Operationalizing Variables - CASRAI (2026)
Operationalization is the process of translating an abstract theoretical construct that cannot be observed or measured directly (for example, “job satisfaction” or “research productivity”) into a concrete, specific operational definition: a stated procedure or instrument, a defined unit or range of values, and a rule precise enough that a researcher who did not design the study could apply it to new data and get a comparable result. A variable is operationalized only when all three hold together — naming the construct, or describing it in general terms, is not the same as operationalizing it.
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NRSA Stipend Levels - CASRAI (2026)
NRSA stipend levels are the fixed, NIH-mandated annual stipend amounts published (roughly annually, via a Notice in the NIH Guide) for individuals supported on a Ruth L. Kirschstein National Research Service Award – whether held as an individual fellowship (F30/F31/F32) or an institutional training grant slot (T32/T90/TL1). What determines the applicable level: career stage (predoctoral vs. postdoctoral) and, for postdoctoral trainees/fellows only, full years of relevant prior postdoctoral research experience at the time the award is issued. Predoctoral levels are a single flat rate regardless of year in the doctoral program; postdoctoral levels step up across eight tiers (Level 0 through Level 7+) by experience year. The published level is a floor the federal award must provide, not a ceiling institutions are barred from supplementing under NIH's own rules.
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OMB Compliance Supplement - CASRAI (2026)
The OMB Compliance Supplement is the annual publication, issued by the US Office of Management and Budget and codified as 2 CFR Part 200, Appendix XI, that gives independent auditors the compliance requirements and suggested audit procedures to test, program by program, when conducting a Single Audit of a non-federal entity under 2 CFR 200 Subpart F.
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Australian Code for the Responsible Conduct of Research - CASRAI (2026)
Australia's foundational research-integrity governance document (the "2018 Code"), jointly issued by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), and Universities Australia in June 2018, replacing the more prescriptive, rules-based 2007 Code. It is a principles-based document setting out eight principles of responsible research conduct (honesty, rigour, transparency, fairness, respect, recognition of the rights of Indigenous peoples to be engaged in research that affects or is of significance to them, accountability, and promotion of responsible research practices) plus 29 specific responsibilities — 13 for institutions (R1–R13) and 16 for researchers (R14–R29). Unlike the National Statement on Ethical Conduct in Human Research, which governs the ethical review of studies involving human participants specifically, the Code covers research-integrity conduct broadly across all disciplines: authorship, data management and retention, supervision, publication and dissemination, peer review, conflicts of interest, and how institutions must manage and investigate potential breaches.
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ARC Future Fellowship - CASRAI (2026)
An ARC Future Fellowship is a competitively awarded, individually held four-year fellowship from the Australian Research Council’s Discovery Program that funds an outstanding mid-career researcher’s salary plus a flexible, non-project-specific pool of research support (reported at up to A$60,000/year), held through an eligible Australian Administering Organisation. Eligibility is set by a PhD-award-date window (adjusted for allowable career interruptions) that shifts with each funding round, not by job title, and the scheme excludes any research meeting the ARC/NHMRC definition of medical research.
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ABRF (Association of Biomolecular Resource Facilities) - CASRAI (2026)
ABRF (Association of Biomolecular Resource Facilities) is the U.S.-based, membership professional association for people who operate, direct, staff, or support shared research core facilities and other biotechnology resource laboratories – it is not a facility, funder, or accrediting body itself. Organized in 1988 and formally incorporated in Delaware in 1989, growing out of a 1986 gathering of protein-sequencing core operators, ABRF today counts more than 4,000 members representing 400+ member laboratories and administrative offices across government, academic, industrial, and commercial settings. Membership and participation in ABRF's Research Groups, annual meeting, and journal is what distinguishes 'the ABRF community' from the broader population of core-facility staff generally – someone who runs a core facility without ever engaging with ABRF is still a core-facility professional, just not part of this specific association.
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Trademark - CASRAI (2026)
A word, phrase, symbol, design, or combination of these that identifies and distinguishes the source of goods or services in commerce (a mark used with goods is a trademark; the identical protection used with services is a service mark). Trademark rights arise automatically from actual use of the mark in commerce, under the Lanham Act (15 U.S.C. § 1051 et seq.); federal registration with the USPTO is not required to have enforceable rights but converts geographically-limited common-law rights into a nationwide, publicly recorded claim. Unlike a patent (protects an invention), a copyright (protects a creative work), or a trade secret (protects confidential information via secrecy), a trademark protects only the identifier itself, and lasts indefinitely as long as the mark stays in active use and any registration is maintained.
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Cover Letter for Journal Submission - CASRAI (2026)
A short letter addressed to a journal's editor that accompanies a manuscript submission, as a separate document from the manuscript itself, in which the corresponding author states the manuscript's novelty and significance in their own words, confirms it is not simultaneously under consideration elsewhere, discloses relevant conflicts of interest (or confirms none exist), confirms all authors have approved the submission, and — where the specific journal's instructions permit — suggests or excludes potential peer reviewers.
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Software License Agreement - CASRAI (2026)
A software license agreement, in a university technology-transfer context, is the contract a TTO uses to grant an outside company or party rights to use, modify, and/or distribute software the university itself developed — the university acting as licensor of its own copyright (and occasionally an associated patent), not as a licensee of someone else's commercial software. Because software is protected primarily by copyright rather than patent (computer programs are "literary works" under 17 U.S.C. § 101, added by the Computer Software Copyright Act of 1980), the agreement's exclusivity controls the specific codebase and its expression, not the underlying idea or method (17 U.S.C. § 102(b)) — a materially different scope of exclusivity than a patent license conveys. Typical negotiated terms include exclusive vs. non-exclusive scope, field-of-use and territory restrictions, royalty/fee structure (upfront fees, running royalties, minimums, or equity), source code delivery/escrow, maintenance and support obligations, ownership of derivative works, sublicensing and audit rights, termination, and — for federally funded software — flow-down of the government's 2 CFR § 200.315 use rights.
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Electronic Data Capture (EDC) - CASRAI (2026)
Electronic Data Capture (EDC) is the general category of software systems that collect clinical or research study data directly in electronic form – via electronic case report forms (eCRFs) – at the point of collection, in place of paper-based data collection. A system counts as EDC when it provides study-specific eCRFs, direct point-of-collection data entry, field-level validation and query management, and an audit trail sufficient to make the electronic record the study's data of record. EDC is the site-facing data-entry layer within the broader discipline of clinical data management; a full Clinical Data Management System (CDMS) is the broader term covering EDC plus surrounding query-management, coding, and database-lock workflow. EDC is distinct from a Clinical Trial Management System (CTMS), which manages trial operations rather than the research data itself. Both non-profit/academic platforms (e.g., REDCap) and commercial, enterprise-scale platforms (e.g., Medidata Rave EDC, Oracle Clinical One) fall within the EDC category.
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Clinical Trials Unit (CTU) - CASRAI (2026)
A unit is a Clinical Trials Unit (CTU) when it is a centralized institutional infrastructure – organizationally part of the same academic medical center, hospital, or university as the investigators it serves, not a separately contracted external entity – that provides shared, reusable operational services (regulatory support, data management, monitoring, biostatistics, and/or budgeting) to more than one investigator or study across the institution, so no individual Principal Investigator has to build that infrastructure from scratch for a single trial. Investigators engage a CTU internally, through a service agreement, cost-recovery charge, or institutional mandate for certain trial types – not through a Clinical Trial Agreement the way an external sponsor engages a Contract Research Organization (CRO).
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NIH Study Section - CASRAI (2026)
An NIH study section (formally a Scientific Review Group, SRG) is a peer-review panel — chartered/standing or a temporary Special Emphasis Panel (SEP) — convened by NIH’s Center for Scientific Review (or, for RFAs and some program-specific competitions, by the awarding Institute/Center) to evaluate the scientific and technical merit of grant applications assigned to it, producing a priority score and summary statement as the first of NIH’s two required levels of peer review.
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NIH Standard Due Dates - CASRAI (2026)
NIH Standard Due Dates are the recurring, government-published submission deadlines NIH sets for applications to its standing funding opportunities (Parent Announcements, PARs, and PAS) — three annual receipt dates per calendar year, occurring on the same months for every cycle, with the exact day varying by activity code (R01; R03/R21/R33/R34/R36/U34/UH2/UH3; K series; F series; T/D series; R15/AREA) and by application type (new vs. renewal, resubmission, or revision, which are typically offset one month later). They are set by NIH policy notice and apply automatically to every standing announcement that references them, in contrast to an RFA's own single, non-recurring receipt date, which each RFA sets independently.
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Fly America Act - CASRAI (2026)
The requirement, under 49 U.S.C. § 40118 and its implementing Federal Travel Regulation (41 CFR part 301-10, subpart B), that air transportation paid for with U.S. government funds – including federal grants and cooperative agreements – be provided by a U.S. flag air carrier, unless a specific, narrowly defined exception applies (an Open Skies bilateral/multilateral agreement, documented necessity, or a defined travel-time/connection threshold).
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Electronic Theses and Dissertations (ETD) - CASRAI (2026)
A thesis or dissertation prepared, submitted, and archived in digital form (typically a PDF plus any supplementary files) rather than only as a bound print copy, submitted to satisfy a degree requirement. A work qualifies as an ETD once digital deposit — most often to an institutional repository, and often onward to a national or international aggregator such as NDLTD — is the accepted or required submission format, even if the institution also retains a print copy alongside it.
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Biosafety Level 3 (BSL-3) - CASRAI (2026)
The CDC/NIH BMBL laboratory-containment tier assigned to a protocol when the biological agent(s) involved can cause serious or potentially lethal disease through inhalation of infectious aerosols, but for which a licensed vaccine or effective treatment is routinely available. An instance of BSL-3 combines controlled/restricted access, sustained directional inward airflow through a double-door entry, HEPA-filtered exhaust, biosafety-cabinet use for all open agent manipulation, and respiratory protection where indicated, with the level itself formally assigned through an Institutional Biosafety Committee (IBC) risk assessment before laboratory work begins.
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Software Patent - CASRAI (2026)
A software patent is a utility patent under 35 U.S.C. § 101 whose claims are directed to a computer-implemented invention — an algorithm, data-processing method, or system whose novelty lies substantially in what a computer program does. There is no separate statutory category for software; instead, software claims are tested against the same judicially created "abstract idea" exception to § 101 that applies to every utility patent, using the two-step framework the Supreme Court set out in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), and applied directly to computer-implemented claims in Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014): (1) is the claim, as a whole, "directed to" an abstract idea, and if so, (2) do the claim elements, individually or in combination, supply an "inventive concept" that amounts to "significantly more" than the abstract idea itself? Generic computer hardware performing a well-known process does not supply that inventive concept. Because software claims reach Step One's abstract-idea inquiry far more often than claims in most other technology areas, and because Step Two sets a genuinely demanding bar, software patents are markedly harder to obtain and to defend against post-grant invalidity challenges than most other utility patents.
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Academic Journal - CASRAI (2026)
A publication counts as an academic (scholarly) journal when it is issued on a continuing basis under a stable title and ISSN, publishes original research or scholarship vetted through a documented peer-review or formal editorial-review process, is overseen by a named editorial board of subject-matter experts, states an explicit aims-and-scope, and is cited within and indexed by the scholarly literature — as distinct from a magazine (general audience, no peer review), a trade publication (practitioner audience, editorial but not scholarly peer review), or a blog/preprint server (no editorial board, no peer review).
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Social Sciences Citation Index (SSCI) - CASRAI (2026)
A journal is considered SSCI-indexed when Clarivate's independent, in-house editorial reviewers have evaluated and accepted it into the Social Sciences Citation Index — the social-sciences-scoped citation index within the Web of Science Core Collection — based on Clarivate's quality criteria (peer review, editorial rigor, timeliness, ethical publishing standards) and its own separate impact/citation-influence assessment. SSCI inclusion is evaluated independently of the Science Citation Index Expanded (SCIE) and the Arts & Humanities Citation Index (AHCI): a journal is not automatically SSCI-indexed just because it appears in one of those companion indexes, and indexing is not permanent — a journal can later be suspended or delisted if it stops meeting Clarivate's criteria.
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PRISMA Flow Diagram - CASRAI (2026)
The standardized figure PRISMA 2020 uses to report the flow of records through a systematic review or meta-analysis, organized under three labeled phases (Identification, Screening, Included), with a numeric box for every stage of attrition and a stated reason for every full-text exclusion.
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OHRP (Office for Human Research Protections) - CASRAI (2026)
OHRP is the HHS office that oversees institutional compliance with the Common Rule (45 CFR 46) for HHS-conducted or HHS-supported human-subjects research. It administers the Federalwide Assurance (FWA) program institutions file to commit to Common Rule compliance, registers the IRBs designated under those assurances, and conducts compliance oversight – not-for-cause evaluations and for-cause investigations – of institutions and IRBs, issuing determination letters and, where warranted, corrective-action or FWA-restriction remedies. OHRP's jurisdiction is the institution's assurance and its IRB's registration and conduct, not direct review or approval of individual study protocols.
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Research fellowship - CASRAI (2026)
A research fellowship is a competitively awarded, individually held package of support for a defined program of research – distinguished from staff pay on a principal investigator's grant, an institutionally-held training slot, or a titled faculty position by who holds the award and why, not by career stage or seniority. It funds a fixed period (commonly one to five years, depending on stage) of research, structured as a stipend, salary-replacement, or salary-plus-allowance package tied to the research itself rather than wages for institutional duties. The same test applies across career stages – graduate/doctoral fellowships (e.g. NSF's GRFP), postdoctoral fellowships (e.g. NIH F32, NSF postdoctoral programs, MSCA), and senior/faculty fellowships (e.g. Guggenheim, ACLS, Fulbright Scholar) – though the specific mechanics differ: predoctoral and postdoctoral fellowships are typically portable to a funder-approved host institution, while senior-stage fellowships more often fund a period of leave from an existing faculty position rather than a portable appointment.
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Research Study Types - CASRAI (2026)
A research study's design type is the structural classification of how it relates to the exposure or intervention under study, decided at the protocol stage: whether the researcher assigns the exposure (experimental) or only observes it occurring naturally (observational), and, for observational designs, whether data collection looks forward from exposure (cohort), backward from outcome (case-control), or captures exposure and outcome at a single point in time (cross-sectional). It is a separate axis from research methodology (qualitative vs. quantitative vs. mixed methods, which describes data type, not design structure).
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Good Pharmacovigilance Practices (GVP) - CASRAI (2026)
Good Pharmacovigilance Practices (GVP) is the European Medicines Agency's formal, numbered set of guidelines (GVP Modules I-XVI, with Modules XI-XIV void) governing how EU marketing-authorisation holders, national competent authorities, and the EMA itself must detect, assess, and prevent adverse effects and other medicine-related problems across an authorised medicine's lifecycle. Issued under Article 108a of Directive 2001/83/EC as amended, GVP requires an EEA-resident Qualified Person Responsible for Pharmacovigilance (QPPV), a maintained Pharmacovigilance System Master File (PSMF), and EudraVigilance-routed safety reporting. GVP incorporates but is not identical to the internationally harmonised ICH E2 guideline series (E2A/E2B/E2C(R2)/E2D): ICH E2 sets the global base definitions and formats several GVP modules cite directly, while GVP adds EU-specific structures (QPPV, PSMF, EudraVigilance, GVP-specific inspection) that ICH E2 does not itself require.
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CFIUS (Committee on Foreign Investment in US) - CASRAI (2026)
CFIUS (the Committee on Foreign Investment in the United States) is the US federal interagency committee, chaired by the Secretary of the Treasury and acting under Section 721 of the Defense Production Act of 1950 (as amended by FIRRMA in 2018) and its implementing regulations at 31 CFR Part 800, that reviews “covered transactions” — foreign acquisitions of control of a US business, and, since FIRRMA, certain non-controlling foreign investments granting governance or information rights in a critical-technology, critical-infrastructure, or sensitive-personal-data US business (a “TID US business”) — for national security risk.
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Patentability of Biological Subject Matter - CASRAI (2026)
Whether a claimed invention involving a living organism, cell, or genetic/biological material is patent-eligible subject matter under 35 U.S.C. § 101 turns on one question: has a human being changed it into something with markedly different characteristics from what exists in nature, or is the claim, in substance, directed to the product or law of nature itself, merely isolated, purified, or observed? "Manufacture" and "composition of matter" in Section 101 reach human-made, human-altered living organisms — the fact that something is alive is not, by itself, a bar to patenting (Diamond v. Chakrabarty, 447 U.S. 303 (1980)). But those same terms do not reach a naturally occurring nucleic-acid sequence merely separated from its surrounding genetic material, because isolating something nature already made is not an act of invention (Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)). A synthetic construct that does not occur in nature — such as complementary DNA (cDNA), which omits the non-coding intron sequences present in the genomic original — remains patent-eligible even under Myriad, because a lab technician creates something structurally new when cDNA is synthesized.
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DOAJ (Directory of Open Access Journals) - CASRAI (2026)
DOAJ (Directory of Open Access Journals) is an independent, community-curated online directory that indexes peer-reviewed open-access journals meeting its published inclusion criteria. A journal counts as "DOAJ-indexed" only once it has applied and DOAJ's editorial team has evaluated and accepted that application against DOAJ's own checkable standards for genuine open access, documented peer review, an identifiable editorial board, ISSN registration, licensing/copyright transparency, and public disclosure of any author-facing fees – self-describing as open access, or being under DOAJ review, is not the same claim as being listed.
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Certificate of Confidentiality (CoC) - CASRAI (2026)
A Certificate of Confidentiality (CoC) is a federal legal protection, under Section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) as amended by the 21st Century Cures Act, that shields a researcher from being legally compelled – by subpoena, court order, or similar legal, administrative, or legislative demand – to disclose names or other identifying information about research participants. For NIH-funded research collecting or using identifiable, sensitive information, a CoC has attached automatically, as a standing term of the award, since October 1, 2017 (NOT-OD-17-109), replacing the prior application-based system under which investigators had to request a certificate for each project. A CoC does not de-identify or otherwise secure the underlying data – it is a legal shield against compelled disclosure through legal process, not a data-security or data-masking control, and it does not protect against every disclosure (recognized exceptions include participant consent, certain legally mandated reporting, and DHHS or FDA regulatory access).
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Qualitative Data Collection Techniques - CASRAI (2026)
A qualitative data collection technique is the specific, repeatable procedure a researcher uses to generate or capture non-numeric primary data within a qualitative study — distinct from the broader methodological tradition (ethnography, phenomenology, grounded theory, narrative research, case study) that determines how techniques are combined, sequenced, and interpreted. Four techniques account for most qualitative primary data: the semi-structured interview (a predetermined but flexible guide of open-ended questions, allowing probes and reordering); the focus group (a facilitated discussion among roughly 6-10 participants per group, in which group interaction itself, not just individual answers, is the data source); participant observation (the researcher observes, and to a chosen degree takes part in, a setting's ordinary activities, recording field notes); and document or artifact analysis (systematic review of pre-existing texts, records, or images the researcher did not create). A single technique can appear inside more than one tradition — semi-structured interviews show up in phenomenology, grounded theory, and case-study designs alike — so naming the technique alone does not establish a study's overall methodological design.
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Good H-Index - CASRAI (2026)
A "good" h-index is not a fixed number: it is only interpretable relative to a researcher's specific field (citation density and publication norms vary widely by discipline), career stage (h-index can only increase over time, so it partly measures career length), and the database it was computed from (Google Scholar, Scopus and Web of Science produce different values for the same person) — and even then should be used only as one input alongside qualitative review of the actual body of work, not as a standalone pass/fail threshold or cross-researcher ranking.
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NSF Biosketch (SciENcv) - CASRAI (2026)
The Biographical Sketch that a proposer submits for NSF senior/key personnel counts as an NSF Biosketch (SciENcv) only when it is generated inside SciENcv using NSF's Biographical Sketch module and follows the NSPM-33 Common Form structure (Identifying Information, Organization and Location, Professional Preparation, Appointments and Positions, Products, Certification) – a hand-typed PDF built outside SciENcv is no longer an accepted substitute for proposals subject to the current PAPPG.
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Data Breach Response Plan - CASRAI (2026)
A data breach response plan for research data is a documented, pre-established procedure – distinct from a generic enterprise IT incident response plan – specifying how an institution or research team will detect, contain, assess the impact of, and report a security incident involving research data, with particular attention to data subject to a specific regulatory, contractual, or funder obligation: HIPAA-covered protected health information (PHI), data obtained under a signed Data Use Agreement or a controlled-access repository's data use certification (e.g., NIH's dbGaP), export-controlled technical data (EAR/ITAR), or identifiable human-subjects data subject to IRB oversight. What distinguishes it from a general IT incident response plan is not the detection/containment mechanics – those follow the same ISO/IEC 27001 Annex A.5.24-A.5.28 discipline any organization uses – but an explicit notification-routing step naming, for each data type, which additional party (an IRB, a funding agency, a repository's Data Access Committee, an export control office) must be notified, and on what timeline, on top of whatever an institution's central IT security office already does for any security incident.
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SBIR Phase II - CASRAI (2026)
The second stage of the U.S. Small Business Innovation Research (SBIR) program: a full research-and-development award, typically up to two years and substantially larger than a Phase I feasibility award, funding prototype development and validation toward commercialization. At most participating agencies a business must have already been awarded (and largely completed) a Phase I award for the same project to be eligible, though a handful of agencies allow a Direct-to-Phase-II exception for firms that can document equivalent feasibility results using non-SBIR funds.
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Utility Patent - CASRAI (2026)
A utility patent is a patent granted under 35 U.S.C. § 101 for a new and useful process, machine, article of manufacture, or composition of matter, or a new and useful improvement of one of those four categories – it protects how an invention works or functions, not its ornamental appearance (design patent, 35 U.S.C. § 171) or its status as a newly-created asexually-reproduced plant variety (plant patent, 35 U.S.C. § 161). It is the default patent category: an application is a utility application unless expressly filed as design or plant. Something qualifies as a utility patent if its claims are directed to one of the four § 101 categories and it separately satisfies novelty, non-obviousness, utility, and enablement during USPTO examination.
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Designated Institutional Official (DIO) - CASRAI (2026)
The individual appointed by an ACGME-accredited Sponsoring Institution's Governing Body who holds institution-wide authority and responsibility for the oversight and administration of every graduate medical education (GME) program the institution sponsors, and who is accountable to the Accreditation Council for Graduate Medical Education (ACGME) for the institution's compliance with its Institutional, Common, and specialty-specific Program Requirements – distinct from the "Institutional Official" role used in federal human-subjects and financial-conflict-of-interest compliance.
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FDA Form 1572 (Statement of Investigator) - CASRAI (2026)
FDA Form 1572 ("Statement of Investigator") is the signed document by which an individual becomes an "investigator" of record on an FDA-regulated drug or biologic trial conducted under an Investigational New Drug (IND) application. Under 21 CFR 312.53, a sponsor may not permit an investigator to begin participating in the study until this form – along with the investigator's curriculum vitae and financial disclosure information – is completed and signed. The investigator's signature affirms they are qualified to conduct the study and constitutes a written commitment to comply with FDA's clinical-investigation regulations, including protocol adherence, IRB oversight, informed consent, adverse-event reporting, and recordkeeping. Only the person who meets the 21 CFR 312.3 definition of "investigator" – the responsible leader of the site's study team, commonly the principal investigator – signs the form; subinvestigators are listed on it but do not sign their own.
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Mixed Methods Research - CASRAI (2026)
Mixed methods research is a study design in which a researcher deliberately collects and analyzes both quantitative and qualitative data within a single study and integrates the two strands at one or more defined points in the design (through merging, connecting, or embedding) for a stated rationale such as triangulation, complementarity, or development — not a study that simply uses one method for one question and a different method for an unrelated question, and not a study that collects both data types but reports them independently without ever connecting them.
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IMRaD Structure - CASRAI (2026)
The four-part sectional structure – Introduction, Methods, Results, and Discussion – used to organize a manuscript reporting original empirical research. A paper qualifies as IMRaD-structured when: (1) the Introduction states the research question against existing background without previewing findings, (2) the Methods (or Materials and Methods) section describes the procedure in enough detail to permit assessment or replication and contains no findings, (3) the Results section reports what was found without interpreting it, and (4) the Discussion interprets those findings against the research question and prior literature. Content placed in the wrong section – most commonly, interpretation appearing in Results instead of Discussion – is a structural defect even when all four section headings are present.
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Biosafety Level 4 (BSL-4) - CASRAI (2026)
The CDC/NIH BMBL's maximum laboratory-containment tier, assigned when a protocol involves biological agent(s) that pose a high risk of life-threatening disease, for which no vaccine or treatment is routinely available, and for which aerosol transmission (or an unpredictable transmission risk tied to a known aerosol-transmissible agent) is a realistic exposure route. An instance of BSL-4 combines a dedicated, physically isolated facility; either a positive-pressure supplied-air suit or a Class III biosafety-cabinet line for all agent manipulation; redundant, dedicated, HEPA-filtered air supply and exhaust; and a mandatory personnel decontamination shower on exit – with the level itself formally assigned through an Institutional Biosafety Committee (IBC) risk assessment, and, for most BSL-4 agents, additional oversight under the Federal Select Agent Program, before laboratory work may begin.
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Athena SWAN Gender Equality Charter - CASRAI (2026)
An accreditation charter run by Advance HE that recognises an institution's or department's commitment to gender equality in higher education and research, awarded at Bronze, Silver, or Gold level after a structured self-assessment of staff/student gender data and working practices and a resulting time-bound action plan. Originated in the UK in 2005 (as Athena SWAN, focused on women in STEMM), broadened in scope in 2015, relaunched as a 'transformed' Charter in 2021, and now has internationally-adapted counterpart schemes (Athena Swan Ireland, SAGE in Australia, SEA Change in the US, Dimensions in Canada).
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Biosafety Level 2 (BSL-2) - CASRAI (2026)
The CDC/NIH BMBL laboratory-containment tier assigned to a protocol when the biological agent(s) involved pose a moderate hazard to personnel and the environment, are generally treatable or preventable, and are transmitted primarily by direct/mucous-membrane contact, ingestion, or percutaneous exposure rather than by infectious aerosol. An instance of BSL-2 combines restricted laboratory access, biohazard signage, a certified biosafety cabinet for any aerosol- or splash-generating procedure, and standard PPE, with the level itself formally assigned through an Institutional Biosafety Committee (IBC) risk assessment before laboratory work begins.
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F32 (NIH Postdoctoral Individual NRSA Fellowship) - CASRAI (2026)
An F32 is an NIH Ruth L. Kirschstein National Research Service Award (NRSA) individual fellowship that funds a postdoctoral researcher's own mentored training plan under a named faculty sponsor, typically at an institution other than the one that granted their doctorate. What makes an award an F32 rather than another NRSA/career-development mechanism: the applicant already holds a qualifying doctoral degree and applies directly for their own mentored postdoctoral training support – as opposed to a predoctoral F31, an institution-held T32 training-grant slot, or a K99/R00 bridge-to-independence award that funds independent research once a faculty position is secured.
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NSF PAPPG (Proposal & Award Policies & Procedures Guide) - CASRAI (2026)
NSF's primary, comprehensive statement of the policies and procedures governing NSF proposal preparation, submission, review, and award administration; specific sections become binding on a given award when referenced in that award's Notice of Award or NSF's Grant General Conditions (GC-1). Organized into Part I (Proposal Preparation and Submission Guidelines, Chapters I-V) and Part II (Award, Administration and Monitoring of NSF Assistance Awards, Chapters VI-XII). Current base edition is NSF 24-1 (effective May 20, 2024), supplemented by targeted policy notices (Supplement 1, NSF 26-200; Supplement 2, NSF 26-202) rather than a full renumbered edition.
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Letter of Reference (Academic and Research Careers) - CASRAI (2026)
A formal, signed endorsement of a specific researcher's qualifications, scholarly record, and professional character, written by someone with direct first-hand knowledge of that researcher's work and submitted at the request of a tenure and promotion committee, fellowship or award nominating body, or hiring committee – distinguished from a letter of support, which endorses a proposed project rather than a person.
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Data Ownership - CASRAI (2026)
The allocation of legal title to and decision-making control over a research dataset. Because raw data is rarely copyrightable and no single U.S. statute assigns default ownership of research data, the operative answer in practice comes from a combination of institutional policy, the funder's terms and conditions, the Data Management Plan, and any executed data sharing/use agreement – not from a single ownership doctrine. Distinguish from data stewardship/custodianship, which describes accountability for a dataset's day-to-day management regardless of who holds title.
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HIPAA Accounting of Disclosures - CASRAI (2026)
A disclosure of protected health information (PHI) is subject to the HIPAA accounting-of-disclosures requirement at 45 CFR §164.528 when a covered entity makes it without the individual's authorization and it does not fall into one of the Privacy Rule's enumerated exempt categories (treatment/payment/health care operations, disclosures to the individual, incidental disclosures, authorized disclosures under §164.508, facility-directory/care-related disclosures, national-security/law-enforcement disclosures, limited-data-set disclosures under §164.514(e), or disclosures made before the covered entity's Privacy Rule compliance date). An individual has the right to request — and the covered entity must provide within 60 days, extendable once by 30 — a written accounting of every disclosure meeting that definition made in the six years preceding the request.
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NIH Grants Policy Statement (NIH GPS) - CASRAI (2026)
NIH's primary, comprehensive statement of the policy requirements that serve as the terms and conditions of NIH grant and cooperative agreement awards, incorporated by reference into every NIH Notice of Award; organized into Part I (general information), Part II (terms and conditions, split into Part IIA general and Part IIB award-specific), and Part III (points of contact), and revised periodically to consolidate NIH Guide Notices issued since the prior edition.
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CTCAE (Common Terminology Criteria for Adverse Events) - CASRAI (2026)
The Common Terminology Criteria for Adverse Events (CTCAE) is NCI/CTEP's standardized terminology and 5-point severity-grading scale (Grade 1-5) for adverse events in clinical trials. An event is graded under CTCAE when a study team assigns it the grade whose published, term-specific criteria it meets in the version specified by the protocol – from Grade 1 (mild; observation only) to Grade 5 (death related to the event) – not an ad hoc severity judgment. CTCAE grades severity only; it is distinct from whether an event separately meets regulatory 'serious adverse event' (SAE) criteria or is causally related to the study intervention.
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Regulatory Affairs - CASRAI (2026)
Regulatory affairs, in a research-institution context, is the function – an office, unit, or role – responsible for identifying which regulatory frameworks apply to a given study (human-subjects protections, FDA drug/biologic/device rules, biosafety and recombinant-DNA oversight, controlled-substance handling, export control, and comparable frameworks outside the US), preparing and maintaining the submissions those frameworks require (e.g., an Investigational New Drug (IND) application under 21 CFR Part 312, or an Investigational Device Exemption (IDE) under 21 CFR Part 812), and keeping the study's regulatory record current for the life of the project. It is distinct from Institutional Review Board (IRB) review, which evaluates a study's ethics and human-subjects protections, and from Good Clinical Practice (GCP) conduct, which governs how a trial is run day to day – regulatory affairs is the function that determines which of those requirements attach to a study in the first place and manages the paper trail with the regulator.
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Open Innovation Networks - CASRAI (2026)
An open innovation network is a multi-party, ongoing arrangement in which a university (typically through its technology transfer office) intentionally sources and shares R&D and intellectual property across organizational boundaries, per Henry Chesbrough's open innovation framework (2003) – rather than relying solely on internally generated, exclusively-held R&D. Three elements distinguish it from an ordinary bilateral deal: (1) multiple external parties (not a single sponsor), (2) a standing, often membership-based structure rather than a one-off transaction, and (3) non-exclusive or shared IP access as the default rather than one party holding exclusive rights. Common forms at research universities include NSF-style Industry-University Cooperative Research Centers (IUCRC), university innovation hubs and accelerators, open-source hardware/software collaborations, and pre-competitive research consortia.
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protocols.io (concept) - CASRAI (2026)
protocols.io is a free, open platform (owned by Springer Nature since 2023) for developing, versioning, and sharing detailed step-by-step research method protocols across life-science, physical-science, and computational disciplines. Each published protocol receives a DataCite DOI, so a specific, citable version of a method persists even as the protocol is later revised, forked, or optimized by other labs.
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PROSPERO Registration - CASRAI (2026)
PROSPERO registration is the prospective submission of a systematic review's protocol (research question, PICO, search strategy, eligibility criteria, and analysis plan) to the International Prospective Register of Systematic Reviews (PROSPERO), maintained by the Centre for Reviews and Dissemination (CRD) at the University of York and funded by the UK's NIHR, before the review has progressed beyond data extraction. Eligible reviews must have a health-related outcome; a registered record receives a permanent, publicly citable CRD42-prefixed identifier.
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NIH Salary Cap - CASRAI (2026)
The NIH salary cap is the maximum annual rate of institutional base salary that NIH (and other HHS agencies applying the same limitation, including CDC, AHRQ, and SAMHSA) will reimburse against a grant, cooperative agreement, or contract. It is not a limit on what an institution may pay an investigator — it is a limit on what federal grant funds may reimburse. The cap is set by statute at the rate for Executive Level II of the Federal Executive Pay Schedule and, since FY2026, can change more than once within a fiscal year: for awards issued October 1, 2025 through December 31, 2025, the cap is $225,700; for awards issued January 1, 2026 through September 30, 2026, it is $228,000 (per Guide Notice NOT-OD-26-034, effective date corrected by NOT-OD-26-038). For a 9-month academic-year appointment, the proportional equivalent of the $228,000 rate is approximately $171,000. Since FY2025 (NOT-OD-25-025), the cap applies to both direct salaries of individuals working on NIH projects and indirect salaries (executive salaries in uncapped cost pools) — not direct salary alone, as was the case FY1990–FY2024. Any portion of an investigator's institutional base salary above the applicable cap, for the percentage of effort charged to an NIH award, cannot be charged to that award — the institution must either cost-share the excess from non-federal funds or reduce the effort percentage charged to stay within the capped amount.
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ResearcherID - CASRAI (2026)
ResearcherID is Clarivate's proprietary author identifier for the Web of Science ecosystem: a unique alphanumeric code (format letter(s)-numbers-year) assigned when a researcher creates a Web of Science Researcher Profile, used to disambiguate that person's publications and citation metrics within Web of Science and InCites. Since Clarivate retired Publons as a separate product in April 2022, ResearcherID exists as the identifier component of the unified Web of Science Researcher Profile rather than a standalone product, and (once a researcher explicitly connects the two accounts) two-way syncs publications with a connected ORCID iD.
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Canada Foundation for Innovation (CFI) - CASRAI (2026)
The Canada Foundation for Innovation (CFI) is an independent, not-for-profit corporation established by the Government of Canada in 1997 (Budget Implementation Act, 1997) that funds research infrastructure — facilities, major equipment, computing hardware, software, and databases — at Canadian universities, colleges, research hospitals, and non-profit research institutions; it does not fund research operating costs, personnel, or stipends, which is what distinguishes it from Canada's Tri-Agency granting councils (CIHR, NSERC, SSHRC).
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OIG Reports - CASRAI (2026)
An OIG report is any audit, evaluation, investigation, or periodic report published by a federal agency's Office of Inspector General (OIG) – an independent oversight unit created under the Inspector General Act of 1978 – documenting findings, recommendations, questioned costs, or enforcement referrals concerning that agency's own programs, operations, grantees, or contractors.
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Cost-Reimbursable Contract - CASRAI (2026)
A FAR Subpart 16.3 contract type in which the federal government pays a contractor's allowable, allocable costs actually incurred, up to a negotiated ceiling, plus a fee. Used instead of a fixed-price contract when requirements or costs cannot be estimated with sufficient accuracy at award (FAR 16.301-2) — most commonly for research and development work whose technical approach is not yet firmly established (FAR 35.006).
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Inspection Readiness - CASRAI (2026)
Inspection readiness is the continuously maintained state of an institution's or clinical trial site's preparedness to undergo a regulatory inspection – an FDA Bioresearch Monitoring (BIMO) inspection, a GMP or GLP inspection, or a sponsor/CRO audit – at any time, rather than a set of tasks performed reactively once a specific visit is scheduled. Operationally, a site is "inspection ready" when its essential documents and regulatory binder (or Trial Master File) are organized and current as a matter of routine, staff know their assigned roles for an inspection visit, internal quality reviews or mock audits are conducted on a recurring schedule (not only pre-visit), and open corrective and preventive action (CAPA) items are being tracked and closed continuously. A site that only assembles its files, briefs its staff, and closes outstanding issues after receiving notice of an inspection is "preparing" for that one visit – it is not inspection ready in the operational sense, because the same gaps would exist if FDA showed up unannounced.
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Parenthetical Citation - CASRAI (2026)
An in-text citation enclosed in parentheses that gives a source's identifying information – author and date, or author and page number, depending on the governing citation style – directly within the sentence, as opposed to a superscript footnote/endnote marker or a bracketed numbered reference pointing to a separately numbered list. The exact contents and punctuation inside the parentheses are set by the citation style in use (e.g., APA's author-date system, MLA's author-page system, Chicago's author-date variant); the defining feature is the parenthetical container itself carrying the identifying information, not any one style's specific formatting.
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Animal Welfare Act (AWA) - CASRAI (2026)
The primary US federal law (7 U.S.C. §2131 et seq., originally enacted 1966 as the Laboratory Animal Welfare Act, Pub. L. 89-544) that sets minimum standards for the humane care, handling, and treatment of certain warm-blooded animals used in research, teaching, testing, exhibition, and transport, enforced by USDA APHIS under the Animal Welfare Regulations (9 CFR Parts 1-3). It excludes rats and mice bred for research, birds bred for research, and cold-blooded animals from its definition of "animal," and — together with PHS Policy — is one of two legal bases requiring a research institution to convene an IACUC.
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Journal Citation Reports (JCR): What It Is and What Is In It - CASRAI (2026)
Journal Citation Reports (JCR) is Clarivate's annual analytics database and publication reporting citation-based metrics — including the Journal Impact Factor, Journal Citation Indicator, Eigenfactor Score, Article Influence Score, and quartile (Q1-Q4) category rankings — for journals in the Web of Science Core Collection. A figure counts as "the JCR number" only when it is what Clarivate itself calculates and publishes in a specific annual release (e.g. JCR 2026), sourced from Web of Science citation data — not a similar-looking figure mirrored by a third-party site or a metric from a different database such as Scopus.
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Originality Report - CASRAI (2026)
An automated text-matching report generated by a plagiarism-detection service (such as Turnitin or iThenticate) that compares a submitted manuscript, thesis, or dissertation against prior publications, previously submitted papers, and web content, expressing the proportion matched as a similarity index — a screening aid for human reviewers, not an automated finding of plagiarism.
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Pseudonymous and Anonymous Authorship - CASRAI (2026)
Pseudonymous authorship is publication under a consistent, invented author name that is not the author's legal name but that the journal or publisher can trace back to a real, accountable person even though that identity is withheld from the public byline – the same pseudonym is typically used across multiple works, building a durable scholarly identity distinct from the legal one. Anonymous authorship is narrower: the published work carries no attributable name or durable alias at all, though COPE's guidance expects the editor to still hold the real author's identity on file even when no name is published. Both are treated as narrow, conditional exceptions to the default expectation of a named, accountable author – legitimate chiefly where disclosure would compromise the author's safety, or (for pseudonyms specifically) by durable convention such as a shared or house pen name – and not where the goal is simply to distance a paper from an employer, avoid a workplace dispute, or preserve general privacy.
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Dimensions (Research Database) - CASRAI (2026)
A record is part of Dimensions when Digital Science's Dimensions platform has ingested it — as a publication, grant, patent, clinical trial, dataset, or policy document — through its largely automated ingestion pipeline (funder data feeds, publisher metadata, patent-office records, clinical-trial registries, and full-text/acknowledgment mining), rather than through the title-by-title editorial selection Scopus and Web of Science apply. Where a funding relationship between a grant and the outputs it produced can be identified, Dimensions represents that link directly in its data model — this explicit funding-to-output linkage is the feature that most consistently distinguishes a Dimensions record from an equivalent Scopus or Web of Science record.
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REDCap (Research Electronic Data Capture) - CASRAI (2026)
REDCap (Research Electronic Data Capture) is a secure, metadata-driven, web-based software platform for building surveys and case-report-form databases for research, originated at Vanderbilt University in 2004. An instance only counts as REDCap if it runs the actual Vanderbilt-distributed software, licensed at no cost to non-profit institutions through the REDCap Consortium and installed/administered by that partner institution – there is no direct commercial purchase path or self-service individual signup. Typical uses include participant surveys, longitudinal case report forms, and multi-site clinical data capture, frequently chosen specifically because the platform supports HIPAA, FDA 21 CFR Part 11, FISMA, and GDPR compliance controls at the institutional level.
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Google Scholar API - CASRAI (2026)
Google, as a matter of long-standing, publicly stated policy, does not operate an official, sanctioned application programming interface for Google Scholar – there is no documented endpoint, no API key registration process, and no rate-limited free or paid tier comparable to those offered by Crossref, ORCID, Scopus, or OpenAlex. "Google Scholar API" as a search term almost always refers to one of two distinct things instead: (1) a third-party commercial scraping service (e.g. SerpApi, Apify, Oxylabs) that queries Google Scholar's public web pages on a customer's behalf and returns the result as structured JSON, or (2) an open-source scraping library (e.g. the Python package "scholarly") that automates a browser or HTTP session against the same public pages with no official sanction from Google. Both categories work by parsing Google Scholar's HTML search-results and profile pages, not by calling an endpoint Google built or documents for that purpose, and both are constrained by Google Scholar's robots.txt disallow rules and general Google Terms of Service language prohibiting automated querying without prior permission.
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3-2-1 Backup Strategy - CASRAI (2026)
A data-protection rule requiring that any dataset worth protecting exist as at least three total copies, stored across at least two different storage media or systems, with at least one of those copies kept at a location or system genuinely separate from where the working copy lives. All three conditions must hold simultaneously – extra copies on the same medium, or an offsite copy with no independent local redundancy, do not satisfy the rule on their own.
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Cooperative Agreement - CASRAI (2026)
The federal legal instrument (31 U.S.C. § 6305; 2 CFR 200.1) used instead of a grant when the awarding agency anticipates substantial involvement – active agency participation in carrying out the funded activity, such as approving a work plan, sitting on a steering committee, or holding milestone go/no-go authority – not just routine grants-management oversight.
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NHMRC Ideas Grant - CASRAI (2026)
An NHMRC Ideas Grant is a competitive, project-specific research funding scheme administered by Australia's National Health and Medical Research Council (NHMRC), open to a team of up to ten Chief Investigators pursuing one or more defined research questions across any area of health and medical research, from discovery to implementation. It funds the project itself — a fixed-term, budgeted piece of research work of one to five years, assessed up to roughly A$750,000 — rather than a researcher's salary or an open-ended program of research; that project-specific scope is what separates it from the NHMRC Investigator Grant, which instead funds a researcher's Salary Support Package plus a flexible, evolving program of research. An application counts as an Ideas Grant, not an Investigator Grant, when its ask is to fund a bounded piece of research work rather than a person's ongoing research direction, and it must not have a clinical trial or cohort study as its primary objective (NHMRC directs those proposals to its separate Clinical Trials and Cohort Studies scheme).
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NHMRC Investigator Grant - CASRAI (2026)
An NHMRC Investigator Grant is a five-year Australian National Health and Medical Research Council award that consolidates an individual researcher's salary support (where needed) and a Research Support Package (RSP) into a single scheme funding that investigator's broader multi-year research program, rather than a single discrete project. Applicants are assessed and funded at one of five levels across two categories — Emerging Leadership (EL1, EL2, for researchers within 10 years post-PhD) and Leadership (L1, L2, L3) — with the RSP fixed per level ($75,000 p.a. at EL1, $200,000 p.a. at EL2, and $400,000 p.a. across L1-L3) and salary support scaled separately to the CI's seniority. A Chief Investigator (CI) may hold at most one Investigator Grant, and may submit only one Investigator Grant application per NHMRC funding round.
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National Statement on Ethical Conduct in Human Research - CASRAI (2026)
Australia's core ethics-governance document for research involving human participants, jointly developed and issued by the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), and Universities Australia under the National Health and Medical Research Council Act 1992. Every Human Research Ethics Committee (HREC) in Australia applies it when reviewing a proposed study; it is organised around four core values (research merit and integrity, justice, beneficence, respect) plus topic-specific chapters, and functions as Australia's counterpart to the US Common Rule/Belmont Report and Canada's TCPS2. The current operative edition is the 2025 update (released 1 April 2025, effective from 23 June 2026), which revised Section 4; the prior 2023 update (effective 1 January 2024) revised Chapter 2.1 and Section 5.
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PubPeer - CASRAI (2026)
PubPeer is an independent, web-based platform where anyone can post public comments — anonymously or under their own name — on papers already published in the scholarly literature, identified by DOI, PubMed ID, or a title/author search. It is a venue for open, informal post-publication commentary, not a peer-review, editorial, or investigative body: it has no authority to correct, retract, or adjudicate a paper, and the mere existence of a PubPeer comment thread on a paper is not, by itself, evidence of research misconduct.
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Funding Opportunity Announcement (FOA) - CASRAI (2026)
A Funding Opportunity Announcement (FOA) is NIH's (legacy, pre-April-2023) umbrella term for a formal, published solicitation of grant or cooperative agreement applications in a defined scientific area. Every NIH FOA is one of two sub-types: a standing, recurring Program Announcement (PA, including Parent Announcements, PARs, and PAS) with no dedicated funds and standard due dates, or a one-time Request for Applications (RFA) with set-aside funds and, usually, a single receipt date. Since April 2023 (NOT-OD-23-109), NIH itself calls new announcements Notices of Funding Opportunity (NOFO) instead, matching the government-wide term standardized in the April 2024 revision to 2 CFR Part 200 – the document type and its two sub-types are unchanged by the rename.
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HIPAA (Health Insurance Portability Act) - CASRAI (2026)
Something is properly described as "HIPAA" (rather than another privacy regime) when it derives from the Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191) or the federal regulations HHS issued under its Title II Administrative Simplification authority – principally the Privacy Rule (45 CFR Part 160 and Subparts A/E of Part 164), the Security Rule (45 CFR Part 160 and Subparts A/C of Part 164), and the Breach Notification Rule (45 CFR Part 164, Subpart D, added via the HITECH Act of 2009). These rules apply only to a 'covered entity' (a health plan, health care clearinghouse, or health care provider that transmits health information electronically in connection with a standard transaction) or its business associates, and only to 'protected health information' (PHI) – individually identifiable health information, as defined at 45 CFR 160.103, held or transmitted by one of those entities. HIPAA is a distinct federal regime from the Common Rule (45 CFR 46), which governs the ethics of human-subjects research (IRB review, informed consent) rather than the privacy/security of health data; the two frequently apply to the same study but are evaluated against different criteria by different offices.
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Acknowledgments Section - CASRAI (2026)
The part of a scholarly manuscript, typically placed after the discussion/conclusion and before the reference list, where the corresponding author names people and entities that contributed to the work but do not meet the journal's or field's authorship criteria (most commonly ICMJE's four-part test), together with any required disclosure of funding sources and grant/award numbers. A contribution belongs here rather than on the byline when it is real but falls short of authorship on at least one prong — ICMJE's own examples include acquisition of funding, general supervision of a research group or general administrative support, and writing assistance, technical editing, language editing, or proofreading. Because naming someone can be read as implying their endorsement of the paper's data and conclusions, ICMJE recommends that editors require the corresponding author to obtain each acknowledged individual's written permission before publication.
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Participatory research - CASRAI (2026)
Research in which people affected by the topic under study — community members, patients, practitioners or service users — share power over one or more phases of the research process (framing questions, designing methods, collecting or interpreting data, or disseminating findings) as co-researchers rather than as subjects or a consulted stakeholder group. The defining test is who controls the process, not which specific method is used.
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Open Science - CASRAI (2026)
The umbrella movement and set of practices for making every stage of the research process — publications, data, code, methods, and materials — openly accessible, transparent, and reusable, rather than treating openness as something that applies only to the final published article. UNESCO’s 2021 Recommendation on Open Science, the first international normative instrument on the subject, organizes it into four pillars: open scientific knowledge, open science infrastructures, open engagement of societal actors, and open dialogue with other knowledge systems.
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Cost Accounting Standards (CAS) - CASRAI (2026)
A cost accounting practice at a US institution of higher education is governed by the Cost Accounting Standards (CAS) when the institution has received $50 million or more in federal awards subject to 2 CFR Part 200 Subpart E in its most recently completed fiscal year, triggering compliance with CAS 501, 502, 505, and 506 (48 CFR 9905.501/.502/.505/.506) as incorporated via 2 CFR 200.419 and Appendix III. The operative test is consistency, not any single accounting method: the same institution must use the same cost-accounting practice when it estimates a cost in a proposal, when it accumulates that cost in its books, and when it reports that cost on an award, and it must apply the same direct-vs-indirect classification to like costs in like circumstances institution-wide. An institution below the $50 million threshold is not CAS-governed in this sense, even though it still must satisfy the separate, universally applicable cost-principle tests of allowability, allocability, and reasonableness.
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Postdoctoral fellowship - CASRAI (2026)
A postdoctoral fellowship is an award of research-training support that is individually competed for and held in the name of the doctorate-holder themselves – typically with a named faculty sponsor or mentor – rather than paid to them as staff out of a principal investigator's grant or held by their department as an institutional training-grant slot. It funds a fixed, time-limited period (commonly two to three years) of mentored postdoctoral research, usually via a stipend or salary plus a separate research/travel/relocation allowance, and because the award belongs to the individual rather than the institution, it is typically portable to a different funder-approved host institution. Examples include NIH's F32, NSF's family of directorate-specific postdoctoral fellowship programs, foundation fellowships (e.g. HFSP, EMBO, Damon Runyon), and the EU's MSCA Postdoctoral Fellowships.
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Data Safety Monitoring Board (DSMB) - CASRAI (2026)
An independent group of clinical, statistical, and (where relevant) bioethics experts, external to a trial's investigators and sponsor, that periodically reviews accumulating – typically unblinded – safety and efficacy data from an ongoing clinical trial at pre-specified intervals, and recommends to the sponsor whether the trial should continue, be modified, or stop, for safety, demonstrated efficacy, or futility. Generally required by NIH policy for multi-site trials with substantial participant risk, most notably Phase III trials. Distinct from bodies that review a protocol before it opens (a Scientific Review Committee), advise on organizational strategy (a Scientific Advisory Board), or conduct human-subjects ethics review (an IRB) – a DSMB's function begins only once a trial is enrolling and is confined to ongoing data monitoring.
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Conflict of Interest (COI) in Research - CASRAI (2026)
A conflict of interest (COI) exists whenever a researcher's, reviewer's, official's, or institution's outside financial or personal interests could reasonably be seen to compromise, or actually do compromise, objective and unbiased conduct, review, or oversight of research. The test is whether a reasonable person could conclude the secondary interest created a risk of undue influence over the primary interest – not whether bias in fact occurred. COI is distinct from research misconduct: an undisclosed or unmanaged conflict is treated as a violation, but the underlying interest itself is not, by default, evidence of wrongdoing.
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Graphical Abstract - CASRAI (2026)
A graphical abstract is a single image (typically one panel combining minimal text with icons, diagrams, or illustrations) that visually summarizes a paper's central finding or methodology, submitted as a separate file from the manuscript and displayed by the publisher alongside the text abstract – in the online table of contents, search-result listings, and the article page – to let a reader grasp the paper's core message without reading the full text.
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Prior Art - CASRAI (2026)
Prior art is any evidence — a patent, a published patent application, a journal article, a conference presentation or poster, a thesis, a product already on sale, or a device already in public use — showing that a claimed invention, or something that would render it obvious, was already publicly known or otherwise available before the patent application's effective filing date (or, for an application claiming priority from an earlier filing, the priority date). Under 35 U.S.C. 102(a)(1), prior art includes material the inventor made public themselves, not only material originating from someone else. Under 102(a)(2), an earlier-filed U.S. patent application naming a different inventor also counts as prior art as of its filing date once it later publishes or issues — so-called "secret prior art" — even though it was not publicly visible at the time. A reference or event functions as prior art only if it discloses the claimed invention outright (defeating novelty under 35 U.S.C. 102) or, in combination with other references, would have made the invention obvious to a person having ordinary skill in the art (defeating non-obviousness under 35 U.S.C. 103).
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Office of Extramural Research (OER) - CASRAI (2026)
The NIH Office of Extramural Research (OER) is the National Institutes of Health's Office of the Director component that owns the corporate, NIH-wide infrastructure, policy, and systems for extramural (externally performed, grant-funded) research administration — the functions shared across all grant-awarding NIH Institutes and Centers (ICs) rather than any single IC's own programmatic decisions. A policy, notice, or system belongs to OER when it applies NIH-wide: eRA (Commons, ASSIST, Reporter), the NIH Guide for Grants and Contracts (the venue for NOT-OD-YY-### Guide Notices), the NIH Grants Policy Statement, and cross-cutting extramural workforce, data-sharing, and research-integrity policy. It does not include an individual IC's own funding priorities or program-officer decisions, and it does not include the scientific peer review of applications, which since 2025 has been centralized in the separate Center for Scientific Review (CSR).
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Risk-Based Monitoring (RBM) - CASRAI (2026)
Risk-based monitoring (RBM) is a clinical trial monitoring methodology, formally incorporated into ICH E6(R2)/(R3) Good Clinical Practice and described in FDA's 2013 guidance for industry, in which a sponsor allocates monitoring resources – the mix of centralized, remote, and on-site activities, and the extent of source data verification (SDV) – according to a documented, protocol-specific risk assessment of what is most likely to affect participant safety and the reliability of trial results. It replaces the older default of fixed-frequency on-site visits with 100% SDV at every site, regardless of actual risk, with a monitoring plan that is proportionate to identified risk and revisited as the trial progresses.
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Traditional Ecological Knowledge (TEK) - CASRAI (2026)
A cumulative body of knowledge, practice, and belief about the relationship of living beings (including people) with one another and their environment, developed through direct experience over generations and passed down by cultural transmission within a specific Indigenous or local community. Following Berkes' foundational framework, TEK operates at four levels: species-specific local knowledge, resource-management practice, the social institutions governing its use, and the worldview that gives it meaning. It is the environmental/ecological subset of the broader concept of Traditional Knowledge (TK).
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F31 (NIH Predoctoral Individual NRSA Fellowship) - CASRAI (2026)
An F31 is an NIH Ruth L. Kirschstein National Research Service Award (NRSA) individual fellowship that funds a doctoral student's own dissertation research training under a named faculty sponsor. What makes an award an F31 rather than another NRSA/career-development mechanism: the applicant is an individual predoctoral student (not a department), enrolled in a research doctoral program and at the dissertation-research stage, applying directly for their own mentored training support – as opposed to a slot inside an institution-held T32 training grant, a postdoctoral F32/F30, or a career-development K award.
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Continued Process Verification (CPV) - CASRAI (2026)
Continued Process Verification (CPV) is Stage 3 of the FDA's three-stage process validation lifecycle, set out in the FDA's January 2011 guidance "Process Validation: General Principles and Practices." It is an ongoing program – required under 21 CFR 211.180(e) – of collecting and statistically trending process and product data during routine commercial production to confirm the manufacturing process remains in a validated "state of control" after Stage 1 (Process Design) established the process and Stage 2 (Process Qualification) demonstrated it was capable of reproducible commercial manufacturing. A single Process Performance Qualification run is Stage 2, not CPV – CPV is the continuing program that follows it for the life of the product.
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ICH E6(R3) (Good Clinical Practice Guideline Revision) - CASRAI (2026)
ICH E6(R3) is the current, staged-adoption revision of ICH's core Good Clinical Practice guideline, replacing E6(R2) (2016). It comprises overarching Principles plus Annex 1 (traditional interventional trials – ICH Step 4 6 January 2025; EU/UK/Switzerland effective 23 July 2025; FDA final guidance 8 September 2025, non-binding) and Annex 2 (non-traditional/decentralized trial designs – ICH Step 4 3 June 2026; EU effective 15 January 2027; FDA has not yet issued Annex 2 guidance). Substantively it shifts to a risk-proportionate, quality-by-design approach, adds explicit technology/electronic-systems and decentralized-trial provisions, and restructures investigator/sponsor responsibilities around the Principles rather than as a standalone checklist.
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Adverse Event (AE) - CASRAI (2026)
Any untoward medical occurrence in a subject administered a pharmaceutical or investigational product, whether or not it is considered related to that product — the causality-neutral base definition set by ICH E2A, from which the narrower Serious Adverse Event (SAE) and Suspected Unexpected Serious Adverse Reaction (SUSAR) categories are derived.
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Laboratory Safety (OSHA Chemical Hygiene Plan) - CASRAI (2026)
A written, laboratory-specific compliance program required under OSHA's Laboratory Standard (29 CFR 1910.1450) whenever hazardous chemicals are used in a laboratory on a non-production basis; it sets out procedures, engineering/administrative controls, PPE, training, exposure monitoring, and a designated Chemical Hygiene Officer, and is distinct from biosafety programs governing biological agents.
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Categorical grant - CASRAI (2026)
A grant restricted by the awarding government to a narrowly defined purpose or category of activity, as set out in the authorizing statute, program regulations, or notice of funding opportunity — the recipient may spend the funds only on the specified purpose and cannot redirect them to other uses at its own discretion. This is a term from US public administration and fiscal federalism, applied here to federal research funding: most federal research grants (an NIH R01, an NSF standard award) are categorical in this sense because the award funds the specific proposed project defined in the application, not general institutional research activity.
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i10-index - CASRAI (2026)
A Google Scholar-specific author metric equal to the count of a researcher's publications that have each individually accumulated at least 10 citations, computed automatically from the citation data attached to a Google Scholar Citations profile.
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NIH Public Access Policy - CASRAI (2026)
A specific NIH funding-compliance requirement — not a general "open access" commitment — under which any peer-reviewed journal article arising in whole or in part from NIH funds must have its Author Accepted Manuscript submitted to PubMed Central (PMC) upon acceptance for publication. For articles accepted for publication on or after July 1, 2025, the manuscript must be made publicly available in PMC immediately, with zero embargo, at the article's official date of publication; articles accepted before that date remain governed by the prior policy's 12-month embargo. Compliance is tracked through a PMCID that grant recipients must cite in progress reports and in any subsequent application or progress report referencing that publication.
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Intent-to-Treat (ITT) vs. Per-Protocol Analysis - CASRAI (2026)
An analysis-population choice for a randomized trial: an intent-to-treat (ITT) analysis includes every participant in the treatment group to which they were originally randomized, regardless of whether they received, adhered to, or completed that assigned treatment. A per-protocol (PP) analysis instead restricts the analysis to the subset of participants who received the assigned treatment as specified in the protocol, with no major deviations. ITT answers "what happens if this treatment is assigned"; per-protocol answers "what happens if this treatment is actually taken as directed" — and which of the two gives the more conservative estimate depends on whether the trial is testing superiority or non-inferiority.
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ICH (International Council for Harmonisation) - CASRAI (2026)
The international standard-setting body — a Swiss non-profit association of drug regulatory authorities and pharmaceutical-industry associations — that develops and maintains the harmonised technical guidelines, grouped into Quality (Q), Safety (S), Efficacy (E), and Multidisciplinary (M) series, used to register medicines for human use across its member jurisdictions; ICH E6 Good Clinical Practice is one specific guideline it publishes, not a synonym for the organization itself.
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Dublin Core - CASRAI (2026)
Dublin Core is the cross-domain metadata vocabulary, governed by the Dublin Core Metadata Initiative (DCMI), built around fifteen core resource-description elements (Title, Creator, Subject, Description, Publisher, Contributor, Date, Type, Format, Identifier, Source, Language, Relation, Coverage, Rights) formally standardized as ISO 15836, ANSI/NISO Z39.85, and IETF RFC 5013 (Simple Dublin Core), plus the larger DCMI Metadata Terms ("dcterms:") vocabulary that adds element refinements, encoding schemes, and additional properties/classes for more precise description (Qualified Dublin Core). A metadata record is a Dublin Core record when its fields map to this DCMI-maintained element set or the extended dcterms vocabulary, rather than to an unrelated, locally invented field set or an unrelated domain-specific schema.
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Investigational Medicinal Product Dossier (IMPD) - CASRAI (2026)
The Investigational Medicinal Product Dossier (IMPD) is the EU/UK clinical-trial-application document presenting the quality (chemistry, manufacturing, controls), nonclinical, and clinical data on a specific medicinal product being used in a clinical trial – submitted under Regulation (EU) No 536/2014, Annex I, Section G (via CTIS) or, in the UK, to the MHRA under SI 2004/1031. It documents the product; it is not the product itself (see Investigational Medicinal Product). A full IMPD follows the ICH CTD Module 3/4/5 format; a simplified IMPD – referencing a current Summary of Product Characteristics (SmPC) instead – is permitted for an already-authorised product used within its marketing authorisation, a previously-assessed unmodified product, or most placebos.
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FDA Form 483 - CASRAI (2026)
An FDA Form 483 is a written list of "inspectional observations" that an FDA investigator hands to a firm's or site's management at the conclusion of an on-site inspection, whenever the investigator judges that observed conditions or practices may violate the Food, Drug, and Cosmetic (FD&C) Act or related FDA regulations. A Form 483 is not a final Agency determination of a violation and does not itself carry legal force — FDA's own guidance is explicit that inspectional observations "do not represent a final Agency determination regarding compliance." The form is used across every type of FDA-regulated inspection — drug and biologic cGMP facilities, medical device manufacturers, food facilities, nonclinical (GLP) testing laboratories, and Bioresearch Monitoring (BIMO) inspections of clinical trial sites, sponsors, and IRBs — wherever an FDA investigator identifies conditions serious enough to document as an observation.
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Human Tissue Act (UK) - CASRAI (2026)
The Human Tissue Act 2004 is the UK statute (England, Wales, and Northern Ireland) governing the removal, storage, and use of human tissue from both the living and the deceased for defined "scheduled purposes," including research into disorders or the functioning of the human body. It makes "appropriate consent" the legal precondition for these activities and establishes the Human Tissue Authority (HTA) to license and inspect the organisations – including research tissue banks – that store human tissue for research.
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Belmont Report - CASRAI (2026)
The Belmont Report is the 1979 statement titled "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (created by the National Research Act of 1974 in response to the Tuskegee Syphilis Study). It establishes three basic ethical principles for human-subjects research – Respect for Persons, Beneficence, and Justice – each linked to a specific application (informed consent, risk/benefit assessment, and equitable selection of subjects, respectively). It is not itself a regulation, but its principles were subsequently codified into binding federal regulation at 45 CFR 46 (the Common Rule) and remain the ethical basis every U.S. IRB applies when reviewing human-subjects research.
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Allocability - CASRAI (2026)
A cost is allocable to a federal award under 2 CFR 200.405 if it is assignable to that award in proportion to the relative benefit received — because it was incurred specifically for the award, benefits both the award and other work in proportions that can be reasonably determined, or is necessary to the organization's overall operation and assignable to the award under the applicable cost-accounting principles. Allocability is distinct from, but works alongside, allowability (200.403) and reasonableness (200.404) as part of the three-part test for whether a cost can be charged to a federal award.
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Data Curator - CASRAI (2026)
A data curator is an institutional role — usually in a library, research data service, or research-computing unit — that prepares research data for deposit, applies metadata standards, checks FAIR readiness, and advises researchers on repository selection and data management plans, distinct from owning the underlying research itself.
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Data Curation - CASRAI (2026)
The active, ongoing management of research data across its lifecycle – organizing files into a coherent structure, describing them with standardized metadata, validating and cleaning values, and taking preservation actions such as format migration and fixity checking – carried out specifically so the data remains findable, interpretable, and reusable by someone other than its original creator, long after the project that produced it ends. Curation is a defined set of actions applied to data over time; it is distinct from simply storing a copy of it.
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dbGaP (Database of Genotypes and Phenotypes) - CASRAI (2026)
The NIH/NCBI repository for genotype-phenotype study data (GWAS results, sequencing/omics data, linked phenotype data), split into an open-access tier (study documentation, summary statistics) and a controlled-access tier (de-identified individual-level genotype and phenotype records) gated by Data Access Committee review of a Data Access Request – distinct from a general sequence archive because the individual-level linkage, not just the data type, is what triggers controlled access.
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De-identification - CASRAI (2026)
De-identification is the process of removing or altering direct and indirect identifiers in a dataset so that a specific individual cannot reasonably be identified from it, either alone or combined with other information a realistic recipient could obtain. It is a general concept operationalized differently across frameworks — HIPAA defines two concrete de-identification methods that remove data from the Privacy Rule's scope entirely, while the GDPR distinguishes reversible pseudonymisation (still personal data) from full anonymisation (outside GDPR's scope) and never uses the term "de-identification" itself. Whether a given approach is adequate always depends on the residual risk of re-identification, not simply which fields were removed.
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ORCID Sign-In / Authentication - CASRAI (2026)
ORCID sign-in ("Sign in with ORCID") is the OAuth 2.0/OpenID Connect process by which a third-party system (a journal, funder, or institutional platform) redirects a researcher to orcid.org to authenticate, then receives back an authenticated ORCID iD and, if broader scopes were requested and approved, an access token to read or write specific parts of the researcher's ORCID record. It is distinct from simply holding an ORCID iD: an iD is a registered identifier; signing in is the act of a specific external system verifying, at that moment, that the researcher controls it, and optionally being granted ongoing record access.
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Web of Science - CASRAI (2026)
Web of Science is Clarivate’s citation-indexing and research-discovery platform, not a single index in its own right. A publication counts as covered by Web of Science only once it has been evaluated and accepted into at least one of the platform’s underlying citation indices — most often the Science Citation Index Expanded, Social Sciences Citation Index, or Arts & Humanities Citation Index within the Web of Science Core Collection, or one of the platform’s regional indices — each governed by its own independent Clarivate selection criteria; being published, or indexed elsewhere such as in Scopus, does not automatically make a title searchable on Web of Science.
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Open Source Software - CASRAI (2026)
Software distributed under a licence that meets the Open Source Initiative's ten-criteria Open Source Definition: the source code is included and modifiable, and the licence permits free redistribution, creation of derivative works, and use for any purpose (including commercial and research use) without discriminating against particular users or fields of endeavour.
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PDF/A (ISO 19005) - CASRAI (2026)
A file is PDF/A-conformant only when it validates against one of the four parts of ISO 19005: every font it uses is embedded rather than referenced, color is specified in a device-independent way, and the file contains no encryption, no JavaScript or executable content, no audio or video, and no reference to external content the renderer would need to fetch. These restrictions make the file self-contained and reproducible without depending on the specific software environment that created it.
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Copyediting - CASRAI (2026)
The mechanical and stylistic edit applied to an accepted manuscript after peer review and the editorial acceptance decision, and before typesetting/layout — correcting grammar, spelling, and punctuation, and enforcing the journal or publisher's house style (commonly built on a named style guide such as AMA, APA, or Chicago) and internal consistency in terminology, abbreviations, units, and formatting, without altering the manuscript's structure, argument, or content.
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21 CFR Part 11: Electronic Records & Signatures - CASRAI (2026)
21 CFR Part 11 is FDA's regulation establishing the criteria under which an electronic record or electronic signature is considered trustworthy, reliable, and equivalent to a paper record or handwritten signature, for any record an FDA predicate rule (e.g., Good Clinical Practice, Good Manufacturing Practice, Good Laboratory Practice) already requires a regulated organization to create, modify, maintain, archive, retrieve, or transmit. It does not create new record-keeping obligations on its own – and, per FDA's 2003 scope-and-application guidance, its full electronic-record controls apply only when the record is maintained electronically in place of paper to satisfy that predicate requirement.
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Investigational Medicinal Product (IMP) - CASRAI (2026)
An Investigational Medicinal Product (IMP) is the EU and UK clinical-trials regulatory term (Regulation (EU) No 536/2014, Article 2(2)(5); the UK's Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031, as amended) for a medicinal product – a drug, biologic, or placebo – that is being tested or used as a reference in a clinical trial, including an already-authorised product used, formulated, or packaged differently than its approved marketing authorisation, used for an indication it isn't approved for, or used to gain further information about an approved use. It is functionally equivalent to, but not the same regulatory term as, the US FDA's "investigational new drug" (21 CFR 312.3) or the ICH E6 GCP-harmonised umbrella term "investigational product" (E6(R2) §1.33).
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HIPAA in Clinical Research - CASRAI (2026)
A research activity falls under 'HIPAA in clinical research' when a HIPAA covered entity (or its business associate) creates, uses, or discloses protected health information (PHI) in connection with a systematic investigation designed to develop or contribute to generalizable knowledge (45 CFR 164.501). Because research is not treatment, payment, or health care operations, the Privacy Rule's general TPO permissions do not apply – a covered entity may use or disclose PHI for research only through one of the pathways the Rule specifically authorizes: (1) a subject-signed Authorization meeting the core-element and required-statement standards of 45 CFR 164.508; (2) an IRB- or Privacy Board-granted waiver or alteration of Authorization under 45 CFR 164.512(i), documented against the Rule's minimal-risk criteria; (3) disclosure as a Limited Data Set under a Data Use Agreement (45 CFR 164.514(e)); (4) de-identification under the Safe Harbor or Expert Determination method (45 CFR 164.514(a)-(b)), which removes the data from HIPAA's scope entirely; or (5) narrower exceptions for reviews preparatory to research and for research on a decedent's information (both at 45 CFR 164.512(i)(1)). HIPAA governs this data-privacy layer only – it is a separate federal regulatory regime from the Common Rule (45 CFR 46) and FDA human-subjects regulations that govern the ethical conduct of the research itself (IRB review, informed consent to participate). A single study involving PHI at a covered entity typically must satisfy both regimes concurrently, through separate, though often procedurally combined, analyses and documents.
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Good Laboratory Practice (GLP) - CASRAI (2026)
Good Laboratory Practice (GLP) is the FDA quality-system regulation (21 CFR Part 58) governing how nonclinical (preclinical) laboratory safety studies — chiefly animal toxicology and safety-pharmacology studies — are planned, conducted, monitored, recorded, and reported when submitted to support an IND, NDA, BLA, or other FDA research or marketing application; internationally, the OECD Principles of GLP serve the same function under the Mutual Acceptance of Data (MAD) system.
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Biosafety Level (BSL) - CASRAI (2026)
The graded laboratory-containment classification – BSL-1 through BSL-4 – assigned under the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) framework, combining a biological agent's Risk Group with the specific laboratory practices, personal protective equipment, and facility engineering controls a given protocol requires. For research involving recombinant or synthetic nucleic acid molecules, the BSL is formally assigned through an Institutional Biosafety Committee (IBC) risk assessment under the NIH Guidelines before any lab work may begin.
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Pseudonymisation - CASRAI (2026)
Under GDPR Article 4(5), pseudonymisation is the processing of personal data so that it can no longer be attributed to a specific data subject without additional information, provided that additional information is kept separately and is protected by technical and organisational measures ensuring non-attribution. Pseudonymised data remains personal data under GDPR (Recital 26) because re-identification stays technically possible with the separately-held key — unlike anonymised data, where re-identification is not reasonably possible and GDPR no longer applies. GDPR Article 89(1) names pseudonymisation directly as an accepted safeguard for processing personal data for scientific/historical research, archiving in the public interest, or statistical purposes, supporting research-specific derogations from certain data subject rights.
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PROV-O (Provenance Ontology) - CASRAI (2026)
PROV-O is the W3C's OWL2 ontology (a W3C Recommendation since 30 April 2013) for expressing data provenance as machine-readable RDF: it defines Entity (a thing with fixed aspects), Activity (something that acts upon or generates entities over time), and Agent (something responsible for an activity or entity), connected by properties such as wasGeneratedBy, used, wasAssociatedWith, and wasDerivedFrom.
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R33 (NIH Exploratory/Developmental Grant) - CASRAI (2026)
An NIH R-series research grant activity code that funds the second, expanded-development phase of a milestone-driven, two-phase award — typically paired with an R21 or R61 exploratory first phase (as "R21/R33" or "R61/R33") — where transition into R33 funding depends on NIH confirming predefined go/no-go milestones were met, rather than a new competing application.
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Canada Research Chair (CRC) - CASRAI (2026)
A Canada Research Chair (CRC) is a Tier 1 or Tier 2 professorship funded through the Government of Canada's Tri-Agency Canada Research Chairs Program (CIHR, NSERC, and SSHRC) and held at an eligible Canadian postsecondary institution; only the institution, not the individual researcher, nominates a candidate for a chair, against a fixed allocation of chairs assigned to that institution.
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Clinical Research Coordinator (CRC) - CASRAI (2026)
A Clinical Research Coordinator (CRC) is the site-based professional who manages the day-to-day conduct of a clinical trial at a single investigational site under the delegation and direction of the Principal Investigator (PI) – screening and consenting participants, scheduling and conducting study visits, entering data into case report forms, and maintaining source documents and regulatory files in compliance with the protocol, Good Clinical Practice (GCP), and applicable regulations. A CRC is employed by the investigational site itself (a hospital, academic medical center, or dedicated trial site), not by the trial sponsor or a contract research organization (CRO) – this employer/authority distinction is what separates a CRC from a Clinical Research Associate (CRA), who is sponsor/CRO-employed and independently monitors a portfolio of sites, including verifying the CRC's own source data, rather than executing day-to-day site operations.
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Scopus - CASRAI (2026)
Scopus is Elsevier's proprietary, subscription-based abstract-and-citation database of peer-reviewed journal articles, conference proceedings, books, and book chapters, launched in November 2004. A title is "in Scopus" only once Elsevier's Content Selection and Advisory Board has evaluated and accepted it against criteria including peer-review policy, publication ethics, and editorial diversity — inclusion is an ongoing editorial decision, not automatic, and previously indexed titles can later be suspended or discontinued if they stop meeting those criteria.
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Federalwide Assurance (FWA) - CASRAI (2026)
A Federalwide Assurance (FWA) is a written, time-limited agreement an institution files with HHS's Office for Human Research Protections (OHRP) committing the institution – not any single study – to comply with the Common Rule (45 CFR 46) for the nonexempt human-subjects research it conducts or supports through funding from HHS or any other U.S. federal department or agency that has adopted the Common Rule and relies on OHRP's FWA. It is signed by an institutional Signatory Official, names a Human Protections Administrator, and must designate at least one IRB already registered with OHRP to perform the review the FWA commits the institution to.
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Technology Control Plan (TCP) - CASRAI (2026)
An institutional document, developed and implemented by a research institution (typically coordinated by the export control office or research security office together with the Principal Investigator), that specifies the physical, IT, and administrative safeguards used to prevent unauthorized access to a specific set of ITAR- or EAR-controlled technology, technical data, software, or equipment. A TCP is required whenever controlled technology is present in a project or lab and no exclusion (fundamental research exclusion) or license exception/exemption fully removes the access restriction — most commonly because a foreign national who is not a US person, per 22 CFR 120.62 and 15 CFR 772.1, will otherwise have physical, visual, electronic, or oral access to the controlled item or data. Its defining feature is that it names the specific controlled technology, identifies by name and citizenship every individual authorized to access it, and sets out concrete, auditable controls — not general policy language — covering access restriction, physical and IT security, personnel screening, and training.
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FERPA (Family Educational Rights and Privacy Act) - CASRAI (2026)
FERPA (20 U.S.C. § 1232g; 34 CFR Part 99) is the U.S. federal law giving eligible students privacy rights over their education records and restricting a federally funded institution from disclosing personally identifiable information from those records without consent; a research project is subject to FERPA whenever it accesses, uses, or receives education records the institution already maintains — as distinct from new data collected directly from consenting participants — and the institution may disclose those records only under a recognized exception (school official, studies exception, de-identified/coded data, or directory information) or with the eligible student's written consent.
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Technology Readiness Level (TRL) - CASRAI (2026)
A rating on a standardized 1-9 scale describing how mature a specific technology is, from basic scientific principles observed and reported (TRL 1) through an actual system proven through successful operations in its real deployment environment (TRL 9). Originally developed at NASA in the 1970s and formalized as a nine-level scale in the early 1990s, TRL (used interchangeably with the phrasing "technical readiness level") is assigned to a technology based on demonstrated physical/functional maturity alone – what has actually been built and tested, and under what conditions – independent of funding source, patent status, or commercial promise. The U.S. Department of Defense, the Department of Energy, the European Commission (Horizon Europe), and university technology transfer offices (TTOs) all use the same nine-level scale, with only minor wording differences at the upper levels.
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Bayh-Dole Act - CASRAI (2026)
The Bayh-Dole Act (Public Law 96-517, enacted December 12, 1980, codified at 35 U.S.C. §§ 200–212) is the federal statute allowing universities, nonprofit institutions, and small businesses to retain title to inventions made under federal funding agreements – grants, cooperative agreements, or contracts – in exchange for disclosing the invention to the funding agency, electing within a set window whether to keep title, filing a patent application, and accepting the government's retained rights, including a nonexclusive government-use license, march-in rights (35 U.S.C. § 203), and a U.S. manufacturing preference on exclusive licenses (35 U.S.C. § 204). It applies only to a 'subject invention' conceived or first reduced to practice under a qualifying federal award held by an eligible recipient; it does not apply to inventions made without federal funding.
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Trade Secret - CASRAI (2026)
Information that (1) derives independent economic value from not being generally known or readily ascertainable by others who could profit from it, and (2) is subject to reasonable efforts by its owner to maintain its secrecy, per the two-element definition shared by the federal Defend Trade Secrets Act (18 U.S.C. § 1839(3)) and the state-law Uniform Trade Secrets Act. Unlike a patent, a trade secret is never registered or examined by a government office and carries no fixed term: it lasts exactly as long as both elements continue to hold, and ends the moment either fails.
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Google Scholar Citations profile - CASRAI (2026)
A self-created, self-curated author page on scholar.google.com that displays a researcher's publications alongside auto-updating citation count, h-index, and i10-index figures computed from Google Scholar's own web index, distinct from database-issued author records such as a Scopus Author ID or an ORCID iD.
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Gateway to Research (GtR) - CASRAI (2026)
UKRI's free, public web portal (gtr.ukri.org) that publishes structured data on UKRI-funded research and innovation projects – overview, organisations, people, publications, and outcomes – for all seven UKRI research councils and Innovate UK, distinct from Researchfish, the grantee-facing system through which much of that outcome data is originally submitted.
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RRID (Research Resource Identifier) - CASRAI (2026)
A string of the form RRID: followed by an accession number issued by an authoritative source database (the Antibody Registry for AB_ numbers, Cellosaurus for CVCL_ cell-line codes, MGI/ZFIN/RGD/IMSR for model organisms, or SciCrunch's own SCR_ registry for software and databases) that resolves, via the SciCrunch resolver or a compatible resolver such as n2t.net, to a single curated record describing exactly one research resource. Developed through FORCE11's Resource Identification Initiative and maintained via SciCrunch's Resource Identification Portal, an RRID exists specifically so a research resource used in a study's methods can be cited unambiguously and traced across the literature, the way a DOI identifies a publication or an ORCID iD identifies a researcher.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Publication Bias - CASRAI (2026)
A study's result (statistically significant/positive vs. null/negative) measurably affects its odds of being submitted for and accepted into publication, so the published literature systematically over-represents positive findings relative to everything that was actually studied.
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UKRI Funding Service - CASRAI (2026)
The UKRI Funding Service is the single online platform (funding-service.ukri.org) that UK Research and Innovation (UKRI) and its seven research councils use to advertise funding opportunities, receive applications, and manage awards through to reporting. An application, account, or award is 'on the Funding Service' when it was created and processed through this platform rather than UKRI's retired Joint Electronic Submission (Je-S) system, which the Funding Service progressively replaced for competitive research council funding from 2023.
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Australian Research Council (ARC) - CASRAI (2026)
The Australian Research Council (ARC) is the Australian Government statutory agency that funds and, historically, evaluates research across all disciplines except clinical medicine and dentistry — a boundary set out in the ARC's own Medical Research Policy, which reserves funding for research into the causes, treatment, prevention, diagnosis, monitoring, or management of human disease for the National Health and Medical Research Council (NHMRC) instead. A grant, fellowship, or infrastructure award falls within the ARC's remit if it is administered through the ARC's National Competitive Grants Program (NCGP) — delivered via the Discovery Program or the Linkage Program — rather than through NHMRC's separate, parallel national competitive grants program.
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Clinical Outcome Assessment (COA) - CASRAI (2026)
A measure that describes or reflects how a clinical trial participant feels, functions, or survives, captured via a clinician's report (ClinRO), the patient's own report (PRO), a non-clinician observer's report (ObsRO), or a standardized performance task (PerfO) — used, per FDA's COA framework, as a direct measure of clinical benefit rather than a substitute (as a biomarker-based surrogate endpoint is).
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Contract Research Organization (CRO) - CASRAI (2026)
An organization counts as a Contract Research Organization (CRO) for a given clinical trial when a sponsor has contracted it, under a written agreement (per ICH E6(R2) Section 5.2 and, for FDA-regulated trials, 21 CFR 312.52), to assume one or more specific trial-related duties and functions – such as site management, monitoring, data management, biostatistics, pharmacovigilance, or regulatory submissions – on the sponsor's behalf. The sponsor retains ultimate responsibility for trial data quality and integrity regardless of which functions are transferred, and must actively oversee the CRO's performance of those functions, including any further subcontracted work.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Data Repository - CASRAI (2026)
A system or platform dedicated to the long-term storage, curation, preservation, and dissemination of research data, providing persistent identifiers, standardized metadata, and defined access/reuse terms – distinct from general-purpose file storage (a network drive or cloud folder), which does not guarantee a dataset stays findable, citable, or usable once active work on it ends.
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Clinical Research Associate (CRA) - CASRAI (2026)
A Clinical Research Associate (CRA) is the industry job title for the professional who performs the ICH E6(R2)-defined clinical trial "monitor" function on behalf of a trial sponsor or a contract research organization (CRO): overseeing an investigational site's conduct, verifying source data against case report forms, confirming protocol and Good Clinical Practice (GCP) compliance, and reporting site-visit findings back to the sponsor. CRAs are employed by the sponsor or a CRO – not by the investigational site itself – and typically travel to a portfolio of assigned sites across the life of a trial.
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Randomized Controlled Trial (RCT) - CASRAI (2026)
A prospective clinical study design in which participants are allocated to two or more comparison groups purely by chance (randomization), with at least one group — the control arm — receiving a placebo, an active comparator, or standard-of-care rather than the intervention under investigation. Randomization is what distinguishes an RCT from an observational study; the presence of a control arm is what distinguishes it from a single-arm trial. Blinding (masking) of participants, investigators, or outcome assessors is a common but analytically separate design feature — an RCT can be randomized, controlled, and still unblinded (open-label).
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Clinical Research Assistant - CASRAI (2026)
An entry- to early-career, site-based clinical trial support role that assists study staff with participant scheduling, data entry, specimen handling, and documentation under supervision – without independent authority to monitor site compliance, review regulatory documents, or verify source data, which distinguishes it from a Clinical Research Associate (CRA).
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Research fellow - CASRAI (2026)
A "research fellow" is a job title used inconsistently across academic systems for a doctorate-holder in a research-focused role – and the two dominant conventions genuinely disagree. In UK/Commonwealth usage, it commonly names a distinct, more senior career grade on a research-only pathway that sits above the entry-level postdoctoral stage (research associate), may be fixed-term or open-ended depending on institution, and can carry a moderate amount of teaching and/or postgraduate supervision. In US usage, it is applied inconsistently: sometimes as a direct synonym for "postdoc" (especially for fellowship-funded, as opposed to grant-funded, positions), and sometimes for a more senior non-tenure-track research faculty rank distinct from the postdoc stage. The title alone does not reliably signal seniority across borders – contract type, funding mechanism, and years post-PhD have to be checked directly.
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Co-First Authorship - CASRAI (2026)
The convention of designating two or more authors as having contributed equally to a work, typically signaled by a shared symbol (a dagger or asterisk) next to each name resolving to a footnote such as "These authors contributed equally to this work." Co-first authorship does not replace or loosen the underlying authorship test – every co-first author must still independently meet the applicable authorship criteria (most commonly ICMJE's four-part test) – it only clarifies that the printed byline order should not be read as a ranking of relative contribution among the marked names. It is a first-author-position-specific instance of the broader equal-contribution signalling convention covered generally by co-authorship.
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Corresponding Author - CASRAI (2026)
The author formally designated, usually at submission, as a manuscript's single point of contact with a journal — responsible for administrative correspondence during submission and peer review, and for remaining reachable for reader queries, data requests, and correction or retraction correspondence after publication. The designation is independent of author order: it can, but need not, be the same person as the first or senior author.
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Core metadata - CASRAI (2026)
The minimal, standard set of descriptive fields — typically title, creator, date, persistent identifier, subject/keywords, format, and rights — that a dataset or research output must carry in order to be findable and citable, independent of any richer, discipline-specific metadata layered on top of it.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

TCPS2 (Tri-Council Policy Statement) - CASRAI (2026)
TCPS2 is the joint policy of Canada's three federal research funding agencies (CIHR, NSERC, SSHRC) that sets the ethical principles and requirements Research Ethics Boards (REBs) apply when reviewing research involving human participants, their data, or their biological materials, and compliance with it is a condition of institutional eligibility for Tri-Agency funding.
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Scientific Advisory Board (SAB) - CASRAI (2026)
An external, independent panel of subject-matter experts convened by a company, research institution, foundation, or funded program to advise leadership on scientific direction and strategy — which programs, indications, or research questions to prioritize, and how the organization's science compares with the field. An SAB is advisory only: it has no governing, regulatory, or fiduciary authority, no independent power to approve, halt, or modify a specific study or protocol, and its recommendations are non-binding.
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Qualitative Research - CASRAI (2026)
An approach to research, not a single method, defined by four things holding together across a whole study: it collects non-numeric data (words, images, observed behavior, or documents) as primary evidence; it asks a meaning- or process-focused question rather than one aimed at measuring a variable or testing a pre-specified hypothesis; its analysis is iterative and inductive, developing codes and themes from the data itself, often while more data is still being collected; and it reports findings as contextualized, thick description rather than a statistical estimate. A study counts as qualitative research only when this bundle governs the design end-to-end, not merely because some of its raw data happens to be text.
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Co-Authorship - CASRAI (2026)
The state of two or more people jointly meeting the criteria for authorship on the same output (most commonly the ICMJE's four-part test), which each co-author must satisfy independently – co-authorship itself is not a separate authorship test but the layer of practice that governs how a qualifying group of authors is organized: byline order (contribution-ranked, alphabetical, or chronological, depending on field convention), whether an equal-contribution note is used, who is designated corresponding author (or co-corresponding authors), and, for cross-institutional teams, how each author's affiliation is listed and which institution mediates if a dispute arises. Co-authorship does not require a shared institution, funder, or country.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Creative Commons License - CASRAI (2026)
A standardized, pre-written public copyright license published by Creative Commons that a rights holder attaches to a work to grant reusers specified permissions (attribution, share-alike, noncommercial, no-derivatives, in any standard combination) in advance, without individual negotiation. CC0 is a related public-domain dedication, not technically a license.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Abstract - CASRAI (2026)
A standalone summary placed at the start of a research paper that states the study's purpose or background, methods, principal results, and conclusions in enough detail that a reader or an indexing database (e.g. PubMed, Scopus, Web of Science) can judge the paper's relevance and content without reading the full text. An abstract is standalone in a specific operational sense: it must be intelligible on its own, so it does not cite other works by reference number, does not rely on abbreviations defined only in the body text, and does not assume the reader has already read (or will go on to read) any other part of the paper. Journals require either a structured abstract (explicit labeled subsections, e.g. Background, Methods, Results, Conclusions) or an unstructured abstract (a single continuous paragraph covering the same elements), and each journal sets its own word limit, most commonly somewhere in the 150-350 word range.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Patent Prosecution - CASRAI (2026)
Patent prosecution is the administrative process of pursuing a patent grant from a patent office (the USPTO in the US, or a foreign equivalent such as the EPO) – drafting and filing the application, responding in writing to the examiner's office actions, amending claims, and carrying the application through to allowance and issuance. It is distinct from patent litigation, which enforces or challenges a granted patent's validity in court after the fact.
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Science Citation Index (SCI/SCIE) - CASRAI (2026)
A journal is considered SCI/SCIE-indexed when it has been formally evaluated and accepted by Clarivate into the Science Citation Index Expanded — the sciences-scoped citation index within the Web of Science Core Collection — based on Clarivate's editorial quality criteria (peer review, editorial rigor, ethical publishing standards) and impact criteria (citation influence). Indexing is not permanent: a journal can be added, and can later be suspended or delisted, if it stops meeting those criteria.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Scientific Review Committee (SRC) - CASRAI (2026)
An institutional committee — distinct from the IRB — that reviews a research protocol’s scientific merit and feasibility (originality, study design, statistical plan, and accrual feasibility) before or alongside IRB ethical review. Most commonly a formal requirement at NCI-designated cancer centers, where it forms part of the NCI-mandated Protocol Review and Monitoring System governing cancer clinical trial protocols.
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SBIR (Small Business Innovation Research) - CASRAI (2026)
A U.S. federal program, established by the Small Business Innovation Development Act of 1982, that reserves a statutory share of participating agencies' extramural R&D budgets for phased, non-dilutive (no equity, no government IP claim) Phase I/II awards to small, for-profit businesses developing technology with both federal-mission relevance and commercial potential; the awardee of record must always be the small business itself, never a university.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Journal Reviewer - CASRAI (2026)
A journal reviewer (also called a peer reviewer or referee) is a subject-matter expert an editor invites, from outside the journal's own staff, to independently evaluate a submitted manuscript's validity, originality, significance, and clarity, then report a written assessment and a recommendation — accept, revise, or reject — back to the editor who requested it. Someone is a journal reviewer only while performing this evaluator role for a specific editor and a specific submission: it is a per-manuscript assignment, not a standing staff position, an authorship credit, or publication-decision authority in its own right.
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Authorship - CASRAI (2026)
The formal status of being credited, by name, as a creator of a scholarly or scientific output (an article, dataset, software package, preprint, or similar citable work) because the named person meets a publisher's or field's explicit authorship criteria – most commonly the ICMJE's four-part test: substantial contribution to the work's conception, design, or data; drafting the work or reviewing it critically for important intellectual content; final approval of the version to be published; and agreement to be accountable for all aspects of the work. All four conditions must be met together (an AND test, not an OR test) – meeting some but not all of them qualifies a person for acknowledgement, not authorship. Authorship is deliberately narrower than 'did real work on this': doing qualifying work without being listed is a form of misattribution (ghost authorship), and being listed without doing qualifying work is also a form of misattribution (gift/honorary authorship).
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CrossMark - CASRAI (2026)
A Crossref member service in which a publisher embeds a button on a published item (its HTML landing page, PDF, and/or ePub) that a reader can click to check the item's current status directly from within the item itself, rather than having to separately search the publisher's site. Clicking the button opens a panel showing whether the record has been updated since original publication – including a correction, retraction, expression of concern, or one of the other editorially significant update types Crossref's schema defines – alongside supporting metadata such as key dates (submission, revision, acceptance), funder information, licence terms, handling editors, and peer-review information where the publisher has chosen to provide it. A publication only counts as CrossMark-enabled if its publisher has (a) registered a DOI-assigned update policy, (b) referenced that policy in the item's Crossref metadata record even when no update yet exists, and (c) implemented the button so the status check happens at the item, not just on a separate corrections page a reader would have to know to look for.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Darwin Core - CASRAI (2026)
A data standard ratified by TDWG (Biodiversity Information Standards) — a glossary of defined terms organized into a small set of classes (Occurrence, Taxon, Event, Location, MaterialEntity, Identification, and others) — used to structure and exchange biodiversity data documenting the occurrence of organisms and the specimens or observations that record them. A dataset counts as Darwin Core data when its fields are actually mapped to defined Darwin Core terms (e.g. dwc:scientificName, dwc:eventDate, dwc:decimalLatitude), not merely because it describes species or specimens in some other format.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Ecological Metadata Language (EML) - CASRAI (2026)
The XML-based metadata specification (current stable release EML 2.2.0) used to document a research dataset, or an associated literature/software/protocol resource, as a single machine-readable package: its identity and citation information, collection methods and sampling design, taxonomic/geographic/temporal coverage, and the structure and attributes of its constituent data tables or other entities. Something is an EML record if it validates against the EML XML schema maintained via the NCEAS/eml specification and describes a dataset (or related resource) at the package level, rather than encoding the individual records within that dataset.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

RightsLink - CASRAI (2026)
RightsLink is the automated permission-clearance and licensing platform operated by the Copyright Clearance Center (CCC), embedded on the article or book-chapter page it covers as a "Get Rights and Content" / "Request Permissions" control. A given reuse falls under RightsLink when the underlying content is traditionally copyrighted (all rights reserved, or held by the publisher under a copyright transfer agreement) and the reader needs the rightsholder's affirmative permission before reusing it beyond fair use/fair dealing – e.g., republishing a figure, including an excerpt in a coursepack, or translating a chapter. Clicking the control routes the request through CCC's hosted workflow, which returns either a generated price and license, a no-fee license for many standard academic uses, or escalates to the publisher's rights department for non-standard requests.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Debarment and suspension verification (SAM.gov) - CASRAI (2026)
Verifying, before a subaward or covered federal contract, that the other party and its principals are not debarred, suspended, or excluded from federal funds. Required by 2 CFR 200.214 and 2 CFR Part 180 via a SAM.gov Exclusions search, a signed certification, or a contract clause under 2 CFR 180.300.
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Cost Accounting Standards Disclosure Statement (DS-2) - CASRAI (2026)
A formal document, tied to 2 CFR 200.419 and reproduced as Appendix III to 2 CFR Part 200, in which an institution of higher education (IHE) describes how it accounts for costs charged to federally sponsored awards – how it distinguishes direct costs from Facilities & Administrative (F&A/indirect) costs, and how it treats items such as depreciation, leave, and deferred compensation. Any IHE receiving an aggregate total of $50 million or more in federal awards subject to Subpart E of the Uniform Guidance during its most recently completed fiscal year is subject to the Cost Accounting Standards Board's standards CAS 501, 502, 505, and 506 (48 CFR 9905.501, .502, .505, .506) – consistency in estimating/accumulating/reporting costs, consistency in allocating costs incurred for the same purpose, accounting for unallowable costs, and cost accounting period, respectively. Before 1 October 2024, crossing that same $50 million threshold also created a standalone obligation to file a DS-2 with the institution's cognizant federal agency for indirect costs (usually HHS or the Department of Defense's Office of Naval Research, assigned by whichever agency provides the majority of the institution's federal funding). OMB's April 2024 revision to the Uniform Guidance, effective for awards made on or after 1 October 2024, removed the standalone DS-2 filing requirement from the regulatory text – the underlying obligation to comply with CAS 501/502/505/506 at the $50 million threshold was not removed, only the separate mandate to submit a dedicated disclosure form documenting it. In practice, many institutions still maintain a DS-2-format document as their internal cost-accounting governance record and as the basis for F&A rate negotiations, even though a fresh regulatory filing is no longer independently required.
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Retraction Watch - CASRAI (2026)
An independent, non-CASRAI nonprofit project — a blog plus the Retraction Watch Database — that identifies, documents, and publicly reports individual retractions, expressions of concern, and corrections across the scholarly literature. It aggregates and investigates after a publisher's own retraction decision; it has no editorial or regulatory authority to retract anything itself.
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Extended level certification (trustworthy repository) - CASRAI (2026)
The middle tier of a three-level trust framework for research-data repositories, positioned above core level (CoreTrustSeal, a peer-reviewed self-assessment against 16 requirements) and below formal level (ISO 16363, a full external audit). A repository holds extended level certification when it has been awarded the nestor Seal for Trustworthy Digital Archives — a plausibility-checked self-assessment against the 34 criteria of the German standard DIN 31644, administered by the nestor competence network at the Deutsche Nationalbibliothek. It is more rigorous than a core-level self-assessment (more criteria, external plausibility review of the evidence submitted) but, unlike formal level, does not involve an accredited external auditor conducting an on-site or fully independent audit.
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ANSI/NISO Z39.106-2023 (Peer Review Terminology Standard) - CASRAI (2026)
The ANSI/NISO standard (Z39.106-2023, Standard Terminology for Peer Review, published July 5, 2023; DOI 10.3789/ansi.niso.z39.106-2023; ISBN 978-1-950980-27-7) that gives journals and publishers a common, structured vocabulary for describing how a manuscript's peer review was actually conducted. Developed from a taxonomy first built by an STM Association working group (convened 2019, brought to NISO in 2021) and refined through public comment and publisher piloting, it organizes description around four dimensions: (1) identity transparency — e.g. single anonymized, double anonymized, all identities visible; (2) who the reviewer interacts with — e.g. editor only, author and editor; (3) what review information is published alongside the article — e.g. none, reviewer identities, review reports, decision letters; and (4) whether post-publication commenting is enabled. A journal's peer-review policy is described using Z39.106 terminology when it states a position on all four dimensions with the standard's controlled terms, rather than a single unqualified label like "blind" or "peer reviewed."
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

NISO Alternative Assessment Metrics (Altmetrics) Initiative - CASRAI (2026)
A NISO-run standards-development initiative (2013–2016), funded by the Alfred P. Sloan Foundation, whose three working groups on (A) definitions and use cases, (B) output types and persistent identifiers, and (C) data quality produced NISO RP-25-2016, “Outputs of the NISO Alternative Assessment Metrics Project” (September 2016) — the first community-vetted recommended practice covering altmetrics terminology, use cases, non-traditional output types, and provider transparency (via the associated Altmetrics Data Quality Code of Conduct). Something counts as an output of this initiative if it was produced by one of its three working groups and published in or alongside RP-25-2016. It names the specific NISO project and its documented deliverables — not the general altmetrics concept those deliverables define, and not any single vendor's proprietary scoring methodology, which the initiative explicitly did not attempt to standardize.
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NISO Access and License Indicators (ALI) - CASRAI (2026)
NISO RP-22: machine-readable metadata (free_to_read, license_ref) letting systems determine an article's access status and reuse terms without parsing prose.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

DOAJ Native XML schema - CASRAI (2026)
DOAJ Native XML is the XML metadata format that DOAJ (Directory of Open Access Journals) defines and maintains for publishers to submit article-level metadata directly into DOAJ's index: title, authors and their ORCID iDs, affiliations, abstract, DOI, ISSN(s), volume/issue/page, publication date, and full-text URL. A file counts as an instance of this schema when it validates against DOAJ's own XSD (not a third-party schema) and arrives through one of DOAJ's inbound submission channels — file upload via a publisher's DOAJ account, DOAJ's API, or an OJS (Open Journal Systems) export plugin that generates DOAJ-conformant XML automatically. It is one of two XML dialects DOAJ accepts for article submission, the other being Crossref XML (versions 4.4.2 or 5.3.1); the two cannot be mixed within a single upload file, and a Crossref XML submission must carry an ISSN for DOAJ to process it.
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NISO Recommended Practice (RP) - CASRAI (2026)
A consensus-based guidance document published by the National Information Standards Organization (NISO) that describes an accepted, emerging, or leading-edge method, format, or convention for information exchange. A Recommended Practice is developed through NISO's normal working-group and public-comment process but is approved without the formal ANSI ballot of NISO's Voting Members that a full ANSI/NISO Standard requires, and it is identified with the sequential designation RP-[number]-[year] (e.g., RP-9-2014) rather than the Z39.xx numbering used for Standards.
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Researcher Profile Optimization Study (RPOS) - CASRAI (2026)
An in-progress Federal Demonstration Partnership (FDP) initiative, run under FDP's Open Government: Research Administration Data (OG:RAD) subcommittee, that surveys researchers and research-administration offices across FDP's member institutions to document how federally required researcher profile information – biosketches, current & pending support, and collaborator disclosures – is captured across agencies and platforms, and to recommend changes that reduce duplicate data entry and support interoperability, research security, and compliance.
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NISO Institutional Identifier (I2) - CASRAI (2026)
A now-inactive NISO initiative (2008–2013) whose output, ANSI/NISO RP-17-2013, is a Recommended Practice for identifying organizations in the scholarly information supply chain. It did not define a new identifier syntax of its own; instead it specified how to apply the existing ISNI standard (ISO 27729) to institutions. The working group has not been active since publishing the Recommended Practice in 2013, and I2 has no ongoing registry of its own — in current research-infrastructure practice, ROR is the identifier institutions actually register for and that funders, publishers, and CRIS systems require.
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Research Data Alliance (RDA) - CASRAI (2026)
The Research Data Alliance (RDA) is a global, community-driven organisation, launched in March 2013 by the European Commission, the US National Science Foundation, the US National Institute of Standards and Technology, and the Australian government, to build the social and technical infrastructure needed for open data sharing across disciplines, technologies, and national borders. RDA operates chiefly through two kinds of groups: time-bounded Working Groups, which typically run around 18 months and produce concrete, adoptable deliverables, and open-ended Interest Groups, which coordinate ongoing discussion, surveys, and less formal outputs across a topic area. Formally endorsed Working Group deliverables are published as RDA Recommendations; less formal outputs from any group type are published as Supporting Outputs. Something qualifies as "RDA" only when it refers to the organisation itself — its membership, governance (Council, Technical Advisory Board, Secretariat), plenaries, and working/interest-group structure — not to any single recommendation, schema, or standard an RDA group has produced, which are distinct, separately citable outputs.
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ORCID service - CASRAI (2026)
An affiliation entry in an ORCID record documenting an ongoing donation of a researcher's time or expertise to an organization or community — board, committee, or editorial-board membership, review panels, or extension work — captured with a role title, disambiguated organization identifier, and start/end dates.
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Clinical Trial Registration - CASRAI (2026)
The act of submitting a clinical trial's identifying and design information — sponsor, condition studied, intervention, key eligibility criteria, and primary/secondary outcome measures — to a recognized public clinical-trial registry (ClinicalTrials.gov or any other WHO ICTRP primary registry) so the trial's existence and design are publicly discoverable independent of whether or how its results are ultimately published. Registration identifies the trial before or during its conduct; posting the trial's results to the same registry after completion is a separate, later obligation (results reporting), not part of registration itself.
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Prospective Clinical Trial Registration - CASRAI (2026)
Registration of a clinical trial in a public, WHO-recognized registry (for example ClinicalTrials.gov or another WHO ICTRP primary registry) at or before the date of first participant consent for enrollment — ICMJE's operative date is when the registry record was submitted, not when it was posted publicly. Registration submitted after enrollment has already begun is retrospective, not prospective, regardless of how far before manuscript submission it occurs.
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Double-anonymized peer review - CASRAI (2026)
A manuscript review model in which neither party can identify the other during review: the reviewer does not know who the author is, and the author does not know who the reviewer is, up to and including the editorial decision. A given review counts as double-anonymized only if both conditions hold - the manuscript file sent to reviewers has been stripped of author names, affiliations, and other directly identifying material, and the editorial system withholds reviewer identity from the author throughout. Withholding only one identity (author-blind but reviewer known, or vice versa) is single-anonymized review, not double.
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ITAR and EAR - CASRAI (2026)
The two primary US federal regimes restricting the export of controlled items, software, technology, and technical data to foreign persons or destinations. The International Traffic in Arms Regulations (ITAR, 22 CFR 120-130) are administered by the State Department's Directorate of Defense Trade Controls (DDTC) and cover defense articles, services, and technical data on the US Munitions List (USML). The Export Administration Regulations (EAR, 15 CFR 730-774) are administered by the Commerce Department's Bureau of Industry and Security (BIS) and cover dual-use items (civil plus military/WMD-related applications) on the Commerce Control List (CCL), classified by an Export Control Classification Number (ECCN). A given controlled item or technical data set falls under one regime or the other, determined by its classification, not by the institution's general research posture.
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Exempt human subjects research - CASRAI (2026)
Human subjects research that an institution's IRB or another authorized reviewer — never the investigator personally — has formally determined falls within one of the eight categories listed at 45 CFR 46.104(d) of the U.S. Common Rule, and has accordingly been relieved from the initial full-board or expedited review pathway and from ongoing continuing review. 'Exempt' describes the outcome of a review decision, not an absence of review: a study is not exempt merely because an investigator judges it low-risk, anonymous, or otherwise harmless. It becomes exempt only once someone with institutional authority has checked the protocol against the specific regulatory category and recorded that determination, typically through the IRB office rather than a convened committee meeting. Four of the eight categories — (d)(2), (d)(3), (d)(7), and (d)(8) — additionally require a 'limited IRB review' of privacy, confidentiality, or broad-consent safeguards before the exemption applies, so even exempt research can pass through IRB scrutiny once; it is only relieved of the continuing, ongoing review that non-exempt research remains subject to.
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ICMJE (International Committee of Medical Journal Editors) - CASRAI (2026)
Working group of medical journal editors whose Recommendations set de facto authorship, disclosure, and trial-registration standards, not a formal regulator.
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Ethics approval statement - CASRAI (2026)
A statement within a manuscript — typically in the Methods or a dedicated ethics-declarations section — asserting that a study involving human participants, human data or tissue, or animals received prior approval from a named, independent ethics review body, and identifying that body, an approval or protocol reference number, and the date of approval (or documenting an applicable exemption or waiver), sufficient for an editor or reader to verify that ethical oversight preceded the research rather than merely occurred at some point.
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Single-anonymized peer review - CASRAI (2026)
The peer-review model in which reviewers are told the identity of a manuscript's authors, but authors are not told the identity of the reviewers assessing their work. Traditionally called "single-blind" review — the STM Association's 2020 peer-review terminology recommends "single-anonymized" instead, since "blind"/"blinded" have an ableist origin, though "single-blind" remains in very wide use in journal policy pages and search queries for the identical practice. It is the long-standing default across most STEM and biomedical publishing, including the majority of Elsevier, Springer Nature, and Wiley journals in those fields, and is distinguished from double-anonymized review (both parties' identities withheld from each other) and open review (some part of the process — identities, reports, or both — made public, before or after publication).
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euroCRIS - CASRAI (2026)
euroCRIS is the international not-for-profit membership association of research-information professionals and institutions that holds custodianship of the CERIF data model and coordinates community infrastructure (the DRIS directory, the CRIS Conference, membership meetings, working groups) for interoperability among Current Research Information Systems. Something qualifies as "euroCRIS" only if it refers to the organisation itself — its governance, membership, task groups, and services — not the CERIF standard or a CRIS software product it helps make interoperable.
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Principles of Transparency and Best Practice in Scholarly Publishing - CASRAI (2026)
A joint framework of 16 disclosure and practice criteria — organized around journal content (name, website, publishing schedule, archiving), journal practices (publication ethics and editorial policies, peer review, access, copyright and licensing), organization (ownership and management, an advisory body, a named editorial team with contact information), and business practices (author fees, other revenue sources, advertising, direct marketing) — jointly developed and maintained by the Committee on Publication Ethics (COPE), the Directory of Open Access Journals (DOAJ), the Open Access Scholarly Publishers Association (OASPA), and the World Association of Medical Editors (WAME). First published in December 2013; subsequent versions were released in 2015, January 2018 (v3), and September 2022 (v4, the current version). A journal or publisher is an instance of 'meeting the Principles' when each of the 16 items is disclosed, verifiable, and consistent with what the framework specifies — not when a publisher merely asserts general trustworthiness. COPE, DOAJ, and OASPA each use the Principles as part of their own membership/indexing assessment criteria, and WAME applies them as part of its membership evaluation — meaning the framework functions as an operational, checkable definition of what a legitimate journal must show, not an aspirational statement. Compliance with the Principles is also cited as one of the criteria major indexing services (e.g. Scopus) weigh when assessing a journal for inclusion, though each index applies its own separate, additional criteria on top of it.
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ORCID Invited Position - CASRAI (2026)
An affiliation item in an ORCID record asserting that the iD holder holds or held a paid or unpaid invited role — such as a visiting lectureship, honorary or guest-researcher appointment, or emeritus professorship — at a named organisation, as distinct from an ordinary employment relationship. Captured with the organisation's name and disambiguated identifier (typically a ROR ID), department, role/title, start date, and optional end date.
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Pending publication (Crossref) - CASRAI (2026)
A Crossref record type that lets a publisher (a Crossref member) register a DOI and a minimal metadata record – at minimum the member name, journal title, and the manuscript's accepted date – for a manuscript that has already cleared peer review and received a formal editorial acceptance decision, but has not yet been published online. Until the work is formally published, the DOI resolves to a Crossref-hosted landing page carrying an acceptance notice and the deposited metadata, not to the article itself. The publisher must later update that same DOI's metadata record to a full journal-article registration once the work is published; only then does the DOI resolve directly to the published content. A record qualifies as a pending publication only if it was deposited by the eventual publisher for an already-accepted manuscript – an unrefereed preprint, or a manuscript still under review, does not qualify.
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Responsible Conduct of Research (RCR) training - CASRAI (2026)
Funder-mandated instruction, required of specific categories of NIH- and NSF-supported researchers and trainees, covering a defined set of research-ethics and integrity topics (authorship, data management, mentoring, peer review, research misconduct, conflicts of interest, and related areas) — distinct from a general institutional code-of-conduct orientation because its topic list, format, and recurrence are set by the funding agency, not the institution alone.
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Metascience - CASRAI (2026)
The empirical, quantitative study of science itself: applying research methods to research methods, reporting practices, evaluation systems, and incentive structures, in order to describe how research is actually conducted and to test interventions that make it more reliable and efficient. Something counts as metascience when its object of study is the research process across a field — study design, statistical power, reporting completeness, peer review, replication rates, or how funding and career incentives shape researcher behavior — rather than a first-order scientific question within a specific discipline. Also called meta-research or, informally, "the science of science."
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OPEN Government Data Act - CASRAI (2026)
A federal agency data asset falls under the OPEN Government Data Act's open-by-default requirement when it was created by, collected by, or is under the control, direction, or maintenance of a federal agency, and its public release as machine-readable data in an open format under an open licence is not otherwise restricted by law (e.g., privacy, national security, confidentiality, or other statutory non-disclosure provisions). Agencies may weigh a cost-benefit analysis before converting an asset to an open format, but the statutory default is publication, not withholding.
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Lab Equipment Lifecycle Assessment - CASRAI (2026)
A structured environmental impact assessment of a laboratory instrument or equipment item across all life-cycle stages, from raw-material extraction and manufacture through use, maintenance, and end-of-life.
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Carbon accounting (research) - CASRAI (2026)
The systematic measurement, calculation, and reporting of greenhouse gas emissions across research activities, applying standard methodologies and emission factors to produce auditable CO2-equivalent totals.
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Scope 1 / 2 / 3 emissions (research org) - CASRAI (2026)
The categorisation of a research organisation's greenhouse-gas emissions following the GHG Protocol: scope 1 (direct on-site combustion), scope 2 (purchased electricity, heat, steam, cooling), and scope 3 (indirect emissions across the value chain, including procurement, commuting, travel, and waste).
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Climate impact statement (in DMP) - CASRAI (2026)
A structured section in a data management plan or research proposal that estimates and discusses the environmental impact of planned research activities, including travel, computing, equipment, consumables, and data storage.
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Climate-aware funding - CASRAI (2026)
Research funding policies and award practices that explicitly incorporate climate and environmental sustainability considerations into eligibility, proposal review, and reporting.
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Open infrastructure energy efficiency - CASRAI (2026)
The energy and carbon performance of shared, community-governed scholarly infrastructure (open repositories, identifier services, preservation systems), considered as part of the sustainability profile of the open scholarship ecosystem.
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Sustainable procurement (research) - CASRAI (2026)
The process of purchasing research goods and services with explicit consideration of environmental, social, and governance criteria across the full supply chain, in addition to price and performance.
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5R Framework (lab sustainability) - CASRAI (2026)
A hierarchical decision framework applied to laboratory consumables and waste: Refuse, Reduce, Reuse, Repurpose, Recycle, considered in that order of preference.
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Hybrid conference - CASRAI (2026)
A scholarly meeting that simultaneously supports in-person and remote participation, with intentional design choices to give remote attendees substantive interactivity rather than passive viewing.
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Virtual conference - CASRAI (2026)
A scholarly meeting held entirely online, with no physical venue or in-person attendance, using video-conferencing, virtual poster halls, and asynchronous discussion channels.
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Conference travel emissions - CASRAI (2026)
The subset of academic travel emissions specifically attributable to attendance at conferences, workshops, and scholarly meetings.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0

Travel emissions (academic) - CASRAI (2026)
The greenhouse gas emissions arising from academic business travel, principally air travel for conferences, fieldwork, collaboration visits, and external examining.
dictionary_term; CASRAI Dictionary v2026.1; CC-BY 4.0