(g)) when it is "the object of an investigation" – being studied in a clinical investigation to generate safety or effectiveness data for a use FDA has not already cleared or approved, rather than being used strictly within its existing cleared/approved labeling. Whether the study needs a full IDE application and FDA approval, or only abbreviated requirements, depends on whether the device is classified significant risk (SR) or nonsignificant risk (NSR) under 21 CFR 812.3(m).
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AI Research Tool - CASRAI (2026)
An AI research tool is software that applies machine learning — typically a large language model (LLM), an embedding-based semantic search index, or both — to a specific stage of the research workflow: finding and screening literature, extracting or summarizing data from papers, mapping citation relationships, drafting or revising manuscript text, or analyzing research data. "AI research tool" is a category label, not the name of any single product: it covers named tools with genuinely different scopes (a citation-mapping tool like Connected Papers does not do what a writing-assistance tool like Paperpal does), and a page or citation that treats it as one interchangeable thing is usually mis-scoped. What makes a tool an instance of this category, rather than a general-purpose AI assistant that happens to get used for research, is that it is built or marketed specifically around a research task — an academic search index, a citation graph, a manuscript-formatting model trained on published literature — rather than being a general chat interface pointed at an arbitrary prompt.
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First Author - CASRAI (2026)
First author is the person listed first in a work's byline (author list). In fields that use a contribution-ranked byline – most consistently biomedicine, the life sciences, and much of the natural sciences – that position is a convention, not a formal criterion: it signals that this person is understood to have done the largest share of the hands-on work behind the paper, typically including the bulk of the experimental or analytical work and the first draft of the manuscript. Being listed first does not, by itself, make someone an author – they still have to independently satisfy the applicable authorship criteria (most commonly the ICMJE's four-part test: substantial contribution to conception, design, or data; drafting or critically revising the work; final approval of the version submitted; and agreement to be accountable for it). First-author position answers a different question from that test: not "does this person qualify to be an author" but "where does this particular author's contribution rank relative to the other authors on this specific paper." It is also field-dependent rather than universal – in mathematics, economics, and parts of theoretical physics, author order is conventionally alphabetical and carries no contribution ranking at all, so "first author" in those fields signals nothing about relative effort.
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NSERC Discovery Grant - CASRAI (2026)
An NSERC Discovery Grant is Canada's core, investigator-held operating-funds award for research programs in the natural sciences and engineering: a competitively evaluated grant, held individually by a faculty researcher (or a small team on a joint application) at an NSERC-eligible Canadian institution, that funds an ongoing program of research — not a single fixed-scope project — for up to five years, renewable through a subsequent competition. It is administered by the Natural Sciences and Engineering Research Council of Canada (NSERC), one of Canada's three federal granting councils alongside CIHR and SSHRC.
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Consolidated Screening List (CSL) - CASRAI (2026)
A single, merged database published by the US Department of Commerce (trade.gov) that consolidates the restricted- and denied-party lists maintained separately by the Departments of Commerce (BIS: Denied Persons List, Entity List, Unverified List, Military End-User List), State (AECA Debarred List, Nonproliferation Sanctions list), and Treasury (OFAC's Specially Designated Nationals List and related sanctions lists). Institutions screen a party's name against the CSL once to check for a match on any contributing list, then trace a hit back to the underlying regulation (EAR, ITAR, or an OFAC sanctions program) it falls under. Source lists are updated daily.
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Major Contributor - CASRAI (2026)
A "major contributor" is an informal, functional description — not a defined category in ICMJE, NISO CRediT (ANSI/NISO Z39.104-2022), or any research-integrity standard — used to describe someone whose input to a research output is substantial and broad enough that it typically meets, or is expected to meet, the threshold for authorship, as opposed to a "minor" contribution that is real but narrower and more appropriately handled through acknowledgement rather than a byline. A contribution generally reads as "major" when it (a) spans more than one narrow, delegable task — for example design plus analysis plus interpretation, not just running one requested test; (b) is difficult to substitute without changing the direction or validity of the work; and (c) is accompanied by the kind of ongoing engagement (reviewing drafts, defending choices, approving the final version) that ICMJE's four authorship criteria and most journals' own policies expect of an author, not just a task contributor.
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ClinicalTrials.gov - CASRAI (2026)
ClinicalTrials.gov is the NLM-operated (NIH, with FDA) public registry and results database for clinical studies, distinguished from clinical trial registration generally by being the specific U.S. system launched in 2000 (FDAMA Sec. 113) whose mandatory-registration and results-reporting requirements were established by the FDAAA 801 final rule (effective 18 January 2017), and which assigns every registered study a unique NCT identifier.
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Grants.gov Registration - CASRAI (2026)
The prerequisite entity-registration process an organization – university, nonprofit, or small business – must complete before it can submit an application through Grants.gov, the federal government's shared portal for discretionary federal grant opportunities. Registration is built on a SAM.gov entity record and a Unique Entity Identifier (UEI), not on Grants.gov itself; Grants.gov authenticates against SAM.gov rather than maintaining a separate applicant database.
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NSF Dear Colleague Letter (DCL) - CASRAI (2026)
A Dear Colleague Letter (DCL) is a formal written communication issued by the U.S. National Science Foundation (NSF) — typically by a directorate, division, or cross-cutting NSF initiative — to inform the research community of a matter that does not require the structure of a full program solicitation. Per NSF's Proposal & Award Policies & Procedures Guide (PAPPG), Chapter I, a DCL is used to provide general information to the community, clarify or amend an existing NSF policy or document, or inform prospective proposers about upcoming funding opportunities and areas of programmatic interest. A communication counts as a DCL, rather than a program solicitation, when it does NOT itself impose a distinct set of eligibility restrictions, proposal-preparation instructions, or a dedicated review process beyond what already exists under NSF's standing proposal types and the PAPPG — a DCL points proposers toward using an existing mechanism (most often Rapid Response Research (RAPID), EArly-concept Grants for Exploratory Research (EAGER), Rapid Assessment of Immediate/Systemic Effects (RAISE), Planning Grants, or Conference/Workshop proposals) rather than creating a new one. If a document instead establishes its own eligibility criteria, submission deadlines, and a standalone competitive review framework, it is a program solicitation (or, more broadly, a funding opportunity announcement), not a DCL, regardless of what it is titled.
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Perverse Incentives (in Research) - CASRAI (2026)
In research integrity, a perverse incentive is a feature of an evaluation, funding, or reward system that motivates behavior contrary to that system's stated goal. Research is organized around proxy metrics for quality — publication count, journal impact factor, citation counts, grant dollars secured — that are easier to measure than the underlying goals they stand in for (rigor, originality, real-world value). When careers, tenure, promotion, and funding decisions are tied tightly to these proxies, researchers face pressure to optimize the measurable proxy rather than the underlying goal, even when doing so degrades the research itself. A situation exhibits a perverse incentive when three conditions hold together: (1) a metric or reward is used as a stand-in for research quality, (2) career or funding consequences are attached to that metric, and (3) the metric can be increased through behavior that does not improve, or actively harms, the actual science.
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Community Advisory Board (CAB) - CASRAI (2026)
A Community Advisory Board (CAB) is a standing group of community members, patient/participant representatives, and other local stakeholders that provides ongoing, non-scientific input into the design, conduct, and dissemination of a research study or program from the perspective of the population it affects. A body qualifies as a CAB when it (1) is composed primarily of community members or affected-population representatives rather than research staff or clinicians, (2) advises on matters such as protocol acceptability, recruitment and retention strategies, informed-consent language, culturally appropriate messaging, and dissemination of results, and (3) operates on an advisory, non-binding basis — it does not have authority to approve, halt, or scientifically review the study. This distinguishes a CAB from bodies with formal regulatory or scientific-oversight authority, such as an Institutional Review Board (IRB), which reviews and approves research for ethical and regulatory compliance, or a Data Safety Monitoring Board (DSMB), which reviews accumulating safety and efficacy data during a trial. A CAB's role is community voice and engagement, not protocol approval or safety monitoring.
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OFAC List (SDN List) - CASRAI (2026)
The "OFAC list" ordinarily refers to the Specially Designated Nationals and Blocked Persons List (SDN List) maintained by the US Department of the Treasury's Office of Foreign Assets Control (OFAC). OFAC administers and enforces economic and trade sanctions based on US foreign policy and national security goals, targeting foreign countries, regimes, terrorists, international narcotics traffickers, weapons-of-mass-destruction proliferators, and other threats. The SDN List names individuals, companies, research institutions, non-profits, vessels, and aircraft with which US persons – including US universities and their employees – are generally prohibited from dealing at all: their property and interests in property that come within US jurisdiction are "blocked" (frozen), and virtually all transactions between them and a US person are prohibited absent a specific OFAC license or applicable general license. OFAC also maintains a broader Consolidated Sanctions List (which folds in several narrower sectoral and program-specific lists) and country-based comprehensive sanctions programs (for example, on Cuba, Iran, North Korea, Syria, and the Russia-related programs); an entity or person can be sanctioned by inclusion in one of those programs without appearing on the SDN List specifically. For research institutions, "checking the OFAC list" is shorthand for restricted-party screening: running a prospective international collaborator, visiting scholar, subrecipient, vendor, or payment counterparty through OFAC's Sanctions List Search tool (which uses fuzzy-name matching) before entering into the relationship or releasing funds or controlled items.
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Independent Review Committee (IRC) - CASRAI (2026)
An Independent Review Committee (IRC) — also called a Blinded Independent Central Review (BICR) in oncology trials — is a panel of qualified, external reviewers (typically radiologists or other specialists) who re-assess protocol-specified efficacy endpoint data, most commonly medical imaging, according to a predefined charter and standardized criteria (e.g., RECIST for tumor response). Reviewers work independently of the trial sponsor, investigators, and local site assessors, and are blinded to treatment assignment and to the local site's own read, to produce a bias-minimized, reproducible determination of endpoints such as objective response rate (ORR), progression-free survival (PFS), or time to progression (TTP). FDA guidance on cancer drug approval and on clinical trial imaging endpoints recommends or requires an IRC/BICR specifically when a trial is not fully blinded and endpoint assessment could otherwise be influenced by knowledge of treatment assignment.
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National Research Act of 1974 - CASRAI (2026)
The National Research Act (Public Law 93-348) is the U.S. federal statute, signed into law by President Nixon on July 12, 1974, that created the modern legal framework for protecting human subjects in research. It established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and charged it with identifying the basic ethical principles that should govern human-subjects research; that mandate is what produced the Belmont Report in 1979. Separately, the Act amended the Public Health Service Act to require that any institution receiving federal funding for biomedical or behavioral research involving human subjects establish an Institutional Review Board (IRB) to review and approve such research before it begins – the statutory origin of mandatory IRB review, later codified in regulation at 45 CFR 46 (the Common Rule). A statute qualifies as "the National Research Act" in this sense only if it is Public Law 93-348 itself (or a provision directly traceable to it); the Belmont Report and the Common Rule are downstream products the Act required or made possible, not the Act itself.
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IRB Number (IRB ID) - CASRAI (2026)
The unique identifier an Institutional Review Board assigns to a single approved research protocol at the time of initial submission, used to track and reference that specific study throughout its review lifecycle (approval, amendment, continuing review, closure) and to cite in manuscripts, consent forms, and funder reports — distinct from the institution's OHRP IRB Registration Number (identifies the review board itself) or Federalwide Assurance (FWA) number (identifies the institution as a whole).
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Early Stage Investigator (ESI) - CASRAI (2026)
An Early Stage Investigator (ESI) is an NIH designation for a Program Director/Principal Investigator (PD/PI) who (1) has completed their terminal research degree, or the end of their post-graduate clinical training (e.g., medical residency), whichever date is later, within the past 10 years, AND (2) has not yet competed successfully as PD/PI for a substantial NIH independent research award (most commonly an R01 or an award NIH treats as equivalent to one). Both conditions must hold at the time of application; meeting only one does not qualify a PD/PI as an ESI. NIH determines ESI status automatically from the eRA Commons personal profile at the time of application submission, based on the degree-completion date the applicant enters, so keeping that profile field current and accurate is what actually controls whether a given application receives ESI consideration – not a separate application or self-certification step.
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Continuing Professional Development (CPD) - CASRAI (2026)
An ongoing, documented pattern of continuing education a research-administration or clinical-research professional completes after entering the field, used either to maintain an active professional credential (via a certifying body's mandatory continuing-education requirement) or, more generally, to keep current with an evolving regulatory and operational landscape. To count operationally, the activity must be tracked (hours/points logged against a reporting period), applied (submitted as evidence toward a recertification cycle, for credential holders), and relevant to the professional's field of practice.
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Clinical Study - CASRAI (2026)
A clinical study is the umbrella term ClinicalTrials.gov and the U.S. National Library of Medicine (NLM, part of NIH) use for any research study involving human volunteers (participants) that is intended to add to medical knowledge. Under this definition, every clinical study is one of two subtypes: an interventional study — commonly called a clinical trial — in which participants are prospectively assigned, according to a protocol, to receive a specific intervention (a drug, device, procedure, or behavioral change) so its effect can be evaluated; or an observational study, in which participants are assessed for health-related outcomes or characteristics as they occur naturally, without the investigator assigning any intervention. "Clinical study" is therefore broader than "clinical trial": every clinical trial is a clinical study, but not every clinical study is a clinical trial. This is a separate axis of classification from NIH's own narrower, funding-and-policy-consequential test for whether a specific study is an "NIH-defined clinical trial" (prospective assignment to an intervention to evaluate its effect on a health-related biomedical or behavioral outcome) — a study can be a clinical trial in the general ClinicalTrials.gov sense while the NIH four-question test is what actually determines registration, reporting, and funding-opportunity obligations for NIH-funded work.
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National Science Foundation (NSF) - CASRAI (2026)
An independent agency of the United States federal government, established by the National Science Foundation Act of 1950 (Public Law 81-507), that funds basic research and education in non-medical fields of science and engineering. NSF is not part of a cabinet department – it reports directly to the President and Congress, governed by a Director (who runs day-to-day operations) and the presidentially-appointed, 24-member National Science Board (NSB), which sets policy and must approve awards or actions above certain dollar thresholds. An entity qualifies as "NSF" for research-administration purposes when it is the specific federal agency headquartered in Alexandria, Virginia that issues funding opportunities, applies the Proposal & Award Policies & Procedures Guide (PAPPG) to its awards, and organizes its research portfolio through a set of subject-based directorates rather than through the disease- or institute-based structure NIH uses. NSF's stated mission, carried over from its founding legislation, is to "promote the progress of science," "advance the national health, prosperity, and welfare," and "secure the national defense." As of the current NSF organizational structure, the agency's research and education activity is organized into seven research directorates – Biological Sciences (BIO); Computer and Information Science and Engineering (CISE); Engineering (ENG); Geosciences (GEO); Mathematical and Physical Sciences (MPS); Social, Behavioral and Economic Sciences (SBE); and Technology, Innovation and Partnerships (TIP, established 2022, the first new directorate in three decades) – plus a STEM Education directorate and offices including International Science and Engineering and the National Center for Science and Engineering Statistics. NSF funds roughly 11,000 competitive awards a year and, by its own account, its investments make up approximately a quarter of federal support for basic research at U.S. colleges and universities.
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Partnership Development Grant - CASRAI (2026)
A funding request qualifies as a SSHRC Partnership Development Grant when it is submitted by a researcher affiliated with an eligible Canadian postsecondary institution to Canada's Social Sciences and Humanities Research Council (SSHRC), and involves a genuine non-academic partner organization that will help shape (not merely receive the outputs of) a bounded, developmental research or knowledge-mobilization activity. The mechanism funds $75,000 to $250,000 over 1 to 3 years (2026 competition figures) and is explicitly developmental in purpose — testing or building a partnership approach rather than sustaining an already-mature, large-scale collaboration.
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Electronic Medical Record (EMR) - CASRAI (2026)
An electronic medical record (EMR) is the digital equivalent of a single healthcare provider's paper chart: a patient's medical and treatment history as captured, stored, and used within one clinical practice or healthcare organization. An artifact is an EMR (rather than an EHR) when its data model, access controls, and interoperability are scoped to a single organization's internal clinical workflow, not designed for structured exchange with external providers, payers, or research systems – even if the underlying software vendor also sells EHR-branded products elsewhere.
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Vulnerable Populations in Research - CASRAI (2026)
A research participant or class of participants that 45 CFR 46 (the Common Rule) subjects to additional, IRB-enforced protections beyond ordinary informed-consent review: either because they fall into one of three subparts with dedicated, codified requirements (Subpart B — pregnant women, human fetuses, and neonates; Subpart C — prisoners; Subpart D — children), or because the IRB determines under §46.111(b) that they are otherwise likely to be vulnerable to coercion or undue influence (e.g., individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons) and documents the additional safeguards included to protect their rights and welfare.
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NSF REU (Research Experiences for Undergraduates) - CASRAI (2026)
An NSF Research Experiences for Undergraduates (REU) award is either an REU Site — an independently proposed, competitively awarded institutional program (under NSF solicitation 23-601) that brings a cohort of undergraduates, typically 8–10 per year, to conduct mentored research over a defined period, most often an 8–10 week summer program — or an REU Supplement — additional funding added to a new, renewal, or already-active NSF research grant or cooperative agreement specifically to support undergraduate participants in that project's existing research. Eligible student participants must be U.S. citizens, U.S. nationals, or U.S. permanent residents; each Site or Supplement runs its own application and selection process independently of NSF.
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Non-Practicing Entity (NPE) - CASRAI (2026)
An entity that owns one or more issued or pending patents but does not manufacture, sell, or otherwise commercially practice the invention itself, and instead generates value from the patent through licensing, litigation/demand-letter assertion, or both. "Non-practicing" describes the entity's relationship to the patent, not the patent's validity – individual inventors, universities and research institutions, pre-commercialization startups, failed operating companies holding residual portfolios, and dedicated patent-acquisition/licensing firms are all NPEs in this technical sense, even though only a narrower subset of them (the FTC's "patent assertion entity," or PAE, category, and the pejorative "patent troll" label) draw the negative connotation the term is often assumed to carry.
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Elicit (AI Research Assistant) - CASRAI (2026)
Elicit is a named AI research-assistant platform (built by the public benefit corporation Elicit, spun out of the nonprofit lab Ought in 2023) that searches an indexed academic-literature corpus and performs structured evidence-extraction tasks – summarizing papers, extracting and tabulating data points across many papers with sentence-level source citations, and supporting systematic-review-style screening and data-extraction workflows aligned to PRISMA 2020. It is a specific product, not a generic label for "AI that helps with research" – distinct from citation-graph discovery tools (Connected Papers, ResearchRabbit) and general-purpose AI writing assistants – and its extraction/screening output requires independent verification against the source papers rather than being treated as ground truth.
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Investigator-Initiated Study (IIS) - CASRAI (2026)
An investigator-initiated study (IIS), also called an investigator-initiated trial (IIT), is a clinical trial that an individual investigator – not a pharmaceutical or device company – designs, initiates, and holds primary regulatory responsibility for conducting. The distinguishing test is not whether an academic clinician is involved (nearly every clinical trial has one), but who originates the protocol and holds the regulatory authorization to conduct it: the Investigational New Drug (IND) application for a US drug/biologic trial, or the Investigational Device Exemption (IDE) for a device trial. Under 21 CFR 312.3, an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered, is a "sponsor-investigator" – a single person who simultaneously carries the regulatory obligations FDA assigns to a sponsor (21 CFR 312 Subpart D, sections 312.50-312.59) and those assigned to an investigator (sections 312.60-312.69). 21 CFR 812.3 defines the equivalent role for device studies conducted under an IDE. This is what distinguishes an IIS from a physician serving only as a participating-site principal investigator in an industry-sponsored multi-site trial, where a company holds the IND/IDE and remains sponsor of record.
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SciScore - CASRAI (2026)
SciScore is an automated text-mining tool from SciCrunch that scores a manuscript's methods section (0-10) against named rigor and resource-transparency criteria – randomization, blinding, sample-size justification, sex as a biological variable, and RRID-identified research resources – drawn from NIH rigor guidelines, MDAR, ARRIVE, CONSORT, and STAR Methods, integrated into journal submission workflows at publishers such as the American Heart Association, Rockefeller University Press, and FASEB.
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Journal Registration (ISSN Registration) - CASRAI (2026)
Journal registration is the process of obtaining an International Standard Serial Number (ISSN) for a serial publication – an 8-digit identifier assigned exclusively by the ISSN Network (a national ISSN Centre, or the ISSN International Centre for countries without one) that uniquely identifies a specific title in a specific medium. A publication counts as "registered" only once the relevant Centre has verified the title, publisher, and format and formally assigned it an ISSN through the ISSN Portal – not merely because a publisher claims or advertises one. It is a bibliographic-identification step, distinct from peer-review vetting, DOAJ inclusion, database indexing, or any copyright/trademark filing.
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Humanitarian Use Device (HUD) - CASRAI (2026)
A device qualifies as a Humanitarian Use Device (HUD) when it is intended to treat or diagnose a disease or condition that affects, or is manifested in, not more than 8,000 individuals in the United States per year (FD&C Act Section 520(m); 21 CFR Part 814, Subpart H). For a diagnostic device, the threshold is applied to the number of people who would be subject to diagnosis by the device, not to the prevalence of the disease itself. HUD designation, granted by FDA's Office of Orphan Products Development, is the required first step before a sponsor may submit a Humanitarian Device Exemption (HDE) application – a marketing authorization that permits FDA approval based on a finding of probable benefit outweighing risk, rather than the reasonable assurance of effectiveness a standard Premarket Approval (PMA) requires.
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FDA (Food and Drug Administration) - CASRAI (2026)
The U.S. Food and Drug Administration (FDA) is the federal agency within the Department of Health and Human Services (HHS) responsible for protecting public health by regulating the safety and effectiveness of human and veterinary drugs, biological products, and medical devices, along with the U.S. food supply, tobacco products, and cosmetics. In a research context, FDA is the authority that reviews and authorizes Investigational New Drug (IND, 21 CFR Part 312) and Investigational Device Exemption (IDE, 21 CFR Part 812) applications before a human clinical investigation of an unapproved drug, biologic, or device may proceed, and it inspects trial sites, sponsors, IRBs, and manufacturing facilities for compliance with its regulations. FDA is organized into center-level components with jurisdiction over different product categories – principally CDER (drugs), CBER (biologics), and CDRH (devices) for research purposes – plus a field-inspection arm, the Office of Inspections and Investigations (OII, renamed from the Office of Regulatory Affairs in an October 2024 reorganization).
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