Statistical Analysis Plan (SAP) - CASRAI (2026)
A Statistical Analysis Plan (SAP) is the pre-specified document that translates a clinical trial protocol's objectives and endpoints into the exact statistical methodology that will be used to analyze the trial's data — which populations are analyzed (e.g. intent-to-treat/full analysis set vs. per-protocol set), which statistical tests and models are applied to each endpoint, how missing data and multiplicity are handled, and what any interim or subgroup analyses will consist of. A document only functions as a genuine SAP if it is finalized and version-locked before database lock and unblinding — that is, before anyone with access to outcome data can see how the results turn out. A statistical methods section written or substantively revised after the analysts already know (or could infer) the results is not a valid SAP in the ICH E9 sense, regardless of what it is called, because it no longer prevents the analytic flexibility (selective reporting, post-hoc subgroup mining, outcome-switching) that pre-specification exists to close off.
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Nature Portfolio Reporting Summary - CASRAI (2026)
A mandatory, standardized fillable-PDF form Nature Portfolio requires with manuscript submission for life sciences, behavioural & social sciences, or ecological/evolutionary/environmental sciences research articles, disclosing statistics reporting, software/code, data availability, and a field-specific study-design track (sample size, data exclusions, replication, randomization, blinding, or their track-specific equivalents), with negative disclosures required rather than fields left blank; the completed form is shared with editors/reviewers during assessment and published alongside the accepted paper.
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ICMJE Generative AI Policy - CASRAI (2026)
The International Committee of Medical Journal Editors (ICMJE) sets out its rules on generative AI in Section II.A.4 of its Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, added in the May 2023 update. The policy rests on three linked rules: (1) chatbots and other AI tools cannot be listed as authors because they cannot take responsibility for the accuracy, integrity, and originality of the work and cannot approve a final version for submission, so they fail ICMJE's own authorship criteria by definition; (2) at submission, authors must disclose whether AI-assisted technologies were used, with the disclosure location depending on how the tool was used — writing, editing, or proofreading assistance is described in the Acknowledgments section, while use of AI to collect or analyze data or to generate figures is reported in the Methods section; and (3) human authors remain fully responsible for any submitted material produced with AI assistance, including reviewing and editing AI output carefully, because such tools can generate authoritative-sounding text that is incorrect, incomplete, or biased.
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DOE AI Policy - CASRAI (2026)
"DOE AI policy" most precisely refers to the U.S. Department of Energy's Generative Artificial Intelligence Policy (DOE P 2031, "Use of Generative Artificial Intelligence," issued December 29, 2025) – a departmental directive governing how DOE's own federal workforce and National Laboratory staff may adopt, deploy, and use generative AI tools in their work. It sits inside DOE's broader 200-series management directives and was written to align with the October 2023 White House Executive Order on AI and the March 2024 OMB Memorandum M-24-10 on federal agency AI governance. It is an internal governance instrument, not an applicant-facing submission requirement: it does not create a DOE-wide rule that external grant applicants, proposers, or awardees must disclose generative AI use when submitting a funding opportunity announcement (FOA) response. Where DOE's policy does touch research practice directly is inside the agency: when generative AI contributes to an idea, approach, or invention developed at DOE or a National Laboratory, DOE staff are expected to identify that specific contribution and cite the GenAI tool as part of the research methodology, consistent with the department's broader research-integrity and record-keeping expectations. Research administrators should not assume this term is interchangeable with the applicant-facing generative AI disclosure notices published by other funders – see NSF AI Policy and Nature Portfolio AI Policy for that different category of policy – and should always check the specific DOE FOA's own instructions and applicable acquisition regulations for any submission-level AI-disclosure requirement, since DOE has not, as of this writing, published a separate proposer-facing AI-disclosure notice comparable to NSF's.
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IEEE Generative AI Policy - CASRAI (2026)
IEEE has no single unified 'AI policy' document; instead it implements two distinct sets of generative-AI rules, disseminated consistently across its journals, transactions, and conferences via the IEEE Author Center and individual IEEE technical societies. The author-side track requires disclosure of generative-AI use in preparing a manuscript, forbids listing an AI system as a co-author, and holds human authors fully accountable for the accuracy and originality of every word, figure, and citation regardless of how it was drafted. The reviewer-side track is a separate and stricter confidentiality rule: reviewers may not upload any part of a manuscript under review to a public generative-AI platform, and may not use such a platform to draft part or all of a review, because doing so risks exposing confidential, unpublished material to a system that can retain or learn from submitted input.
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Comparator Sourcing - CASRAI (2026)
Comparator sourcing is the procurement of an already-approved active comparator drug for use as a trial's control-arm treatment (instead of, or alongside, placebo), plus the blinding, chain-of-custody/authenticity verification, and regulatory handling (GMP/GDP, IMP labeling, import licensing) required once that product enters the study.
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PHI Exemptions From the HIPAA Privacy Rule - CASRAI (2026)
PHI is exempt from the HIPAA Privacy Rule only when it meets one of three conditions: (1) it has been de-identified under the Safe Harbor or Expert Determination method (45 CFR 164.514), (2) it is held by a person or organization that is not a HIPAA covered entity or business associate, or (3) it is a deceased individual's information more than 50 years after death (45 CFR 164.502(f)). PHI that is disclosed for research without individual authorization under a waiver, a review preparatory to research, the decedent-research pathway, or as a Limited Data Set (all under 45 CFR 164.512(i) or 164.514(e)) remains PHI and remains subject to the Privacy Rule – it is not exempt, merely disclosable through a permitted exception.
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Closeout Costs (2 CFR 200.344) - CASRAI (2026)
Closeout costs, in the 2 CFR 200 (Uniform Guidance) sense, are not a separate cost category but the set of financial-disposition actions a federal award recipient must complete once the period of performance ends: submitting all required final financial and performance reports, liquidating any remaining obligations, refunding to the federal awarding agency any unobligated balance the recipient is not authorized to retain, and accounting for and disposing of any equipment or property acquired with federal funds. These duties are set out in 2 CFR 200.344 ("Closeout") and, for property specifically, cross-reference 2 CFR 200.310 through 200.316 and 200.330.
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Penalty for Misuse of Federal Funds - CASRAI (2026)
The 'penalty for misuse of federal funds' is not a single fixed penalty – it is a tiered range of consequences that scales with the severity, intent, and materiality of the misuse, running from purely administrative remedies through civil liability to, in the most serious cases, criminal prosecution. At the administrative end, a Federal awarding agency acting under 2 CFR 200.339 (Remedies for noncompliance) can temporarily withhold payments, disallow the specific costs and require repayment, impose special (more restrictive) award conditions under 2 CFR 200.208, suspend the recipient's ability to draw down funds from the Payment Management System, or suspend or terminate the award itself in part or in whole. Because misspent federal money routed through a claim for payment or a certified financial report can constitute a 'false claim,' the same conduct can separately trigger civil liability under the False Claims Act (31 U.S.C. 3729-3733) – treble damages plus a per-claim civil penalty, pursued either by the Department of Justice or by a private whistleblower (a 'relator') in a qui tam action, with no requirement to prove specific intent to defraud ('knowingly' includes reckless disregard). Independent of both administrative remedies and FCA liability, an agency can initiate suspension or debarment proceedings under 2 CFR Part 180, which exclude the recipient (and, government-wide, any of its covered personnel) from receiving further federal awards or subcontracts for a defined period. Where the misuse involves intentional fraud, false statements, or embezzlement of federal funds, criminal statutes – most commonly 18 U.S.C. 641 (theft or conversion of federal property/funds) and 18 U.S.C. 1001 (false statements) – can result in prosecution, fines, and imprisonment. These four tracks are not mutually exclusive: a single instance of misused federal grant funds can produce a repayment demand, an FCA settlement, a debarment, and a criminal referral simultaneously, because each track is triggered by a different legal test and pursued by a different actor (the awarding agency, DOJ Civil Division, a qui tam relator, and DOJ Criminal Division or a U.S. Attorney's office, respectively).
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NHMRC HREC Registration - CASRAI (2026)
NHMRC HREC registration is the process by which an Australian institution formally registers its Human Research Ethics Committee (HREC) with the National Health and Medical Research Council (NHMRC), submitting the committee's membership list, Terms of Reference, and Standard Operating Procedures for review against the composition and operating requirements set out in Section 5 of the National Statement on Ethical Conduct in Human Research. Registration is what makes an institution's HREC eligible to review NHMRC-funded research and is a prerequisite for – though distinct from – separate certification under NHMRC's National Certification Scheme for the Ethics Review of Multi-centre Research.
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Nature Portfolio AI Policy - CASRAI (2026)
Nature Portfolio's AI policy is the set of editorial rules, published on nature.com and applied across Nature, its sister research and Nature Reviews journals, Scientific Reports, and other Nature Portfolio titles, governing generative AI use in submitted manuscripts. A submission is treated as compliant only if: (1) no AI tool (large language model, chatbot, or image generator) is listed as an author or co-author, since authorship requires accountability that a tool cannot hold; (2) any substantive use of an LLM or other generative AI tool in preparing the manuscript is disclosed in the Methods section (or an equivalent alternative section for article types without one) — minor AI-assisted copyediting of already-written text does not require disclosure; and (3) no AI-generated or AI-substantially-modified image, video, or figure is used, except in the narrow case of a piece specifically about AI itself, reviewed case-by-case by the editor, or artwork sourced through an agency with a contractual chain that makes its provenance legally clear.
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NIH Guidelines for Human Stem Cell Research - CASRAI (2026)
The NIH Guidelines for Human Stem Cell Research is the federal oversight framework, issued by the National Institutes of Health in 2009 (following Executive Order 13505) and amended in 2010, that governs whether federally funded research may use a given human embryonic stem cell (hESC) line. A research activity falls under the Guidelines whenever a US institution seeks NIH funding for work involving hESCs derived from embryos donated after in vitro fertilization (IVF) treatment. Under the Guidelines, two conditions must both be satisfied before federal funds may be used: (1) the specific hESC line must be listed on the NIH Human Pluripotent Stem Cell Registry (hPSCR), which NIH adds a line to only after confirming the embryo was donated voluntarily, with specific informed consent, by IVF patients whose decision to donate was kept separate from their clinical fertility care and was not induced by payment; and (2) many institutions additionally require the protocol to clear review by an institutionally convened Embryonic Stem Cell Research Oversight (ESCRO) committee before the work proceeds, a review that is separate from and in addition to standard Institutional Review Board (IRB) review of the original donor-consent process. The Guidelines govern use of already-derived hESC lines; they do not authorize federal funding of embryo derivation itself, which remains separately restricted by the Dickey-Wicker Amendment, an annual appropriations rider unaffected by the 2009 Guidelines.
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Vertebrate Animals Section (VAS) - CASRAI (2026)
The Vertebrate Animals Section (VAS) is the required narrative component of an NIH grant application or cooperative-agreement proposal covering any proposed use of live vertebrate animals. Per NIH guidance (originally NOT-OD-10-027, simplified by NOT-OD-16-006), it must describe the proposed procedures and species/strains/ages/sex/numbers; justify the choice of species and why a non-animal alternative cannot achieve the research goals; describe interventions minimizing pain and distress, including analgesia, anesthesia, and humane endpoints; and state whether the planned euthanasia method is consistent with the AVMA Guidelines for the Euthanasia of Animals. It is evaluated by NIH Scientific Review Groups as part of merit review and is distinct from, and does not substitute for, the institution’s own IACUC protocol approval and PHS Assurance.
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Office of Sponsored Programs (OSP) - CASRAI (2026)
The centralized institutional office (at a university, hospital, or research institute) responsible for administering the full lifecycle of externally sponsored funding — proposal review and submission, award negotiation and acceptance, post-award financial and compliance administration, and closeout — acting as the institution's authorized signing authority on behalf of sponsors such as federal agencies, foundations, and industry partners.
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IRB Violations (Serious or Continuing Noncompliance) - CASRAI (2026)
An IRB violation, in federal human-subjects-research regulatory usage, is an instance of "serious or continuing noncompliance" with the IRB's requirements, the approved protocol, or applicable regulation — the threshold that triggers the IRB's own suspension/termination authority under 45 CFR 46.113 and 21 CFR 56.113, and that an institution holding a Federalwide Assurance (FWA) is independently obligated to self-report to the HHS Office for Human Research Protections (OHRP) outside the routine continuing-review cycle. This is a narrower, higher-severity category than the broader IRB reportable event umbrella: a single missed signature or a minor, corrected protocol deviation is ordinarily handled as a routine reportable event or logged at continuing review, not escalated as "noncompliance" in the regulatory sense. What makes a finding an IRB violation, operationally, is severity and/or a pattern: (1) the deviation from the approved protocol or IRB requirements is serious — it affected subject safety, subject rights and welfare, or the integrity of study data — or (2) it is continuing, meaning it is a repeated pattern rather than an isolated, corrected lapse, or the investigator/site has been unresponsive to prior IRB direction to fix it.
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Biosafety in Microbiological and Biomedical Laboratories (BMBL) - CASRAI (2026)
Biosafety in Microbiological and Biomedical Laboratories (BMBL) is the primary US reference manual for laboratory biosafety practice, jointly produced by the CDC and the NIH and now in its 6th edition (2020). It defines the four Biosafety Level (BSL-1 through BSL-4) containment tiers, the risk-group classification system for infectious agents, and the standard and special microbiological practices, safety equipment, and facility design requirements associated with each tier. BMBL is an advisory best-practice document rather than a standalone binding federal regulation, but it carries practical regulatory force because it is incorporated by reference into binding frameworks, including the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the Federal Select Agent Program.
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SUSAR (Suspected Unexpected Serious Adverse Reaction) - CASRAI (2026)
A SUSAR (Suspected Unexpected Serious Adverse Reaction) is an adverse event in a clinical trial that meets three conditions at the same time: it is serious under the ICH E2A seriousness criteria (death, life-threatening, hospitalization/prolongation, persistent or significant disability, congenital anomaly, or another medically important event), the investigator or sponsor judges there is a reasonable possibility it was caused by the investigational product (a suspected causal relationship, not confirmed causation), and it is unexpected — not listed or not consistent in nature, severity, or specificity with the reference safety information in the current Investigator's Brochure (or approved labeling for an active comparator). All three elements must hold; an event failing any one of them is not a SUSAR. Identifying a SUSAR is what triggers expedited, individual-case safety reporting to regulators, separate from and faster than routine trial adverse-event reporting.
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Clinical Trial Transparency - CASRAI (2026)
Clinical trial transparency is the umbrella principle that every clinical trial's existence, design, and outcome should be made public regardless of what the results show. A given practice counts as advancing clinical trial transparency when it does at least one of three things: (1) makes a trial discoverable before it enrolls participants (prospective registration in a WHO-recognized registry such as ClinicalTrials.gov, ISRCTN, or EU CTIS), (2) makes that trial's summary results discoverable after it ends, including when results are negative, null, or unfavorable to the sponsor (results reporting, most concretely enforced in the US through FDAAA 801 and its implementing regulation, 42 CFR Part 11), or (3) makes the underlying protocol, statistical analysis plan, or individual participant-level data available for independent scrutiny (clinical data sharing). It is a movement and a set of overlapping obligations and voluntary commitments, not a single regulation – a trial can satisfy one pillar (say, registration) while failing another (results reporting), which is precisely the gap transparency advocacy has spent over a decade trying to close.
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Program Income - CASRAI (2026)
Program income is gross income earned by a non-Federal entity that is directly generated by a federally supported activity, or earned as a result of a Federal award, during the award's period of performance (2 CFR 200.307(a)). It must be applied to the original purpose of the award using one of three methods – deduction, addition, or cost sharing/matching – as specified by the awarding agency's regulations or the award's terms and conditions; deduction applies by default for most recipients, but addition applies by default for institutions of higher education and nonprofit research institutions when no method is specified.
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MRC Guidance on GDPR and Confidentiality in Health Research - CASRAI (2026)
MRC GDPR and confidentiality guidance refers to the compliance framework the UK Medical Research Council (MRC), acting through UKRI and its MRC Regulatory Support Centre (RSC), sets out for researchers processing personal data – especially health data – in MRC-funded or MRC-affiliated research. It treats UK GDPR/Data Protection Act 2018 (DPA 2018) compliance and the separate common law duty of confidentiality as two distinct, cumulative obligations: satisfying one does not satisfy the other, and MRC-funded research is only compliant when both are addressed. Meeting the standard means (1) identifying a lawful basis for processing under UK GDPR Article 6 – for MRC/UKRI research this is typically 'public task' or 'legitimate interests' rather than consent, since consent as a GDPR lawful basis carries withdrawal rights that are usually impractical for long-running research datasets – (2) satisfying a separate condition for processing special category (e.g. health) data under UK GDPR Article 9(2) and DPA 2018 Schedule 1, and (3) independently respecting the common law duty of confidence owed to anyone whose confidential information – most often identifiable NHS or health/social care data – is accessed or shared, which GDPR compliance alone does not discharge.
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Radiation Safety Committee (RSC) - CASRAI (2026)
A Radiation Safety Committee (RSC) is an institutional oversight committee, required as a condition of certain NRC or NRC Agreement State radioactive-materials licenses, that reviews and approves research and clinical uses of radioactive material and radiation-producing equipment and oversees the institution's radiation protection program. A committee qualifies as an RSC when it is established under a broad scope byproduct material license (10 CFR 33.13, with membership including the Radiation Safety Officer, a management representative, and trained/experienced users) or a medical use license authorizing two or more types of use (10 CFR 35.24, with membership including an authorized user for each use type, the RSO, a nursing-service representative, and an independent management representative) – as distinct from an Institutional Biosafety Committee (IBC), which reviews recombinant/synthetic nucleic acid and biological hazards under the NIH Guidelines, and an IACUC, which reviews live-vertebrate-animal research under the Animal Welfare Act and PHS Policy.
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Significant Financial Interest (SFI) - CASRAI (2026)
A Significant Financial Interest (SFI) is any financial interest an Investigator (or their spouse/dependent children) holds that meets the dollar or equity thresholds defined at 42 CFR 50.603 – generally, remuneration exceeding $5,000 in the prior 12 months from a single publicly traded entity, or exceeding $5,000 or any equity at all from a single non-publicly traded entity – subject to specific regulatory exclusions (e.g., the Investigator's own institutional salary, and compensation from U.S. government agencies or U.S. institutions of higher education for seminars/teaching/review-panel service). Meeting the SFI threshold triggers a disclosure obligation to the institution; it does not by itself mean a conflict of interest exists.
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SMART IRB Reliance Agreement - CASRAI (2026)
The SMART IRB Reliance Agreement is a master common reliance agreement – a single legal contract that participating US institutions each sign once with the SMART IRB platform – that pre-establishes the terms under which any two (or more) participating institutions may rely on one another's IRB review for a given multi-site human subjects study. Once an institution has executed the master agreement, individual studies between it and any other participating institution invoke that existing agreement through an online reliance-determination process, rather than each study requiring its own bespoke IRB Authorization Agreement negotiated and signed from scratch.
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Cambridge University Press Open Access Policy - CASRAI (2026)
Cambridge University Press's (CUP) approach to open access publishing centred on Read & Publish (R&P) agreements: multi-year deals negotiated with individual institutions or national/regional library consortia that bundle subscription reading access to Cambridge's journal portfolio (400+ titles) with open-access publishing rights for the institution's or consortium's corresponding authors, typically at no additional article processing charge (APC) to the author, or at a reduced/capped cost, up to a negotiated article quota. An author qualifies under a given agreement only if they are the corresponding author and are affiliated with a participating institution at the time of acceptance; the publishing platform identifies eligibility automatically at submission and offers the author an open-access route (usually CC BY) in place of, or alongside, the subscription/hybrid route.
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Open Access Publishing Fund - CASRAI (2026)
An open access publishing fund is a dedicated pool of money, typically administered by a university library, that pays or reimburses Article Processing Charges (APCs) on behalf of researchers at that institution who have no other funding source available to cover them. Awards are usually capped per article and per researcher, contingent on the article having no other eligible funding, and available only until the fund’s annual allocation is exhausted — distinguishing it from institutional-level Read & Publish or transformative agreements, which cover OA publishing through a negotiated publisher license rather than an individually applied-for grant.
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Reviewer Recognition Programs - CASRAI (2026)
A reviewer recognition program is a formal mechanism – run by a publisher, a cross-publisher platform, or a professional society – that creates a documented, and often verifiable and portable, record of a researcher's peer review activity. It exists because manuscript peer review is, by scholarly-publishing convention, unpaid, uncredited, confidential volunteer labor: an editor solicits a review, the reviewer submits comments, and outside the editor's own records nothing else normally happens. A reviewer recognition program is anything that closes that gap with a verifiable artifact – a certificate, a platform-logged review history, or a portable credit entry – that the reviewer can point to, as distinct from an informal 'thank you' with no lasting or checkable record.
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IEEE Double-Blind Peer Review - CASRAI (2026)
IEEE's double-blind (also called double-anonymized) peer review is a submission-review model, adopted by specific IEEE journals, transactions, and conferences rather than applied IEEE-wide, in which the manuscript sent to reviewers has been stripped of author names, affiliations, acknowledgments, funding sources, and other directly identifying material, and reviewer identities are withheld from authors throughout review. A submission counts as following IEEE double-blind policy only if the venue itself has formally adopted the model (checkable in that publication's author guidelines) and the author has met its specific anonymization requirements at submission – most IEEE publications instead use IEEE's default single-anonymized model, where the author's identity is visible to reviewers but not vice versa, so double-blind status is never assumed from the IEEE name alone.
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CoARA Signatories - CASRAI (2026)
An organisation that has formally signed the Agreement on Reforming Research Assessment and thereby joined the Coalition for Advancing Research Assessment (CoARA), as distinct from an organisation that merely endorses the Agreement's principles informally.
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SERU (Shared E-Resource Understanding) - CASRAI (2026)
SERU (Shared Electronic Resource Understanding) is a NISO Recommended Practice (NISO RP-7-2012) that lets a subscribing library and a content provider (publisher, aggregator, or other vendor) forgo negotiating and signing a bespoke license agreement for an e-resource. Instead, both parties rely on a shared set of expectations grounded in existing copyright law and standard library/publisher practice, plus the model understanding set out in the RP-7-2012 document itself, which addresses the roles of the content provider, the subscribing institution, and authorized users; the scope of permitted and restricted use; privacy and confidentiality of usage data; online performance and service provision; and archiving/perpetual access. A given e-resource transaction counts as SERU-based when both the institution and the provider have indicated, typically by each being listed in NISO's SERU Registry, that they accept SERU's terms for that transaction in place of a signed license — at which point the order can be placed and access provisioned without a license ever being drafted, routed to counsel, or countersigned.
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Accessibility Remediation Metadata (ARM) - CASRAI (2026)
Accessibility Remediation Metadata (ARM) is a metadata model, in development through a NISO working group that began work in January 2024, for documenting the process and outcome of remediating a publication or other content resource for accessibility – that is, altering an existing, inaccessible format (for example, a scanned PDF with no text layer, or an image-only textbook chapter) into a version usable with assistive technology, and recording what was done, to what standard, for whom, and where the resulting accessible file can be found or requested. ARM does not describe the accessibility of a resource as originally published; it describes remediation work performed after the fact – who remediated it, which accessibility standard the remediated version targets (for example WCAG or an EPUB Accessibility conformance level), what format it is in, and how it can be discovered and reused so the same item is not remediated redundantly by multiple institutions. A resource is within ARM's scope if it involves an accessible alternative produced from a source resource, has metadata identifying the remediation process/outcome, and is intended to support discovery and/or deposit of that alternative in a shared repository.
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Guest Editor Vetting - CASRAI (2026)
The process a journal or publisher uses to confirm that an individual invited to serve as a guest editor for a themed special issue actually holds the institutional affiliation, independent publication record, and editorial independence they claim, before that person is given authority to invite submissions, select peer reviewers, and recommend accept/reject decisions. Vetting is present only when a publisher independently confirms these facts (for example against ORCID, institutional directories, or a prior publication history in the field) rather than accepting a guest editor's self-reported credentials or an unsolicited nomination at face value.
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NISO CREC (Communication of Retractions, Removals, and Expressions of Concern) - CASRAI (2026)
NISO CREC refers to NISO RP-45-2024, the Communication of Retractions, Removals, and Expressions of Concern Recommended Practice published by the National Information Standards Organization (NISO) on June 27, 2024 (DOI 10.3789/niso-rp-45-2024). CREC is not a new editorial rule about *when* something should be retracted — that judgment remains the domain of editorial-ethics guidance such as COPE's Retraction Guidelines. It is a communication standard about *how* a retraction, removal, or expression of concern (EoC), once decided, gets represented consistently in metadata and on-page display so that both human readers and machine systems (indexers, citation databases, reference managers, library discovery layers, aggregators) can detect and propagate the status automatically, rather than relying on someone noticing a notice. A publisher, platform, or content system is applying CREC when it implements RP-45-2024's paired recommendations: (1) metadata — structured, machine-readable status elements attached to the item's record (classified in the Recommended Practice as Essential, Essential if Available, or Recommended), covering the original publication, the retraction/removal/EoC notice itself, dates, and reasons; and (2) display — visible, human-facing signals, including prepending “RETRACTED:” to the title, watermarking and labelling the content in both HTML and PDF renderings, and linking a distinct, easily located notice to the affected item rather than burying it in an unrelated editorial page.
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Journal Article Versions (JAV) - CASRAI (2026)
Journal Article Versions (JAV) is the NISO/ALPSP-defined controlled vocabulary (NISO RP-8-2008) for distinguishing the successive states a scholarly journal article passes through between first draft and final publication. A document instance is properly labelled with a JAV term — Author's Original (AO), Submitted Manuscript Under Review (SMUR), Accepted Manuscript (AM), Proof (P), Version of Record (VoR), Corrected Version of Record (CVoR), or Enhanced Version of Record (EVoR) — based on where it sits in the peer-review and publication workflow, not on its file format or where it happens to be hosted; the same PDF hosted in three different repositories is still one JAV stage, and two files with identical content but different peer-review status are different JAV stages.
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NISO MECA (Manuscript Exchange Common Approach) - CASRAI (2026)
NISO MECA (Manuscript Exchange Common Approach), published as NISO Recommended Practice RP-30, is a technical protocol and package format specifying how manuscript files, associated metadata, and peer review history can be transferred automatically, in a machine-readable way, between different journals' and publishers' manuscript submission systems. A file transfer counts as MECA-compliant only if it (1) packages the manuscript files, metadata, and any transferred reviewer reports into the structured format the recommended practice defines, and (2) moves that package between systems through an automated, standardized transfer mechanism rather than a person manually re-uploading files and re-typing review comments into a second system.
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COUNTER 5 - CASRAI (2026)
COUNTER 5 (formally the COUNTER Code of Practice, Release 5, or 'COP5') is the current international standard governing how publishers, aggregators, and other content platforms must record and report usage statistics — searches, investigations, and requests — for the electronic resources (journals, databases, books, and multimedia items) they license to libraries and consortia. A usage report qualifies as 'COUNTER 5 compliant' only if it is produced from one of COP5's defined Master Report templates, uses COP5's controlled Metric_Types vocabulary, applies COP5's double-click and robot-filtering deduplication rules consistently, and (where automated) is retrievable via the COUNTER API (formerly called SUSHI, the Standardized Usage Statistics Harvesting Initiative). The standard exists so that a usage number from one publisher platform means the same thing as the equivalent number from another, letting libraries compare cost-per-use and make collection-development and renewal decisions on a like-for-like basis.
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Cascading Peer Review - CASRAI (2026)
Cascading peer review (also called portable or transferable peer review) is a manuscript-handling workflow in which a journal that rejects a submission – typically for reasons of scope, fit, or relative significance rather than a fatal flaw in the work – offers the author the option to transfer the manuscript, along with the completed reviewer reports and editorial decision letter, to another journal, most often a sister title within the same publisher's portfolio. The receiving journal's editor can then make a faster decision using the existing reviews (obtaining only a fresh check on any points the original reviewers flagged, or a brief update review) instead of restarting peer review from a blank slate. A workflow counts as cascading peer review only if three things are true: (1) a rejection or a 'suggest transfer' decision already occurred at the first journal, (2) the author has given informed consent for the manuscript and reviews to move, and (3) the receiving journal's editorial process actually reuses the transferred review material rather than treating the submission as brand-new. It is a portfolio-level triage mechanism, not a form of peer review in its own right – the review methodology itself (single-anonymized, double-anonymized, open, etc.) is whatever the originating journal already used.
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Hijacked journal - CASRAI (2026)
A journal is operating as a hijacked journal when a website solicits and accepts manuscripts, typically for a fee, under the name, ISSN, and/or editorial identity of a specific real, previously or currently legitimate journal, without authorization from that journal's actual publisher or editorial board. The operational test is genuine continuity with, or authorization from, the real publisher of record, checkable against the ISSN Portal, the journal's own site, or its listing in the index it claims.
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Crossref Event Data - CASRAI (2026)
Crossref Event Data was a free Crossref service that captured and made available structured records of "events" – online mentions such as tweets, Wikipedia citations, newspaper articles, blog posts, and Wikipedia edits – that referenced scholarly content identified by a DOI. Each event linked a source (e.g. a specific tweet or Wikipedia page) to a subject (a DOI-identified research output) with a timestamp, and the resulting data fed into third-party altmetrics tools and dashboards. Crossref formally sunset the service: the public Event Data API and related infrastructure stopped being available from 23 April 2026, after roughly a decade in operation, and it should now be described in the past tense as a discontinued service, not an active one.
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Exclusive License (Publishing) - CASRAI (2026)
A publishing agreement in which the author keeps ownership of copyright but grants the publisher the sole, exclusive right to publish, reproduce, and distribute the work. It is offered by many journals as an alternative to a Copyright Transfer Agreement (CTA): under a CTA the author assigns copyright ownership itself to the publisher, whereas under an exclusive license the author retains ownership and grants only a defined bundle of exclusive rights, keeping whatever rights the agreement does not expressly grant away.
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ACM Artifact Review and Badging - CASRAI (2026)
ACM Artifact Review and Badging is a formal peer-evaluation process, run alongside conventional paper peer review at ACM-sponsored conferences and in ACM journals, in which authors of a computer-science research paper voluntarily submit their supporting 'artifacts' – source code, datasets, containers, build scripts, or other digital objects needed to run the reported experiments – to a separate Artifact Evaluation Committee (AEC). The AEC checks whether the artifact is documented and runnable, and in stricter tracks, whether running it actually reproduces the paper's reported results. A paper that passes earns one or more standardized badge icons (Artifacts Available, Artifacts Evaluated – Functional, Artifacts Evaluated – Reusable, Results Reproduced, Results Replicated), printed on the published paper itself as a visible, per-paper certification distinct from the paper's own peer-review outcome.
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Rights Retention Strategy (RRS) - CASRAI (2026)
A compliance mechanism, developed by cOAlition S in 2020, under which a funded researcher asserts a CC BY (or CC BY-equivalent) licence over the Author Accepted Manuscript (AAM) at the point of submission – typically via a standard statement in the cover letter, on the manuscript's first page, or in the acknowledgements – rather than negotiating open-access rights with the publisher after acceptance. Because the author (via their funder's grant conditions) retained the necessary rights from the outset, the publisher's own copyright transfer agreement, embargo policy, or self-archiving terms cannot override the licence already applied. An instance qualifies as RRS only if the licence statement is made at submission, before any publisher agreement is signed; a rights claim asserted only after acceptance, or general institutional self-archiving without a prior funder-mandated statement, does not count.
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Peer Review Fraud - CASRAI (2026)
The deliberate corruption of the manuscript peer-review process to obtain a favorable or falsely legitimate-looking editorial decision, via fabricated reviewer identities, reciprocal peer-review rings, or coercive demands unrelated to manuscript merit. Distinguished from good-faith reviewer error, ordinary editorial disagreement, or unconscious reviewer bias by the presence of deliberate intent to subvert the review process itself.
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Acceptable Similarity Percentage - CASRAI (2026)
There is no single, official percentage that marks a similarity/originality report as acceptable or unacceptable. Turnitin, Crossref Similarity Check, and iThenticate all publish a numeric similarity index, but none of the vendors, COPE, or ORI define a universal cutoff – individual institutions, journals, and graduate schools sometimes set an informal internal benchmark (commonly cited figures cluster around 15% or 20%) purely as a triage trigger for closer human review, not as a formal misconduct threshold. What actually determines whether a score is a problem is what the flagged text consists of: properly quoted and cited material, a shared reference list or bibliography, standard field terminology, and (for theses) a candidate's own previously deposited coursework all inflate the percentage without indicating misconduct, so a report has to be opened and read, not just scored, before any percentage is meaningful.
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Frontiers Collaborative Peer Review - CASRAI (2026)
Frontiers Collaborative Peer Review is Frontiers Media's proprietary peer-review workflow in which reviewers and authors are put into direct, real-time dialogue – typically through an online review forum – to resolve concerns together, rather than exchanging one-way reports mediated entirely by an editor. A submission qualifies as having gone through this process if it moved through two distinct phases on Frontiers' platform: an independent review phase, where each reviewer prepares and submits a report without seeing the other reviewers' comments, followed by an interactive review phase, where the editor opens a shared online forum and authors, reviewers, and the handling editor can all read and respond to each other's comments directly until the reviewers are satisfied or a decision is reached. The reviewers' and handling editor's names are published alongside the final article, rather than kept anonymous indefinitely.
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Open Peer Review - CASRAI (2026)
A peer review model in which review reports, reviewer identities, and/or post-publication comment threads are disclosed to readers rather than kept within a confidential editor-reviewer-author loop. A given implementation counts as open peer review to the extent it publishes review information (reports, decision letters, reviewer names) and/or enables open commenting - per the ANSI/NISO Z39.106-2023 peer review terminology framework - not merely because reviewer identity is known internally to the editor or author.
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Co-Editor-in-Chief - CASRAI (2026)
A co-editor-in-chief structure exists when a journal names two or more individuals to jointly hold the editor-in-chief role, sharing final editorial authority over the journal (policy, contested decisions, ethics escalations) rather than one editor-in-chief delegating subordinate work to associate or section editors beneath a single top authority. Journals use this model to distribute workload, cover distinct subject-area or methodological expertise, manage a leadership transition, or reflect shared governance across co-publishing institutions. The title is applied inconsistently across publishers – some co-editors-in-chief hold fully independent, co-equal sign-off authority; others function as a senior deputy to one lead editor-in-chief – so a journal's own editorial policy or masthead documentation, not the title alone, determines actual decision authority.
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Work Made for Hire - CASRAI (2026)
A work is a "work made for hire" under US copyright law (17 U.S.C. Section 101) when it falls into one of two categories: (1) a work prepared by an employee within the scope of their employment, or (2) a work specially ordered or commissioned for use in one of nine specific categories (a contribution to a collective work, part of a motion picture or audiovisual work, a translation, a supplementary work, a compilation, an instructional text, a test, answer material for a test, or an atlas) where the parties expressly agree in a signed written instrument that the work is a work made for hire. Under 17 U.S.C. Section 201(b), the employer or commissioning party – not the individual who actually created the work – is treated in law as the "author" and default owner of the copyright, unless the parties have agreed otherwise in writing. This is distinct from a copyright assignment: an assignment transfers rights the creator originally held; work-made-for-hire status means the creator never held authorship or copyright in the work to begin with.
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Heliyon’s Journal Impact Factor (JIF) - CASRAI (2026)
Heliyon's Journal Impact Factor (JIF) is a specific, illustrative instance of the general Journal Impact Factor metric published annually by Clarivate in the Journal Citation Reports (JCR) – with a current wrinkle: Heliyon does not have an active JIF as of this writing (last verified 2026-08-16). Heliyon, launched by Elsevier/Cell Press in 2015, is a broad-scope, open-access megajournal that peer-reviews submissions for technical and ethical soundness rather than perceived novelty. Clarivate placed Heliyon on hold in Web of Science indexing in September 2024 (the same month as Cureus) and lifted that hold on 2026-05-14, per Retraction Watch's reporting, following an Elsevier internal audit that Retraction Watch reports resulted in roughly 1,197 corrections including approximately 687 retractions (RW-sourced, not Clarivate-confirmed). Because its citation data was suppressed for part of the assessment window, Heliyon did not receive a JIF in the June 2026 JCR release; Clarivate is expected to issue one in the October 2026 release instead. CASRAI attempted direct verification against Elsevier's own Heliyon pages (sciencedirect.com/journal/heliyon, cell.com/heliyon/home) this session; both returned HTTP 403 and could not be read. Any pre-hold aggregator figure (historically reported near 4.3 for the 2024 data year) should be treated as superseded historical background, not a current, citable number.
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Scientific Data (journal) - CASRAI (2026)
Scientific Data is a peer-reviewed, open-access journal published by Springer Nature (Nature Portfolio), launched in 2014 specifically to publish formal, citable descriptions of research datasets. Its primary article type is the Data Descriptor – not a conventional research article – which combines a structured, machine-readable description of a dataset (methods, data-collection and processing steps, technical validation, and standardized metadata) with a narrative sufficient for another researcher to understand and reuse the data. A submission qualifies as a Data Descriptor, and is evaluated in peer review, on the technical soundness, completeness, and reusability of the dataset and its documentation – not on the novelty, scientific impact, or hypothesis-driven conclusions that a traditional research article is judged on. The underlying data must be deposited in a recognized, community-endorsed public repository and made available under an open license; the Data Descriptor itself is the journal article that points to, documents, and formally credits that deposited dataset.
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Environmental Science and Pollution Researchs Journal Impact Factor (JIF) - CASRAI (2026)
The Journal Impact Factor (JIF) of Environmental Science and Pollution Research (ESPR) is the Clarivate-calculated, Journal Citation Reports (JCR) metric for this Springer (Springer Nature) journal, covering environmental chemistry, ecotoxicology, and pollution-monitoring research. Per third-party JCR-tracking aggregators (Research.com, BioxBio, Resurchify) rather than a direct jcr.clarivate.com subscription check this session, ESPR's JIF rose through the early 2020s – from roughly 2.6 in 2012 to about 5.8 for the 2022 JCR data year – before falling to an aggregator-reported figure of approximately 5.59 for the 2024 JCR data year (2025 release), a decline these sources describe as consistent with a broader multi-year retrenchment across the journal's citation counts. As with any single aggregator-sourced figure, treat the exact decimal as indicative rather than authoritative until cross-checked against Clarivate's own JCR platform, and note that a journal's JIF is only ever one input into assessing where to submit or how to read a single paper's citation context – not a substitute for reading the paper itself.
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PLOS Pathogens Impact Factor (2026 Update) - CASRAI (2026)
PLOS Pathogens' Journal Impact Factor (JIF) would, if PLOS promoted one, be the Clarivate-computed, journal-level citation ratio published annually in the Journal Citation Reports (JCR). PLOS's own journal-information page states directly that it does not consider Impact Factor 'a reliable or useful metric to assess the performance of individual articles' and will only provide the figure to individuals on request – CASRAI verified this policy language directly against journals.plos.org on 16 August 2026 (shared boilerplate across PLOS's journal-information pages, including PLOS Pathogens'). PLOS instead promotes article-level metrics, CiteScore, SJR, and the h-index. Because PLOS Pathogens remains a JCR-indexed title, Clarivate does compute a JIF for it (current cycle: 2025 data year, released June 2026), but that figure sits behind institutional JCR access and was not independently checked by CASRAI; it should not be sourced from a third-party JCR-tracking aggregator or Wikipedia. PLOS Pathogens is a selective, subject-specific PLOS title (launched September 2005) restricted to research on pathogens and host-pathogen interaction, distinct from both the broad-scope selective flagship PLOS Biology and the soundness-only multidisciplinary megajournal PLOS ONE.
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Self-Citation - CASRAI (2026)
Citing one's own previously published work (an article, dataset, preprint, or other output) within a new manuscript. Self-citation is legitimate, and often necessary, when it substantively supports the current work — building on prior results, pointing to a previously validated method instead of repeating it, or situating a study within a sustained research programme. It becomes problematic — citation manipulation rather than ordinary scholarly practice — when self-citations are added primarily to inflate personal or journal-level citation metrics rather than because the cited work is genuinely relevant, including reciprocal citation-stacking arrangements between authors or journals.
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Nature Cancer’s Journal Impact Factor (JIF) - CASRAI (2026)
Nature Cancer's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Nature Cancer journal receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to Nature Cancer's citable items from the two preceding years, divided by that item count. Independent JCR-tracking aggregators report Nature Cancer's 2-year Impact Factor at approximately 14.3 for the JCR release covering 2024 data, with several aggregators reporting a further jump to approximately 28.0 for the most recent release (2025 data, released June 2026) – an unusually large year-over-year increase worth treating cautiously. nature.com's own journal-information page could not be directly confirmed for this draft (login-gated), so treat these figures as reported rather than independently verified, and check jcr.clarivate.com or nature.com/natcancer before citing formally. Nature Cancer is a distinct, separately scored journal from Nature, Nature Medicine, Nature Communications, and the other Nature Portfolio titles published by Springer Nature, and is also a separate journal from the similarly-named Nature Reviews Cancer. Per DORA and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in Nature Cancer or the merit of its authors.
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MDPI (Multidisciplinary Digital Publishing Institute) - CASRAI (2026)
MDPI (Multidisciplinary Digital Publishing Institute) is a Basel, Switzerland-headquartered academic publisher, founded in 1996, that publishes exclusively open access: every article it accepts is made freely readable on publication, funded by an author-side Article Processing Charge (APC) rather than reader subscriptions. MDPI operates several hundred peer-reviewed journals across the sciences, social sciences, and humanities – examples include International Journal of Molecular Sciences (IJMS), Sustainability, and Nutrients – structured heavily around themed 'Special Issues' with guest editors, and is known for comparatively fast median times from submission to first editorial decision and to publication relative to many subscription journals. MDPI is a member of the Committee on Publication Ethics (COPE) and the Open Access Scholarly Publishing Association (OASPA). It is a real, currently operating publisher, not a defunct or fictitious one – but the label 'MDPI journal' does not, by itself, tell you the editorial rigor of any specific title, which varies journal by journal and has been the subject of genuine, documented scrutiny from indexing bodies and parts of the research community (see below).
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Society for Scholarly Publishing (SSP) - CASRAI (2026)
The Society for Scholarly Publishing (SSP) is a nonprofit, member-based professional association – not a standards body or an accrediting authority – for people who work across the scholarly-publishing ecosystem. A person or organization qualifies as 'part of SSP' by joining as a member (individual or organizational), which in practice draws from publishers, librarians, technology and service vendors, researchers, and consultants working in scholarly communication. SSP's core activities are networking and professional development rather than standard-setting: an annual meeting held each spring, ongoing educational seminars and webinars, topical Focus Groups, and – its best-known public-facing output – The Scholarly Kitchen, an editorially independent blog SSP publishes on scholarly-communication trends, policy, and industry analysis.
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The Lancet’s Journal Impact Factor (JIF) - CASRAI (2026)
The Lancet's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the flagship Lancet journal (published by Elsevier since 1823, ISSN 0140-6736 print / 1474-547X online) receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. This term covers only the flagship Lancet title; the wider Lancet family (The Lancet Oncology, The Lancet Neurology, The Lancet Public Health, The Lancet Digital Health, and others) consists of separately edited, separately JCR-indexed journals each with its own distinct Impact Factor, not covered individually here. Third-party JCR-tracking aggregators and Wikipedia's journal infobox report figures that diverge across releases and trackers – roughly 88.5 attributed to the 2024 JCR data year and roughly 109.0 attributed to the 2025 data year have both been seen, inconsistently labeled – and CASRAI has not independently reconciled these against a single primary source (jcr.clarivate.com is subscription-gated; thelancet.com's own journal-information page was not independently confirmed at the time of writing). Treat any single number you see cited as time-stamped to a specific JCR release – Clarivate updates JCR every June – and check jcr.clarivate.com or thelancet.com directly for the current, release-dated figure before citing it in a formal context such as a CV, grant application, or tenure file. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article The Lancet has published, nor of the researchers who authored it.
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mBio’s Journal Impact Factor (JIF) - CASRAI (2026)
mBio's Journal Impact Factor (JIF) is the two-year citation ratio Clarivate calculates and publishes annually in the Journal Citation Reports (JCR) for mBio, the American Society for Microbiology's (ASM) broad-scope, gold open-access microbiology journal (ISSN 2150-7511, inaugural issue published 18 May 2010, founding Editor-in-Chief Arturo Casadevall). Because ASM does not publish the underlying JCR figure on the journal's own homepage, an instance of 'mBio's JIF' as used on this site means whichever figure the current JCR release actually reports for mBio, cross-checked across independent tracker sites rather than taken from a single aggregator, since third-party trackers do not always agree with each other or with the prior year's release in the interim before the next JCR update.
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Cureus’s Journal Impact Factor (JIF) - CASRAI (2026)
Cureus's Journal Impact Factor (JIF) is a specific, illustrative instance of the general Journal Impact Factor metric published annually by Clarivate in the Journal Citation Reports (JCR) – with one important current wrinkle: Cureus does not have an active JIF as of this writing (last verified 2026-08-16). Cureus (ISSN 2168-8184), an open-access general medical journal owned by Springer Nature since December 2022, was placed 'on hold' by Clarivate in September 2024 and formally removed from the Web of Science Master Journal List in October 2025, following a period of substantial retraction activity and stated article-quality concerns. Removal from Web of Science means Cureus no longer accrues the citation counts a JIF is calculated from and does not receive a JCR figure for 2025 or any subsequent year. Before delisting, third-party JCR-tracking aggregators reported Cureus's most recent 2-year JIF variously as approximately 1.2 (2022 JCR release) and approximately 1.3 (2024 release); cureus.com's own current marketing copy separately cites an undated 'Impact Factor of 1.3' that does not acknowledge the delisting. Any impact-factor number for Cureus found online should be treated as historical, not current, and checked against Clarivate's live Master Journal List rather than cited as an active figure.
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Journal of Neuroscience’s Journal Impact Factor (JIF) - CASRAI (2026)
The Journal of Neuroscience's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio that JNeurosci – the flagship weekly research journal of the Society for Neuroscience (SfN) – receives each year in the Journal Citation Reports (JCR): citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. The journal (ISSN 0270-6474 print, 1529-2401 online) has published continuously since 1981 and is indexed in Clarivate's Science Citation Index Expanded, which makes it JIF-eligible on the same mechanical basis as every other JCR-indexed title. Aggregator trackers (bioxbio.com, Wikipedia's infobox citing JCR) converge on a 2024 JIF of approximately 4.0, down from a reported peak near 6.7-6.9 in 2012-2013 – a multi-year decline consistent with a broader pattern of JIF compression across many established neuroscience and biomedical titles as the denominator (citable items) and citation landscape have shifted. Treat any single figure as time-stamped to a specific JCR release – Clarivate updates JCR every June – and check jcr.clarivate.com or the journal's own page at jneurosci.org directly for the current, release-dated number before citing it in a formal context such as a CV, grant application, or tenure file. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article the Journal of Neuroscience has published, nor of the researchers who authored it.
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Blood (ASH Journal)’s Journal Impact Factor (JIF) - CASRAI (2026)
Blood's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio that Blood – the flagship, weekly peer-reviewed journal of the American Society of Hematology (ASH) – receives each year in the Journal Citation Reports (JCR): citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. This entry is specifically about Blood the hematology journal (ISSN 0006-4971 print, 1528-0020 online), published continuously by ASH since 1946 – not about the common noun 'blood' or any life-sciences journal with a similar-sounding title. Blood is indexed in Clarivate's Science Citation Index Expanded, which makes it JIF-eligible on the same mechanical basis as any other JCR-indexed title. Reported figures for Blood's current JIF diverge across sources: ASH's own hematology.org materials have cited a figure near 23.9, third-party JCR-tracking aggregators (BioxBio, JournalsInsights, journalmetrics.org) show figures in roughly the 20-24 range for recent releases, and one ASH-affiliated page referenced 21.0 tied to the 2023 JCR release. These differences most likely reflect different JCR release years and aggregator caching lag rather than disagreement about the underlying data – the same pattern seen across most single-journal JIF pages. Treat any one number as time-stamped to a specific JCR release – Clarivate updates JCR every June – and confirm the current, release-dated figure directly against ashpublications.org/blood or jcr.clarivate.com before citing it formally.
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PLOS Biology Impact Factor (2026 Update) - CASRAI (2026)
PLOS Biology's Journal Impact Factor (JIF) would, if PLOS promoted one, be the Clarivate-computed, journal-level citation ratio published annually in the Journal Citation Reports (JCR). PLOS's own journal-information page states directly that it does not consider Impact Factor 'a reliable or useful metric to assess the performance of individual articles' and will only provide the figure to individuals on request – CASRAI verified this policy language directly against journals.plos.org on 16 August 2026 (shared boilerplate across PLOS's journal-information pages, including PLOS Biology's). PLOS instead promotes article-level metrics, CiteScore, SJR, and the h-index. Because PLOS Biology remains a JCR-indexed title, Clarivate does compute a JIF for it (current cycle: 2025 data year, released June 2026), but that figure sits behind institutional JCR access and was not independently checked by CASRAI; it should not be sourced from a third-party JCR-tracking aggregator or Wikipedia. Unlike its PLOS sibling title PLOS ONE, PLOS Biology is a selective flagship journal that peer-reviews for perceived significance and broad interest within biology alongside technical soundness, publishing a small fraction of what it receives.
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Neuron’s Journal Impact Factor (JIF) - CASRAI (2026)
Neuron's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Cell Press neuroscience journal Neuron receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Neuron (ISSN 0896-6273 print, 1097-4199 online) is Cell Press's flagship neuroscience title, published continuously since 1988, and it is distinct from Cell and other Cell Press journals – each carries its own separately computed JIF. The current JCR cycle is the 2025 data year, released June 2026; CASRAI attempted to verify Neuron's figure for that cycle directly against Cell Press's own pages this session (last verified 2026-08-16) and could not complete the request (redirect/bot-protection behavior), so no current figure is stated as fact. The last figure CASRAI can attribute to a specific, dated cycle is approximately 15.0 for the 2024 data year (June 2025 release), reported by third-party aggregators (journalmetrics.org, bioxbio.com) and Wikipedia's infobox, with a reported JCR Quartile 1 placement in neuroscience – that figure is one cycle old, not current. Check jcr.clarivate.com or cell.com/metrics for the current, authoritative figure before citing it in a formal context. Per DORA and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
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Cancer Discovery’s Journal Impact Factor (JIF) - CASRAI (2026)
Cancer Discovery's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the AACR journal Cancer Discovery receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Per journal-metrics tracker data reflecting the JCR release, Cancer Discovery's reported Impact Factor was approximately 29.5 for the 2025 JCR data year (Clarivate's June 2026 release), following a reported 33.3 for the 2024 data year and 29.7 for the 2023 data year – Clarivate updates this figure every June, so treat any single number, including these, as time-stamped to a specific release rather than a fixed property of the journal. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
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Cancer Cell’s Journal Impact Factor (JIF) - CASRAI (2026)
Cancer Cell is a peer-reviewed oncology and cancer-biology journal published by Cell Press (an Elsevier imprint), first issued in 2002 (ISSN 1535-6108 print / 1878-3686 online). Its Journal Impact Factor (JIF) is the annual Clarivate Journal Citation Reports (JCR) metric calculated as the mean number of citations, in the JCR year, to articles the journal published in the two preceding years, divided by the number of citable items in that window. Per Clarivate's JCR (as reported via Wikipedia's sourced infobox and corroborated by independent JIF-aggregator sites), Cancer Cell's most recently released JIF is 56.1, based on 2025 citation data (2026 JCR release) – up from a reported 44.5 for the 2024 data year (2025 release). Always confirm the current figure directly against Clarivate's Journal Citation Reports (subscription-gated) or the publisher's own journal page before citing it in a CV, grant application, or promotion dossier, since JIF is recalculated annually and aggregator sites can lag or round the official release.
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Current Biology’s Journal Impact Factor (JIF) - CASRAI (2026)
Current Biology's Journal Impact Factor (JIF) is a specific, illustrative instance of the general Journal Impact Factor metric published annually by Clarivate in the Journal Citation Reports (JCR). Current Biology is a Cell Press biweekly life-sciences journal (Cell Press became part of Elsevier in 1998/2001) launched in 1991 (ISSN 0960-9822), covering molecular biology, cell biology, genetics, neurobiology, ecology, and evolutionary biology. Its JIF is calculated and reported entirely independently of the JIF for Cell Press's founding flagship journal, Cell, even though both share the Cell Press imprint. See the general Journal Impact Factor entry for how the metric is defined and its well-documented limitations as a research-assessment tool.
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Frontiers in Immunology’s Journal Impact Factor (JIF) - CASRAI (2026)
Frontiers in Immunology's Journal Impact Factor (JIF) is the annual Clarivate Journal Citation Reports metric for this Frontiers Media open-access immunology journal, currently reported by the publisher's own journal page as 7.0 for the 2025 JCR data year (June 2026 release), up from 5.9 for the 2024 data year – a title whose reported JIF has moved unusually widely release to release, so the current figure should be confirmed directly against Clarivate before formal citation.
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Advanced Materials’ Journal Impact Factor (JIF) - CASRAI (2026)
Advanced Materials' Journal Impact Factor (JIF) is the annual two-year citation metric Clarivate publishes for the journal in the Journal Citation Reports (JCR): citations in a given JCR year to Advanced Materials articles published in the preceding two years, divided by the number of citable items Advanced Materials published in those two years. Advanced Materials is a materials-science journal published by Wiley-VCH since 1989 (independent from an earlier Angewandte Chemie supplement dating to 1988; ISSN 0935-9648 print, 1521-4095 online). Third-party JCR-tracking aggregators report its JIF at approximately 26.8 for the 2024 JCR data year (2025 release); CASRAI attempted to confirm this directly against Wiley's own journal page on 16 August 2026 and could not (subscription/paywall response), so treat the figure as reported/secondary-source only, not primary-verified.
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Types of Variables - CASRAI (2026)
"Types of variables" is not one classification but shorthand for two independent frameworks used to describe any variable in a study. The first, measurement level (or scale of measurement), classifies a variable by the mathematical properties of the values it can take: nominal (unordered categories), ordinal (ordered categories without equal spacing), interval (equal spacing, no true zero), or ratio (equal spacing with a true zero). The second, design role, classifies a variable by the function it plays in a specific study's causal or descriptive structure: independent/dependent (manipulated or predictor vs. measured outcome in an experimental design), explanatory/response (the same relationship in an observational or correlational design), and confounding (a third variable associated with both that can distort the apparent relationship). Every variable in a study is classified along both dimensions at once – measurement level is a property of how the variable was recorded, while design role is a property of what a specific analysis is asking the variable to do.
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Title Page (Research Paper) - CASRAI (2026)
A title page is the first page of an academic manuscript that identifies the work and its authors before the reader reaches the abstract or main text. What makes a page function as a title page — as opposed to just a cover sheet — is that it carries a defined, checkable set of identifying elements: at minimum the full title, the author byline, and institutional affiliation. Beyond that minimum, exactly which additional elements are required, and where each one goes, is set by whichever style guide or journal the manuscript is being formatted for — not by a single universal template. A style manual such as APA's 7th edition and an individual journal's author guidelines can require different elements in different positions, and where they conflict, the target journal's own instructions take precedence over the general style guide.
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P-Value - CASRAI (2026)
The p-value is the probability of observing a result at least as extreme as the one found in a sample, calculated on the assumption that the null hypothesis is true. It is not the probability that the null hypothesis is true, and it does not measure effect size or practical importance — only how surprising the observed data would be if there truly were no effect.
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Category A Bioterrorism Agents - CASRAI (2026)
Category A is the highest-priority tier of CDC's three-tier (A/B/C) bioterrorism-agent classification, used for public-health emergency-preparedness planning rather than as a compliance roster. An agent qualifies as Category A if it can be easily disseminated or transmitted person-to-person, causes high mortality with potential for major public-health impact, might cause public panic and social disruption, and requires special action for public health preparedness (e.g., stockpiling, enhanced surveillance, and public-communication planning). CDC groups six agents/diseases under Category A: anthrax (Bacillus anthracis), botulism (Clostridium botulinum toxin), plague (Yersinia pestis), smallpox (variola major), tularemia (Francisella tularensis), and viral hemorrhagic fevers caused by filoviruses (e.g., Ebola, Marburg) and arenaviruses (e.g., Lassa, Machupo). This is distinct from, though heavily overlapping with, the Federal Select Agent Program's regulated roster: Category A is a preparedness-prioritization label with no independent registration or compliance obligation attached to it directly, while the Select Agent List is the specific set of agents and toxins an entity must register to legally possess, use, or transfer.
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Critical Literature Review - CASRAI (2026)
A critical literature review is a form of literature review whose organizing purpose is evaluative and argumentative rather than descriptive: the writer selects significant sources on a topic, appraises the quality, validity, and coherence of the claims and evidence in each, and uses that appraisal to identify gaps, contradictions, and unresolved debates, ultimately advancing the writer's own interpretation, argument, or conceptual position. It is distinguished from a systematic or scoping review by search strategy (selective and purposive rather than exhaustive and reproducible) and from a purely descriptive literature review by its explicit evaluative stance: a critical review does not just summarize what each source found, it judges the strength of the evidence and the soundness of the reasoning behind it.
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IRB Reportable Events - CASRAI (2026)
An IRB reportable event is any occurrence, finding, or piece of new information arising during an already-approved, ongoing human subjects study that federal regulation or an institution's Human Research Protection Program (HRPP) policy requires the study team to report to the IRB outside the routine continuing-review cycle. This is distinct from the initial IRB application/approval process (see IRB/REC Approval Process) and from a planned protocol amendment submitted for prior approval before a change is implemented – a reportable event concerns something that has already happened during the conduct of the study. The umbrella category typically includes: unanticipated problems involving risks to subjects or others (UPIRSOs), protocol deviations (especially those affecting subject safety, rights, or data integrity), adverse events and serious adverse events, subject complaints, breaches of confidentiality, and non-compliance with the approved protocol or applicable regulations.
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Statistical Test - CASRAI (2026)
A statistical test is a formal procedure for deciding whether a pattern observed in sample data is likely to reflect a genuine feature of the population it was drawn from, or could plausibly have arisen from random sampling variation alone. Every statistical test works the same way at a structural level: it states a null hypothesis (typically 'no effect' or 'no difference'), computes a test statistic from the observed data, and compares that statistic (via its p-value) against a pre-specified significance threshold to decide whether the null hypothesis can be rejected. A specific procedure only counts as 'the right statistical test' for a given analysis if its underlying assumptions match the data actually collected: the measurement type (categorical vs. continuous), the number of groups or variables being compared, the study design (independent vs. paired/repeated observations), and, for parametric tests, the shape of the sampling distribution.
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I.e. vs. E.g. - CASRAI (2026)
"I.e." (Latin id est, "that is") restates or clarifies the statement it follows with an exhaustive equivalent, while "e.g." (Latin exempli gratia, "for example") introduces one or more illustrative, non-exhaustive examples. The operational test: if you can replace the abbreviation with "that is" or "in other words" without changing the sentence's meaning, "i.e." is correct; if the material that follows is one option among others rather than a full restatement, "e.g." is correct. In academic writing, misuse of either changes what the sentence actually claims – writing "i.e." before a partial list implies it is complete when it isn't, and writing "e.g." before a defining criterion understates that the criterion is required.
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Sampling Methods: Probability and Non-Probability Types Explained - CASRAI (2026)
A sampling method is the defined procedure a study uses to select which members of a population are observed or measured. It qualifies as a probability method only if every population member has a known, non-zero chance of selection via a defined chance mechanism (simple random, stratified, systematic, or cluster sampling) – this is what supports formal statistical inference and generalizability claims back to the population. Non-probability methods (convenience, purposive/judgmental, snowball, quota sampling) select participants without a defined chance mechanism, which is legitimate and standard in qualitative and exploratory research but does not, on its own, support formal population-level generalization.
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Delimitations - CASRAI (2026)
Delimitations are the boundaries a researcher deliberately sets on the scope of a study during its design – the population, timeframe, geography, variables, and theoretical framework chosen to include or exclude so the study stays focused and answerable. A factor qualifies as a delimitation, not a limitation, when it was a choice the researcher made rather than a constraint imposed on them: narrowing a survey to one country, one age range, one industry, or one time period are all delimitations because the researcher could have drawn the boundary differently but chose not to for reasons of focus, relevance, or feasibility. Delimitations are stated in the methods or scope section, in the first person and past tense of intentional design ('this study was delimited to...'), and they define what the study's conclusions can legitimately be generalized to.
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Descriptive Research - CASRAI (2026)
Descriptive research is a research design category whose goal is to accurately describe the characteristics, behaviours, or conditions of a population, phenomenon, or situation as they naturally exist, without manipulating any variable and without attempting to establish a cause-and-effect relationship between variables. A study qualifies as descriptive research if it answers 'what is/are the characteristics of X' rather than 'does X cause Y' – the researcher observes and records rather than intervenes. Common forms include case studies (in-depth examination of a single individual, group, organisation, or event), cross-sectional surveys (data collected from a population at one point in time), observational studies, and case series/ecological studies in clinical and public-health research. Because it does not involve random assignment to conditions or control of independent variables, descriptive research cannot by itself support causal claims – it can identify patterns, prevalence, and associations that generate hypotheses for later experimental or quasi-experimental testing, but it cannot confirm them.
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Figure Legend - CASRAI (2026)
A figure legend (also called a figure caption) is the block of text accompanying a figure – typically placed directly beneath it, or grouped on a separate legends page/section depending on the target journal's submission format – that must let a reader understand the figure entirely on its own, without needing to reread the Methods or Results text. To meet that standalone-comprehension bar, a complete figure legend generally includes: a short declarative title sentence stating the figure's main point or finding; a description of what each panel shows (for multi-panel figures, keyed to the panel letters used in the image); definitions of every abbreviation, symbol, and color/line code used in the figure; the statistical test applied and what error bars or shaded regions represent (e.g., SD, SEM, 95% CI); and the relevant sample size (n). A figure legend is distinct from an in-text figure reference or callout (e.g., 'as shown in Figure 2', 'see Fig. 3B'), which is a pointer embedded in the manuscript's running prose directing the reader to look at the figure – the legend is the self-contained explanatory text that travels with the figure itself.
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Research Questionnaire - CASRAI (2026)
A research questionnaire is a structured written instrument consisting of a fixed, standardized set of questions (items) with defined response formats, administered identically to every respondent so their answers can be compared and analyzed. It is distinct from a survey, which is the broader data-collection methodology (sampling, administration mode, response-rate reporting) built around the questionnaire; a questionnaire's quality is judged on item wording, question-type selection (closed- vs. open-ended, Likert-type vs. dichotomous), and validity and reliability established through pilot testing before the full study fields it.
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Confidence Interval - CASRAI (2026)
A confidence interval is a range of values, calculated from sample data using a defined estimation procedure (point estimate plus a margin of error derived from the sampling distribution of the estimator), constructed at a stated confidence level (commonly 95%). The confidence level describes the long-run reliability of the construction procedure across repeated sampling – the proportion of such intervals that would contain the true, fixed population parameter if the sampling were repeated many times – not the probability that this specific interval contains the parameter. A range lacking a stated confidence level and a defined estimation procedure (e.g. a bare sample min-max) is not a confidence interval.
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Forest plot - CASRAI (2026)
A forest plot is the standard graphical display for a meta-analysis: each included study is shown as a point estimate (a square, sized in proportion to that study's weight in the pooled analysis) with a horizontal line marking its confidence interval, stacked one row per study, with a vertical reference line at the value of no effect. A diamond at the bottom of the plot shows the pooled summary estimate across all studies, with the diamond's width representing the pooled estimate's confidence interval. A forest plot is used to visually assess both the direction/size of each individual study's effect and how consistent (or heterogeneous) those effects are with one another before and after pooling.
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Chi-Square Test (χ²) - CASRAI (2026)
A hypothesis test for categorical data that compares observed category counts to the counts expected under a null hypothesis — either testing whether two categorical variables are independent (chi-square test of independence) or whether one categorical variable's observed distribution matches a specified expected distribution (goodness-of-fit). Distinct from t-tests and ANOVA, which test differences in a continuous outcome's mean rather than differences in categorical counts.
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Expansion Cohort - CASRAI (2026)
An expansion cohort is a group of participants enrolled at a dose already selected during a Phase 1 trial's dose-escalation stage – typically the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) – to further characterize that dose's safety and generate preliminary evidence of clinical activity. A trial design qualifies as using expansion cohorts when it runs dose escalation and one or more fixed-dose expansion cohorts under a single protocol, most commonly in first-in-human oncology trials; multiple expansion cohorts run in parallel (by tumor type or biomarker) at the same dose are described as a multiple expansion cohort (MEC) design.
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Simplified Consent Arrangements for Adults Lacking Capacity (UK Clinical Trials) - CASRAI (2026)
In UK clinical trials of investigational medicinal products (CTIMPs), "simplified consent arrangements for adults lacking capacity" refers to the alternative consent pathway set out in Schedule 1, Part 5 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) that applies when a prospective or enrolled participant cannot give informed consent for themselves. Rather than the participant's own signature, the regulations require consent from a legal representative acting on the adult's behalf: first a personal legal representative (someone not connected with the conduct of the trial who is suitable by virtue of their relationship with the adult, and who is available and willing to act), or, if no personal legal representative is available, a professional legal representative (typically the doctor primarily responsible for the adult's medical treatment, provided they are independent of the trial, or a person nominated by the relevant health service body). A further, narrower simplification applies to genuinely urgent research: where the trial's protocol has been specifically approved by a recognised Research Ethics Committee for enrolment in urgent situations, an incapacitated adult may be entered into the trial without any prior consultation of a legal representative if urgent action is needed to give the investigational medicinal product and it is not reasonably practicable to consult one first — on condition that consent (or continued participation) is then sought from a legal representative, or the adult themselves if capacity is regained, as soon as reasonably possible afterwards. CTIMPs are explicitly excluded from the separate Mental Capacity Act 2005 research provisions (MCA s.30) precisely because this dedicated Schedule 1 regime governs them instead; other (non-CTIMP) research involving adults who lack capacity in England and Wales instead follows the MCA 2005 consultee-based framework. This term covers the CTIMP-specific, legal-representative pathway only.
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MHRA GCP Inspection - CASRAI (2026)
An MHRA GCP inspection is an on-site or remote audit conducted by the UK Medicines and Healthcare products Regulatory Agency's GCP Inspectorate to assess whether a clinical trial sponsor, contract research organisation (CRO), or investigator site is conducting research in compliance with the UK Clinical Trials Regulations and the principles of Good Clinical Practice (GCP) set out in ICH E6. Inspections are the mechanism by which the MHRA verifies that trial data submitted in support of a marketing authorisation can be trusted and that participants' rights, safety, and wellbeing were protected during the conduct of the trial.
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ICH E9 (Statistical Principles for Clinical Trials) - CASRAI (2026)
ICH E9, "Statistical Principles for Clinical Trials," is the International Council for Harmonisation guideline (finalized 1998) that sets out the core statistical methodology expected of a confirmatory clinical trial submitted to a regulatory authority. A trial's design and statistical analysis plan (SAP) are ICH E9-consistent when they are pre-specified before unblinding and address, at minimum: the trial's overall design and hypothesis structure (superiority, non-inferiority, or equivalence, each with its own margin and testing logic); the randomization and blinding scheme; the sample-size/power justification; the choice of analysis populations, most centrally the Full Analysis Set (FAS, an operationalization of the intention-to-treat principle) and the Per-Protocol Set (PPS); the handling of missing data; and the control of Type I error across multiple endpoints, interim looks, or comparisons (multiplicity). ICH E9 was substantially extended, not replaced, by its 2019 addendum ICH E9(R1), which introduced the estimand framework to address a gap the original guideline left largely implicit: how a trial's statistical objective should be translated into a precisely defined treatment-effect question before an analysis method is chosen to answer it.
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FDA Biomarker Qualification Program - CASRAI (2026)
A biomarker is qualified under FDA's Biomarker Qualification Program (BQP) when FDA has completed formal review under Section 507 of the FD&C Act (added by the 21st Century Cures Act, 2016) and determined the biomarker is reliable for a specific, defined context of use (COU) – meaning any sponsor may rely on it for that COU across multiple, unrelated drug development programs without independently re-justifying its validity to FDA each time. This is distinct from a biomarker FDA accepts, or does not object to, only within one sponsor's single IND or trial – that acceptance is program-specific, not portable, and must be independently re-justified for any other use.
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ICH M4 (Common Technical Document / CTD) - CASRAI (2026)
ICH M4 is the International Council for Harmonisation (ICH) multidisciplinary guideline that defines the Common Technical Document (CTD): a standardized, five-module dossier structure for organizing the quality, safety, and efficacy data submitted to regulatory authorities when registering a pharmaceutical for human use. A submission is CTD-compliant when its content is organized into Module 1 (region-specific administrative information), Module 2 (CTD summaries), Module 3 (quality/CMC data), Module 4 (nonclinical study reports), and Module 5 (clinical study reports), with Modules 2-5 following the same harmonized content and ordering regardless of which ICH regulatory authority receives the application. M4 is a family of related documents rather than a single guideline: the overarching M4 organizational guideline is supplemented by M4Q (Quality), M4S (Safety/nonclinical), and M4E (Efficacy/clinical), each specifying the detailed content and ordering for its respective module.
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NIH Inclusion Policies (Women, Minorities, and Across the Lifespan) - CASRAI (2026)
A study satisfies NIH inclusion requirements when its application describes the planned participant population by sex/gender, race/ethnicity, and age range appropriate to the science; provides a compelling rationale for any exclusion of women, a minority group, or an age range rather than defaulting to exclusion; and, for Phase III trials, includes a valid analysis plan for whether effects differ by sex/gender and race/ethnicity. This combines two distinct NIH policies: the statutory Inclusion of Women and Minorities policy (sex/gender and race/ethnicity, in force since the 1993 NIH Revitalization Act) and the Inclusion Across the Lifespan policy (age, including children and older adults, in force since January 25, 2019 under NOT-OD-18-116).
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USDA Research Security Training Requirement - CASRAI (2026)
The USDA Research Security Training Requirement is the U.S. Department of Agriculture's implementation of the government-wide research-security training mandate created by Section 10634 of the CHIPS and Science Act of 2022 (42 U.S.C. Section 19234) and directed by NSPM-33 — the same policy family behind the parallel DOE and NASA requirements. Multiple institutional sponsored-programs offices report that USDA introduced the requirement via Secretary's Memorandum SM 1078-014 (dated July 8, 2025) and folded it into USDA's General Terms and Conditions for financial assistance awards, effective December 31, 2025: named 'covered individuals' on a USDA-funded application or award must complete an approved research-security training course, with completion certified to USDA as part of the award's terms and conditions. CASRAI could not independently confirm this text against a primary usda.gov source at the time of writing (the USDA PDF did not load during verification); treat the SM 1078-014 number and December 31, 2025 effective date as reported-tier pending direct confirmation against USDA's own published memorandum and General Terms and Conditions before relying on them for a compliance deadline.
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45 CFR 46 Subpart C (Additional Protections for Prisoners in Research) - CASRAI (2026)
The section of the Common Rule (45 CFR 46, §§46.301-46.306) that governs HHS-conducted or HHS-funded biomedical or behavioral research involving prisoners as subjects. A protocol falls under Subpart C whenever a subject meets the §46.303 definition of "prisoner" — involuntary confinement or detention in a penal institution, including pretrial detainees and individuals in alternative-to-incarceration facilities. The reviewing IRB must satisfy the §46.304 composition requirements (a non-prison-affiliated majority plus at least one prisoner or prisoner representative), make the additional findings required by §46.305, and may approve the research only if it fits one of the four categories permitted under §46.306.
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NSF AI Policy - CASRAI (2026)
NSF AI policy is not a single rule but a set of related National Science Foundation positions on artificial intelligence that a proposer or awardee needs to track separately: (1) guidance, currently framed as encouraged rather than mandatory, on disclosing generative-AI use in preparing a proposal; (2) an explicit statement that fabrication, falsification, or plagiarism committed with the assistance of AI-based tools counts as NSF research misconduct under the Proposal & Award Policies & Procedures Guide (PAPPG); and (3) NSF's own AI research-infrastructure investments, chiefly the National AI Research Resource (NAIRR) and the NSF AI Institutes program, which are funding/access policy rather than proposal-conduct policy. Treat these as three distinct tracks that happen to share the same agency and the same underlying 2023-2025 policy push, not one unified 'AI rule.'
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FAR Part 31 (Contract Cost Principles and Procedures) - CASRAI (2026)
FAR Part 31 (48 CFR Part 31), 'Contract Cost Principles and Procedures,' is the section of the Federal Acquisition Regulation that governs which costs a contractor – including a university or research institution performing a federally funded CONTRACT rather than a grant – may charge to, or recover from, the U.S. government. A cost is chargeable under FAR Part 31 only if it independently satisfies three tests set out in FAR 31.201-2: it must be reasonable (FAR 31.201-3, the 'prudent person' standard), allocable to the specific contract (FAR 31.201-4), and, where the contractor is subject to Cost Accounting Standards, measured, assigned, and allocated consistently with the applicable CAS. Subpart 31.2 (Contracts with Commercial Organizations) is the subpart most relevant to universities and other non-profit or commercial entities performing federal contract research; FAR 31.205 then works through more than 50 named 'selected cost' categories – compensation, independent R&D and bid-and-proposal costs, entertainment, alcoholic beverages, fines and penalties, lobbying, and more – either allowing them outright, allowing them subject to a stated limitation, or declaring them expressly unallowable regardless of reasonableness or allocability. FAR 31.201-6 additionally requires a contractor's accounting system to identify and separately account for unallowable costs so they are never included in a billing, claim, or proposal to the government.
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Appearance of a Conflict of Interest - CASRAI (2026)
An appearance (or perceived) conflict of interest exists when a reasonable, informed outside observer could conclude that a researcher's, reviewer's, or official's outside relationships or interests might improperly influence their professional judgment – even though, on closer examination, no actual conflict is present (there is no real financial or professional stake in the specific decision, or the relationship in fact has no bearing on it). It is judged from the observer's vantage point, not the individual's own confidence in their objectivity, which is precisely why most institutional, funder, and journal conflict-of-interest policies require an appearance-level situation to be disclosed and managed on essentially the same terms as an actual conflict: unmanaged appearances erode trust in research even when no bias actually occurred.
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USDA Covered Species - CASRAI (2026)
The set of animal species that fall within the Animal Welfare Act's (AWA) statutory definition of "animal" under 9 CFR 1.1, and are therefore subject to USDA APHIS registration, inspection, and recordkeeping requirements. A species is "covered" if it is a live or dead dog, cat, non-human primate, guinea pig, hamster, rabbit, or other warm-blooded animal used or intended for use in research, teaching, testing, experimentation, or exhibition, or as a pet. Critically, the AWA's definition of "animal" explicitly excludes birds, rats of the genus Rattus, and mice of the genus Mus that are bred for use in research, as well as cold-blooded species (fish, amphibians, reptiles) and most farm animals used for food/fiber production research. Because purpose-bred rats, mice, and birds are the large majority of animals used in US biomedical research, most laboratory animals are, by this narrow legal definition, not "covered species" under the AWA – even though the same animals are typically still covered under other frameworks (chiefly PHS Policy) when the research is federally funded.
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Attending Veterinarian (AV) - CASRAI (2026)
The Attending Veterinarian (AV) is the credentialed veterinarian (DVM/VMD) with direct or delegated authority and responsibility for the health and well-being of all research, teaching, and testing animals at an institution. Required under the Animal Welfare Act (9 CFR 2.33) and PHS Policy, the AV is a voting IACUC member and holds documented authority to provide or order veterinary treatment, require appropriate anesthesia/analgesia, and suspend a procedure or study causing unrelieved animal pain or distress.
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Clinical Data Registry - CASRAI (2026)
A clinical data registry is an organized system that collects standardized, defined-variable clinical and outcomes data on patients sharing a common condition, procedure, exposure, or device, on an ongoing rather than fixed-enrollment basis. What makes a data-collection effort a registry, rather than an ordinary clinical database or a clinical trial, is a combination of: (1) a defined denominator population identified by disease, procedure, or exposure, not by eligibility for a specific tested intervention; (2) a standardized, pre-specified data dictionary applied consistently across contributing sites, enabling pooled and benchmarked analysis; and (3) an ongoing or periodically re-opened collection window rather than a protocol-bound enrollment period. Registries are most often sponsored by a medical specialty society, a health system, a public health agency, or a manufacturer under a post-market surveillance obligation, and their stated purposes typically include quality improvement and benchmarking, observational research, public health surveillance, and, in a growing but still bounded set of cases, support for regulatory decision-making.
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45 CFR 46 Subpart A (Basic HHS Policy for Protection of Human Research Subjects) - CASRAI (2026)
The foundational section of the Common Rule (45 CFR 46, §§46.101-46.124) that establishes the general framework HHS-conducted or HHS-funded human-subjects research must satisfy: which activities and institutions it covers (§46.101), the core definitions of "human subject" and "research" (§46.102), the institutional assurance and IRB registration structure (§46.103), the eight categories of exempt research (§46.104), IRB membership and operating requirements (§46.107-46.115), and the general standards for informed consent (§46.116-46.117). Subpart A is the baseline every other subpart (B, C, D) layers additional, population-specific protections on top of — in ordinary usage, "the Common Rule" and "Subpart A" refer to essentially the same body of regulatory text.
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HIPAA and Retrospective Research - CASRAI (2026)
A retrospective study (most commonly a retrospective chart review) uses protected health information (PHI) that was already recorded in the medical record before the research began, rather than PHI generated by a prospective study protocol. Because the individuals were treated in the past and often cannot practicably be found and asked for HIPAA authorization, retrospective research typically proceeds under 45 CFR 164.512(i)(1)(i): an IRB or Privacy Board grants a full or partial waiver of authorization after documenting, per 164.512(i)(2), that (1) the use/disclosure involves no more than minimal privacy risk, based on an adequate plan to protect identifiers, an adequate plan to destroy identifiers at the earliest opportunity absent a health or research justification to retain them, and written assurances against reuse or redisclosure; (2) the research could not practicably be conducted without the waiver; and (3) the research could not practicably be conducted without access to the PHI. A study only qualifies as retrospective-research-under-waiver if it is genuinely using pre-existing records for a defined research protocol – not if it is a 'review preparatory to research' (164.512(i)(1)(ii), used only to help design a study or assess feasibility, with no PHI leaving the covered entity) or decedent-only research (164.512(i)(1)(iii)), which are the Rule's two other, separate no-authorization pathways.
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Data Protection Act 2018, Schedule 2, Paragraph 27 (Research Exemption) - CASRAI (2026)
The provision in Part 6 of Schedule 2 to the UK Data Protection Act 2018 that lets a controller processing personal data for research or statistical purposes disapply specific UK GDPR data-subject rights – the right of access (Article 15(1)-(3)), rectification (Article 16), restriction of processing (Article 18(1)), and objection (Article 21(1)) – to the extent that applying them would prevent or seriously impair achievement of the research or statistical purposes, provided the processing also satisfies the UK GDPR's research-safeguards requirements. The access-right disapplication carries an additional, narrower condition: it applies only where the results of the research or any resulting statistics are not made available in a form that identifies a data subject.
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Retraction Statement - CASRAI (2026)
The formal notice a journal or publisher issues to retract a published article — a standalone document, not the article itself, that identifies the article, states who initiated the retraction and why, and is bidirectionally linked to the retracted paper. A publication counts as a retraction statement only when the journal publishes it under its own editorial authority and explicitly labels it as a retraction, distinct from a correction, erratum, or expression of concern.
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Exception from Informed Consent (EFIC) for Emergency Research - CASRAI (2026)
EFIC (Exception from Informed Consent) is the regulatory pathway under 21 CFR 50.24 that permits FDA-regulated clinical investigations of a drug, biologic, or device to enroll subjects in a life-threatening emergency without prospective informed consent from the subject or a legally authorized representative (LAR). A study qualifies as EFIC only when all of the following are true: (1) subjects are in a life-threatening situation for which available treatments are unproven or unsatisfactory; (2) obtaining informed consent is not feasible because the condition requires intervention before consent from the subject or LAR can reasonably be obtained; (3) participation holds the prospect of direct benefit to the subject; (4) the research could not practicably be carried out without the waiver; and (5) additional protections are in place, most notably community consultation and public disclosure conducted before the study begins, and an independent data monitoring committee. IRB approval of the full protocol, including the community consultation and disclosure plan, is required before enrollment can start under the exception.
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45 CFR 46 Subpart B (Additional Protections for Pregnant Women, Human Fetuses, and Neonates) - CASRAI (2026)
The section of the Common Rule (45 CFR 46, §§46.201-46.207) that governs HHS-conducted or HHS-funded research in which the subjects are pregnant women, human fetuses, or neonates. A protocol falls under Subpart B whenever a subject meets the §46.202 definition of pregnant woman, fetus, or neonate; the IRB must then apply the specific risk/benefit and consent conditions for the applicable subject category (§46.204 pregnant women/fetuses, §46.205 neonates, §46.206 material obtained after delivery) before approving the research, with §46.207 available as a narrow, HHS-Secretary-level pathway for research that does not otherwise qualify.
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OLAW (Office of Laboratory Animal Welfare) - CASRAI (2026)
OLAW is the office within NIH's Office of the Director responsible for implementing and interpreting the PHS Policy on Humane Care and Use of Laboratory Animals: it negotiates and approves each institution's Animal Welfare Assurance, evaluates reports of noncompliance from Assured institutions, and runs a nationwide PHS Policy education program. It governs any live vertebrate animal used in PHS-supported (including NIH-funded) research, testing, or training. OLAW does not replace an institution's own IACUC, and it does not conduct the on-site facility inspections that USDA/APHIS carries out under the Animal Welfare Act – OLAW's authority runs through the PHS funding relationship, not independent statutory inspection power.
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Confidentiality Advisory Group (CAG) / Section 251 - CASRAI (2026)
The Confidentiality Advisory Group (CAG) is an independent advisory body in England and Wales that reviews applications from researchers and other organisations seeking to access or use confidential patient information without patient consent, and advises whether there is sufficient public interest to justify granting that access. CAG does not itself hold decision-making power: for research applications it advises the Health Research Authority (HRA), which makes the final decision; for non-research applications (for example, national disease registries or public health surveillance) it advises the Secretary of State for Health and Social Care, or in some cases NHS England. The legal basis CAG operates under is Section 251 of the NHS Act 2006, which allows the common law duty of confidentiality to be set aside temporarily where anonymised or pseudonymised data cannot meet the research purpose and seeking individual consent is not practicable. Section 251 is given operational effect through the Health Service (Control of Patient Information) Regulations 2002 (the “COPI Regulations”) — specifically Regulation 5 (support for research and other purposes) and Regulation 3 (support for communicable disease surveillance and other public health risks). Approval obtained this way is commonly referred to as “Section 251 support,” “Regulation 5 support,” or a “CAG approval,” and the terms are used largely interchangeably in UK research-governance practice. CAG membership is drawn from a mix of clinicians, academics, and lay members, reflecting the requirement to weigh both the research/public-interest case and the patient-confidentiality interest.
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NASA Research Security Training (GIC 26-02) - CASRAI (2026)
NASA's research security training requirement, established under Grant Information Circular (GIC) 26-02 (issued February 2026), requires every 'covered individual' – a Principal Investigator or Co-PI on a NASA grant or cooperative agreement at any level of effort, or a Co-Investigator committing 10% or more effort annually – to certify completion of qualifying research security training. The requirement takes effect for proposals and annual progress reports due on or after August 5, 2026, and is evidenced through updated NASA Biographical Sketch and Current and Pending (Other) Support forms rather than a separate standalone certificate.
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Equipment (2 CFR 200.1 Definition) - CASRAI (2026)
Under 2 CFR 200.1 (Uniform Guidance), "Equipment" is tangible personal property, including IT systems, with (1) a useful life of more than one year AND (2) a per-unit acquisition cost equal to or exceeding the lesser of the institution's own capitalization level or $10,000 (raised from a $5,000 federal floor in a 2024 Uniform Guidance revision, effective for awards issued on/after October 1, 2024). NIH applies this same government-wide definition to its own awards rather than a separate NIH-specific threshold. Items failing either prong are classified as "Supplies" instead.
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DOE Research Security Training Requirement - CASRAI (2026)
DOE's research security training requirement, announced via Policy Flash PF 2025-04 (Financial Assistance Letter FAL 2025-02) under Section 10634 of the CHIPS and Science Act of 2022 (42 U.S.C. Section 19234) and NSPM-33, requires that 'covered individuals' named on a DOE R&D financial-assistance application complete research security training – addressing cybersecurity, international collaboration/travel, foreign interference, and rules on proper use of funds, disclosure, conflict of commitment, and conflict of interest – within the 12 months prior to submitting that application. The applicant organization certifies completion for all listed covered individuals via Current and Pending Support disclosure certification; DOE does not require use of any specific pre-approved training course.
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PRIM&R (Public Responsibility in Medicine and Research) - CASRAI (2026)
PRIM&R (Public Responsibility in Medicine and Research) is a US-based 501(c)(3) nonprofit membership organization, founded in 1974 and headquartered in Boston, Massachusetts, that supports the ethical conduct of research involving human participants and animals. An organization or individual falls within PRIM&R's operational scope when their work touches research oversight – Institutional Review Boards (IRBs) reviewing human-subjects research, or Institutional Animal Care and Use Committees (IACUCs) overseeing animal research – rather than the conduct of a specific study itself. PRIM&R does not review protocols or approve studies; it trains and credentials the professionals and administrators who staff the committees that do.
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Case Report IRB Exemption - CASRAI (2026)
A case report is generally treated as exempt from IRB (Common Rule) jurisdiction when it describes routine clinical care of one patient (or a small, non-systematically-assembled number), written up retrospectively with no predefined data-collection protocol and no intent to test a hypothesis or produce a generalizable conclusion — i.e., it fails the 45 CFR 46.102(l) definition of 'research' even though the patient meets the 46.102(e) 'human subject' definition. The determination is made by the IRB or a delegated research-compliance office, not by the author; institutional thresholds and required documentation vary, and HIPAA authorization/waiver plus patient consent for publication remain separately required regardless of Common Rule status.
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Ethical Approval - CASRAI (2026)
Ethical approval is the prospective, documented authorization a research ethics body issues before a study involving human participants (or, in a parallel but separate system, live animals) may begin — confirming the protocol's risk-benefit balance, consent process, and participant protections meet the applicable regulatory and ethical standard. It is granted by whichever committee has jurisdiction in a given country, which is why the same underlying requirement is described using different national names.
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Close-Out Visit (COV) - CASRAI (2026)
A Close-Out Visit (COV) is the final monitoring visit a sponsor or its Clinical Research Associate (CRA) conducts at a clinical trial site after the site has finished its participation in a study – either because the site reached its last participant's last visit (LPLV) or because the trial or the site's participation was terminated early. A monitoring visit qualifies as a COV, rather than a routine Interim Monitoring Visit (IMV), only when it is the final visit for that site and confirms four things together: all outstanding data queries are resolved (or an agreed plan exists for any that cannot be), all required essential documents are complete and filed in the Trial Master File (TMF), investigational product (IP) has been reconciled and, per protocol/sponsor instruction, returned or destroyed with documentation, and the investigator/institution has notified (or is arranging to notify) the IRB/REB of study closure at that site.
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Questionable research practices - CASRAI (2026)
A questionable research practice (QRP) is a design, analysis, or reporting choice – such as p-hacking, HARKing, selective outcome reporting, or salami-slicing – made after seeing data or results and then presented as if it had been planned in advance, or otherwise used to manufacture a favourable result, without inventing or altering the underlying data itself. QRPs are distinct from research misconduct (fabrication, falsification, plagiarism – FFP), which does involve inventing or altering data or appropriating others' work; QRPs sit below that legal/regulatory threshold but are still recognised as damaging to research integrity.
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Joint Associations Group (JAG) on Indirect Costs - CASRAI (2026)
The Joint Associations Group (JAG) on Indirect Costs is a coalition of national higher-education and research associations – including AAU, APLU, AAMC, ACE, AASCU, AIRI, COGR, NACUBO, NAICU, and the Science Philanthropy Alliance – formed in 2025 to develop and advocate for a replacement model for how the federal government reimburses universities' facilities and administrative (F&A) costs on federally sponsored research. It is a policy-advocacy coalition, not a standards body or a rate-setting authority: it does not itself negotiate or set any institution's indirect cost rate, and it has no regulatory authority under 2 CFR 200. Its output is a set of recommendations submitted to federal officials and Congress, produced through a subject-matter-experts process that draws on people with direct experience in university finance, grant administration, and F&A cost-rate regulation.
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Ag Guide (Guide for the Care and Use of Agricultural Animals in Research and Teaching) - CASRAI (2026)
An institution follows the Ag Guide (Guide for the Care and Use of Agricultural Animals in Research and Teaching, FASS, 4th edition 2020) when agricultural animals – livestock, poultry, and other food/fiber species – are used in research or teaching whose purpose is agricultural (improving nutrition, breeding, management, production efficiency, or food/fiber quality). The determining factor is the purpose and context of the work, not the species alone: the same species used instead for biomedical purposes (e.g., a pig as a cardiovascular-device model) is typically reviewed under the Guide for the Care and Use of Laboratory Animals rather than the Ag Guide.
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Randomization Methods in Clinical Trials - CASRAI (2026)
A randomization method is the pre-specified, reproducible procedure by which a clinical trial assigns each participant to a treatment or control arm based on chance rather than on the choice of the investigator, the participant, or any deterministic rule (e.g., alternating assignment or day-of-week). A procedure qualifies as randomization only if the allocation sequence is generated by a chance mechanism, is concealed from whoever enrolls participants until after enrollment (allocation concealment), and is documented so the trial's statistical analysis plan can account for it. The choice of method – simple, block, stratified, or covariate-adaptive – determines how tightly the resulting treatment groups are balanced on sample size and on prognostic factors, but all four share the same underlying purpose described by ICH E9, Statistical Principles for Clinical Trials: minimizing selection bias in treatment assignment and providing a sound statistical basis for comparing groups.
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Time and Effort Reporting - CASRAI (2026)
The institutional system for documenting that salary and wages charged to, or cost-shared against, a federal award correspond to the effort an employee actually performed on that award, satisfying the internal-control standard at 2 CFR 200.430(g). It covers the full cycle – budgeting effort at proposal stage, recording/monitoring effort during the award period, and after-the-fact review or confirmation (often called effort certification) that reconciles charged percentages against actual activity – and does not correspond to any single federally mandated form; institutions design their own compliant forms or systems (Plan Confirmation, After-the-Fact Activity Records, Multiple Confirmation Records, or electronic effort-reporting platforms) as long as the underlying system provides reasonable assurance charges are accurate, allowable, and properly allocated based on records reflecting total compensated activity not exceeding 100 percent.
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Decentralized Clinical Trials (DCTs) - CASRAI (2026)
A clinical trial is decentralized to the extent that trial-related activities normally performed at an investigational site — participant visits, specimen collection, investigational product dispensing, or outcome data collection — are instead performed via telehealth, a local lab/imaging facility or visiting health-care provider, direct-to-participant shipment, or a digital health technology, while the same IND/IDE, GCP, informed-consent, and safety-reporting requirements continue to apply. DCTs range on a spectrum from hybrid (some site visits, some remote) to fully decentralized (no in-person site visits).
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Research Ethics Board (REB) - CASRAI (2026)
A Research Ethics Board (REB) is the committee constituted under Canada's TCPS2 (Tri-Council Policy Statement) at institutions eligible for CIHR, NSERC, or SSHRC funding that reviews, approves, requires modification of, or disapproves research involving human participants before that research may begin. It is the Canadian institutional counterpart to a US Institutional Review Board (IRB): the same underlying function of prospective ethics review, carried out under different national policy and terminology.
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Umbrella Trial - CASRAI (2026)
An umbrella trial is a clinical trial design in which multiple investigational therapies are evaluated within a single disease population under one overarching master protocol, with each treatment arm matched to a different biomarker or molecular subtype found within that disease. The disease is held constant across the trial; the drug arm assigned to a given patient varies according to the biomarker their tumor or condition carries. FDA formally recognizes the umbrella trial as one of three related master-protocol designs, alongside the basket trial and the platform trial, in its guidance on master protocols for oncology drug and biologic development.
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Endpoint Adjudication Committee (CEC) - CASRAI (2026)
An Endpoint Adjudication Committee (EAC) — often called a Clinical Events Committee (CEC) — is an independent group of clinical experts, typically blinded to each participant's treatment assignment, that reviews reported clinical events (deaths, hospitalizations, strokes, myocardial infarctions, and other complex or subjective outcomes) against pre-specified, standardized criteria defined in the trial protocol and a dedicated adjudication charter, and issues a formal, documented determination of whether each event meets the definition of a study endpoint. Adjudication exists to remove site-to-site and investigator-to-investigator variability in how an outcome gets diagnosed and classified — a real risk whenever the endpoint depends on clinical judgment rather than a single objective lab value — and it is a distinct function from safety oversight: a CEC classifies individual events against fixed criteria, it does not conduct comparative interim analyses across arms or recommend stopping the trial.
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2 CFR 200 Subpart D (Post-Federal Award Requirements) - CASRAI (2026)
2 CFR 200 Subpart D (§§200.300–200.346) is the set of Uniform Guidance provisions governing how an already-made federal grant or cooperative agreement is administered, from the recipient's financial management system and internal controls through property/procurement standards, performance and financial reporting, subrecipient monitoring, record retention, and closeout. A requirement falls under Subpart D if it governs the administration of an active award; requirements governing the application/award-decision process belong to Subpart C, and the allowability of specific costs is governed by Subpart E.
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AI and Ethics’ Journal Impact Factor (JIF) - CASRAI (2026)
AI and Ethics' Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Springer Nature journal AI and Ethics receives in the Journal Citation Reports (JCR) once it is JCR-indexed and citation-eligible – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. AI and Ethics (ISSN 2730-5953 print, 2730-5961 online) launched in 2021 and publishes on the ethical, regulatory, and policy implications of artificial intelligence, a comparatively young and fast-growing field for a dedicated journal. Third-party tracking sites report differing figures for the journal depending on the metric and window used – for example, exaly.com reports a 2024 figure of roughly 6.1 alongside a separately labeled '2-year impact' figure of roughly 3.68 for the same year, which do not match each other and may not both be Clarivate JCR figures specifically (aggregators sometimes report Scopus/CiteScore-style metrics under an 'impact factor' label). CASRAI could not independently confirm a single authoritative JCR figure against jcr.clarivate.com (subscription-gated) or link.springer.com/journal/43681 (login-walled at the time of writing). Given the journal's 2021 launch, confirm directly with jcr.clarivate.com or the journal's own Springer page whether AI and Ethics is currently JCR-indexed at all, and if so for which data year, before citing any specific number formally.
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FDP Data Transfer and Use Agreement (DTUA) - CASRAI (2026)
A Data Transfer and Use Agreement (DTUA) is the standardized data-sharing contract template published by the Federal Demonstration Partnership (FDP) for moving research data between U.S.-based nonprofit and/or governmental organizations for research or public health purposes. An agreement qualifies as an FDP DTUA when it follows the FDP's modular structure – a Face Page plus a set of standard Attachments – rather than being negotiated from scratch between the transferring institution (discloser) and receiving institution (recipient). The template is maintained by the FDP's Data Stewardship Subcommittee (within the Research Compliance Committee) and exists specifically to cut the time and legal back-and-forth that fully bespoke data-sharing agreements require, by giving both sides' institutional counsel a pre-vetted starting point with known, community-reviewed language.
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Estimand Framework - CASRAI (2026)
The estimand framework, introduced in the ICH E9(R1) addendum to 'Statistical Principles for Clinical Trials' (final version adopted November 2019), is the structured approach a clinical trial protocol uses to state precisely, before the trial is analyzed, what treatment effect the trial is actually designed to estimate. A trial's estimand is defined by specifying five attributes: (1) the target population (the patients the clinical question is about), (2) the treatment conditions being compared, (3) the variable or endpoint measured for each participant, (4) the strategy for handling intercurrent events – post-randomization events, such as treatment discontinuation, use of rescue medication, or death, that affect either the interpretation or the existence of the planned measurement – and (5) the population-level summary used to compare the treatment conditions (for example, a difference in means, an odds ratio, or a hazard ratio). A trial only has a well-defined estimand when all five attributes are specified together and agreed before unblinding; changing how one attribute is handled (most consequentially, the intercurrent-event strategy) changes what the resulting number actually means, even if the same raw data and the same statistical test are used to produce it.
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Assent vs. Consent (in Research) - CASRAI (2026)
Assent is the affirmative agreement of a prospective research subject who lacks the legal capacity to give informed consent on their own behalf – typically a minor – to take part in a research study. Under 45 CFR 46 Subpart D (§46.402(b), §46.408), assent is distinct from, and required in addition to, the informed permission of a parent or legally authorized guardian: a child's willingness to participate does not substitute for parental permission, and parental permission does not substitute for the child's own assent where an Institutional Review Board (IRB) has determined the child is capable of providing it. Critically, assent must be an affirmative 'yes' – the regulation explicitly states that a child's mere failure to object, absent some affirmative agreement, may not be construed as assent. The IRB decides, on a study-by-study or even subject-by-subject basis, whether assent is required, how it should be solicited (verbally, in writing, or via an age-appropriate script), and whether it may be waived under the conditions set out in §46.408(a).
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JAMA Network Open’s Journal Impact Factor (JIF) - CASRAI (2026)
JAMA Network Open's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the journal receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. JAMA Network Open's own journal page (jamanetwork.com) states this figure as 11.7, the highest among large-volume general-medicine open-access journals; CASRAI verified this directly against the publisher's page on 16 August 2026 rather than a third-party tracker or Wikipedia. It reflects the current JCR cycle – the 2025 data year, released by Clarivate in June 2026. It is a separate, independently computed figure from the flagship JAMA journal's own JIF, and the two should never be quoted interchangeably. JAMA Network Open launched in 2018 as an open-access, general-medicine title within the JAMA Network family published by the American Medical Association (AMA); unlike the subscription-model flagship JAMA, it publishes open access across all areas of medicine rather than a curated weekly selection, which shapes how its citation volume accumulates relative to JAMA's.
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International Journal of Molecular Sciences (IJMS) Impact Factor (JIF) - CASRAI (2026)
The Impact Factor (JIF) of the International Journal of Molecular Sciences (IJMS) is the Journal Citation Reports (JCR) metric Clarivate publishes for this MDPI-owned title, calculated as the average number of 2026 citations to articles IJMS published in 2024-2025, divided by the number of citable items it published in those two years. As of the most recent JCR release (June 2026, covering 2025 citation data), third-party trackers that mirror Clarivate's JCR figures report a 2-year Impact Factor of approximately 5.6 and a 5-year Impact Factor of approximately 6.3, placing IJMS in JCR Quartile 1 (Q1) of the Biochemistry & Molecular Biology category. CASRAI did not independently fetch jcr.clarivate.com for this figure (subscription-gated); treat the number as REPORTED-tier, cross-corroborated across multiple independent JCR-tracking sites rather than confirmed directly against Clarivate's own portal, and re-verify before citing it in a high-stakes context such as a promotion or tenure file.
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Molecular Cell’s Journal Impact Factor (JIF) - CASRAI (2026)
Molecular Cell's Journal Impact Factor (JIF) is a specific, illustrative instance of the general Journal Impact Factor metric published annually by Clarivate in the Journal Citation Reports (JCR). Molecular Cell (ISSN 1097-2765) is a Cell Press life-sciences research journal founded in 1997/1998, editorially and commercially distinct from both Cell Press's flagship title Cell and its open-access sister journal Cell Reports — each carries its own, separately computed JIF despite the shared Cell Press imprint.
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Journal of Biological Chemistry’s Journal Impact Factor (JIF) - CASRAI (2026)
The Journal of Biological Chemistry's (JBC) Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio JBC receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. JBC (ISSN 0021-9258, e-ISSN 1083-351X) is published by the American Society for Biochemistry and Molecular Biology (ASBMB) and has been in continuous publication since 1905, making it one of the longest-running biochemistry journals still active; it converted to a fully open-access model in 2021. Third-party JCR-tracking aggregators report JBC's 2-year JIF at roughly 4.1 for the 2025 JCR data year (released June 2026), up from roughly 3.76 for the 2024 data year, with a reported 5-year JIF near 4.3 and a JCR Quartile 2 placement in biochemistry and molecular biology. These aggregator figures do not always agree with one another, and ASBMB's own jbc.org site was not independently reachable to confirm one authoritative figure at the time of writing. Treat any single number you see cited as time-stamped to a specific JCR release – Clarivate updates JCR every June – and check jcr.clarivate.com or jbc.org directly for the current, release-dated figure before citing it in a formal context such as a CV, grant application, or tenure file. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
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Nucleic Acids Research’s Journal Impact Factor (JIF) - CASRAI (2026)
Nucleic Acids Research's Journal Impact Factor (JIF) is the annual citation metric Clarivate publishes for the journal in the Journal Citation Reports (JCR): citations in a given JCR year to Nucleic Acids Research articles published in the preceding two years (or five, for the 5-year version), divided by the number of citable items the journal published in that window. Nucleic Acids Research (NAR) is an open-access, biweekly molecular biology and biochemistry journal published by Oxford University Press since 1974 (ISSN 0305-1048 print, 1362-4962 online). Per Oxford University Press's own journal page (academic.oup.com/nar), verified 16 August 2026, NAR's 2025 Impact Factor is 15.0 (2-year) and its 2025 Five-Year Impact Factor is 17.6.
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JCI Insight’s Journal Impact Factor (JIF) - CASRAI (2026)
JCI Insight's Journal Impact Factor (JIF) is the annual Clarivate-calculated citation ratio published in the Journal Citation Reports (JCR) for JCI Insight specifically. JCI Insight is a separate journal from the Journal of Clinical Investigation (JCI): it is the gold open-access companion title the American Society for Clinical Investigation (ASCI) launched in 2016 (ISSN 2379-3708), separately indexed in the JCR with its own figure, whereas "JCI" on its own means ASCI's flagship Journal of Clinical Investigation (ISSN 0021-9738 print / 1558-8238 online), which CASRAI covers on a separate page. JCI Insight's own journal-information page (insight.jci.org/kiosks/about) states an Impact Factor of 6.8 for the 2025 JCR data year, verified 7 August 2026; Clarivate updates the JCR every June, so treat that number as current only as of that release and confirm it before citing it in a CV, tenure file, or funder report. No figure on the JCI Insight page applies to the Journal of Clinical Investigation, or vice versa.
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New England Journal of Medicine’s Journal Impact Factor (JIF) - CASRAI (2026)
The New England Journal of Medicine's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Massachusetts Medical Society's flagship clinical-medicine journal receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. NEJM (ISSN 0028-4793 print, 1533-4406 online) has published continuously since 1812, making it one of the oldest continuously published medical journals in the world, and is indexed in Clarivate's Science Citation Index Expanded, which makes it JIF-eligible. Third-party JCR-tracking aggregators report NEJM's 2-year JIF in the high-70s to mid-80s range for recent releases – figures cited include roughly 78.5 and roughly 84.5 for figures described as the '2025 impact factor,' attributed inconsistently to the 2025 versus 2026 JCR release across different aggregator pages – with a reported 5-year JIF near 84.9. These aggregator figures do not agree with one another even when describing what appears to be the same release, and NEJM's own journal-information page was not independently reachable to confirm one authoritative figure at the time of writing (returned an access-restricted response during verification). Treat any single number you see cited as time-stamped to a specific JCR release – Clarivate updates JCR every June – and check jcr.clarivate.com or nejm.org directly for the current, release-dated figure before citing it in a formal context such as a CV, grant application, or tenure file. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article NEJM has published, nor of the researchers who authored it.
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Interim Monitoring Visit (IMV) - CASRAI (2026)
An Interim Monitoring Visit (IMV) – also called a routine monitoring visit or periodic site monitoring visit – is a monitoring contact, on-site or remote, that a sponsor or its designated Clinical Research Associate (CRA) conducts at intervals throughout the active conduct phase of a clinical trial, after a site has been initiated and is enrolling or following participants, and before the site closes out. Its purpose, per ICH E6(R2) Section 5.18.3, is to verify that the rights and well-being of trial participants are protected, that reported trial data are accurate, complete, and verifiable from source documents, and that the trial is being conducted in compliance with the currently approved protocol/amendments, Good Clinical Practice (GCP), and applicable regulatory requirements. A contact only qualifies as an IMV if it occurs during this ongoing conduct period and covers the recurring monitoring activities – source data verification, investigational product (IP) accountability, regulatory-document currency, and safety-reporting checks – described below; a visit conducted before a site has enrolled its first participant, or after the site has permanently stopped activity, falls under a different visit type instead.
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NEJM AI - CASRAI (2026)
NEJM AI is a peer-reviewed monthly journal published by NEJM Group (a division of the Massachusetts Medical Society, the same publisher as the flagship New England Journal of Medicine) that publishes original research, reviews, perspectives, and policy analysis on the application of artificial intelligence and machine learning to medicine and health care. It launched in December 2023, with its inaugural issue in January 2024. NEJM AI is editorially and operationally distinct from NEJM itself: it has its own submission portal (ai.nejm.org), its own editorial board and peer-review process, and a narrower topical scope than the flagship journal's general internal medicine remit. A manuscript is within NEJM AI's scope if its central contribution is an AI/ML method, dataset, or system applied to a biomedical or clinical problem, or an analysis of AI's technical, regulatory, ethical, or health-system implications — not simply a clinical study that happens to use software.
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Cell Reports Medicine’s Journal Impact Factor (JIF) - CASRAI (2026)
Cell Reports Medicine’s Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio this journal receives each year in the Journal Citation Reports (JCR) — citations in the JCR data year to the journal’s citable items from the two preceding years, divided by that item count. Cell Reports Medicine is a Cell Press open-access journal, launched in 2020, publishing translational and clinical biomedical research — distinct from its broader-scope sister title Cell Reports, which covers life sciences generally and carries its own separate JIF. Multiple third-party JCR-tracking aggregators converge on a figure of approximately 14.0 for the 2025 JCR data year (Clarivate’s June 2026 release), placing the journal in JCR Quartile 1, but CASRAI was not able to independently confirm this against jcr.clarivate.com (subscription-gated) or reach Cell Press’s own metrics page directly at the time of writing, so treat this as a cross-corroborated but secondary-source figure rather than a primary-verified one. Clarivate updates JCR every June; check jcr.clarivate.com or cell.com/cell-reports-medicine for the current, release-dated figure before citing a number in a formal context. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
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ACS Nano’s Journal Impact Factor (JIF) - CASRAI (2026)
ACS Nano's Journal Impact Factor (JIF) is the annual two-year citation metric Clarivate publishes for the journal in the Journal Citation Reports (JCR): citations in a given JCR year to ACS Nano articles published in the preceding two years, divided by the number of citable items ACS Nano published in those two years. ACS Nano is a nanoscience and nanotechnology journal published by the American Chemical Society since 2007 (ISSN 1936-0851 print, 1936-086X online); its reported JIF has sat in the mid-to-high-teens range across recent JCR releases (approximately 16.0 for the 2024 data year per secondary trackers, up from a reported 15.8 for 2023).
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Registrational Trial - CASRAI (2026)
A registrational trial (also called a pivotal trial) is a clinical study designed and executed specifically to generate the primary efficacy and safety evidence submitted in a marketing application — a New Drug Application (NDA), Biologics License Application (BLA), or comparable submission — to a regulatory authority such as FDA. What makes a trial ‘registrational’ is not its phase number but its regulatory purpose: it is prospectively designed as an adequate and well-controlled investigation under 21 CFR 314.126, with a prespecified primary endpoint and statistical analysis plan agreed with the regulator (often via a Special Protocol Assessment), and powered to provide the ‘substantial evidence of effectiveness’ the Federal Food, Drug, and Cosmetic Act requires for approval. Most registrational trials are Phase 3 studies, but a well-controlled Phase 2 trial can serve the same function in accelerated-approval or rare-disease programs where a full Phase 3 program is used to confirm benefit post-approval.
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Site Qualification Visit (SQV) - CASRAI (2026)
A Site Qualification Visit (SQV) is the pre-selection assessment visit a sponsor or CRO conducts at a prospective investigative site, before that site is contracted or selected for a specific clinical trial, to evaluate whether it should be chosen. A visit counts as an SQV when its purpose is evaluative and its timing is pre-selection: it examines the site's facilities and equipment, staff qualifications and prior trial experience, patient population and recruitment feasibility, and quality systems/SOPs, in order to inform a go/no-go selection decision. A visit is NOT an SQV if it occurs after the site has already been selected, contracted, and IRB-approved and is instead confirming the site is ready to begin enrollment – that is a Site Initiation Visit (SIV) – or if it occurs during active enrollment to review ongoing conduct, which is a routine monitoring visit.
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Confounding Variable - CASRAI (2026)
A confounding variable (confounder) is a third factor that is associated with both the independent variable (or exposure) and the dependent variable (or outcome) under study, and is not simply a step on the causal path between them. Because it moves with the presumed cause and also influences the presumed effect, an unaccounted-for confounder can produce, inflate, mask, or reverse an apparent association – meaning a manuscript's reported effect is partly or wholly attributable to the confounder rather than the variable of interest. A factor only qualifies as a confounder for a given design if it meets all three conditions: it is associated with the independent variable, it independently affects the dependent variable, and it is not a mediator (a variable that lies on the causal pathway between the two, which requires different handling in analysis and reporting).
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Effect Size - CASRAI (2026)
Effect size is a standardized, quantitative measure of the magnitude of a difference, relationship, or association observed in a study, reported independently of sample size and distinct from statistical significance. Where a p-value indicates only whether an observed effect is unlikely to be due to chance, an effect size (e.g., Cohen's d, Pearson's r, an odds ratio) indicates how large or practically meaningful that effect actually is. The APA Publication Manual (7th edition, Section 6.5) requires reporting an effect size and confidence interval for each primary outcome, and most major journals across the behavioral, social, and biomedical sciences hold manuscripts to an equivalent expectation.
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Cancer Research’s Journal Impact Factor (JIF) - CASRAI (2026)
Cancer Research's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the AACR journal Cancer Research receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. The last independently corroborated figure is 22.6 for the 2024 JCR data year (2025 release); Clarivate's current release cycle covers the 2025 JCR data year (released June 2026), but CASRAI could not reach the publisher's own journal page (aacrjournals.org/cancerres) to confirm that newer figure as of 16 August 2026. Verify the current figure at the journal's own metrics page or jcr.clarivate.com before citing it formally. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
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Nature Medicine’s Journal Impact Factor (JIF) - CASRAI (2026)
Nature Medicine's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Nature Medicine journal receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to Nature Medicine's citable items from the two preceding years, divided by that item count. Per Nature Portfolio's own journal-impact page (nature.com/nm/journal-impact), Nature Medicine's 2-year Impact Factor is 52.5 and its 5-year Impact Factor is also 52.5, both for the 2025 JCR data year (JCR release published June 2026); last verified directly against that page August 16, 2026. Nature Medicine is a distinct, separately scored journal from Nature, Nature Communications, and the other 60-plus Nature Portfolio titles published by Springer Nature – a JIF reported for a sister journal is never Nature Medicine's own figure. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in Nature Medicine or the merit of its authors.
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ANOVA (Analysis of Variance) - CASRAI (2026)
Analysis of Variance (ANOVA) is an inferential statistical test used to compare the means of a continuous outcome across three or more groups, or across the combined levels of two or more categorical factors, by partitioning total observed variance into a between-group component and a within-group (error) component. The ratio of those two components produces an F-statistic: a study is using ANOVA, rather than a t-test, whenever it is testing for a difference among three or more group means (or a factorial combination of grouping variables) using that between/within variance ratio, rather than comparing exactly two means directly.
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Unallowable Cost (2 CFR 200) - CASRAI (2026)
An unallowable cost under 2 CFR 200 is any expense that federal cost-principle rules bar an institution from charging to a federal award, whether as a direct charge or through the indirect (F&A) cost rate. A cost becomes unallowable in one of two ways under Subpart E. First, it can fail the general allowability test at 2 CFR 200.403 – it is not necessary and reasonable for the award, not allocable to it, treated inconsistently with how the institution handles like costs, non-compliant with GAAP or the award's own terms, double-counted toward a cost-sharing commitment, or inadequately documented. Second, and distinctly, it can fall into one of the specifically-named categories in the 'selected items of cost' catalog at 200.421-200.475, which addresses named cost types one by one – alcoholic beverages, entertainment, lobbying, fines and penalties, bad debts, contributions and donations, fundraising, and dozens more – regardless of whether the institution would otherwise treat the cost as reasonable or allocable. This second route is what distinguishes 'unallowable' from a cost that merely fails allocability or reasonableness on its own facts: a cost can be perfectly reasonable and allocable to a specific project and still be unallowable outright because Subpart E names that category of cost as barred. Per 200.420, the named-category list is illustrative, not exhaustive – an unlisted cost item is not automatically allowable; it still has to clear the general 200.403 test and is evaluated by analogy to similar listed items. Unallowable costs must be identified and excluded from any proposal, invoice, or financial report submitted to the federal government, and from the base used to calculate the institution's indirect cost rate – charging one to a federal award, intentionally or through inadequate internal controls, is one of the most commonly cited findings in a Single Audit under 2 CFR 200 Subpart F.
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ALCOA+ (Clinical Trial Data Integrity Principles) - CASRAI (2026)
ALCOA+ is the nine-attribute framework regulators use to judge whether a clinical-trial data record is trustworthy enough to support a marketing application or inspection finding. A record satisfies ALCOA+ when it is Attributable (traceable to the specific person or system that created it, with no shared logins or unattributed edits), Legible (readable and permanent for the life of the record, including any correction), Contemporaneous (recorded at the time the activity occurred, not reconstructed later from memory), Original (the first recording of the data, or a verified true copy carrying equivalent authority), and Accurate (free of error, and reflecting what actually happened) – the original five FDA ALCOA attributes – plus Complete (nothing selectively omitted, including repeat or rejected results), Consistent (chronologically dated, time-stamped, and internally coherent), Enduring (surviving on durable media for the full required retention period), and Available (retrievable for review, audit, or inspection throughout that period). A record that fails any one of the nine is a data-integrity finding, regardless of whether the underlying clinical result itself is otherwise plausible.
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Bayesian Adaptive Design - CASRAI (2026)
A Bayesian adaptive design is a clinical trial design in which the statistical framework starts from a prior probability distribution over treatment effects and formally updates that distribution into a posterior distribution as outcome data accumulate during the trial, using Bayes' theorem rather than waiting for a single fixed-sample-size final analysis. What makes a design specifically Bayesian-adaptive, rather than merely adaptive, is that the pre-specified adaptation rules (whether to modify randomization allocation, stop a trial arm early for efficacy or futility, or re-estimate sample size) are driven by these continuously updated posterior probabilities rather than by frequentist p-value or alpha-spending boundaries alone. The most common operational form is Bayesian response-adaptive randomization: the probability that a newly enrolled participant is assigned to a given arm shifts over the course of the trial toward arms whose posterior probability of superiority is higher, based on outcomes observed so far in the shared, concurrently randomized control comparison. This distinguishes a Bayesian adaptive design from a conventional frequentist fixed-sample design, in which the randomization ratio and total sample size are fixed at the outset by a power calculation and the treatment-effect hypothesis is tested once, at a single pre-planned analysis (or at a small number of pre-specified interim looks using a fixed alpha-spending function), with no allocation-ratio changes based on relative arm performance mid-trial.
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Pre-Screening - CASRAI (2026)
Pre-screening is the informal, preliminary process of assessing whether a prospective clinical trial participant is likely to meet inclusion/exclusion criteria, conducted before the protocol-defined formal screening visit and generally before the participant signs the informed consent form (ICF). It typically takes the form of a brief phone or in-person eligibility interview using an IRB-approved script, or a review of existing medical records/EHR data conducted under a HIPAA waiver of authorization or the reviews-preparatory-to-research provision (45 CFR 164.512(i)). A candidate excluded at this stage never enters the trial's formal screening and enrollment log and is not counted toward the trial's screen failure rate.
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HREC (Human Research Ethics Committee) - CASRAI (2026)
The Australian term for the committee that reviews and approves research involving human participants before it may lawfully or ethically proceed. An HREC is constituted and registered under the National Health and Medical Research Council (NHMRC)'s National Statement on Ethical Conduct in Human Research, and its review is the Australian institutional counterpart to an IRB (Institutional Review Board) in the United States or an REC (Research Ethics Committee) in the UK/EU. A study is subject to HREC review whenever it involves human participants, their identifiable data, or their tissue and is designed to produce generalisable knowledge; the depth of that review is graded by risk rather than uniform for every protocol.
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Experimental Design - CASRAI (2026)
A study’s design counts as experimental when the researcher manipulates the independent variable, assigns participants or units to at least one comparison/control condition (ideally via randomization), and builds in mechanisms — randomization, blinding, standardized protocol — to control extraneous and confounding variables, so that any resulting difference in the dependent variable can be attributed to the manipulation rather than to a pre-existing group difference.
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SRA International (SRAI) - CASRAI (2026)
SRA International (formally the Society of Research Administrators International, founded 24 June 1967) is a professional membership association of roughly 5,000 research administrators across about 40 countries. It is not a regulator or exam-based credentialing body: its main output is a catalog of 11 completion-based certificate programs (e.g. Pre-Award, Financial Management, Clinical Trials Research Administration) earned through conference workshops and electives, distinct from RACC's proctored CRA/CPRA/CFRA credentials and from NCURA, the comparable US-focused membership association.
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Science Translational Medicine’s Journal Impact Factor (JIF) - CASRAI (2026)
Science Translational Medicine's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the AAAS journal receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Science Translational Medicine (ISSN 1946-6234 print, 1946-6242 online), launched October 2009, is a distinct, separately-indexed AAAS title from Science and Science Advances. The current JCR cycle is the 2025 data year, released June 2026; CASRAI attempted to verify the journal's figure for that cycle directly at science.org/journal/stm this session (last verified 2026-08-16) and the request was blocked by the publisher's Cloudflare bot protection (a 'Cookie Absent' error page was returned), so no current figure is stated as fact. The last figure CASRAI can attribute to a specific, dated cycle is approximately 14.6 for the 2024 data year (June 2025 release), per third-party JCR-tracking sources, with at least one independent aggregator instead reporting a close but distinct figure near 13.6 for the same data year – an unresolved cross-tracker discrepancy. Per DORA and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in Science Translational Medicine or the merit of its authors.
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Communications Biology’s Journal Impact Factor (JIF) - CASRAI (2026)
Communications Biology's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the Springer Nature journal receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Communications Biology (ISSN 2399-3642) is a Nature Portfolio, fully open-access, broad-scope biology journal launched in 2018, and it is a distinct title from Nature Communications despite the similar name – each carries its own separately computed JIF, and the two should never be cited interchangeably. Third-party JCR-tracking aggregators report Communications Biology's 2-year JIF at approximately 5.1 for the 2024 JCR data year (2025 release) and approximately 5.8 for the 2025 JCR data year (2026 release, issued June 2026), placing the journal in JCR Quartile 1 within its category. CASRAI could not independently confirm either figure directly against Nature Portfolio's own journal-impact page (nature.com/commsbio/journal-impact), which sits behind an account-gated redirect, or against jcr.clarivate.com directly, at the time this entry was written – treat both numbers as reported, not CASRAI-verified, and check the journal's own metrics page or jcr.clarivate.com for the current, release-dated figure before citing one in a formal context such as a CV, grant application, or tenure file. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
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Descriptive Statistics vs. Inferential Statistics - CASRAI (2026)
In a research manuscript, descriptive statistics summarize the data actually collected – means, medians, standard deviations, frequencies, and proportions that describe the sample in hand – while inferential statistics use that sample data to draw a conclusion about a larger population, quantifying uncertainty through tools such as p-values, confidence intervals, and hypothesis tests. The distinction is not about which formulas are used but about the claim being made: a descriptive statistic describes only the data collected, while an inferential statistic makes a probabilistic claim that extends beyond it. Manuscripts that report a difference between groups (e.g., a higher mean score in one arm) without an accompanying inferential test are making a descriptive observation, not a generalizable finding – reviewers routinely flag this conflation in Results sections.
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Screen Failure - CASRAI (2026)
A participant who provides informed consent and enters the protocol-defined screening process for a clinical trial, but is not subsequently randomized or assigned to study intervention because they fail to meet one or more inclusion/exclusion criteria, withdraw consent before randomization, or otherwise become ineligible prior to enrollment. The defining boundary is randomization/assignment to study intervention: everything before that point that ends without assignment is a screen failure; anything after it is a post-randomization withdrawal or discontinuation, not a screen failure.
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Journal of Clinical Investigation’s Journal Impact Factor (JIF) - CASRAI (2026)
The Journal of Clinical Investigation (JCI)'s Journal Impact Factor (JIF) is that specific journal's own annual Clarivate metric – citations in a given year to the articles and reviews it published in the two preceding years, divided by the number of those citable items – published in the Journal Citation Reports (JCR). It is a single journal's instance of the general JIF metric, not a separate calculation method, and it changes with every annual JCR release (Clarivate updates JCR every June). "JCI" on its own refers to this journal, The Journal of Clinical Investigation (ISSN 0021-9738 print / 1558-8238 online). It is a separate journal from JCI Insight, ASCI's gold open-access companion title launched in 2016 (ISSN 2379-3708), which is separately indexed in the JCR and carries its own, different figure – see CASRAI's JCI Insight entry, and never substitute one journal's number for the other's. Per the journal's own information page (jci.org/kiosks/about), verified 7 August 2026, JCI's Impact Factor is 14.3 for the 2025 JCR data year.
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Cell’s Journal Impact Factor (JIF) - CASRAI (2026)
Cell's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the flagship Cell Press journal Cell receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count; a separate 5-year JIF uses a five-year window instead. Cell (ISSN 0092-8674) is Cell Press's founding, subscription/hybrid flagship life-sciences journal, published continuously since 1974, and it is distinct from Cell Reports, Cell Press's open-access sister journal launched in 2012 – each carries its own separately computed JIF. Third-party JCR-tracking aggregators report Cell's 2-year JIF at roughly 42.5 for the 2024 JCR data year and roughly 45.1 for the 2025 JCR data year, with a separately reported 5-year JIF near 48.9 (not a more-current version of the 2-year figure, but a different window). CASRAI attempted to confirm these directly against Cell Press's own metrics page (cell.com/metrics) on 16 August 2026 and could not (access blocked), so treat all figures as aggregator-reported, not primary-verified – check jcr.clarivate.com or cell.com/metrics for the current, authoritative figure before citing it formally. Per DORA and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
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Umbrella Review - CASRAI (2026)
An umbrella review (overview of reviews) systematically identifies, appraises, and synthesizes previously published systematic reviews and/or meta-analyses on a broader topic, using those reviews rather than primary studies as its unit of analysis. Included reviews are typically appraised with AMSTAR-2, checked for overlap of underlying primary studies (e.g. via the Corrected Covered Area metric), and the umbrella review itself is reported per PRISMA 2020 or the purpose-built PRIOR statement.
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PLOS ONE Impact Factor (2026 Update) - CASRAI (2026)
PLOS ONE's Journal Impact Factor (JIF) would, if PLOS promoted one, be the Clarivate-computed, journal-level citation ratio published annually in the Journal Citation Reports (JCR). PLOS's own journal-information page states directly that it does not consider Impact Factor 'a reliable or useful metric to assess the performance of individual articles' and will only provide the figure to individuals on request – CASRAI verified this policy language directly against journals.plos.org/plosone/s/journal-information on 16 August 2026. PLOS instead promotes article-level metrics, CiteScore, SJR, and the h-index. Because PLOS ONE remains a JCR-indexed title, Clarivate does compute a JIF for it (current cycle: 2025 data year, released June 2026), but that figure sits behind institutional JCR access and was not independently checked by CASRAI; it should not be sourced from a third-party JCR-tracking aggregator or Wikipedia. PLOS ONE is also a megajournal that peer-reviews for scientific and methodological soundness rather than perceived novelty or impact, which reinforces why a single journal-level citation figure – where one exists – is an unusually poor stand-in for the quality of any individual PLOS ONE article.
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SCImago Journal Rank (SJR) - CASRAI (2026)
SCImago Journal Rank (SJR) is a free, publicly available journal-prestige indicator produced by the SCImago Research Group (a joint initiative of the Consejo Superior de Investigaciones Cientificas and the University of Granada, Spain) and published via scimagojr.com, using citation data licensed from Elsevier's Scopus database. A journal's SJR score is not a simple citation count or average – it is computed with an iterative, PageRank-style algorithm that redistributes 'prestige' across the citation network so that a citation from a higher-prestige journal counts for more than a citation from a lower-prestige one. The calculation uses a 3-year citation window (citations received in year Y to documents published in years Y-1, Y-2, and Y-3), and caps journal self-citation at a maximum of 33% of a journal's total outgoing references so a journal cannot inflate its own score by citing itself. SCImago also publishes each journal's placement into quartiles (Q1-Q4) within its Scopus subject category, which is what most researchers use day to day to gauge a journal's relative standing among its direct peers.
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Equivalence Trial - CASRAI (2026)
An equivalence trial is a clinical trial designed to show that a new intervention's effect is neither meaningfully better nor meaningfully worse than an active comparator – the treatment difference must fall within a pre-specified equivalence margin in both directions. It is one of three ways a comparative trial's primary hypothesis can be framed at the protocol design stage: a superiority trial sets out to show one arm is better than another (or than placebo); a non-inferiority trial sets out to show a new arm is not unacceptably worse than an active comparator, using only a single lower margin; an equivalence trial requires the treatment difference's confidence interval to fall entirely within a symmetric two-sided margin, written (-delta, +delta), that was fixed before the trial started as the largest difference still considered clinically unimportant. Which of the three applies is a design decision documented in the protocol and statistical analysis plan – it is not something inferred after the fact from a trial's results.
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Cell Reports’ Journal Impact Factor (JIF) - CASRAI (2026)
Cell Reports' Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio Cell Reports receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Cell Reports is a Cell Press (Elsevier) open-access, broad-scope life-sciences journal, and its JIF has placed it in JCR Quartile 1 for Cell Biology in recent releases; third-party JCR-tracking services report figures in roughly the high-6-to-8 range across the last several JCR releases, but they do not agree on an exact current figure, and Cell Press's own site was not independently reachable to confirm one at the time of writing. Treat any single number you see cited as time-stamped to a specific JCR release – Clarivate updates JCR every June – and check jcr.clarivate.com or the journal's own metrics page at cell.com/cell-reports for the current, authoritative figure before citing it in a formal context. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
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Study Data Tabulation Model (SDTM) - CASRAI (2026)
The Study Data Tabulation Model (SDTM) is a CDISC foundational standard that defines a standard structure for organizing clinical trial data into a set of named, model-conformant domain datasets (e.g. DM, AE, VS) for submission to regulatory authorities such as the FDA and Japan's PMDA. A dataset counts as SDTM-conformant when its observations are classified into one of SDTM's general observation classes (Interventions, Events, Findings, or Findings About), each variable maps to a controlled SDTM domain/variable name, and the dataset is accompanied by a define.xml metadata file describing its structure. SDTM governs the submission-ready tabulation format, not how data is collected at the site (that is CDASH) and not the software used to capture it (that is EDC).
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Cross-Sectional Study - CASRAI (2026)
A cross-sectional study is an observational research design in which exposure and outcome (or any set of variables) are measured on a defined sample at a single point in time, rather than by following participants forward or reconstructing their history backward. Participants are selected on inclusion/exclusion criteria for the population of interest, not on their exposure or outcome status – that selection rule is what separates a cross-sectional design from a cohort study (selected on exposure, followed forward) or a case-control study (selected on outcome, examined retrospectively). Because everything is captured in a single snapshot, a cross-sectional design can describe prevalence and association but cannot, on its own, establish temporal sequence or causation.
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Serious Adverse Event (SAE) - CASRAI (2026)
An adverse event (AE) that meets at least one of six regulatory seriousness criteria defined by ICH E2A, regardless of causality or perceived clinical severity: it results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another medically important event that the investigator judges may jeopardize the subject or require intervention to prevent one of the other outcomes. Seriousness is a fixed regulatory classification, distinct from clinical severity (mild/moderate/severe) and distinct from causality.
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Centralized Monitoring - CASRAI (2026)
Centralized monitoring is a clinical-trial oversight technique in which qualified personnel – typically data managers, biostatisticians, or medical monitors – remotely and systematically review accumulating trial data across all participating sites (via EDC, laboratory feeds, and other data streams), rather than verifying individual records in person at each site. It is a data-level, aggregate, cross-site review aimed at identifying which sites or subjects actually need targeted follow-up, as opposed to applying uniform monitoring effort everywhere regardless of risk. Centralized monitoring is one specific technique within the broader Risk-Based Monitoring (RBM) strategy – a component of RBM, not synonymous with it.
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Survey Research Methods - CASRAI (2026)
A data-collection methodology in which a standardized instrument (structured questionnaire or interview protocol) is administered consistently to respondents drawn from a defined sampling frame, to measure self-reported attitudes, behaviors, beliefs, or characteristics in quantifiable, comparable form. Distinguished from qualitative interview methods by its fixed, uniform instrument and from experimental designs by the absence of manipulated independent variables; evaluated on sampling procedure, response rate, and the instrument's reliability and validity.
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Platform Trial - CASRAI (2026)
A platform trial is a clinical trial conducted under a single master protocol that evaluates multiple interventions against a shared control arm, for a single disease or condition, on a perpetual or long-running basis — arms can be added or dropped over time as interventions are found effective, futile, or superseded, without stopping the trial and writing a new protocol from scratch. The FDA's 2018/2022 master-protocol guidance groups platform trials alongside two related but distinct designs sharing the same master-protocol infrastructure: basket trials (one intervention tested across multiple diseases or molecular subtypes) and umbrella trials (multiple interventions tested for one disease, but with a fixed, pre-specified set of arms rather than an open-ended one). What makes a design a platform trial specifically, rather than a generic multi-arm study, is the combination of (1) a single overarching master protocol and statistical analysis plan governing all arms, (2) a shared, concurrently randomized control group that multiple experimental arms are compared against, and (3) a pre-specified adaptive mechanism — typically Bayesian response-adaptive randomization or interim futility/efficacy stopping rules — for adding, dropping, or reallocating arms as data accumulate.
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iThenticate - CASRAI (2026)
iThenticate is a text-matching (similarity-checking) service, owned and operated by Turnitin, that is marketed to publishers, journal editorial offices, funding agencies, and research institutions rather than to classroom instructors. A document qualifies as having been "run through iThenticate" when it has been submitted to the service's own web interface or via an API/editorial-management integration, compared against iThenticate's reference corpus (current and archived web content, previously submitted documents, and licensed academic publications, journals, and periodicals), and returned as a similarity report with a percentage-based similarity index and a source-by-source match breakdown. iThenticate is the same underlying detection engine Turnitin uses for its education product, packaged and licensed separately for non-classroom, professional research contexts: manuscript submission, grant proposal screening, and pre-publication or pre-submission self-checks. Crossref Similarity Check is a related but distinct service that Crossref operates on top of the iThenticate engine for its member publishers; a document checked through Crossref Similarity Check is, technically, still being matched by iThenticate's underlying engine, just accessed through Crossref's integration rather than a direct iThenticate license.
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Science Advances Impact Factor (2026 Update) - CASRAI (2026)
Science Advances' Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio Science Advances receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. CASRAI verified a current figure directly against AAAS's own Journal metrics page (science.org/content/page/journal-metrics): 13.9 (2-year) and 14.8 (5-year) for the 2025 JCR data year, Clarivate's June 2026 release, Quartile 1 in Multidisciplinary Sciences – cross-corroborated by Wikipedia's infobox and by library-services vendor Wolters Kluwer/Ovid's journal listing, which attributes the same figure directly to the Journal Citation Report/Web of Science. Science Advances is a peer-reviewed, multidisciplinary, fully open-access journal published by AAAS, indexed in Clarivate's Science Citation Index Expanded since its 2015 launch.
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Active Voice vs. Passive Voice - CASRAI (2026)
In scientific and academic writing, active voice makes the sentence's grammatical subject the agent performing the action ('We measured the samples'), while passive voice makes the subject the recipient of the action, with the agent optional or omitted ('The samples were measured'). Neither is a grammar error — the choice is stylistic and governed by disciplinary convention. Current guidance (APA Style; the author instructions of most high-impact journals, including Nature- and Science-family titles) treats active voice as the default for clarity throughout most of a manuscript, while passive voice remains the traditional — and often still preferred — register in Methods sections, where the procedure is the focus rather than who performed it.
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Electronic Clinical Outcome Assessment (eCOA) - CASRAI (2026)
The technology/platform category (provisioned device, BYOD app, IVR/IWR, or site-based terminal) used to capture Clinical Outcome Assessment (COA) data — PRO, ClinRO, ObsRO, or PerfO — electronically at the point of assessment, in place of a paper case-report form, typically requiring mode-of-administration equivalence to the original paper instrument and 21 CFR Part 11-consistent audit trails/access controls before the resulting data is relied on for a trial endpoint.
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Nature’s Journal Impact Factor (JIF) - CASRAI (2026)
Nature's Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio the flagship Nature journal receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to Nature's citable items from the two preceding years, divided by that item count. Multiple independent JCR-tracking aggregators report Nature's 2-year Impact Factor at approximately 56.1 for the most recent JCR release (2025 citation data, released June 2026), up from approximately 48.5 the prior release; nature.com's own journal-information page could not be directly confirmed for this draft (login-gated), so treat the figure as reported rather than independently verified, and check jcr.clarivate.com or nature.com for the current number before citing it formally. Nature is a distinct, separately scored journal from Nature Communications, Scientific Reports, and the other 60-plus Nature Portfolio titles published by Springer Nature – a JIF reported for a sister journal is never Nature's own figure. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in Nature or the merit of its authors.
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Late-Phase Clinical Study - CASRAI (2026)
A late-phase clinical study is a Phase IIIb or Phase IV clinical investigation of a drug or biologic conducted at, or just after, regulatory marketing submission or approval, rather than during the pre-approval IND-governed Phase 1-3 sequence defined at 21 CFR 312.21. Late-phase studies do not primarily generate the initial efficacy/safety data needed for approval; instead they expand the evidence base after (or just before) approval, supporting label expansion, fulfilling FDA-mandated Postmarketing Requirements (PMRs) or voluntary Postmarketing Commitments (PMCs), and generating real-world evidence (RWE) and pharmacovigilance data on an approved product's safety and effectiveness in broader, real-world populations.
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Sub-Investigator - CASRAI (2026)
A sub-investigator is a member of a clinical trial site team who is designated and supervised by the principal investigator (PI) to perform critical trial-related procedures and/or make important trial-related decisions, without themselves holding overall responsibility for the trial's conduct at that site. Under FDA regulations, the PI signs the FDA Form 1572 (Statement of Investigator) and lists sub-investigators by name as persons assisting in the investigation (21 CFR 312.53(c)); sub-investigators do not sign the 1572 themselves. What specific duties a given sub-investigator is authorized to perform is documented separately, on the site's Delegation of Authority (DoA) log, which the PI is responsible for maintaining under ICH E6(R2) Section 4.1.5. Common sub-investigator duties include obtaining informed consent, conducting protocol-specified assessments, and making eligibility or safety-related clinical judgments – but the PI retains ultimate accountability for the trial's conduct at the site under 21 CFR 312.60, regardless of which duties are delegated.
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3Rs (Replacement, Reduction, Refinement) - CASRAI (2026)
The 3Rs – Replacement, Reduction, and Refinement – are the founding ethical framework for the humane use of animals in research. A protocol satisfies the 3Rs when it documents, for the specific study: (1) Replacement – whether a non-animal or less-sentient alternative (in vitro, in silico, or lower-order organism) could answer the scientific question instead; (2) Reduction – that the number of animals proposed is the minimum needed for a statistically and scientifically valid result, no more; and (3) Refinement – that procedures, housing, and endpoints are designed to minimize pain, distress, and suffering for the animals that are still used. The 3Rs are not a single compliance checkbox but a standing analytic lens applied at every protocol-review stage by the Institutional Animal Care and Use Committee (IACUC).
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Scientific Reports’ Journal Impact Factor (JIF) - CASRAI (2026)
Scientific Reports' Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio Scientific Reports receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Nature Portfolio's own journal page (nature.com/srep) states a 2-year impact factor of 4.9 for the 2025 JCR data year (2025 Journal Citation Reports, Clarivate Analytics, released 2026), confirmed directly by CASRAI on 16 August 2026 – up from approximately 3.9 for the prior (2024 data year) release. Scientific Reports is a large, open-access, multidisciplinary Nature Portfolio journal that accepts submissions on technical soundness rather than perceived novelty, so per DORA and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in it.
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APA Authorship Guidelines - CASRAI (2026)
APA authorship guidelines are the authorship-determination rules set out in Standard 8.12 ("Publication Credit") of the American Psychological Association's Ethical Principles of Psychologists and Code of Conduct. They govern two separate questions: who qualifies as an author at all (Standard 8.12a: only someone who has actually performed the work or substantially contributed to it — formulating the problem or hypothesis, structuring the experimental design, conducting the statistical analysis, or interpreting the results), and how author order and credit should be assigned once the author list is settled (Standard 8.12b: order must accurately reflect each person's relative scientific or professional contribution, never institutional rank or seniority alone). A separate provision, Standard 8.12c, addresses student work specifically: except in exceptional circumstances, a student is listed as principal (first) author on any multi-authored article substantially based on that student's doctoral dissertation. The guidelines apply within the ethical code psychologists are bound by professionally — they are not a citation-formatting rule, and are distinct from the APA Publication Manual's separate reference-list and in-text citation conventions.
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Operational Definition - CASRAI (2026)
A statement that specifies the exact, observable procedure used to measure or manipulate an abstract construct or variable within a specific study, so that another investigator could apply the same procedure to the same phenomenon and obtain comparable data. An operational definition is distinct from a conceptual (or constitutive) definition, which states what a construct means in theory without specifying how it will be observed; a definition only counts as operational if it names the instrument, coding rule, threshold, or manipulation used, not just the general idea being studied.
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Defining the Population (Study Population) - CASRAI (2026)
Defining the population is the step in a research design, before sampling begins, where the researcher states precisely who or what the study's findings are meant to describe or generalize to. It has two working layers that a methods section should distinguish explicitly: the target population (the full group the researcher ultimately wants to draw conclusions about, e.g. "adults with type 2 diabetes") and the accessible or study population (the subset of that target population the researcher can actually reach and sample from, e.g. "adults with type 2 diabetes attending three primary-care clinics in one region between 2024 and 2026"). A population definition is complete only when it specifies inclusion criteria (the characteristics a unit must have to qualify), exclusion criteria (characteristics that disqualify an otherwise-eligible unit), and the relevant time and place boundaries. Defining the population is a distinct step from drawing the sample: the population is the group being described; the sample is the subset actually measured or observed. See Independent vs. Dependent Variable and Operationalizing Variables for the companion steps of specifying a design's other core elements before data collection begins.
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OECD AI Principles - CASRAI (2026)
The OECD AI Principles are the first intergovernmental standard on artificial intelligence, adopted by OECD member and partner governments in May 2019 and updated in May 2024 to address general-purpose and generative AI. They consist of five values-based principles for trustworthy AI (inclusive growth/sustainable development/well-being; human rights, democratic values and fairness including privacy; transparency and explainability; robustness, security and safety; and accountability) plus five recommendations for policymakers (invest in AI research and development; foster an inclusive AI-enabling ecosystem; shape an enabling, interoperable governance and policy environment; build human capacity and prepare for labour-market transition; and pursue international co-operation for trustworthy AI). As of the 2024 update, 47 countries and jurisdictions adhere to the Principles, including all OECD members, the European Union, and several non-member states. A research institution or research-performing organization can treat the Principles as an operational baseline for AI governance when: (1) it can point to a documented AI risk-management or oversight process addressing all five values-based principles (not just one, e.g. privacy) as applied to a specific AI use case in the research lifecycle; (2) that process is proportionate to the AI system's stage and context of use rather than a single one-time sign-off; and (3) it is paired with actual transparency to affected parties (participants, authors, reviewers) about where and how AI was used. Simply having an internal 'AI policy' document does not, on its own, satisfy the Principles — the OECD frames them as principles for actors across the AI system lifecycle, not a checklist to file away.
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Nature Communications’ Journal Impact Factor (JIF) - CASRAI (2026)
Nature Communications' Journal Impact Factor (JIF) is the Clarivate-computed, journal-level citation ratio Nature Communications receives each year in the Journal Citation Reports (JCR) – citations in the JCR data year to the journal's citable items from the two preceding years, divided by that item count. Per Nature Portfolio's own journal-impact page (nature.com/ncomms/journal-impact), Nature Communications' directly-sourced 2-year Impact Factor is 18.1 (5-year: 18.9) for the 2025 JCR data year (JCR release published June 2026); last verified directly against that page August 16, 2026. Clarivate updates this figure every June, so treat the number as time-stamped to a specific release, not a fixed property of the journal. Per DORA (San Francisco Declaration on Research Assessment) and CoARA guidance, this journal-level figure should not be used as a proxy for the quality of any individual article published in the journal or the merit of its authors.
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Esploro (Ex Libris) - CASRAI (2026)
Esploro is a commercial current research information management (RIM/CRIS) platform sold by Ex Libris (a Clarivate company). Institutions use it to aggregate and showcase research assets – publications, datasets, and other outputs – captured from sources such as ORCID, Scopus, Web of Science, PubMed, and Crossref, alongside researcher profiles, and to expose that data through public-facing research portals, funder/compliance reporting, and open-access workflows. It can be deployed standalone or alongside Ex Libris's Alma library services platform, though the vendor markets it as usable independently of Alma.
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PLOS ONE Author Contributions Statement - CASRAI (2026)
A PLOS ONE author contributions statement is the mandatory, structured disclosure every PLOS ONE submission must include, attributing specific tasks in the reported work to each named author individually. It is required at online submission, is separate from PLOS's authorship-eligibility criteria (adapted from McNutt et al. 2018 rather than the ICMJE four-point test) and from the acknowledgments section (which credits non-author helpers, not listed authors), and is published alongside the final article. Since PLOS's 2016 taxonomy switch, the statement is built from the 14-role CRediT (Contributor Roles Taxonomy, now ANSI/NISO Z39.104-2022) vocabulary. Before that, from PLOS ONE's 2006 launch through 2016, the same requirement existed but used PLOS's own five-category list: Conceived and designed the experiments; Performed the experiments; Analyzed the data; Contributed reagents/materials/analysis tools; Wrote the paper.
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Section 889 (Covered Telecommunications Equipment Ban) - CASRAI (2026)
A federal restriction, originating in Section 889 of the FY2019 NDAA and implemented for grant recipients at 2 CFR 200.216 (effective August 13, 2020), that prohibits an institution from using federal award funds to procure, obtain, extend, or renew a contract for telecommunications or video surveillance equipment or services produced by Huawei, ZTE, Hytera, Hikvision, or Dahua (or their subsidiaries/affiliates, or other PRC-government-connected entities so designated), when that equipment or service is a substantial or essential component of a system or constitutes critical technology. It attaches to the federal funding stream used for a specific procurement, not to an institution's equipment inventory generally.
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ACM Policy on Authorship - CASRAI (2026)
The ACM Policy on Authorship is the Association for Computing Machinery's publisher-wide rule set, applied across its journals, transactions, magazines, and 70+ conference proceedings, defining who may be listed as an author on an ACM-published work, prohibiting generative AI tools from being listed as authors, and requiring authors to disclose any use of generative AI tools and technologies in producing the work — with a narrow exemption for basic word-processing aids such as spelling and grammar checkers.
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Good Clinical Data Management Practices (GCDMP) - CASRAI (2026)
A clinical data management (CDM) process, procedure, or document is following Good Clinical Data Management Practices (GCDMP) when it is explicitly built against a specific chapter of SCDM's published GCDMP document – covering an area such as CRF/eCRF design, database design and validation, discrepancy management, medical coding, database lock, or data transfer/archival – and can be shown to meet that chapter's Minimum Standards tier (the baseline for defensible CDM) or its Best Practices tier (a higher-maturity level beyond the minimum). GCDMP is a practice/process standard, not software: an EDC or CDMS platform is the technology a GCDMP-conformant process typically runs through, not GCDMP itself.
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Source Data Verification (SDV) - CASRAI (2026)
Source data verification (SDV) is the clinical-trial monitoring activity of comparing data entered on a case report form (CRF or eCRF) against the source document it was transcribed from – a clinic note, hospital chart, lab report, imaging read, ECG tracing, or participant diary – to confirm that the CRF entry is accurate, complete, and consistent with the original record. SDV checks a specific, already-transcribed value against its origin; it is a monitoring/quality-control activity, not a data-entry platform. Neither ICH E6 nor FDA guidance has ever required verifying 100% of CRF fields against source; since the early 2010s, regulatory guidance has explicitly encouraged sponsors to target SDV, as part of a broader risk-based monitoring (RBM) strategy, toward the data most critical to participant safety and primary trial endpoints rather than exhaustively verifying every field by default.
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Congressionally Directed Funding (Earmarks) - CASRAI (2026)
A federal research award is Congressionally Directed Funding (commonly called an earmark, or 'Community Project Funding' / 'Congressionally Directed Spending' in current House and Senate terminology) when Congress specifies, in appropriations bill or accompanying report language, a particular recipient, project, or narrow topic area for a defined amount of budget authority — bypassing the awarding agency's normal competitive, peer-reviewed, or formula-driven selection process. It is distinguished from ordinary agency-administered research funding by the source of the selection decision: for a competitive award, the agency (via merit/peer review) decides who receives funds within a congressionally set appropriation total; for congressionally directed funding, Congress itself (or an individual member, subject to certification and disclosure rules) decides the recipient or topic before the agency ever runs a review. Once such funds reach a university or research institution, two federal anti-lobbying statutes constrain how the recipient can use any federal award dollars in connection with seeking or renewing that funding: 18 U.S.C. § 1913 and 31 U.S.C. § 1352 (the Byrd Anti-Lobbying Amendment), operationalized for grant cost allowability at 2 CFR § 200.450.
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Thesis - CASRAI (2026)
A formal, original-research document that a student submits, and typically defends before a faculty committee, to satisfy the research requirement of an academic degree. Whether "thesis" denotes master's-level or doctoral-level work depends on country: in the US/Canada it usually means the master's-level document (the doctoral one is a dissertation); in the UK/Commonwealth the convention typically reverses.
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Decentralized Clinical Trial (DCT) Platform - CASRAI (2026)
A decentralized clinical trial (DCT) platform is the software and connected-service layer that lets some or all trial activities happen away from a traditional investigative site, in line with FDA's trial-conduct model for decentralized elements. In practice a DCT platform is not one thing but an integration of several components under a single participant- and site-facing interface: telehealth/video-visit tooling for remote investigator encounters, eConsent for remote informed consent, home health or mobile-nursing coordination for in-home visits and specimen collection, connections to local or community labs and pharmacies as alternate data-collection or dispensing sites, direct-to-patient (DtP) investigational product (IMP) shipment and chain-of-custody tracking, and eCOA/ePRO or connected devices for participant-reported and sensor-derived data — usually feeding a central EDC and safety database in real time. A trial "uses a DCT platform" when a vendor's connected toolset, rather than a single point solution, is the operational backbone for how remote or hybrid visits are scheduled, conducted, documented, and reconciled against the protocol. The defining administrative complication is that decentralizing activities does not decentralize accountability: the sponsor and the trial's IRB(s) of record remain responsible for GCP compliance, and each local nurse, telehealth clinician, lab, or pharmacy performing a delegated trial activity must be added to the delegation-of-authority log, must practice within a jurisdiction where they are licensed, and must be covered by the same monitoring and oversight expectations as staff at a traditional site.
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ARC Research Management System (RMS) - CASRAI (2026)
The Research Management System (RMS) is the Australian Research Council's web-based platform for administering the full lifecycle of applications to its National Competitive Grants Program (NCGP): preparing and submitting applications, assigning and recording assessor evaluations, handling applicant rejoinders, announcing outcomes, and managing the resulting grant agreement, including post-award activity such as variations, annual/end-of-year reporting, and final reports. It is accessed at rms.arc.gov.au by registered users, and Administering Organisations (AOs) – the Australian universities and other eligible institutions through which ARC grants are held – are generally required to submit NCGP applications through RMS unless the ARC advises otherwise for a specific scheme.
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Independent vs. Dependent Variable - CASRAI (2026)
In a study's methods section, the independent variable is the factor treated as the presumed cause — manipulated in an experiment or selected as the predictor in an observational design — and the dependent variable is the outcome measured to detect whether it changes with the independent variable. The roles are relative to a specific design: manipulation supports causal language, measurement-only designs support only associative language, and a manuscript should state explicitly which applies.
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NSF Broadening Participation - CASRAI (2026)
NSF Broadening Participation is the National Science Foundation's coordinated set of programs, funding requirements, and strategic goals aimed at increasing the involvement of individuals, institutions, and geographic regions historically underrepresented in STEM research and education. NSF defines the target groups as individuals – women, underrepresented racial and ethnic minorities, and persons with disabilities – plus institutions (women's colleges, minority-serving institutions, institutions primarily serving persons with disabilities) and geographic areas (rural, urban, and EPSCoR jurisdictions) that participate in NSF programs at rates lower than their overall representation in the relevant population. Something is a genuine Broadening Participation activity – rather than just any diversity-adjacent outreach – when it is a specific, funded NSF program, plan requirement, or reporting element built around this defined set of target groups, not a generic institutional DEI initiative NSF happens to be aware of.
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CRC-P Grants (Cooperative Research Centres Projects) - CASRAI (2026)
A funding arrangement qualifies as a CRC-P (Cooperative Research Centres Projects) Grant when it is an Australian Government matched-funding grant, administered under the Cooperative Research Centres Program by the Department of Industry, Science and Resources, awarded to a short-term (up to three years), industry-led research collaboration whose lead applicant is a small to medium enterprise (SME) partnered with at least one additional Australian industry organisation and at least one Australian research organisation, to develop a product, service, or process that solves an identified industry problem. It is distinguished from the flagship, multi-year Cooperative Research Centres (CRC) grants by its shorter duration, smaller and more flexible partner structure, and its explicit industry-led (rather than research-organisation-led) governance.
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NRSA (National Research Service Award) - CASRAI (2026)
An award is an NRSA (National Research Service Award, formally the Ruth L. Kirschstein NRSA) if it is made under the statutory authority created by Title I of the National Research Act of 1974 (Public Law 93-348) to support predoctoral or postdoctoral research training rather than to fund a specific research project directly. NRSA support is stipend-based (a training allowance to the trainee/fellow, set annually by NIH notice) rather than a PI salary drawn against direct research costs, and it comes in two structural forms: institutional awards (the 'T' series – T32, T90, TL1, and related mechanisms – where an institution or program holds the grant, is the grant's PD/PI of record, and nominates individual trainees into funded training slots) and individual fellowships (the 'F' series – F30, F31, F32, and related mechanisms – where the trainee or fellow themselves is the named PD/PI, applying with a specific faculty sponsor and research training plan). A postdoctoral NRSA recipient (T- or F-series) also incurs a service payback obligation for the first 12 months of postdoctoral NRSA support, discharged through subsequent NRSA-supported training, health-related research, health-related teaching, or a combination, averaging at least 20 hours per week; predoctoral NRSA recipients incur no payback obligation.
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IDE Application (Investigational Device Exemption Application) - CASRAI (2026)
An IDE application is the formal submission a sponsor files with FDA's Center for Devices and Radiological Health under 21 CFR 812.20 to request an Investigational Device Exemption – FDA authorization to ship and use an unapproved medical device in a clinical study before it has been cleared or approved for commercial distribution. A full IDE application, and FDA's affirmative or default clearance to proceed, is required only for significant risk (SR) device investigations; nonsignificant risk (NSR) studies proceed on abbreviated requirements reviewed by the IRB, without a separate FDA-submitted application.
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Bibliography - CASRAI (2026)
A bibliography is a systematic list of the sources an author consulted or judged relevant while researching a work, presented in a standardized citation format and arranged for reader verification. It is distinct from a reference list or works-cited list, which (under APA and MLA convention) includes only sources actually cited in the text; a bibliography, particularly under the Chicago notes-bibliography system, can additionally include background sources the author consulted but never directly cited. This broader scope is why the bibliography sense persists in literature reviews, monographs, annotated-bibliography assignments, and grant or manuscript submissions that ask authors to document the literature surveyed, not just the literature quoted.
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R34 (NIH Planning Grant) - CASRAI (2026)
An R34 is an NIH grant activity code for a Planning Grant: a time-limited, relatively small award used to fund the preparatory work needed before a larger study can be competitively proposed, rather than to fund the study itself. Typical R34-supported activities include finalizing a clinical trial design and protocol, developing a manual of procedures, drafting informed consent forms and case report forms, establishing multi-site or community partnerships, piloting recruitment feasibility, and producing milestone and timeline plans. There is no single standing parent funding opportunity announcement (FOA) for the R34 across all of NIH; instead, individual NIH Institutes and Centers (ICs) issue their own R34 Notices of Funding Opportunity (NOFOs) – as Program Announcements (PAs/PARs) or Requests for Applications (RFAs) – each with its own scope, eligibility, and review criteria, so whether an R34 is currently open, and for what, depends entirely on which IC's NOFO an applicant is applying under.
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