FAIR-Aware - CASRAI (2026)
FAIR-Aware is a free, self-guided online self-assessment questionnaire developed by DANS (Data Archiving and Networked Services, the Netherlands) to help researchers and data stewards gauge their own understanding of, and their dataset's likely alignment with, the FAIR Data Principles before depositing data in a repository. It was developed and refined through the FAIRsFAIR EU project, and its assessment metrics are built substantially on the indicators separately developed by the RDA FAIR Data Maturity Model Working Group — so a FAIR-Aware score gives a rough, self-reported proxy for how a dataset would likely perform against that more granular indicator set, without requiring the technical setup an automated tool needs.
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C2PA Content Provenance - CASRAI (2026)
C2PA content provenance refers to the tamper-evident metadata record — called a Content Credential — attached to a piece of digital media (image, video, audio, or document) under the technical specification published by the Coalition for Content Provenance and Authenticity (C2PA). C2PA is a standards initiative founded by Adobe, Microsoft, Intel, the BBC, and Truepic, since joined by a large roster of member organizations including Google, Meta, OpenAI, Amazon, and Sony. Its specification (versioned; C2PA 2.x as of 2026) defines a cryptographically signed, chained record of who or what created a piece of media, what tools or AI models touched it, and what edits were subsequently made — designed so a viewer can inspect that chain without having to trust a single central authority.
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AI Output Verification - CASRAI (2026)
AI output verification is the practice of checking generative-AI-produced content — text, code, data analysis, citations, or images — for accuracy, validity, and fabricated material before it is used, published, or relied upon in a research context. It is the necessary corollary to disclosure: telling a reader that an AI tool was used does not, on its own, discharge a researcher's responsibility for whether what the tool produced is actually correct. ICMJE's recommendations state that authors are responsible for all aspects of their work, including any content produced with the assistance of an AI tool, and must vouch for its accuracy and for the absence of plagiarism; COPE's position statement on AI tools similarly places responsibility for verifying AI-generated content on the human author rather than the tool, and does not permit an AI tool to be listed as an author precisely because it cannot take on that accountability.
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AI Transparency Marker - CASRAI (2026)
An AI transparency marker is a visible label, watermark, or embedded machine-readable metadata tag attached to a piece of content — text, image, audio, or video — to disclose that it was generated or substantially modified by an artificial intelligence system. The concept spans two related but distinct mechanisms: human-readable disclosure (a statement in a manuscript, caption, or figure legend that AI assistance was used) and technical marking embedded directly in the file itself (for example, a C2PA Content Credential or an invisible watermark) that software can detect even if the disclosure text is stripped or ignored.
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Contributor Role Ontology (CRO) - CASRAI (2026)
The Contributor Role Ontology (CRO) is a formal OWL ontology, developed by the data2health consortium and published via the OBO Foundry and NCBO BioPortal, that extends CASRAI's CRediT (Contributor Roles Taxonomy) into a machine-reasonable class hierarchy. Where CRediT defines a flat, non-hierarchical list of 14 contribution roles (Conceptualization, Data curation, Writing — original draft, and so on) intended for a human to pick from a fixed list on a manuscript submission form, CRO represents each role — plus additional roles beyond CRediT's 14 — as a formally defined ontology class with a unique persistent identifier in the form CRO:NNNNNNN, explicit parent/child relationships, and logical axioms suitable for automated reasoning and integration into knowledge graphs and biocuration systems.
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FAIR Implementation Profile (FIP) - CASRAI (2026)
A FAIR Implementation Profile (FIP) is a structured, machine-actionable declaration of the specific technology choices — repositories, metadata standards, identifier schemes, vocabularies, and access protocols — that a research community selects in order to implement the FAIR Guiding Principles (Findable, Accessible, Interoperable, Reusable) in practice. Each declared technology choice is called a FAIR Enabling Resource (FER). A FIP is normally produced through a structured question-and-answer process — historically in facilitated FIP Wizard workshops run by the GO FAIR Foundation, now increasingly self-service via the FIP Wizard 4.0 tool — and is published as an openly reusable dataset (in nanopublication-compatible, machine-actionable form, alongside human-readable PDF/Word/Excel/CSV exports) rather than kept as an internal policy document.
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NSF Common Forms - CASRAI (2026)
NSF Common Forms refers to the pair of standardized, NSPM-33-driven disclosure documents the US National Science Foundation requires on proposals – the Biographical Sketch and the Current and Pending (Other) Support statement – built to a shared structure across federal funders and generated through SciENcv rather than agency-specific templates. The 'common' in the name refers to the underlying form structure being shared across federal agencies implementing NSPM-33, not to NSF and other agencies sharing a single deadline: NSF's Common Forms mandate took effect in 2023, well before NIH's equivalent mandate, which did not take effect until proposals or reports due on or after January 25, 2026.
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Scholarly Communication Librarian - CASRAI (2026)
A scholarly communication librarian is an academic or research library position focused on an institution's engagement with the scholarly publishing and communication system, as distinct from traditional collection development and reference work. Typical responsibilities include interpreting and supporting compliance with open access policies (institutional and funder mandates), managing and populating the institutional repository, advising researchers on copyright and author rights in publisher agreements, administering article processing charge (APC) funds and transformative or read-and-publish agreements, and, at many institutions, supporting research data management and researcher identifier (ORCID) adoption.
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WHO International Clinical Trials Registry Platform (ICTRP) - CASRAI (2026)
The WHO International Clinical Trials Registry Platform (ICTRP), initiated in 2000 and operated by the World Health Organization, is a search portal and aggregation platform over a network of independently operated national and regional 'primary registries' – it is not itself a registry that a trial registers with directly. Each primary registry (ClinicalTrials.gov, the EU's CTIS, ISRCTN, ANZCTR, CTRI, ChiCTR, DRKS, JPRN, and others) independently meets WHO's registry-quality criteria and sends regular data feeds to ICTRP, which pools records into a single global, searchable database. A trial is registered once, with one primary registry, and becomes automatically discoverable through ICTRP's search portal.
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eduGAIN - CASRAI (2026)
eduGAIN is an interfederation service, operated by GÉANT, that interconnects independently operated national and regional research-and-education identity federations (such as InCommon in the United States, the UK federation, and their counterparts in dozens of other countries) under a common technical and policy framework. It does not issue identities or authenticate users directly – it lets a service provider that trusts its own national federation extend that trust to users from any other eduGAIN-connected federation, and vice versa, without negotiating bilateral trust agreements one federation at a time.
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Publons - CASRAI (2026)
Publons was a researcher-facing web platform, launched in 2012, that let researchers log, verify, and get credit for peer review and editorial work performed for academic journals, building a portable reviewer history and profile. Clarivate acquired Publons in 2017 and progressively integrated it with Web of Science; Clarivate retired Publons as a separate destination in 2022, migrating existing profiles and their verified review history into the native Web of Science Researcher Profile. Publons is a retired, absorbed product, not a currently operating independent service – content and guidance referring to 'signing up for Publons' or maintaining a separate Publons profile describes a discontinued workflow.
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Funnel Plot - CASRAI (2026)
A funnel plot is a scatter plot used in meta-analysis in which each included study's effect estimate (x-axis) is plotted against a measure of its precision – typically standard error, with precision increasing up the y-axis, or sometimes sample size directly. Under no bias and no meaningful heterogeneity, the plot should form a roughly symmetric, inverted funnel: small, low-precision studies scatter widely near the bottom, while large, high-precision studies cluster narrowly near the top, close to the pooled effect. Funnel plots are a diagnostic tool for so-called 'small-study effects' – the tendency for smaller studies in a meta-analysis to report systematically different (usually larger) effects than larger studies – not a direct measurement of publication bias itself.
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JOSS (Journal of Open Source Software) - CASRAI (2026)
JOSS is a peer-reviewed, diamond open-access academic journal, founded in 2016 under the Open Journals umbrella, that publishes short papers (roughly 750-1750 words) about research software rather than the software itself. Acceptance requires an OSI-approved open-source licence, substantial and feature-complete engineering work, adequate documentation and tests, and a version-specific DOI from an archiving service (e.g. Zenodo or figshare) obtained after review; accepted papers receive their own Crossref DOI.
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ORCID Member API - CASRAI (2026)
The ORCID Member API is the paid, OAuth-scoped tier of ORCID's API, available only to organizations holding ORCID membership, which lets a trusted party (an institution, publisher, funder, or recognition service the researcher has authorized) read and write specific sections of a researcher's ORCID record on the researcher's behalf. It is distinguished from the free Public API by write access and by the trusted-party permission model: the researcher grants scoped authorization and the member organization acts only within that scope. An integration that merely reads public ORCID data does not require the Member API.
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Problematic Paper Screener (PPS) - CASRAI (2026)
A free, public automated screening website, built and maintained by Guillaume Cabanac with Cyril Labbé and Alexander Magazinov, that flags candidate papers exhibiting tortured phrases, computer-generated text (SCIgen/Mathgen), or heavy reliance on retracted references ('Feet of Clay'), posting the results to PubPeer for human review rather than issuing findings itself.
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Citation File Format (CITATION.cff) - CASRAI (2026)
A CITATION.cff file is a plain-text, YAML-formatted metadata file, conforming to the Citation File Format schema, placed in the root of a code (or dataset) repository to record machine- and human-readable citation information – authors (ideally with ORCID iDs), title, version, release date, identifiers such as a DOI, and licence – so tools and humans can produce a correct, consistent citation without guesswork.
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NIH AI Policy - CASRAI (2026)
NIH AI policy is not one document but three separate NIH Guide notices, each governing a different actor at a different stage of the grant lifecycle: NOT-OD-23-149 (June 2023) prohibits NIH scientific peer reviewers from using generative AI tools to analyze applications or draft critiques, on confidentiality grounds; NOT-OD-25-132 (July 2025) tells applicants that NIH will not treat an application substantially developed by AI as an original idea, and caps any PI to six new/renewal/resubmission/revision applications per calendar year; and a May 2026 Extramural Nexus notice extends the standard federal research-misconduct definition (fabrication, falsification, plagiarism) to AI-related lapses in the conduct and reporting of already-funded research. Which rule applies to a given situation depends on which lifecycle stage - review, application, or funded-research conduct - it falls into.
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Sale-Leaseback (Equipment) - CASRAI (2026)
An equipment sale-leaseback is a two-part transaction, executed together, in which an institution that already owns a piece of equipment (1) sells it to a buyer-lessor at fair market value and (2) immediately leases the same equipment back for continued operational use. It qualifies as a distinct instance of this concept only when both legs occur as part of the same arrangement and the seller retains uninterrupted physical use of the asset; a disposal followed by acquiring different, replacement equipment is not a sale-leaseback, and a loan collateralized by owned equipment (with no transfer of title) is not a sale-leaseback either.
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Ancillary Materials in Cell Therapy Manufacturing - CASRAI (2026)
A raw material used during the manufacture of a cell, gene, or tissue-engineered product that contacts the cells or construct during processing but is not intended to remain in the final product administered to the patient (e.g., growth factors, cytokines, enzymes, selection reagents, culture media additives) – as distinct from a 'component,' which is a raw material deliberately carried through into the finished product. Qualification rigor is risk-tiered per USP General Chapter <1043>, based on the material's existing quality pedigree (cGMP manufacturing history, prior regulatory approval) versus weaker documentation such as research-use-only labeling.
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Temperature Monitoring Alarm - CASRAI (2026)
A temperature monitoring alarm is the notification component of a temperature monitoring system: the function that detects a monitored storage condition moving outside its defined safe range and actively alerts a responsible person, rather than simply recording the excursion for later review. A monitoring setup only has a functioning alarm – as distinct from a data logger that merely stores readings – when three things are true together: (1) a defined threshold (high, low, or both, and often a duration threshold to filter brief door-opening events from real excursions) triggers the notification automatically, without a person having to check a screen or download a log; (2) the notification reaches a specific accountable person or on-call rotation through a channel independent of a single point of failure, typically an escalation sequence – local audible/visual alarm, then app push or email, then SMS or automated phone call, then a secondary contact or central monitoring station if the first contact does not acknowledge within a defined window; and (3) the alarm's own function (power supply, connectivity, and trigger logic) is itself periodically tested and that testing is documented, since an alarm that has never been verified to actually fire is not meaningfully different from having no alarm.
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21 CFR Part 11 Temperature Monitoring - CASRAI (2026)
A temperature-monitoring system (freezer, refrigerator, incubator, or cold-room monitor) is accurately called "21 CFR Part 11 compliant" only when its electronic records – and any electronic signatures applied to them – meet 21 CFR Part 11 Subpart B/C requirements as actually configured, validated, and used at a specific site: a secure audit trail, unique attributable user accounts, documented system validation (IQ/OQ/PQ), retrievable retention, access controls, and (if used) compliant electronic signatures. It is a property of site-level configuration and validation, not a certificate a vendor sells.
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Thermal Cycler Specifications - CASRAI (2026)
Thermal cycler specifications are the documented set of performance parameters — block format and sample capacity, ramp rate, temperature accuracy and uniformity, gradient range, lid control, and connectivity/data-logging features — that a manufacturer publishes for a PCR instrument and that a buyer uses to compare models against a specific assay's requirements. In a procurement context, a spec sheet is not a marketing document to skim; it is the primary evidence a lab manager or procurement officer can hold a vendor to, and it is what should be cross-checked against method validation records, accreditation requirements, and service contracts before an order is placed. A thermal cycler that is technically capable of amplifying DNA does not necessarily meet the documented performance a regulated or accredited lab needs for a specific application — that gap is exactly what a specifications comparison is meant to close.
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Scientific Data Management System (SDMS) - CASRAI (2026)
A scientific data management system (SDMS) is laboratory software that automatically captures, indexes, and archives electronic data files generated by lab instruments (chromatography, spectroscopy, balances, plate readers, raw instrument logs) in their original native format, and makes that archive centrally searchable, version-controlled, and audit-trail-protected. It is distinguished operationally from a shared drive or manual file store by automated unattended capture direct from the instrument, metadata extraction that makes files findable without opening each one, and a tamper-evident audit trail logging every access, export, or modification attempt. An SDMS is the raw-data archive layer beneath a LIMS (sample/workflow/results management) and an ELN (experimental narrative record), and typically integrates with one or both rather than replacing either.
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True Lease vs. Finance Lease - CASRAI (2026)
A true lease (an operating lease under ASC 842) is an equipment lease where the lessor retains ownership for tax purposes, claims depreciation, and bears residual-value risk; the lessee simply expenses rental payments and, if there is a purchase option, it is priced at genuine fair market value. A finance lease (formerly called a capital lease under ASC 840) transfers substantially all the economic risks and benefits of ownership to the lessee – via a bargain purchase option, a lease term covering most of the asset's useful life, payments approximating the asset's fair value, or a specialized asset with no alternative use – so the lessee is treated as the owner for accounting and typically tax purposes, capitalizing the asset and recording depreciation and interest expense instead of rent.
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Veterinary Cytology - CASRAI (2026)
Veterinary cytology is the diagnostic technique of collecting, preparing, staining, and microscopically examining individual cells (rather than intact tissue architecture, as in histopathology) obtained from an animal by fine-needle aspiration, impression smear, scraping, swab, or body-fluid sampling, in order to characterize a lesion, mass, effusion, or organ as inflammatory, infectious, hyperplastic, or neoplastic — and, for neoplastic samples, to assess features consistent with malignancy. A sample or workflow counts as veterinary cytology, in the operational sense used here, when it involves: (1) a minimally invasive collection method that disaggregates or exfoliates cells rather than removing an intact tissue block; (2) a rapid stain (commonly a Romanowsky-type stain such as Diff-Quik, Wright-Giemsa, or new methylene blue for fluids) applied to an air-dried or fixed smear; and (3) microscopic interpretation — performed in-house by a trained veterinarian or veterinary technician, or referred to a board-certified veterinary clinical pathologist (Diplomate, American College of Veterinary Pathologists, ACVP-Clinical Pathology) — that produces a cytologic diagnosis or descriptive report distinct from a surgical histopathology report. Procurement and lab-management decisions in this category generally split into two connected questions: what in-house capability (microscope, stains, slide-prep supplies, staff training) a practice or diagnostic lab maintains for first-pass or triage interpretation, and which reference laboratory or telecytology service it uses for definitive, board-certified review — most practices use both, routing straightforward or urgent cases in-house and referring diagnostically challenging, potentially malignant, or medicolegally significant samples out.
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ELAP Certification (Environmental Laboratory Accreditation Program) - CASRAI (2026)
A laboratory holds ELAP certification when California's State Water Resources Control Board (Division of Drinking Water) has accredited it for specific matrix/analyte/method combinations, called "fields of accreditation," allowing it to perform environmental testing whose results can be used to satisfy California regulatory compliance reporting. Certification is field-specific rather than a single blanket credential, and it requires ongoing proficiency testing participation plus a documented quality management system consistent with the TNI Standard.
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What Is A2LA? American Association for Laboratory Accreditation Explained - CASRAI (2026)
A2LA (American Association for Laboratory Accreditation) is a US-based, nonprofit, third-party accreditation body, founded in 1978, that formally recognizes a testing/calibration laboratory, medical laboratory, inspection body, biobank, or certification body meets the requirements of a specific ISO/IEC conformity-assessment standard (e.g. ISO/IEC 17025 for testing and calibration labs, ISO 15189 for medical labs, ISO 20387 for biobanks). A2LA does not itself test or certify products; it audits and accredits the bodies that do, and is a signatory to the international mutual-recognition arrangements consolidated under Global Accreditation Cooperation Incorporated (Global ACI), which brought ILAC and IAF together on 1 January 2026; accreditations issued under the former ILAC MRA and IAF MLA remain recognised.
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Tier II Reporting Software - CASRAI (2026)
Tier II reporting software is compliance software purpose-built to compile a facility's hazardous chemical inventory into the data fields, threshold calculations, and submission format required under EPCRA Section 312 (40 CFR Part 370), and to generate or submit the annual Emergency and Hazardous Chemical Inventory ("Tier II") report to the State Emergency Response Commission (SERC), Local Emergency Planning Committee (LEPC), and local fire department. To qualify, a tool must apply EPCRA's threshold-planning-quantity logic (not just list inventory) and output in a format the recipient agency accepts, such as EPA's Tier2 Submit schema or a state's electronic portal.
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Colilert - CASRAI (2026)
Colilert is a defined-substrate technology (DST) reagent, manufactured by IDEXX Laboratories, used to simultaneously detect and enumerate total coliform bacteria and Escherichia coli (E. coli) in a single water sample. A test is correctly described as 'Colilert' only when it uses IDEXX's proprietary ONPG/MUG nutrient-indicator reagent, incubated per the manufacturer's protocol (24 hours for Colilert, 18 hours for the Colilert-18 variant) and read for color change (yellow indicates total coliform presence) and fluorescence under 365 nm UV light (indicates E. coli presence). Quantification requires pairing the reagent with IDEXX's Quanti-Tray or Quanti-Tray/2000 sealing system to produce a Most Probable Number (MPN) result per 100 mL. The method is standardized as Standard Methods 9223B (Enzyme Substrate Coliform Test) and is included on the U.S. EPA's list of approved analytical methods for Safe Drinking Water Act compliance monitoring under 40 CFR Part 141.
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Types of Equipment Leases - CASRAI (2026)
An equipment lease type is defined by two independent things: (1) the commercial end-of-term structure the vendor or leasing company offers – fair market value (FMV), $1 buyout, 10% option, or Terminal Rental Adjustment Clause (TRAC) – which determines whether and how the lessee can own the equipment when the term ends and how monthly payments are set; and (2) the ASC 842 accounting classification of that lease as a finance lease or an operating lease, which determines balance-sheet and income-statement treatment rather than end-of-term ownership. A lease is not fully specified by the word "lease" alone – comparing two lease offers requires knowing both of these dimensions.
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TRAC Lease (Terminal Rental Adjustment Clause) - CASRAI (2026)
A TRAC lease is a motor-vehicle lease governed by IRC Section 7701(h)'s terminal rental adjustment clause exception: the lessee guarantees the vehicle's end-of-term residual value and pays (or is credited) the difference between that guaranteed figure and the vehicle's actual value when the lease ends, while the lease still qualifies as a true lease for tax purposes rather than being recharacterized as a financed purchase. It applies specifically to motor vehicles and trailers, not general lab or clinical equipment, and sits alongside fair market value (FMV) leases and dollar buyout leases as one of the standard vehicle-lease structures procurement and fleet teams compare.
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Scale vs Balance - CASRAI (2026)
A scale is a general-purpose weighing instrument (commonly strain-gauge based) optimized for capacity and ruggedness with coarser readability, while a balance is a precision weighing instrument (traditionally comparative, now typically electromagnetic force restoration) optimized for fine resolution – down to 0.1 mg or better – under controlled, draft-free conditions; procurement should be driven by the required readability/minimum sample weight, applicable regulatory framework (NTEP/Handbook 44 for legal-for-trade, OIML R76 accuracy class, USP <41> for pharmacopeial work), and calibration traceability, not by marketing language alone.
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What Is ANAB? ANSI National Accreditation Board Explained - CASRAI (2026)
ANAB (the ANSI National Accreditation Board) is a US laboratory and certification-body accreditation organization, operated as a subsidiary of ANSI, that formally recognizes a testing/calibration laboratory, medical laboratory, inspection body, biobank, or certification body meets the requirements of a specific ISO/IEC conformity-assessment standard (e.g. ISO/IEC 17025 for testing and calibration labs, ISO 15189 for medical labs, ISO 20387 for biobanks). ANAB does not itself test or certify products; it audits and accredits the bodies that do, and is a signatory to the international mutual-recognition arrangements consolidated under Global Accreditation Cooperation Incorporated (Global ACI), which brought ILAC and IAF together on 1 January 2026; accreditations issued under the former ILAC MRA and IAF MLA remain recognised.
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Xeno-Free Media - CASRAI (2026)
Xeno-free (XF) media is cell-culture medium formulated to contain no components derived from a species other than the one being cultured, used to eliminate the risk of xenogeneic contamination (viral, prion, and immunogenic non-human antigens) that comes with animal-derived supplements like fetal bovine serum. A product qualifies as xeno-free specifically when every raw material's species of origin has been checked against the cell type being grown – human-derived components (e.g., human platelet lysate, human serum albumin) are permitted in xeno-free media intended for human cell culture, which is what distinguishes it from the stricter 'animal-component-free' (ACF) or 'animal-origin-free' (AOF) designation, where no animal-derived material of any species, including human, is used at all.
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Unique Molecular Identifiers (UMIs) - CASRAI (2026)
Short, random or semi-random nucleotide sequences (typically 6-12 base pairs) added to individual DNA or RNA fragments during next-generation sequencing (NGS) library preparation, before PCR amplification, so that reads descended from the same original molecule can be identified and collapsed into a single consensus read.
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Cryo-EM Microscope - CASRAI (2026)
A cryo-EM microscope is a transmission electron microscope purpose-built or fitted with an integrated cryogenic specimen workflow – a cryo-transfer/autoloader system, a stable cryo-stage held below devitrification temperature, a field emission electron source, and (for modern structural-biology use) a direct electron detector and usually an energy filter – so vitrified biological specimens can be imaged in a near-native, non-crystalline-ice state at near-atomic to atomic resolution. It depends on, but does not itself perform, upstream vitrification (plunge-freezing) of the specimen.
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SEFA 8 (Laboratory Fume Hoods Recommended Practice) - CASRAI (2026)
SEFA 8 is the Laboratory Fume Hoods Recommended Practice published by the Scientific Equipment and Furniture Association (SEFA), setting construction requirements and tracer-gas containment/face-velocity test protocols (As-Manufactured, As-Installed, As-Used) that laboratory fume hood procurement specifications cite to verify vendor performance claims.
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PhiX Control - CASRAI (2026)
PhiX control (PhiX Control v3) is an adapter-ligated sequencing library derived from the bacteriophage PhiX174 genome, spiked into Illumina NGS runs at a defined percentage to calibrate base-calling and error-rate metrics, and, at higher spike-in levels, to supply base-composition diversity that low-diversity libraries (e.g., amplicon panels, ChIP-seq, bisulfite sequencing) lack for reliable cluster calling and index demultiplexing.
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Single-Use Assemblies (SUAs) - CASRAI (2026)
A single-use assembly (SUA) is a pre-fabricated, pre-sterilized fluid-path component – typically some combination of flexible tubing, bags, connectors, filters, and sensors – manufactured, irradiated, and supplied ready to install into a bioprocess for exactly one production run before being discarded rather than cleaned and reused. What separates an SUA from ordinary disposable plasticware is that it is qualified as a controlled process component: it comes with sterilization-validation and, for GMP or GMP-adjacent use, extractables-and-leachables documentation, rather than being purchased as a generic consumable on a certificate of conformance alone.
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Chemically Defined Media (CDM) - CASRAI (2026)
Chemically defined media (CDM) is a cell-culture growth medium in which every component – salts, amino acids, vitamins, lipids, and any protein supplements – is a known, individually specified chemical entity added at a documented concentration, with no undefined biological components such as serum, hydrolysates, or tissue extracts. A formulation qualifies as CDM only when its full composition is disclosed and quantified, protein supplements (if present) are purified/recombinant and identified by expression source, and no ingredient is an undefined animal- or plant-derived mixture – a medium that is merely 'serum-free' does not automatically meet this bar if it still contains an undefined hydrolysate or extract.
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Chemical Safety Software - CASRAI (2026)
Chemical safety software is a category of purchased or subscribed platforms that help a lab, facility, or manufacturer manage the compliance obligations that come with owning, using, or producing hazardous chemicals. In procurement terms, a product qualifies as chemical safety software if it automates at least one of these core workflows: safety data sheet (SDS) management (collecting, indexing, and making supplier SDSs searchable at the point of use), GHS-compliant labeling (generating secondary-container and workplace labels with the correct pictograms, signal words, and hazard statements under 29 CFR 1910.1200 or the EU CLP Regulation), chemical inventory tracking (quantities, locations, and container-level data tied to a chemical's CAS number), exposure and risk assessment (flagging incompatible storage, threshold quantities, or reactive combinations), and regulatory reporting (EPA EPCRA Tier II / Form R, state fire-code chemical inventories, or waste manifests). A single-purpose spreadsheet or a manual paper SDS binder does not meet this definition even though it stores some of the same information — the defining feature of the category is automated compliance workflow, not just data storage. Buyers evaluating this category should distinguish it from two narrower, adjacent purchases it often gets bundled or confused with: a chemical inventory management system, which focuses specifically on tracking what chemicals exist, in what quantity, and where; and SDS authoring software, which generates new, regulator-compliant SDSs for chemicals an organization manufactures or reformulates under its own label, rather than managing SDSs received from suppliers. Many commercial chemical safety platforms bundle inventory tracking, SDS management, and labeling into one subscription; others are sold as separate modules. Neither is inherently the correct scope — the right purchase depends on which specific compliance obligations (OSHA HazCom, EPCRA reporting, fire-code inventory limits, internal EHS audit requirements) a facility actually has to meet.
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Glove Compatibility Chart - CASRAI (2026)
A glove compatibility chart is a reference table, published by a glove manufacturer, distributor, or standards body, rating a specific glove product's resistance to specific named chemicals, typically as a breakthrough-time-based class (ANSI/ISEA 105's 0-6 scale, or an EN ISO 374 Type A/B/C letter code) derived from ASTM F739 or EN 16523-1 permeation testing. A table only qualifies as compatibility-grade data if it ties a named test method to a specific product, a specific chemical (not a category), and a time-based rating rather than a plain yes/no label; procurement and EHS teams use it, alongside Section 8 of the relevant Safety Data Sheet, as the documented basis for specifying which glove is fit for a given task.
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NELAC (National Environmental Laboratory Accreditation Conference) - CASRAI (2026)
NELAC (National Environmental Laboratory Accreditation Conference) was the multi-state, EPA-supported effort that created the original national standard for accrediting environmental testing laboratories, replacing separate state-by-state certification schemes. The standard is now governed by The NELAC Institute (TNI) and implemented through the National Environmental Laboratory Accreditation Program (NELAP), under which recognized state and other Accreditation Bodies grant scoped accreditation – specific to matrix, analyte, and test method – to individual labs. In field usage, 'NELAC accreditation' commonly means current NELAP accreditation to the TNI Standard.
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Fetal Bovine Serum (FBS) - CASRAI (2026)
Fetal bovine serum (FBS), also called fetal calf serum (FCS), is the liquid fraction of blood collected from bovine fetuses at slaughter, clarified and filtered for use as a growth-supporting supplement added to basal cell-culture media (typically 5-10% of final volume). It qualifies as FBS specifically when the source animal is a bovine fetus, distinguishing it from newborn calf serum (collected postnatally) and adult bovine serum (collected from mature cattle) – both related but compositionally and functionally distinct products.
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Eyewash Station - CASRAI (2026)
An eyewash station is emergency safety equipment that delivers a controlled, hands-free stream of flushing fluid to a person's eyes (or eyes and face) to remove a hazardous substance following an accidental exposure. In U.S. laboratory and facility procurement, "eyewash station" means specifically equipment designed and installed to meet ANSI/ISEA Z358.1, the voluntary consensus standard OSHA cites as the benchmark for the general duty created by 29 CFR 1910.151(c) to provide "suitable facilities for quick drenching or flushing of the eyes and body." A device only counts as an eyewash station in this operational sense if it can deliver flushing fluid to both eyes simultaneously, hands-free, for a continuous 15-minute minimum, at a minimum flow rate of 0.4 gallons per minute (eyewash-only) or 3.0 gpm (eye/face wash) in the tepid 60-100°F (16-38°C) range Z358.1 specifies — a first-aid-kit eye-flush bottle or a sink does not meet this definition even though it can rinse an eye.
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Nitrile Glove Sizing: Chart, Fit, and Facility Size-Mix - CASRAI (2026)
Nitrile glove sizing is the mapping between a glove's dimensional designation (XS through XXL) and hand-circumference measurements, used both to fit an individual wearer and, for institutional buyers, to translate a facility's hand-size distribution into a purchase-order size split. Because ASTM D6319 and its counterpart exam-glove standards set performance requirements rather than a mandatory dimensional band per size label, the same size letter can differ measurably between manufacturers.
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Nitrile Glove Thickness (Mil) - CASRAI (2026)
Nitrile glove thickness in mils measures the gauge of the glove material – one mil equals 0.001 inch (0.0254 mm) – and is reported per point on the glove (fingertip, palm, cuff) because dipped-glove manufacturing, the standard nitrile exam-glove process under ASTM D6319, produces uneven thickness across a single glove. Within a given material, higher mil thickness generally increases puncture resistance and permeation breakthrough time, and decreases tactile sensitivity and increases hand fatigue. It is a secondary variable within a material choice, not a stand-alone chemical-protection rating: material compatibility with the specific chemical in use governs whether a glove protects against it at all.
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Procurement Card (P-Card) - CASRAI (2026)
A procurement card (P-card, used interchangeably with 'purchasing card') is a commercial charge or credit card an institution issues to a named individual for direct, point-of-sale purchases within defined transaction and monthly limits, reconciled centrally against the institution's own accounts after the fact rather than approved through a purchase order beforehand. To qualify: the card must be tied to the institution's own commercial card program (not personal credit used for later reimbursement); the purchase must occur directly at point of sale, not via a purchase order or punchout catalog; and institutional limits plus post-purchase reconciliation, not pre-purchase approval, are the control mechanism.
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Central Stores - CASRAI (2026)
A centralized institutional department – part of a university's or hospital's supply chain, procurement, or facilities organization – that receives, inspects, warehouses, and internally distributes commonly used supplies, chemicals, and equipment to the labs and departments it serves, instead of each unit receiving and stocking its own shipments independently. Central stores sits downstream of purchasing: it governs how an already-ordered item physically arrives and gets stocked/distributed, not which vendor or price it was bought at.
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Simplified Acquisition Threshold (SAT) - CASRAI (2026)
The simplified acquisition threshold (SAT) is the dollar ceiling, set in FAR 2.101 and cross-referenced by 2 CFR 200.1 for federal grant recipients, up to which a buyer may use streamlined, informal purchasing procedures instead of formal sealed bidding or a competitive request-for-proposals process. A purchase counts as falling under the SAT when its total anticipated value – not a single invoice or line item, but the full requirement, since the FAR and 2 CFR 200 both prohibit splitting a purchase into smaller pieces to stay under a threshold – is above the micro-purchase threshold but at or below the current SAT figure. Cross the SAT and the buyer must switch to formal procurement methods (sealed bidding under FAR Part 14, or competitive proposals under FAR Part 15 for direct federal contracts; sealed bids or competitive proposals under 2 CFR 200.320(b) for non-federal entities spending federal award funds), plus additional documentation obligations such as an independent cost estimate and, for construction, bonding.
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GPO Administrative Fee - CASRAI (2026)
A GPO administrative fee is the percentage-based payment a vendor makes to a group purchasing organization (GPO), tied to the volume of purchases its member institutions make under that vendor's GPO contract, which the GPO retains to fund its own contracting and member-services operations rather than billing members a direct fee. The payment runs vendor-to-GPO, not buyer-to-GPO, and is what distinguishes this arrangement, for Anti-Kickback Statute purposes, from a direct vendor discount to a buyer.
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What Is a DICOM Conformance Statement? - CASRAI (2026)
A DICOM conformance statement is a vendor-published document, structured per DICOM PS3.2 (Conformance), that specifies exactly which SOP (Service-Object Pair) classes a medical-imaging device or software supports and in which network role (SCU or SCP), which transfer syntaxes it can send or receive, which network and media-storage services it offers, and any vendor-specific extensions or restrictions. A document counts as a real conformance statement only if it specifies this level of protocol detail; a marketing claim of 'DICOM compliant' with no published SOP-class/transfer-syntax detail does not meet the bar, because it gives a buyer no way to verify whether two specific devices will actually interoperate.
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ECCN (Export Control Classification Number) - CASRAI (2026)
An Export Control Classification Number (ECCN) is a five-character alphanumeric code assigned to an item, software package, or technology when it matches a specific entry on the US Commerce Control List (CCL) under the Export Administration Regulations (EAR, 15 CFR Parts 730-774), administered by the Department of Commerce Bureau of Industry and Security (BIS). The code format is: one digit (0-9) for product category, one letter (A-E) for product group, and three digits identifying the specific CCL entry and reason(s) for control. Items subject to the EAR that match no CCL entry are not assigned an ECCN; they are designated EAR99 instead.
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CGA Pamphlet P-1 - CASRAI (2026)
CGA Pamphlet P-1 (Safe Handling of Compressed Gases in Containers) is the Compressed Gas Association's industry consensus standard covering the in-plant handling, storage, and use of compressed gas cylinders, portable tanks, and similar containers. It is incorporated by reference into US federal law at 29 CFR 1910.101(b), OSHA's general industry rule for compressed gases, which states that 'the in-plant handling, storage, and utilization of all compressed gases in cylinders, portable tanks, rail tankcars, or motor vehicle cargo tanks shall be in accordance with Compressed Gas Association Pamphlet P-1-1965.' A lab, hospital, or industrial site is operating 'under CGA P-1' whenever its cylinder-securing, storage-segregation, and handling practices trace back to this pamphlet's requirements, whether an EHS policy cites the pamphlet by name or simply cites the OSHA regulation that incorporates it. Because OSHA's text still names the 1965 edition specifically, facilities should treat that citation as the enforceable floor and CGA's more recent revisions (the association updates its pamphlets periodically, as it does across its full P-, C-, V-, and S-series) as current good-practice guidance layered on top.
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CGA Fittings - CASRAI (2026)
A CGA fitting is the standardized valve outlet/regulator inlet connection, identified by a CGA (Compressed Gas Association) three-digit number under CGA V-1 / ANSI B57.1, that is matched to a specific gas or group of compatible gases so that a regulator built for one gas cannot readily be connected to an incompatible one. It answers 'will this regulator connect to this cylinder,' a separate question from the gas identity or the cylinder size.
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USP Class VI Certification - CASRAI (2026)
USP Class VI certification is a designation that a specific plastic material or component has passed the most stringent tier of biological reactivity testing under United States Pharmacopeia (USP) General Chapter <88>, "Biological Reactivity Tests, In Vivo." Chapter <88> defines six plastic classes (I through VI) based on which combination of three in-vivo bioassays – systemic (acute) toxicity injection, intracutaneous reactivity, and implantation – a material passes, and at what extraction rigor. A material reaches Class VI, the highest of the six classes, only when it passes all three bioassays using extracts prepared at the most demanding temperature/duration condition the material can withstand without degrading. Certification is specific to a tested formulation and manufacturing process, not a general property of a polymer family: it is not automatically inherited by variants, colorants, regrind blends, or downstream-sterilized versions of the same base resin, and passing Class VI does not by itself satisfy the broader ISO 10993 biocompatibility program most finished medical devices require.
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Type I Borosilicate Glass - CASRAI (2026)
Type I borosilicate glass is a pharmaceutical primary-packaging glass classified under USP General Chapter <660>, Containers—Glass, as meeting the highest hydrolytic-resistance category through borosilicate composition and a passing result on the chapter's powdered glass test. A glass lot or container qualifies for the 'USP Type I' designation only once tested and documented under this method — borosilicate composition is necessary but not sufficient on its own; the designation follows from a specific tested result, not from raw material alone. It is distinct from the general-purpose term 'borosilicate glass' used for laboratory apparatus under ASTM E438, a different standard that covers non-pharmaceutical labware such as beakers and flasks.
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Biospecimen - CASRAI (2026)
A biospecimen is a biological material — such as blood, tissue, urine, saliva, or a derived product like extracted DNA/RNA, plasma, or a cell line — that has been collected from a human or other living source and preserved under a documented chain of custody for use in research, clinical testing, or long-term storage in a biorepository or biobank. What distinguishes a biospecimen from a routine clinical sample is retention beyond the point of care: it is collected, labeled, and stored specifically so that it (or data derived from it) can be used again, often by someone other than the original collector, under a defined protocol and consent framework.
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EAR99 Classification - CASRAI (2026)
EAR99 is the residual classification for an item, software, or technology that is subject to the US Export Administration Regulations (EAR, 15 CFR 730-774) but matches no specific Export Control Classification Number (ECCN) entry on the Commerce Control List (CCL). It is reached by elimination – comparing an item's technical parameters against the CCL's Order of Review (15 CFR 774, Supplement No. 4) and finding no match – not selected directly. Most EAR99 items may be exported to most destinations and end users without an individual license (No License Required, NLR status), but the EAR's General Prohibitions still apply: restricted-party screening (Denied Persons List, Entity List, Unverified List, OFAC SDN list), comprehensively embargoed/sanctioned destinations, and prohibited end-uses or end-users under 15 CFR Part 744 (including the Military End-User rule) can all still require a license for an EAR99 item.
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Vendor Neutral Archive (VNA) - CASRAI (2026)
A vendor neutral archive (VNA) is a medical-imaging storage architecture that ingests, indexes and stores diagnostic images and related clinical content in standard formats (typically DICOM for images, non-DICOM objects via XDS-style wrapping) with vendor-agnostic access interfaces, so the archive is decoupled from any single PACS (Picture Archiving and Communication System) vendor's proprietary database. A storage system counts as a true VNA only if a hospital or health system could, in principle, replace its front-end PACS/viewer without a forced, costly data-migration project — normalization of incoming studies to a consistent format, standards-based query/retrieve (DICOM Query/Retrieve, IHE XDS-I.b, HL7/FHIR for metadata), and no lock-in to a single vendor's schema are the defining tests, not simply 'a central image store.'
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What Is a Radiology Information System (RIS)? - CASRAI (2026)
A radiology information system (RIS) is the software that manages a radiology or imaging department's operational workflow around an exam — patient scheduling and registration, order/accession tracking from request through signed report, radiologist reporting and dictation, results distribution, procedure-based billing/coding, and departmental resource management — as distinct from a PACS, which stores and displays the diagnostic images themselves, and from a hospital's general EHR/HIS, which holds the full patient record across every department, not just imaging.
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cGMP Facility - CASRAI (2026)
A cGMP facility is a drug, biologic, device, or API manufacturing site that meets FDA's current Good Manufacturing Practice regulations (21 CFR Parts 210/211 for drugs; Part 600-series provisions for biologics; Part 820/QMSR for devices; ICH Q7 for APIs) through qualified facilities and equipment (IQ/OQ/PQ), an independent quality unit, documented and followed procedures, trained personnel, and demonstrated process validation. cGMP status is verified through FDA registration, listing, and inspection — FDA does not issue a one-time 'cGMP certificate.'
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ANSI/AIHA Z9.5 (Laboratory Ventilation) - CASRAI (2026)
ANSI/AIHA Z9.5 ("Laboratory Ventilation") is the American National Standards Institute-approved consensus standard, developed and maintained by AIHA (the American Industrial Hygiene Association), that specifies engineering and performance criteria for laboratory ventilation systems, including general room air-change rates, fume hood design and containment performance, and the recurring testing needed to verify a hood or ventilation system still performs as designed. It is periodically revised by an AIHA-accredited standards committee, with the most recent edition dated 2022; the core testing benchmarks below have held stable across recent revisions. A laboratory or ventilation system is operating "to Z9.5" when it meets both the initial design/commissioning criteria in the standard and the ongoing routine-testing schedule it sets out.
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GMP Facility - CASRAI (2026)
A GMP facility is a manufacturing, packaging, testing, storage, or distribution site that is designed, qualified, and operated to meet Good Manufacturing Practice requirements applicable to its product type (21 CFR Part 211 for finished drugs, ICH Q7 for APIs, 21 CFR Part 820/QMSR for devices, or equivalent EU/international GMP regulation) – demonstrated through a documented quality system (qualified premises via IQ/OQ/PQ, environmental controls, batch records, CAPA, calibrated equipment, trained personnel) that a regulatory authority can inspect and hold the site to, rather than a self-declared or purely physical description of the space.
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Compressed Gas Cylinder Sizes - CASRAI (2026)
A compressed gas cylinder size designation is the alphanumeric code (for example lecture bottle, size 150, size 200, size 300, or letter codes such as D, K, Q, and T) that gas suppliers use to describe a cylinder's physical dimensions (diameter and height), water capacity, and the resulting volume of gas it delivers at a given fill pressure. Labs use the designation, not the raw dimensions, to specify what to order because it determines storage footprint, how it fits in a gas cabinet or cylinder rack, how often it needs to be swapped or refilled at a given consumption rate, and which regulator and CGA fitting it takes.
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CLIA-Waived Test - CASRAI (2026)
A CLIA-waived test is a laboratory test the FDA has determined is simple and accurate enough to perform under a CLIA Certificate of Waiver – 42 CFR 493.15's criteria are that the methodology is "so simple and accurate as to render the likelihood of erroneous results negligible" and poses no reasonable risk of harm if performed incorrectly. Waived status attaches to a specific FDA-cleared test system, not to a facility or a general category of testing; a facility can hold waived and non-waived tests side by side depending on which certificate(s) it holds.
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ACT Label (ACT Ecolabel) - CASRAI (2026)
The ACT Label (ACT Ecolabel) is a product-level sustainability rating for laboratory equipment and consumables, administered by My Green Lab and independently validated by its third-party partner Verico. A product carries a genuine ACT Label only when it has a listed, verified entry in My Green Lab's ACT database with a weighted score out of 100 across categories such as energy use, materials, chemical hazards, and end-of-life impact — a manufacturer's own 'eco-friendly' marketing claim, without that database listing, does not qualify.
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Purchasing Cooperative - CASRAI (2026)
A purchasing cooperative is a membership-based arrangement in which two or more independent organizations — typically public entities such as states, municipalities, school districts, public universities, or hospital systems — pool their buying volume and jointly use a single, competitively solicited contract, so that any member can purchase against it directly instead of running its own bid or RFP for the same goods or services. Membership is usually formal (a signed participation or membership agreement) and the lead contract is awarded through one member's or one cooperative's own competitive solicitation process, which is what lets other members 'piggyback' on it and still satisfy their own competitive-procurement requirements.
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Specific Pathogen-Free (SPF) Mice - CASRAI (2026)
A colony or shipment of mice qualifies as specific pathogen-free (SPF) when it is bred and housed in a barrier facility and is documented, through a formal, periodic health-monitoring program, to be free of a defined list of excluded microorganisms and parasites (the 'exclusion list' or 'agent panel'). SPF is a relative, list-bound status, not a claim of total sterility: two colonies can both be validly called SPF while being screened against different panels, so the operative question for procurement and research use is always 'SPF with respect to which agent list, tested how recently, and by whom' rather than a single universal standard.
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Gnotobiotic Mice - CASRAI (2026)
A mouse (or other laboratory animal) is gnotobiotic when its microbial status is completely known and controlled, rather than merely reduced or partially defined. This is a stricter standard than "clean": a gnotobiotic mouse is either (a) germ-free (axenic) — free of all detectable bacteria, fungi, viruses, and parasites — or (b) deliberately colonized with a specific, fully characterized set of microorganisms (the animal's defined "gnotobiote" community), with no other organisms present. The term comes from the Greek gnotos (known) plus bios (life) — literally "known life." Operationally, an animal only qualifies as gnotobiotic if all three of the following hold: it was derived by a method that excludes environmental microbial contamination (aseptic hysterectomy/hysterotomy or embryo transfer into a germ-free foster dam, followed by hand-rearing in isolation); it is housed for its entire life in a gnotobiotic isolator — a sealed, HEPA-filtered, positive- or negative-pressure enclosure with sterilized food, water, bedding, and air supply, entered only through a sterilizable transfer port or dunk tank; and its microbial status is periodically verified by culture-based and molecular (e.g., 16S rRNA sequencing, PCR) monitoring to confirm no unintended organisms have been introduced.
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Emergency Unblinding - CASRAI (2026)
Emergency unblinding (an emergency code-break) is the procedure by which a blinded clinical trial participant's individual treatment assignment is disclosed to their treating investigator or a qualified sub-investigator during an acute medical event, so clinical management is not compromised by not knowing whether the participant received active study drug, an active comparator, or placebo. It is authorized in advance by the protocol and, typically, an IRT (Interactive Response Technology) system's standard operating procedure – the treating clinician does not need real-time sponsor approval to act, consistent with ICH E6(R2)'s principle that participant safety takes precedence over maintaining the blind. It is a single-participant, investigator-level safety procedure, distinct from the aggregate, by-arm unblinding a Data Safety Monitoring Board (DSMB) performs for a scheduled interim trial-level review.
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Shut the Sash - CASRAI (2026)
A behavioral/energy-conservation practice and campaign name instructing fume hood users to lower the sash to its closed or minimum-opening position whenever the hood is not in active use, reducing the volume of conditioned air a variable-air-volume (VAV) hood exhausts and, in turn, the lab's ventilation energy cost. Distinct from keeping the sash at its certified working height while actively using the hood, which is a separate safety practice.
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Biosafety Cabinet (BSC) - CASRAI (2026)
A biosafety cabinet (BSC) is a ventilated enclosure that uses HEPA filtration (removing at least 99.97% of particles 0.3 microns in diameter) combined with directional, certified airflow to contain biological aerosols generated during laboratory procedures. A device only counts as a biosafety cabinet, in the operational sense used across biosafety programs, if it (1) HEPA-filters air before it reaches the work surface, the exhaust, or both; (2) maintains inward airflow at its front opening (Class I and most Class II) or is fully gas-tight and glove-operated (Class III), so aerosols generated inside cannot reach the operator uncontrolled; and (3) has been performance-tested and field-certified — typically against NSF/ANSI 49 in the U.S. — rather than simply having a fan and a filter installed. Class I protects the worker and environment only; Class II protects the worker, product, and environment together and is the most common type in research and clinical microbiology labs; Class III is a gas-tight glovebox providing the highest level of containment, used for BSL-4 work. A biosafety cabinet is not a chemical fume hood (no certified chemical vapor containment unless specifically a Class II Type B cabinet) and is not a laminar flow "clean bench" (which protects only the sample and provides no worker protection at all).
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Sustainable Purchasing Leadership Council (SPLC) - CASRAI (2026)
The Sustainable Purchasing Leadership Council (SPLC) is a US-based membership nonprofit that develops purchasing guidance, criteria, and training to help institutional buyers embed sustainability considerations into procurement decisions. Members include research universities, hospital systems, government agencies, and corporations. SPLC organizes its guidance by purchasing category rather than by institution type; one of these categories, Laboratory Supplies and Services, sets out sustainability-related purchasing considerations specific to research-lab consumables, reagents, and equipment — including the energy use of cold storage and analytical instruments, packaging and take-back programs, hazardous-material substitution, and supplier sustainability disclosure. An institution is 'using SPLC guidance' when its procurement office cites SPLC category resources or criteria in an RFP, supplier scorecard, or purchasing policy, or when staff complete SPLC training and certificate programs, or when the institution holds SPLC membership to access peer benchmarking data. SPLC itself does not certify individual products, suppliers, or laboratories — it is a guidance, standards-development, and training body, not an accreditation or certification scheme. That distinction matters for procurement officers evaluating standards bodies: a supplier or lab can point to SPLC-informed purchasing criteria in a policy document, but cannot hold an 'SPLC certification,' because SPLC does not issue one.
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Capital Equipment Depreciation Schedule - CASRAI (2026)
A capital equipment depreciation schedule is the itemized calculation, specific to one capitalized asset, that spreads its depreciable cost (acquisition cost minus salvage value) across its useful life using a defined method (typically straight-line) and shows the resulting depreciation charge for each accounting period. It is the auditable record behind depreciation figures used in indirect cost rate proposals and core-facility rate-setting, distinct from simply noting that an asset depreciates.
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Universal waste disposal requirements - CASRAI (2026)
A waste item is subject to universal waste disposal requirements — rather than full hazardous-waste rules — only if it falls into one of the categories EPA designates under 40 CFR Part 273 (batteries, pesticides, mercury-containing equipment, lamps, and, since 2019, aerosol cans, plus any categories a state adds) and the generator meets that rule's labeling, containment, and one-year accumulation-time-limit conditions. Items outside those designated categories remain fully regulated hazardous waste regardless of volume or apparent low risk.
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Fume Hood - CASRAI (2026)
A fume hood (also called a chemical fume hood) is a ventilated enclosure that captures, contains, and exhausts airborne hazardous vapors, gases, dust, and fumes generated by chemical work, drawing room air in through an open front (the sash) and expelling it — usually after passing through ductwork, and sometimes through filtration — outside the building or to a treatment system. It protects the worker, not the material inside it: contaminated room air is pulled away from the user's breathing zone rather than the hood creating a sterile or particle-free zone around the work. A device only counts as a fume hood, in the operational sense used across lab-safety programs, if it (1) has continuous mechanical exhaust ventilation drawing air inward through a face opening, (2) is tested and certified to maintain a minimum face velocity (commonly cited around 80–120 feet per minute under ANSI/AIHA Z9.5, the U.S. consensus standard for laboratory ventilation) rather than simply having a fan running, and (3) is used specifically to control chemical exposure — not biological aerosols and not sample contamination, which are the jobs of a biosafety cabinet and a laminar flow hood respectively.
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ANSI/AAMI ST79 - CASRAI (2026)
ANSI/AAMI ST79 is the ANSI-approved consensus standard, developed by AAMI (Association for the Advancement of Medical Instrumentation), titled "Comprehensive guide to steam sterilization and sterility assurance in health care facilities." A sterile processing program is operating to ST79 when it documents, for every steam sterilizer and load type: (1) installation, operational, and performance qualification (IQ/OQ/PQ) testing at commissioning and after major repair or relocation; (2) routine physical monitoring (time, temperature, pressure) on every cycle; (3) a chemical indicator inside every package and a Bowie-Dick air-removal test on each dynamic-air-removal (pre-vacuum) sterilizer, run daily before the first processed load; (4) a biological indicator (BI) in at least one load per sterilizer per day and in every load containing an implantable device, with the implant load held until a negative BI result returns; and (5) written procedures for immediate-use steam sterilization (IUSS), wet-pack investigation, and load recall when a monitoring result fails. The current edition is ST79:2017, the consolidated base text plus amendments issued through 2020; AAMI has not published a full replacement edition since 2017, so "ANSI/AAMI ST79 2020" and "ANSI/AAMI ST79 latest version" both refer to this same amended 2017 text rather than a separate edition. ST79 is a voluntary consensus standard rather than a federal regulation in its own right, but it is the document nearly universally treated as the baseline standard of care for hospital-based steam sterilization in the United States, and many state health department licensing rules and hospital accreditation surveys reference it directly.
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LIMS vs LIS: What’s the Difference? - CASRAI (2026)
A system is a LIMS (Laboratory Information Management System) when its central unit of record is the sample: it registers specimens and aliquots, tracks them through testing, quality control and disposition or storage, manages instrument interfaces and inventory, and is built for research, industrial, environmental, quality-control and reference laboratories. A system is an LIS (Laboratory Information System, sometimes called a Laboratory Information Systems platform) when its central unit of record is the patient encounter: it receives test orders from an electronic health record (EHR), routes the associated specimen through a clinical diagnostic workflow, and returns a coded, clinician-facing result (commonly mapped to LOINC codes) back into the patient's chart, typically operating under CLIA and CAP oversight in the United States. The dividing line is audience and unit of record, not the feature list — both categories commonly include barcoding, instrument connectivity, chain-of-custody tracking and audit trails, so those features alone do not tell you which category a given system belongs to.
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Second-Party Audit - CASRAI (2026)
A second-party audit is an audit an organization conducts, or commissions, against one of its own suppliers, contractors, or external providers — using the customer's own criteria (a contract, quality agreement, or specification) — to decide whether to qualify, continue, or remove that supplier, as distinct from a first-party (internal self-audit) or a third-party (independent certification/regulatory) audit.
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HS Code for Chemicals - CASRAI (2026)
An HS code for chemicals is the numeric classification assigned to a chemical substance or product under the World Customs Organization's (WCO) Harmonized System (HS) nomenclature, used by customs authorities to determine import duty rates, admissibility requirements, and statistical reporting for a shipment. It is not the same as the chemical's CAS Registry Number, its UN transport hazard number, or its Export Control Classification Number (ECCN) – those identify what the substance is or how it must be shipped/exported, while the HS code determines how it is classified and taxed at the customs border. In the United States, HS codes are implemented as 10-digit Harmonized Tariff Schedule (HTSUS) codes for imports, maintained by the U.S. International Trade Commission (USITC) and enforced by U.S. Customs and Border Protection (CBP); exports use the related but separate Schedule B code maintained by the U.S. Census Bureau.
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DEA Form 161 - CASRAI (2026)
DEA Form 161, officially the 'Application for Permit to Export Controlled Substances,' is the permit application a DEA registrant with export authority must file with the DEA Diversion Control Division before shipping a Schedule I-V controlled substance out of the United States. It is transaction-specific – filed for a defined substance and schedule, quantity, destination country, and consignee – and it is not itself a registration: holding a DEA registration whose authorized business activity includes exporting is a precondition for filing Form 161, not a consequence of filing it. A DEA 'Researcher' registration, which authorizes possession and use of controlled substances for research, does not by itself authorize export.
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DEA Form 357 - CASRAI (2026)
DEA Form 357 ("Application for Permit to Import Controlled Substances") is the application a DEA registrant – typically a research or analytical lab that is not registered as a DEA Importer – files with DEA's Diversion Control Division to obtain a shipment-specific permit to bring a controlled substance into the United States for a scientific, research, or analytical purpose, under 21 CFR Part 1312.
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Class 9 Dangerous Goods - CASRAI (2026)
Class 9 (Miscellaneous Dangerous Goods) is the transport hazard classification, under the UN Model Regulations, the IATA Dangerous Goods Regulations (DGR), the US DOT Hazardous Materials Regulations (49 CFR Parts 171-180), and the IMDG Code for ocean freight, that captures any substance or article presenting a hazard during transport that isn't already covered by Classes 1 through 8. It functions as a catch-all class. In a research lab, the two shipments that trigger Class 9 most often are dry ice (UN1845, solid carbon dioxide, used as a coolant for biological and temperature-sensitive materials) and lithium batteries (UN3480/UN3481 lithium-ion, UN3090/UN3091 lithium metal) packed in or with instruments, sensors, and data loggers.
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IMDG Code Classes (Ocean Freight Dangerous Goods) - CASRAI (2026)
The IMDG Code (International Maritime Dangerous Goods Code) is the International Maritime Organization's (IMO) mandatory code for classifying, packing, marking, labeling, and documenting dangerous goods carried by sea in packaged form, given legal force under SOLAS Chapter VII. A material is governed by the IMDG Code's class system whenever it is offered for carriage on a vessel and meets one of the same nine UN hazard-class definitions used across every transport mode — the classes themselves come from the UN Recommendations on the Transport of Dangerous Goods (the 'Orange Book'), so a chemical's or biological substance's UN number, proper shipping name, hazard class, and packing group (I, II, or III) do not change between air, road, and sea. What changes for ocean freight is the layer of sea-specific requirements the IMDG Code adds on top of that shared classification: Emergency Schedules (EmS) codes for firefighting and spillage response, a separate 'Marine Pollutant' designation and marking driven by aquatic-toxicity criteria (which can apply on top of a substance's primary class), 18 segregation groups controlling which dangerous goods cannot be stowed near each other, and lettered stowage categories describing where on or below deck a package may be carried relative to accommodation and machinery spaces. The Code is amended on a two-year cycle by IMO's Maritime Safety Committee, drawing on the same biennial UN Model Regulations updates that also feed the IATA Dangerous Goods Regulations and (in the US) 49 CFR.
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Packing Group I, II & III (Hazmat) - CASRAI (2026)
A packing group is the DOT/UN three-tier severity classification (I = great danger, II = medium danger, III = minor danger) assigned to a hazardous material within its hazard class, using class-specific criteria under 49 CFR 173.121-173.137, that determines the required UN-specification packaging performance level, maximum shipping quantities, and eligibility for limited/excepted quantity provisions.
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Cold Chain - CASRAI (2026)
A cold chain is an unbroken sequence of temperature-controlled storage, handling, and transport steps that keeps a temperature-sensitive product inside its defined safe range from the point of manufacture or collection to the point of use. A given movement of goods qualifies as a cold chain only when all of the following hold together: (1) the product itself has a defined temperature specification (e.g., 2-8C for most vaccines and many biologics, or a validated frozen/ultra-cold range) set by the manufacturer or a pharmacopeial standard; (2) every storage and transport step in the sequence – warehouse, courier, transit hub, receiving site – uses equipment qualified to hold that range; (3) temperature is continuously monitored and logged, not just checked at the start and end points; and (4) there is a documented procedure for what happens when a monitored excursion occurs (assessing whether the product is still usable, commonly via a Mean Kinetic Temperature calculation per USP <1079.2>, and disposing of or quarantining product that fails). A single unmonitored or unqualified segment – even if brief – breaks the chain and invalidates the temperature assurance for everything downstream of it, regardless of how well-controlled the rest of the movement was.
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Mean Kinetic Temperature (MKT) - CASRAI (2026)
A calculation counts as mean kinetic temperature (MKT), in the USP <1079> sense, if it meets both of the following: (1) it is an Arrhenius-weighted average of a time series of temperature readings, using an assumed activation energy constant, so each reading's contribution scales exponentially rather than linearly with its temperature; and (2) it is expressed as a single equivalent isothermal temperature – the constant storage temperature that would produce the same overall thermal degradation effect as the actual, fluctuating record over the same period. A plain arithmetic average of the same readings is not MKT, and because degradation reactions generally accelerate exponentially with temperature, MKT is always equal to or slightly above the simple arithmetic mean – never below it.
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Punchout Catalog - CASRAI (2026)
A punchout catalog is a live link between a buyer's e-procurement system (such as SAP Ariba, Coupa, or Jaggaer) and a supplier's own hosted online catalog. Instead of storing a static price list inside the buyer's system, the requester clicks a supplier tile inside the procurement portal, is redirected ("punched out") to that supplier's real-time storefront to browse and select items at negotiated contract pricing, then returns the completed shopping cart ("punched in") to the buyer's system as a structured requisition – typically transmitted using the cXML or OCI protocol – where it re-enters the institution's normal approval, budget-check, and purchase-order workflow.
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Capital Equipment - CASRAI (2026)
A tangible, non-consumable asset with a useful life of more than one year and a per-unit acquisition cost that meets or exceeds an institution's capitalization threshold, recorded on the fixed-asset register and depreciated over its useful life rather than expensed in the year of purchase.
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IQ/OQ/PQ (Installation, Operational, and Performance Qualification) - CASRAI (2026)
IQ/OQ/PQ is the three-stage documented qualification sequence used to prove equipment, instruments, utilities, or systems were installed correctly (Installation Qualification), operate correctly across their full specified range (Operational Qualification), and perform consistently under actual conditions of use (Performance Qualification). An activity counts as IQ/OQ/PQ only when it produces signed, documented evidence tied to pre-defined acceptance criteria for that specific stage and that specific unit as installed — vendor factory testing, calibration, and routine preventive maintenance are related but distinct activities that do not by themselves satisfy any of the three stages.
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JAMA Network Impact Factor: Why There’s No Single Figure - CASRAI (2026)
JAMA Network's Impact Factor is not a single figure: JAMA Network is the American Medical Association's family of 13 peer-reviewed journals (including flagship JAMA and the open-access JAMA Network Open), and Clarivate assigns a Journal Citation Reports (JCR) Journal Impact Factor separately to each individual title, not to the family as a whole. Neither the AMA nor Clarivate publishes a blended or family-wide figure; any source quoting one number for 'JAMA Network' has either mislabelled a single member journal's figure or invented the number. A searcher wanting a specific figure must specify which of the 13 journals – JAMA, JAMA Network Open, JAMA Cardiology, JAMA Dermatology, JAMA Health Forum, JAMA Internal Medicine, JAMA Neurology, JAMA Oncology, JAMA Ophthalmology, JAMA Otolaryngology-Head & Neck Surgery, JAMA Pediatrics, JAMA Psychiatry, or JAMA Surgery – they mean, then look that title up directly at jamanetwork.com or in the JCR (jcr.clarivate.com).
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Kerndatensatz Forschung (KDSF) - CASRAI (2026)
The Kerndatensatz Forschung (KDSF) is Germany's national standard defining how universities and non-university research institutions structure and report information about research activity – projects, personnel, publications, funding, and infrastructure – using a shared base data model (Basisdatenmodell), topic-scoped modules, and standardised reference queries (Referenzabfragen). Voluntary adoption was recommended by the German Council of Science and Humanities (Wissenschaftsrat) in January 2016; ongoing governance now sits with the Kommission fur Forschungsinformationen in Deutschland (KFiD).
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SocArXiv - CASRAI (2026)
SocArXiv is a free, open-access preprint repository for the social sciences. It was founded in 2016 by sociologist Philip N. Cohen in partnership with the nonprofit Center for Open Science (COS) and runs on the Open Science Framework (OSF) — the same underlying infrastructure that hosts OSF Preprints and sibling branded servers such as PsyArXiv (psychology) and engrXiv (engineering). SocArXiv launched alongside those two services on December 5, 2016, as part of COS's branded-server model, in which a scholarly community operates its own named, separately moderated preprint service on shared OSF backend infrastructure rather than building hosting from scratch. SocArXiv is not a COS-run editorial operation in the way a journal is. It is governed by a volunteer steering committee of scholars and library professionals under the banner "SocOpen," and since 2021 its institutional home has been the University of Maryland Libraries, which provides the administrative and legal footing for the service as an ongoing academic unit rather than a standalone nonprofit. Operational definition A deposit is properly identified as a "SocArXiv preprint" if it meets all of the following: It was submitted through the SocArXiv service on OSF (osf.io/preprints/socarxiv), not simply cross-listed or mirrored from another repository such as arXiv or SSRN. It falls within sociology or a closely related social-science field — SocArXiv accepts working papers, preprints, published-paper copies, data, and code across the social sciences broadly, not sociology alone. It has passed SocOpen's moderation screen, which is a scope-and-completeness check, not peer review: moderators confirm the item is scholarly, falls within a supported research area, is plausibly categorized, is correctly attributed to its stated authors, is in a moderated language, and is submitted in a text-searchable format (PDF or DOCX, not a scanned image). It has received an automatically assigned, persistent DOI on upload, making it citable independent of eventual journal publication; a prior DOI issued by another publisher can also be linked to the same record. It carries one of SocArXiv's permitted reuse terms — CC BY 4.0, CC0 (public-domain dedication), or no license — selected by the author at deposit. What SocArXiv is not Posting to SocArXiv is explicitly not peer review, and a SocArXiv record is not, by itself, evidence that a manuscript has been formally accepted anywhere. Moderation checks scope and completeness, not scientific merit, methodology, or novelty. SocArXiv is also free to authors and readers — there is no submission fee or paywall, which distinguishes it from many venues that require an article processing charge (APC) at the journal stage. Examples A sociologist deposits a working paper analyzing survey data on labor-market outcomes to SocArXiv ahead of submitting it to a peer-reviewed journal, receiving a citable DOI immediately and using that DOI in grant reports and CVs while the manuscript is still under review elsewhere. A research team posts the accepted-but-not-yet-typeset version of a political-science article to SocArXiv under a publisher-permitted embargo, satisfying a funder's open-access mandate without waiting for the journal's own publication date. Counter-example A working paper in economics or sociology posted only to SSRN, a university's own institutional repository, or a personal website is not a "SocArXiv preprint," even though it may cover an identical topic and serve a similar function — the term refers specifically to material submitted through and moderated by the SocArXiv service on OSF, not to social-science preprints in general (for that broader category, see preprint). Related terms Preprint OSF Preprints PsyArXiv Open Science Framework (OSF) DOI How to Choose a Preprint Server Preprint Servers Explained
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TGA CTN and CTA (formerly CTX) Schemes - CASRAI (2026)
The CTN (Clinical Trial Notification) and CTA (Clinical Trial Approval, formerly called CTX – Clinical Trial Exemption) schemes are the two regulatory pathways Australia's Therapeutic Goods Administration (TGA) uses to permit the lawful supply of an 'unapproved' therapeutic good – one not yet entered on the Australian Register of Therapeutic Goods (ARTG) – for use in a clinical trial. A trial is a CTN trial if the sponsor self-assesses the product and trial as suitable to proceed on notification alone: the sponsor lodges a CTN with the TGA (via the TGA Business Services online CTN form) after the trial protocol has HREC (Human Research Ethics Committee) approval, pays the CTN fee, and the trial may then start – the TGA does not review the scientific data before the trial begins. A trial is a CTA trial if the sponsor instead applies for the TGA's formal evaluation and approval of the unapproved good before the trial can start; the TGA reviews the supporting data (quality, safety, and available efficacy information) and must approve the application before recruitment begins. Both schemes sit alongside, not instead of, HREC ethical review and (for CTN trials) the relevant institution's own governance authorisation – TGA approval or notification concerns lawful supply of the unapproved product, not the ethics of the study design.
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TCET (Transitional Coverage for Emerging Technologies) - CASRAI (2026)
TCET (Transitional Coverage for Emerging Technologies) is a CMS coverage pathway, finalized August 2024 (final procedural notice CMS-3421-FN, effective August 12, 2024), that expedites Medicare national coverage for a limited set of FDA-designated Breakthrough Devices by running the device through CMS's existing National Coverage Determination (NCD) and Coverage with Evidence Development (CED) machinery on an accelerated, pre-planned timeline rather than creating a new coverage authority. A device becomes TCET-eligible only if it holds FDA Breakthrough Device designation, has received FDA market authorization, falls within an existing Medicare benefit category, and is not already the subject of an NCD; CMS finalized an exclusion for digital-only technologies and capped the pathway at five new candidates accepted per year, reviewed on a quarterly cycle. A manufacturer engages CMS well before authorization: a non-binding Letter of Intent roughly 18-24 months out, formal self-nomination roughly 12 months out, a CMS-contractor-generated evidence preview identifying gaps in the existing clinical evidence, and a manufacturer-authored Evidence Development Plan (EDP) mapping how those gaps will be closed. If accepted, CMS pursues an NCD conditioned on CED, giving the device national Medicare coverage for several years – potentially up to roughly five – while the manufacturer collects the additional outcomes data the evidence preview identified as missing.
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PMDA Clinical Trial Notification (CTN) - CASRAI (2026)
A Clinical Trial Notification (CTN, chiken todokede) is the regulatory filing a sponsor must submit to Japan's Ministry of Health, Labour and Welfare (MHLW) – reviewed on MHLW's behalf by the Pharmaceuticals and Medical Devices Agency (PMDA) – before initiating a clinical trial of an unapproved drug, or a new indication/dosage of an approved drug, in Japan. It is Japan's functional counterpart to a U.S. FDA Investigational New Drug (IND) application, but operates as a notification-and-review-window system rather than an affirmative approval: for an initial CTN, PMDA has a 30-day review period after receipt in which it can raise questions or object; if PMDA raises no objection within that window, the sponsor may proceed to start the trial. A submission counts as a CTN when it is filed under Japan's PMD Act (Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices) and includes the trial protocol, investigational product information, and details of the investigators and institutions where the trial will be conducted.
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Patent Pool - CASRAI (2026)
A patent pool is an arrangement among two or more independent patent holders – which can include a university technology transfer office – to combine a defined set of patents into a single licensing package administered through one licensor or pool entity, so a licensee can obtain rights to every pooled patent in one transaction, with royalties divided among members by a pre-agreed allocation formula. Distinct from a standard bilateral exclusive or non-exclusive license, which involves a single licensor.
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Reach-Through Royalty - CASRAI (2026)
A reach-through royalty is a licensing clause requiring the licensor of a research tool (an assay, screening platform, reagent, or similar upstream technology) to be paid a share of revenue from a future product the licensee later discovers or develops using that tool – even though the tool's own patent claims do not cover, and are not incorporated into, that downstream product. It is distinguished from an ordinary running royalty by that gap: the royalty base is a product outside the scope of what was actually licensed.
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QDR (Qualitative Data Repository) - CASRAI (2026)
The Qualitative Data Repository (QDR) is a domain repository dedicated to curating, preserving, and providing access to digital data generated through qualitative and multi-method social science research — interview transcripts, fieldnotes, focus-group recordings, participant-observation records, and other unstructured or semi-structured data types that do not fit the tabular, quantitative deposit model most general-purpose repositories are built around. It is hosted by the Center for Qualitative and Multi-Method Inquiry at Syracuse University's Maxwell School of Citizenship and Public Affairs. A dataset qualifies as a QDR deposit when it is submitted through QDR's own curation and review workflow, receives a persistent identifier (a DataCite DOI), and is described with QDR's qualitative-data-specific metadata and, where the depositing researcher chooses to use it, QDR's Annotation for Transparent Inquiry (ATI) format for linking published claims back to underlying data excerpts.
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GBIF (Global Biodiversity Information Facility) - CASRAI (2026)
GBIF (the Global Biodiversity Information Facility) is an intergovernmental network and open-access data infrastructure – coordinated by a Secretariat in Copenhagen and funded by its participating governments and organizations – that aggregates, indexes, and republishes species-occurrence and specimen records contributed by data-holding institutions worldwide through a global network of national and thematic Participant Nodes. A dataset counts as GBIF-mediated when it has been registered through a GBIF Participant Node (or directly via GBIF.org) and is discoverable, searchable, and downloadable through the GBIF occurrence-search interface and API; the great majority of datasets reach GBIF as Darwin Core Archives (DwC-A), most commonly built and published using GBIF's own Integrated Publishing Toolkit (IPT). GBIF itself does not define a data standard – it consumes Darwin Core, the pre-existing TDWG biodiversity-data standard – and is best understood as the largest aggregating platform built on top of that standard, not the standard itself.
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REMS (Risk Evaluation and Mitigation Strategy) - CASRAI (2026)
A REMS is a required FDA drug safety program, authorized under Section 505-1 of the Food, Drug, and Cosmetic Act (added by the 2007 FDAAA), imposed on a drug or biologic when FDA determines its serious risks require controls beyond standard professional labeling. It can combine a Medication Guide, a prescriber/provider communication plan, and Elements to Assure Safe Use (ETASU) such as prescriber or pharmacy certification, restricted dispensing settings, mandatory patient monitoring, or registry enrollment – with an implementation system required whenever ETASU is used.
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GA4GH (Global Alliance for Genomics and Health) - CASRAI (2026)
An international not-for-profit alliance, founded in 2013, that develops and maintains technical interoperability specifications and policy frameworks (such as the Data Use Ontology, GA4GH Passport, Beacon, htsget, Crypt4GH, and Phenopackets) enabling genomic and health-related data to be shared responsibly across research and clinical institutions worldwide; GA4GH does not host data itself but defines the standards that repositories, biobanks, and national genomic initiatives implement to interoperate.
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Publish or Perish (Harzing’s citation-analysis software) - CASRAI (2026)
Publish or Perish is a free desktop program, created by Anne-Wil Harzing and first released in October 2006, that queries academic data sources (as of version 8: Google Scholar, Google Scholar Profile, Crossref, PubMed, OpenAlex, Lens.org, Scopus, Semantic Scholar, and Web of Science) for a given author, journal, or search term, then calculates citation-based metrics such as the h-index and g-index from whatever results are returned. It holds no citation data itself and is not a database, persistent identifier registry, or CRIS – it is a query-and-calculate client for other providers' data, so results vary by which source was queried and change over time as underlying citation counts change.
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Kudos (research-impact platform) - CASRAI (2026)
Kudos is a free platform on which an author or institution takes a Crossref-DOI-registered publication and (1) attaches a plain-language explanation of the work, (2) enriches it with supporting links, data, or media, and (3) shares that package through built-in social/email distribution tools, with usage, download, and attention-metric data reported back afterward. It does not register DOIs, host full text, or index the literature itself – it is an outreach and measurement layer sitting on top of publications already registered elsewhere.
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TechRxiv - CASRAI (2026)
A manuscript counts as a TechRxiv deposit if it has been submitted to, and cleared the appropriateness screening of, TechRxiv — the free, IEEE-operated preprint server for unpublished research in engineering, computer science, and related technology. TechRxiv's scope is bounded to IEEE's core subject areas (electrical and electronics engineering, computer science, telecommunications, and adjacent technology fields) rather than open to any discipline, and it exists to let authors post a manuscript publicly, with a citable identifier, before or during formal peer review at a journal or conference. The screening TechRxiv applies is editorial and scope-based only: a moderator confirms the submission is a genuine, appropriately-scoped, non-plagiarized research manuscript, not that its findings are accurate, complete, or novel — that judgment is reserved for peer review at whatever venue eventually considers the work for publication.
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Professor’s Privilege - CASRAI (2026)
Professor's privilege is the legal default, historically common in continental European patent law, under which an individual academic inventor – rather than the employing university – automatically owns the patent rights to inventions arising from their own research, including the right to decide whether to patent, license, or exploit the result. It is the structural inverse of institutional-ownership regimes like the U.S. Bayh-Dole Act, and today survives in full among major European research systems primarily in Sweden (the lärarundantaget, or 'teacher's exemption'); Germany, Italy, Denmark, Finland, and Norway have each abolished it in favor of university ownership over the past two decades.
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Bronze open access - CASRAI (2026)
An open access article that is free to read on the publisher's own website but carries no explicit open license (such as a Creative Commons license) and is not published in a DOAJ-indexed fully open-access journal — meaning the free-to-read status is not contractually guaranteed and can be withdrawn or altered by the publisher at any time.
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Open Database License (ODbL) - CASRAI (2026)
The Open Database License (ODbL) is a copyleft license from Open Data Commons (a project of the Open Knowledge Foundation), version 1.0 published June 2009, that grants reuse rights to a database subject to attribution and share-alike conditions, drafted specifically around database rights and database structure/contents rather than adapted from a creative-works copyright license.
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DMPTool - CASRAI (2026)
DMPTool is a free, web-based data management plan (DMP) authoring service operated by the California Digital Library (CDL), through its University of California Curation Center (UC3), on behalf of an international partner consortium. It runs on the open-source DMPRoadmap codebase – the same platform underlying the Digital Curation Centre's UK-based DMPonline – and is the DMPRoadmap deployment used predominantly by US institutions and funders. An instance qualifies as DMPTool (rather than a generic DMPRoadmap deployment or DMPonline) when it is accessed at dmptool.org, uses CDL/UC3-maintained funder templates (NSF, NIH, NEH, DOE, IMLS, and others), and is administered under an institution's DMPTool participation agreement rather than a DCC/DMPonline subscription.
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Grounded Theory - CASRAI (2026)
Grounded theory is a qualitative research methodology in which a theory is generated inductively from data, rather than proposed in advance and tested against it. A study counts as grounded theory only when three things hold together: data collection and analysis proceed simultaneously and iteratively, not sequentially; codes and categories are developed and refined through the constant comparative method, systematically comparing each new piece of data against categories built from earlier data; and further data collection is directed by theoretical sampling – deliberately seeking cases likely to test, extend, or challenge the emerging categories – continuing until theoretical saturation, the point at which new data stops adding new properties to the core categories. The output is a substantive theory: interrelated concepts explaining a process or pattern of social action, grounded in and traceable back to the data itself.
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Commerce Control List (CCL) - CASRAI (2026)
The Commerce Control List (CCL) is the master list of 'dual-use' items – goods, software, and technology with both civilian and military, terrorism, or weapons-of-mass-destruction-related applications – that are subject to the Export Administration Regulations (EAR, 15 CFR Parts 730-774) and administered by the Department of Commerce's Bureau of Industry and Security (BIS). The CCL is organized into ten numbered categories (0-9) and, within each category, five lettered product groups (A-E); an item that matches a specific CCL entry is assigned an Export Control Classification Number (ECCN), while an item that is subject to the EAR but matches no CCL entry falls into the residual EAR99 classification.
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K01 (NIH Mentored Research Scientist Development Award) - CASRAI (2026)
A K01 is an NIH individual, mentored career-development activity code (Mentored Research Scientist Development Award) that funds a research-doctorate-holding investigator's three-to-five-year transition toward independent, NIH-fundable research through protected effort (at least 75% of full-time professional effort), a qualified mentor, and a formal career-development plan. What distinguishes a K01 from other individual mentored K mechanisms: it requires a research doctorate (PhD or equivalent) rather than a clinical doctorate, carries no fixed postdoctoral-experience ceiling the way K99/R00 does, and runs as a single mentored phase for its full duration with no automatic transition into a separate independent-phase award.
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Research Collaboration Agreement (RCA) - CASRAI (2026)
A research collaboration agreement (RCA) is a contract between two or more independent institutions or organizations that jointly and actively perform research work toward a shared objective, allocating rights and obligations among genuine co-participants – as distinct from a sponsored research agreement, where one party funds a single performing institution's defined scope of work, and a material transfer agreement, which governs only the transfer of a physical research material with no joint research performed. An RCA typically covers background vs. foreground IP ownership and licensing, publication-review timelines, data ownership and sharing, funding/cost-sharing across parties, and liability and termination terms.
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Research Manuscript - CASRAI (2026)
A research manuscript is the complete, submission-ready written account of a study — background, methods, results, and discussion (or the equivalent structure for the field) — that an author submits to a journal, conference, or other venue for editorial and peer review, before it has been accepted, copyedited, or published. The term marks a stage in the publication lifecycle, not a content type: the same underlying work is a manuscript from first submission through any round of revision, and stops being called a manuscript once it is accepted and moves toward publication, at which point more specific terms apply — author accepted manuscript (AAM) for the peer-reviewed, accepted-but-not-yet-typeset version, and version of record (VoR) for the final published form. A document only counts as a research manuscript if it is (a) a structured, complete write-up of original research or scholarship, and (b) has been or is intended to be submitted somewhere for editorial evaluation. A rough draft circulated only among co-authors, or a preprint posted to a server outside any journal's review process, are related but distinct in most editorial and funder usage — see the counter-examples below.
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Spencer Foundation - CASRAI (2026)
The Spencer Foundation is a private, non-federal U.S. foundation dedicated exclusively to funding research aimed at the understanding and improvement of education, broadly construed across disciplines, methodologies, and education levels. A project qualifies as Spencer-funded research if it is submitted under one of the Foundation's active grant mechanisms – principally the Small Research Grants on Education program (budgets up to $50,000) or the Large Research Grants on Education program (budgets of $125,000 to $500,000) – through an eligible non-profit or public administering institution, since the Foundation does not award grants directly to individuals. A related but separately administered mechanism, the NAEd/Spencer Dissertation Fellowship, supports individual doctoral candidates directly through the National Academy of Education rather than through Spencer's own research-grant portal.
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FAIR Data Principles - CASRAI (2026)
The FAIR data principles are a set of four foundational goals — Findable, Accessible, Interoperable, and Reusable — for how research data and its metadata should be described, deposited, and structured so that both humans and machines can locate, retrieve, and reuse it with minimal manual effort. FAIR is a set of guiding goals for data stewardship, not a certification, a checklist with one correct implementation, or a data-sharing mandate in itself: a dataset is 'FAIR' to the degree its metadata and deposit environment satisfy the fifteen sub-principles across the four categories, and different repositories, disciplines, and data types satisfy them by different concrete means.
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H-Index Inflation - CASRAI (2026)
H-index inflation is a rise in a researcher's h-index that is driven mainly by co-authorship on a small number of very-large-team papers, rather than by a broader pattern of individually-led, independently cited work. Because the h-index counts a paper toward every listed co-author identically regardless of team size or individual contribution, a researcher who appears as one name among several hundred or several thousand co-authors on a heavily-cited paper receives the same per-paper credit as a sole author of an equally-cited paper. An h-index is flagged as inflated, in bibliometric practice, when a meaningful share of the citing papers behind it trace back to a handful of hyperauthored publications rather than to a broad base of independent outputs – a distinction visible on inspection of the underlying publication list, not from the index number alone.
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Digitally Anonymised Data - CASRAI (2026)
Digitally anonymised data is an electronic dataset that has been processed with computational techniques so that no living individual can reasonably be re-identified from it, either on its own or by combination with other information a realistic adversary could plausibly obtain, and no key, lookup table, or other additional information exists anywhere that could reverse the process. It differs from data that is merely stored in digital form and stripped of obvious direct identifiers: to count as digitally anonymised, a dataset has to pass the same substantive test any anonymisation method must meet under frameworks such as GDPR Recital 26 (identifiability assessed against 'all the means reasonably likely to be used', accounting for cost, time, and available technology) – the 'digitally' in the term describes how the anonymisation was performed (masking, generalisation, aggregation, noise addition, k-anonymity/differential-privacy methods, or synthetic-data generation applied by software to an electronic source dataset), not a lower or different bar than anonymisation achieved by any other means. If a re-identification key is retained anywhere, even encrypted or access-controlled, the output is pseudonymised data, not digitally anonymised data, and remains personal data under GDPR (Recital 26; Article 4(5)).
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Textual Plagiarism - CASRAI (2026)
Textual plagiarism is unattributed copying of another person's written words — as distinct from plagiarism of ideas, where an author paraphrases someone else's argument or findings thoroughly enough that no wording matches but the underlying contribution still goes uncredited. The U.S. Office of Research Integrity (ORI) uses this exact two-way split — plagiarism of text vs. plagiarism of ideas — in its own research-integrity guidance. A passage counts as an instance of textual plagiarism when matching or near-matching wording appears without both a citation to the source AND quotation marks (or block-quote formatting) marking exactly which words are borrowed; a citation alone, without quotation marks around verbatim language, is not sufficient. Because it is defined by the words on the page rather than by intent, textual plagiarism is the category similarity-checking software (Turnitin, iThenticate, Crossref Similarity Check) is built to surface — these tools compare submitted text against a reference corpus and report string-level matches. They cannot detect plagiarism of ideas, since a thoroughly reworded passage produces no textual match at all.
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NSF Regional Innovation Engines (NSF Engines) - CASRAI (2026)
The NSF Regional Innovation Engines program (branded "NSF Engines") is a large-scale National Science Foundation funding mechanism, authorized under Section 10388 of the CHIPS and Science Act of 2022 and administered by NSF's Directorate for Technology, Innovation and Partnerships (TIP). Rather than funding an individual investigator's research question, an NSF Engines award funds a multi-year, multi-institution coalition — typically spanning universities, industry, nonprofits, state/local government, and community organizations — that commits to building a self-sustaining, technology-driven innovation ecosystem around a defined regional focus area (a specific technology domain paired with a societal or economic challenge). A submission qualifies as an NSF Engine, operationally, when it names a lead institution accountable for a CEO-led governance structure, documents a coalition of partners across multiple sectors, defines a regional geography the ecosystem is meant to strengthen, and proposes a multi-phase plan (nascent, emergent, growth) for translating research into regional economic and workforce outcomes over up to a decade — not merely a shared research interest among co-PIs.
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SURF (Summer Undergraduate Research Fellowship) - CASRAI (2026)
SURF (Summer Undergraduate Research Fellowship) is a category of institutionally administered summer research program that places undergraduates into a mentored, full-time research placement – typically 8 to 11 weeks – under a faculty or staff scientist, usually with a stipend and often modeled on the grant-seeking process: the student writes a short research proposal to be accepted, conducts the project over the summer, and closes the program with a written report and an oral or poster presentation at a culminating symposium. 'SURF' is not one single national program; it is a naming convention independently adopted by dozens of individual institutions for their own summer undergraduate research fellowship, most prominently the California Institute of Technology (Caltech), whose SURF program is the oldest and most widely cited namesake of the term. A program counts as a SURF in the operational sense used here if it (a) is undergraduate-only, (b) runs as a discrete summer term rather than during the academic year, (c) pairs each student with an individual faculty/research mentor rather than a classroom instructor, and (d) issues a stipend or fellowship award rather than treating the position as employment paid hourly.
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Leverhulme Trust - CASRAI (2026)
An independent UK charitable foundation, endowed under the will of William Hesketh Lever (founder of Lever Brothers, now part of Unilever) and operating since 1925, that funds academic research and personal fellowships across all disciplines – including arts, humanities, and social sciences – without the thematic remit restrictions that apply to UKRI's discipline-specific research councils.
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Pharmaceutical Company Research Grants (Investigator-Initiated Studies) - CASRAI (2026)
A pharmaceutical company research grant, in the investigator-initiated study (IIS/ISS) sense, is funding a pharmaceutical or biopharmaceutical company provides for a research project that a physician, scientist, or other qualified investigator conceives, designs, and directs – distinguishing it from company-sponsored clinical trials, where the company itself designs the protocol and directs the study through a sponsor or sponsor-CRO relationship. A grant counts as an investigator-initiated study grant, and not ordinary trial sponsorship, only when the funding company has no control over hypothesis, design, endpoints, or data interpretation – its role is limited to scientific review of the proposal, funding decision, and (for studies involving its product) supply of drug or device as specified in the grant agreement.
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MRC (Medical Research Council, UK) - CASRAI (2026)
The MRC (Medical Research Council) is the UK statutory research council responsible for funding biomedical, clinical, and translational health research. It is one of the seven discipline-based research councils operating as constituent parts of UK Research and Innovation (UKRI) — a project or researcher qualifies as "MRC-funded" when the award is made under an MRC scheme (an applicant-led responsive-mode grant, an MRC-badged fellowship, or funding to one of MRC's own institutes/units) and its subject matter falls within MRC's biomedical/clinical remit, as distinct from awards made by UKRI's other councils (ESRC for social science, BBSRC for biosciences, EPSRC for engineering/physical sciences, and so on) or by the separately governed National Institute for Health and Care Research (NIHR).
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EPSRC (Engineering and Physical Sciences Research Council) - CASRAI (2026)
The EPSRC (Engineering and Physical Sciences Research Council) is the UK statutory research council responsible for funding engineering, physical sciences, mathematics, and digital/AI research. It is one of the seven discipline-based research councils operating as constituent parts of UK Research and Innovation (UKRI) — an award qualifies as "EPSRC-funded" when it is made under an EPSRC scheme (responsive-mode grants, EPSRC-badged fellowships and studentships, or EPSRC-led cross-council calls) and its subject matter falls within EPSRC's remit (engineering, physical sciences, mathematical sciences, chemistry, materials, digital technologies and AI), as distinct from awards made by UKRI's other councils (STFC for particle physics, astronomy and space science; MRC for biomedical/clinical research; BBSRC for biosciences; and so on) or by non-statutory private funders.
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NSF FastLane (Legacy Grants Portal) - CASRAI (2026)
NSF FastLane (fastlane.nsf.gov) was the National Science Foundation's original web-based electronic system for proposal preparation, submission, and award administration, launched in the 1990s. A document or workflow is properly described as "a FastLane submission" or "a FastLane-era award" if it was prepared, submitted, or administered through that platform prior to NSF's cutover to Research.gov. As of 2023, FastLane is decommissioned as a live proposal-submission channel: NSF's Proposal & Award Policies & Procedures Guide (PAPPG) NSF 23-1 removed FastLane as a submission option for all NSF funding opportunities effective January 30, 2023, and NSF phased out FastLane's remaining functions (award documents, organizational reports, Grants.gov integration) in the months that followed, including a further phase in November 2023. The fastlane.nsf.gov domain now 301-redirects to research.gov, confirming there is no live FastLane instance to submit to. Research administrators encountering the term today are almost always dealing with historical records, legacy award documentation, or institutional process guides that have not yet been updated to reflect the transition.
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Statement of Work (SOW) - CASRAI (2026)
A Statement of Work (SOW) is the contractual document – typically an exhibit or attachment incorporated by reference into a sponsored research contract, industry-funded research agreement, or subaward – that specifies the concrete work a recipient is legally obligated to perform: the specific tasks, deliverables, timeline, and milestones the funded party must complete. It functions as a binding technical and performance specification, not as a scientific narrative. That distinguishes it from a grant proposal's Specific Aims (or Research Strategy) section, which argues the scientific rationale and hypotheses behind proposed work to persuade a funder or peer-review panel of merit, but does not itself create an enforceable task list. A SOW's tasks and deliverables are what the contracting parties monitor performance against and, in a true contract, what a breach or termination-for-default claim would be measured against; missed Specific Aims in a grant typically trigger a progress-report conversation, not a contractual remedy.
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BBSRC (Biotechnology and Biological Sciences Research Council) - CASRAI (2026)
BBSRC is one of the seven discipline-based research councils inside UK Research and Innovation (UKRI), responsible for funding fundamental and applied bioscience research and postgraduate training in the UK – from molecular and cellular biology through to agriculture, food security, engineering biology, and biotechnology. An award counts as BBSRC funding when it is made through a BBSRC-branded scheme (responsive-mode grants, fellowships, doctoral training partnerships, Institute Strategic Programme funding, or industry-partnered awards) rather than through one of UKRI's other six research councils, even though all UKRI councils share the same underlying application system, costing model, and outcome-reporting requirements.
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Advarra IRB - CASRAI (2026)
Advarra is a commercial (independent) Institutional Review Board (IRB) provider based in Columbia, Maryland, formed in 2017 through the merger of Chesapeake IRB and Schulman IRB and expanded in 2019 through the acquisition of Quorum Review IRB. It is one of the largest commercial IRBs operating in the United States, reviewing human-subjects research on a fee-for-service basis for pharmaceutical, biotech, medical-device, and academic sponsors, and is frequently designated as the central IRB / single IRB of record (sIRB) for multi-site clinical trials. Advarra is registered with the Office for Human Research Protections (OHRP) under 45 CFR 46 and with FDA under 21 CFR Part 56, and holds full accreditation from AAHRPP. Sites and sponsors submit and track studies through Advarra's electronic platform, the Center for IRB Intelligence (CIRBI).
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William T. Grant Foundation - CASRAI (2026)
The William T. Grant Foundation (WTGF) is a private, non-federal U.S. foundation, headquartered in New York City, that funds research in the social sciences. Since 1936 it has supported studies aimed at reducing inequality in the outcomes of young people (ages 5-25) in the United States and, more recently, at improving how research evidence is used by the policymakers, agency leaders, and other decision-makers who shape youth-serving systems. A project qualifies as WTGF-funded research if it is submitted under one of the Foundation's active funding mechanisms — principally the Research Grants on Reducing Inequality program and the Research Grants on Improving the Use of Research Evidence program — and is reviewed and awarded through the Foundation's own letter-of-inquiry and full-proposal process, which runs on its own cycle and criteria rather than a federal grants system such as Grants.gov or NIH's eRA Commons.
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ESRC (Economic and Social Research Council) - CASRAI (2026)
The ESRC (Economic and Social Research Council) is the UK statutory research council responsible for funding economic, social, behavioural, and human data science research. It is one of the seven discipline-based research councils operating as constituent parts of UK Research and Innovation (UKRI) — a body qualifies as "ESRC-funded" when its award is made under an ESRC scheme (responsive-mode grants, ESRC-badged fellowships and studentships, or ESRC-led cross-council calls) and its subject matter falls within ESRC's social-science remit, as distinct from awards made by UKRI's other councils (EPSRC for engineering/physical sciences, MRC for biomedical/clinical research, BBSRC for biosciences, and so on) or by non-statutory private funders.
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Network Meta-Analysis (NMA) - CASRAI (2026)
Network meta-analysis (NMA) is a statistical technique that estimates the comparative effectiveness of three or more interventions within a single unified model by combining two kinds of evidence: direct evidence, from trials that compared two of the interventions head-to-head, and indirect evidence, inferred through one or more common comparators (such as a shared placebo or standard-of-care arm) that connect trials which never compared those two interventions directly. A body of evidence qualifies as an NMA, rather than a standard pairwise meta-analysis, when it (1) includes three or more interventions across the included trials, (2) links those trials into a connected network via shared comparators, and (3) produces relative-effect estimates for treatment pairs even when no trial tested that pair directly. NMA rests on an assumption called transitivity — that trials contributing indirect evidence are similar enough in patient population, setting, and other effect modifiers that comparisons through a common comparator are valid — and its statistical counterpart, consistency, which checks that direct and indirect estimates for the same pair of interventions agree.
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Research.gov - CASRAI (2026)
Research.gov is the U.S. National Science Foundation's primary electronic system for the full lifecycle of an NSF award: proposal preparation and submission, panel/merit review support, and post-award administration. Its post-award functions include submitting annual and final project reports, project outcomes reports, no-cost extension requests, and other award actions that an authorized organizational representative (AOR) or principal investigator (PI) performs after an award is made. Research.gov has progressively absorbed the functions of NSF's legacy FastLane system: since 2018 the two systems ran in parallel, but NSF has moved specific proposal types and modules to Research.gov-only submission over time (for example, SBIR/STTR proposals must now be submitted through Research.gov, and the Proposal Evaluation System (PES) replaced FastLane's Interactive Panel System (IPS) for NSF-wide merit review in FY2024). A submission counts as made through Research.gov, rather than FastLane or Grants.gov, when the specific funding opportunity's program solicitation or the current NSF Proposal & Award Policies & Procedures Guide (PAPPG) designates Research.gov as the required or available submission route for that proposal type.
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ARPA-H (Advanced Research Projects Agency for Health) - CASRAI (2026)
A U.S. federal award qualifies as ARPA-H funding when it is issued under a Program Manager-defined program announced via an Innovative Solutions Opening (ISO), rather than through NIH's standard investigator-initiated peer-review process – typically structured as an Other Transaction agreement, contract, or cooperative agreement with funding disbursed against pre-negotiated technical milestones, and subject to Program Manager oversight and go/no-go performance review rather than a fixed project period awarded purely on initial peer-review score.
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Investigator’s Brochure (IB) - CASRAI (2026)
The Investigator's Brochure (IB) is the ICH E6(R2)-required compilation of physical, chemical, pharmaceutical, nonclinical, and available clinical data on an investigational product, supplied by the sponsor to investigators and the IRB/IEC before a trial begins and kept current through an ongoing review-and-update obligation for as long as the product remains investigational, so investigators can make an informed risk-benefit assessment and comply with protocol-specified dosing and safety monitoring.
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Non-Patent Literature (NPL) - CASRAI (2026)
Non-patent literature (NPL) is any published material submitted or cited as prior art in a patent search or examination that is not itself a patent or published patent application. It covers journal articles, conference proceedings and papers, theses and dissertations, preprints, technical standards, product manuals and datasheets, trade publications, websites, and even oral presentations or public demonstrations with a documented date. A document counts as NPL for a given invention when two conditions are both met: it was publicly accessible before the invention's effective filing (or priority) date, and it discloses subject matter relevant to novelty or obviousness. NPL is functionally equivalent to patent prior art in legal weight — a single relevant journal article can invalidate a patent claim exactly as a prior patent can — but it is indexed far less consistently, which is what makes NPL search its own distinct skill within prior art search rather than a simple extension of a patent database query.
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European Research Council (ERC) - CASRAI (2026)
The European Research Council (ERC) is the European Union's funding body for frontier basic research, established in 2007 and operating as part of the Horizon Europe programme (2021-2027). A funding instance qualifies as ERC-administered if it is awarded through one of the ERC's own investigator-driven grant schemes – Starting, Consolidator, Advanced, or Synergy Grants, plus the smaller Proof of Concept top-up for existing grantees – selected on scientific excellence alone via a bottom-up, discipline-blind peer review process, rather than through a thematic Horizon Europe call defined around a predetermined policy priority.
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NIH ASSIST - CASRAI (2026)
ASSIST (Application Submission System & Interface for Submission Tracking) is NIH's own web-based system for preparing, submitting, and tracking electronic grant applications through Grants.gov to NIH. It is one of three ways an institution can get an application from the eRA Commons/Grants.gov ecosystem to NIH — the others being institutional system-to-system (S2S) software (e.g. Cayuse, InfoEd, ProposalCentral) or, less commonly today, Grants.gov Workspace used directly — and NIH designates it as required, rather than optional, for certain complex application types, most notably multi-project applications submitted under the Program Project/Center (PPG) forms family, where S2S vendor support is often incomplete.
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eRA Commons: Accounts, Roles, ORCID Linking & Troubleshooting - CASRAI (2026)
eRA Commons (commons.era.nih.gov) is NIH's web-based portal for post-submission electronic Research Administration: the system where a Principal Investigator, institutional Signing Official, or other registered role accesses and manages an NIH application and award after it has been submitted through Grants.gov. Grants.gov is where an application package is transmitted to NIH; eRA Commons is where nearly everything that happens to it afterward – assignment tracking, summary statements and scores, Just-in-Time (JIT) submissions, Research Performance Progress Reports (RPPR), ORCID linkage, no-cost extension requests, prior-approval requests, and final closeout – takes place. A task counts as "in eRA Commons" if it requires an eRA Commons account and role-based login (era.nih.gov credential) to view or act on, as distinct from the one-time act of transmitting an application via Grants.gov.
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NIH Activity Codes - CASRAI (2026)
An NIH activity code is the two-to-three-character alphanumeric code – one or two letters followed by two digits, such as R01, K08, T32, F31, U01, or P01 – that NIH assigns to classify a specific type of funding mechanism (grant, cooperative agreement, or fellowship) by the kind of support it provides, independent of the awarding Institute or Center, the scientific topic, or the specific Notice of Funding Opportunity (NOFO) issuing it. The activity code is the second element of a full NIH grant number (after the application-type digit and before the Institute/Center code and serial number), for example the 'R01' in '1 R01 CA123456-01.' A funding mechanism is correctly described as belonging to an activity code – rather than being one – when its scope, review criteria, budget structure, and duration are all defined NIH-wide (or Common-Fund-wide) by that code's own governing policy, rather than being invented ad hoc by a single NOFO.
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Reporting Guidelines - CASRAI (2026)
Reporting guidelines are checklists, flow diagrams, or structured-text tools that specify the minimum set of information authors must include when writing up a specific type of study, so that readers, peer reviewers, and editors can judge what was done and trust that nothing material has been left out. The EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network, an international initiative founded in 2006 and based at the University of Oxford's Centre for Statistics in Medicine (NDORMS), is the field's central clearinghouse: it defines a reporting guideline as a checklist, flow diagram, or structured text developed using an explicit, documented consensus methodology to guide authors in reporting a specific type of research, and it maintains a searchable library of several hundred such guidelines spanning study designs, specialties, and report sections. A reporting guideline is not a methodological standard. It does not tell an investigator how to design a trial, calculate a sample size, randomize participants, or run an assay – that is the job of methodological/conduct standards such as ICH Good Clinical Practice, CIOMS guidance, or a funder's data-collection protocol. Nor is a reporting guideline a critical-appraisal or risk-of-bias tool – it does not score how well a study was conducted (that is the role of instruments such as the Cochrane risk-of-bias tools). A reporting guideline answers a narrower, prior question: given that the study was conducted a particular way, has the write-up disclosed enough about it – the eligibility criteria, the randomization method, the funding source, the flow of participants – for a reader to evaluate and, ideally, reproduce the work? An author can follow a reporting guideline to the letter while having run a methodologically weak study, and a well-conducted study can still be reported so incompletely that a reader cannot tell.
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Cochrane Handbook for Systematic Reviews of Interventions - CASRAI (2026)
The Cochrane Handbook for Systematic Reviews of Interventions is the methodological standard maintained by Cochrane (founded 1993, named after epidemiologist Archie Cochrane) that specifies how a systematic review of a health intervention must be planned, conducted, and reported to qualify as a Cochrane Review. It requires a registered protocol with a PICO-structured question, a comprehensive pre-specified search strategy across multiple databases, dual independent screening and data extraction, formal risk-of-bias assessment (the RoB 2 tool for randomized trials, ROBINS-I for non-randomized studies), GRADE-based certainty-of-evidence rating, and, where studies are sufficiently similar, meta-analysis. Reviews that follow the Handbook are published in the Cochrane Database of Systematic Reviews (CDSR) within the Cochrane Library and are maintained as living documents, updated as new evidence emerges.
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Plain Language Summary (PLS) - CASRAI (2026)
A plain language summary (PLS) is a short, jargon-free account of a clinical trial's design and results, written so that a layperson — typically framed as a trial participant or member of the public — can understand what the study tested, what it found, and what that means, without needing scientific or medical training. In EU-regulated clinical trials it is a defined regulatory deliverable, not an optional courtesy: under Regulation (EU) No 536/2014 (the EU Clinical Trials Regulation, CTR), sponsors of trials authorised under the Regulation must submit a lay summary of the trial's results to the Clinical Trials Information System (CTIS) alongside the technical results summary, generally within 12 months of the trial's global end date. That deadline extends to up to 30 months for certain non-therapeutic Phase 1 trials, and shortens to 6 months for paediatric trials. Lay summaries must generally be provided in the official language(s) of the EU/EEA member state(s) where the trial was conducted, not only in English. An instance of a PLS is a written summary that (a) covers the trial's purpose, participant population, methods, and results including any relevant safety information, (b) is written for a non-specialist reading level (commonly targeted around a 12-14 year-old reading age in EMA/national guidance), and (c) is submitted as a distinct, identifiable document alongside — not merged into — the technical/scientific summary of results. A document that simply restates the scientific abstract in shorter form, or that omits the trial's actual findings in favour of only describing its design, does not meet the operational bar even if labelled a lay summary.
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PICOTS Criteria - CASRAI (2026)
A research question is PICOTS-structured when it explicitly specifies all six elements — Population, Intervention, Comparator, Outcome, Timing, and Setting — rather than only the four PICO elements, typically to derive study-eligibility criteria for a systematic review, evidence synthesis, or health-technology assessment protocol.
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Conference Travel Grant (Award) - CASRAI (2026)
A conference travel grant (also called a conference travel award) is a discrete funding mechanism – distinct from a project's general travel budget line – that pays some or all of the cost of a researcher attending and presenting at an academic or professional conference. It is an instance of this concept when: (1) the funds are awarded competitively or by defined eligibility criteria rather than simply drawn down from an existing project budget; (2) the covered costs are conference-specific (registration fee, travel, lodging, and sometimes per diem/subsistence) rather than general research expenses; and (3) eligibility and award size are set by a funder, professional society, or institution operating a named award program, not negotiated ad hoc. Three source types are common: (a) institutional travel funds administered by a graduate school, department, or office of research, typically capped per award ($300-$1,500 is a common range) and limited to one award per researcher per year; (b) professional-society travel awards tied to a specific annual meeting, frequently reserved for student, postdoctoral, or early-career members and conditioned on having an accepted abstract or paper; and (c) funder-level mechanisms built into a federal grant program, such as NIH's R13/U13 Support for Scientific Meetings and Conferences (Parent R13, e.g. PA-25-080) and comparable NSF conference/travel solicitations, which are typically awarded to the hosting institution or organization – not to an individual researcher directly – to subsidize the meeting itself and, within that award, the travel of students, trainees, and junior investigators attending it. This is a funding-mechanism concept, not a cost-allowability concept: whether a specific expense charged against any of these awards is allowable follows ordinary sponsor cost policy (2 CFR 200.475, the Fly America Act for federally funded international air travel, per diem rules) – see Travel cost (grant) for that separate question.
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Patient Consent for Case Report Publication - CASRAI (2026)
The written authorization a patient (or parent/guardian/legally authorized representative) gives before a clinical case report describing their presentation, treatment, images, or outcome is submitted to a journal – required whenever the report contains identifiable information, per ICMJE's patient-privacy recommendations and CARE Guidelines checklist item 13, independent of any separate IRB determination about the underlying case.
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NIH Director’s New Innovator Award (DP2) - CASRAI (2026)
The NIH Director's New Innovator Award (DP2) is a Common Fund High-Risk, High-Reward Research grant that funds early-career investigators (Early Stage Investigators, within 10 years of their terminal degree or clinical training) proposing exceptionally creative, high-risk research, without requiring the extensive preliminary data a standard R01 application expects. It provides a single award, historically up to $1.5 million and more recently up to $2.375 million in total direct costs, over a five-year project period.
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NIH R03 (Small Grant Program) - CASRAI (2026)
An R03 is an NIH research-grant activity code — the Small Grant Program — that funds modest, short-term, self-contained research projects rather than the extended, larger-scale programs an R01 supports. R03 budgets are capped at up to $50,000 in direct costs per year, over a project period of up to two years (commonly cited as up to $100,000 in direct costs total across the period). No preliminary data are required to apply, though supporting evidence can strengthen an application. NIH designates the R03 mechanism for a defined set of uses: pilot or feasibility studies, secondary analysis of existing data, small self-contained research projects, development of new research methodology, and development of new research technology. The mechanism has no Type 2 competing-renewal option, and not every NIH Institute or Center (IC) participates in the Parent R03 Funding Opportunity Announcement (FOA) — applicants must confirm the specific IC's current participation and any IC-specific R03 announcement before applying.
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Retrospective Study - CASRAI (2026)
A retrospective study is an observational research design in which investigators identify subjects, exposures, and outcomes that have already occurred and reconstruct the exposure-outcome relationship from data recorded before the study began – most often clinical records, administrative/claims data, registries, or prior test results – rather than measuring events as they unfold going forward. What makes a study retrospective is not its statistical method but the timing relationship between the start of the study and the events under analysis: if the outcome had already happened before subjects were identified and data collection began, the study is retrospective, regardless of whether it is framed as a cohort, case-control, or case-series design. Because the data were typically generated for clinical care, billing, or another purpose unrelated to the study's hypothesis, retrospective studies trade weaker control over data quality and measurement consistency for speed, lower cost, and the ability to study rare outcomes or long latency periods that a forward-looking design could not practically capture.
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ANSI/NISO Z39.56 (SICI — Serial Item and Contribution Identifier) - CASRAI (2026)
A code counts as a SICI only if it assembles all three ANSI/NISO Z39.56-1996 [R2002] segments in sequence — an Item segment (ISSN + chronology + enumeration), a Contribution segment (starting page + title-code checksum for the specific article), and a Control segment (structure/version/check-character) — to identify one specific item within a serial. NISO withdrew the standard in 2012; new article-level identification now runs through the DOI.
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ANSI/NISO Z39.14 (Guidelines for Abstracts) - CASRAI (2026)
ANSI/NISO Z39.14-1997 (R2015), Guidelines for Abstracts, is an American National Standard developed by the National Information Standards Organization (NISO) that gives authors and editors guidance on writing abstracts for research publications and other scholarly works – specifically, texts reporting the results of experimental work or descriptive or discursive studies. It is a guideline, not a mandatory format: it does not set a single fixed word limit or template that every abstract must follow. Instead it covers where an abstract should be placed in a publication, the different types of abstracts and what content each type is expected to cover, document-type-specific abstracting recommendations, style guidance, and worked examples. A document's abstracting practice can be described as following Z39.14 when it applies this general guidance – consistent placement, content coverage matched to abstract type, and a style suited to standalone use by abstracting and indexing services – rather than any one publisher's or journal's own house-style abstract instructions.
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NISO Z39.29 (Bibliographic References) - CASRAI (2026)
ANSI/NISO Z39.29-2005 (R2010), Bibliographic References, is the American National Standard that specifies the data elements and construction rules for citing print, audiovisual, and electronic materials, both published and unpublished. It does not mandate a single citation style (it does not compete with APA, MLA, Chicago, or Vancouver); instead it defines the underlying data elements a reference needs to uniquely identify a source (creator, title, date, publisher/source, locator, and medium-specific descriptors) and the construction rules for assembling them, organized across fifteen broad categories of material (books, articles, technical reports, audiovisual works, maps, patents, online/electronic resources, unpublished materials, and others). A document or metadata record operationally conforms to Z39.29 when it captures the standard's required data elements for its material category and assembles them per the standard's ordering/punctuation rules — the same underlying logic that named citation-style guides (APA, MLA, etc.) each format differently on the page. The standard was approved by ANSI in July 2005 and reaffirmed by NISO in May 2010 (hence the "R2010" suffix); as of this writing no newer published edition supersedes it, though NISO solicited volunteers for a possible revision in 2016.
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IACUC Adverse Event and Unanticipated Outcome Plan - CASRAI (2026)
An IACUC adverse event and unanticipated outcome plan is the written contingency component of an approved animal-use protocol specifying: (1) trigger criteria for what counts as an adverse event or unanticipated outcome for that study (pain, distress, injury, illness, or a clinical sign exceeding the approved humane endpoints); (2) who is authorized to act immediately, in practice the Attending Veterinarian or delegated veterinary staff, who can order treatment, analgesia, or euthanasia without prior investigator consent when welfare requires it; (3) a defined internal reporting pathway and timeframe from the observer to veterinary staff to the IACUC office; and (4) a documented outcome record distinguishing an isolated clinical event from a pattern indicating the protocol itself needs IACUC-reviewed modification. Institutions holding a PHS Animal Welfare Assurance must additionally report specific categories of event – serious or continuing noncompliance, serious deviation from the Guide for the Care and Use of Laboratory Animals, or an IACUC-ordered suspension – to OLAW under PHS Policy IV.F.3.
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SPRE (Strategy, People and Research Environment) - CASRAI (2026)
SPRE is the REF 2029 assessment element scoring the conditions an institution and its submitting units put in place to enable research, replacing REF 2021's Environment element (REF5a/REF5b). It is worth 20% of the overall REF 2029 quality profile, combining an Institution-Level Statement (ILS, 60% of the SPRE score) and a Unit-Level Statement (ULS, 40%), each covering context/mission/strategy, people, income/infrastructure/facilities, and collaboration/engagement/impact. Guidance is still being finalised through 2026.
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TCPS 2 Chapter 7 (Conflicts of Interest) - CASRAI (2026)
TCPS 2 (the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans), Chapter 7, "Conflicts of Interest," is the chapter of Canada's tri-agency human-research ethics policy that governs how researchers, research ethics boards (REBs) and institutions identify, disclose and manage conflicts of interest arising in human-participant research. A conflict of interest under Chapter 7 exists whenever a person's or institution's duties toward research participants and the research record could be compromised, or could reasonably appear to be compromised, by a competing personal, financial, professional or institutional interest. The chapter treats real, potential and perceived conflicts as equally disclosable – a conflict does not need to have actually influenced a decision to trigger Chapter 7's disclosure and management requirements, only to create a reasonable appearance that it might. Chapter 7 applies at three distinct levels: individual conflicts (a researcher's own competing interests), institutional conflicts (the institution's own financial or other stake in a study's outcome), and REB-member conflicts (a board member with a personal or professional stake in a protocol under that board's review).
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Data Protection Act 2018, Section 19 (Research Safeguards) - CASRAI (2026)
DPA 2018 Section 19 was the UK domestic provision requiring that research/archiving/statistics processing under UK GDPR Article 89(1) not be likely to cause substantial damage or distress, and not be used for decisions about a particular individual unless for approved medical research. It was omitted from 5 February 2026 by the Data (Use and Access) Act 2025; the same safeguards now sit in UK GDPR Articles 84B and 84C.
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ISO 18626 (Interlibrary Loan Transactions — Application Protocol) - CASRAI (2026)
ISO 18626, Information and documentation — Interlibrary loan transactions, is the international application-protocol standard for the messages that library systems exchange to request, supply, and track resource-sharing loans and copies between institutions. A transaction qualifies as ISO 18626-compliant when it is carried out as a defined sequence of XML messages — a Request from the borrowing (requesting) library, and Supplying Agency and Requesting Agency status/action messages exchanged between the two systems — rather than as free-text email, fax, or a proprietary, non-standard API. First published by ISO in 2014, revised in 2017, and further revised as ISO 18626:2021, the standard is maintained under ISO/TC 46, the technical committee for information and documentation.
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NISO Z39.98 (Authoring and Interchange Framework for Adaptive XML Publishing) - CASRAI (2026)
ANSI/NISO Z39.98-2012, Authoring and Interchange Framework for Adaptive XML Publishing Specification (commonly called the A&I Framework, or by its DAISY-side identifier Z3998), is a joint NISO/DAISY Consortium standard, published in 2012, that defines a modular framework for building XML markup languages for accessible, adaptive publishing rather than a single fixed document format. A publication workflow is 'Z39.98-conformant' when its source XML is authored against a document model built on the A&I Framework's shared architecture (a common core vocabulary plus resource-type-specific modules for books, periodicals, and other content types), so that a single authored source can be transformed into multiple universally accessible output formats – braille, large print, synthetic speech/DAISY talking book, and EPUB – without re-authoring content per format. It supersedes ANSI/NISO Z39.86-2005(R2012), the original DAISY Digital Talking Book (DTB) specification, of which it is a substantial, non-backward-compatible redesign – which is why NISO and the DAISY Consortium issued it under a new standard number rather than as a further DTB revision.
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Participant Health Literacy - CASRAI (2026)
Participant health literacy is the degree to which a prospective or enrolled research participant can find, understand, and act on the information needed to make a voluntary decision about joining a study and to follow study procedures once enrolled. In practice, a research team is designing for participant health literacy whenever it (1) writes consent forms, recruitment materials, and result-summary/plain-language-summary documents at a reading level and format the target population can actually process (commonly benchmarked to roughly a 6th-8th grade level, though neither the Common Rule nor FDA regulations set a numeric threshold – both simply require information 'understandable to the subject'), and (2) actively checks comprehension rather than assuming it, most often via the teach-back method: asking the participant to restate key study facts (purpose, main procedures, risks, voluntariness, right to withdraw) in their own words before consent is finalized. A document or process only counts as addressing health literacy if both elements – accessible language AND a comprehension check – are present; a well-simplified form that nobody ever asks the participant to explain back is a partial, not complete, application of the concept.
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IRB Approval and Expiration of Recruitment Materials - CASRAI (2026)
IRB approval and expiration of recruitment materials refers to the fact that flyers, advertisements, social-media posts, phone/email scripts, screening questionnaires, and other materials used to identify and approach prospective participants are themselves reviewed and approved by the IRB as part of the informed-consent process – not treated as separate marketing collateral – and that approval carries its own expiration date, tied to the study's current approval period, independent of whether the underlying protocol itself continues. A recruitment or screening document is an approved recruitment material only for the interval the IRB has authorized; once that interval lapses, the material cannot be used to recruit or screen new participants even if the protocol has not been suspended or terminated and even if continuing review is only pending, not yet complete.
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Research Security - CASRAI (2026)
Research security is the set of institutional and federal policies, disclosures, and safeguards designed to protect the U.S. federally funded research enterprise against foreign government interference, undisclosed foreign support, and the misappropriation of research and development. The controlling federal definition comes from National Security Presidential Memorandum 33 (NSPM-33) (issued January 2021) and its implementing guidance from the National Science and Technology Council (NSTC): research security means "safeguarding the research enterprise against the misappropriation of research and development to the detriment of national or economic security, related violations of research integrity, and foreign government interference." An activity, disclosure, or policy is an instance of research security – as distinct from general information security, export control, or research integrity – when it satisfies three conditions together: (1) it concerns federally funded or federally regulated research; (2) it addresses a risk tied to foreign government interference, undisclosed foreign talent recruitment, or misuse of research outputs for national/economic security ends; and (3) it maps to one of the concrete compliance mechanisms federal research agencies now require – disclosure of foreign financial support and affiliations, foreign travel security, research security training, export control training, and cybersecurity controls for federally funded R&D. Under NSPM-33's implementation, research organizations that receive more than $50 million per year in federal research funding must certify they operate a research security program covering four elements: cybersecurity, foreign travel security, research security training, and export control training.
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ICH E6(R2) Section 5 Sponsor Obligations - CASRAI (2026)
A duty ICH E6(R2) Section 5 (subsections 5.0 through 5.23) assigns by default to the trial sponsor – spanning quality management, quality assurance/control, CRO oversight, trial management and recordkeeping, investigator selection, subject/investigator compensation, investigational-product supply, safety reporting and monitoring, audit, noncompliance handling, trial termination/suspension, and multicenter-trial coordination – that the sponsor retains unless specifically transferred in writing to a CRO under Section 5.2.
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DARPA Countering Foreign Influence Program (CFIP) - CASRAI (2026)
A DARPA-specific risk-review process, applied to proposed awards, in which senior/key personnel disclosures are screened against a qualitative risk rubric covering participation in foreign talent programs, affiliation with denied or restricted entities, funding or in-kind support from foreign government sources, and affiliation with designated high-risk foreign institutions, generally over the preceding four years, with results assigned a risk level from low to very high that informs (but does not automatically decide) award negotiation.
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AAALAC Accreditation Requirements - CASRAI (2026)
The specific set of standards and recurring obligations an institution must satisfy to achieve and then keep AAALAC International accreditation: evaluating its animal care and use program against AAALAC's Three Primary Standards (principally the Guide for the Care and Use of Laboratory Animals), submitting a detailed Program Description and hosting an on-site peer review before initial accreditation, then filing an Annual Report every year and undergoing a full site visit roughly every three years to keep that status.
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Program of Veterinary Care (PVC) - CASRAI (2026)
A Program of Veterinary Care (PVC) is the documented set of policies, procedures, and staffing arrangements through which an institution's Attending Veterinarian provides adequate veterinary care to animals used in research, teaching, and testing. It is a required component of an animal-care-and-use program under Animal Welfare Act regulations (9 CFR 2.33) and, in parallel, under PHS Policy for PHS-supported vertebrate-animal research. A program qualifies as an adequate PVC only if it addresses, at minimum: preventive medicine (quarantine, disease surveillance, herd/colony health monitoring, vaccination and parasite control where applicable); appropriate methods for preventing, controlling, diagnosing, and treating disease and injury; guidance and oversight of surgery (pre-, intra-, and post-operative care) and of anesthesia and analgesia use, including a mechanism for the Attending Veterinarian to require or adjust pain relief; a means of communication so personnel promptly report animal health concerns; and 24-hour availability of emergency veterinary care. Where the Attending Veterinarian serves in a part-time or consultant capacity rather than full-time employment, 9 CFR 2.33 requires the arrangement to be formalized through a written program of veterinary care and regularly scheduled site visits, not an informal or on-call-only relationship.
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EU AI Act Annex III (High-Risk Use Cases) - CASRAI (2026)
A system falls under EU AI Act Annex III when it (1) is one of the eight listed use-case categories – biometrics, critical infrastructure, education and vocational training, employment, essential services, law enforcement, migration, or administration of justice – and (2) performs the specific function that category text describes (e.g., for education: admissions/access decisions, evaluating learning outcomes, assessing appropriate education level, or monitoring prohibited test behaviour). Matching both conditions triggers high-risk status under Article 6(2), subject to the narrow Article 6(3) exception, which itself never applies if the system profiles natural persons.
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TCPS 2 Article 3.1 (Free and Informed Consent) - CASRAI (2026)
TCPS 2 (the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2022 edition) Article 3.1, in Chapter 3 ('The Consent Process'), sets out Canada's core requirement that participation in research involving human participants be based on free, informed, and ongoing consent. A consent process satisfies Article 3.1 when: (1) it is FREE – given voluntarily, without manipulation, undue influence, or coercion; (2) it is INFORMED – the prospective participant has enough understandable information about the research's purpose, procedures, reasonably foreseeable risks and potential benefits to make a genuine choice; and (3) it is ONGOING – treated as a continuing process rather than a single signature, with researchers under a standing obligation to disclose material changes in risk or benefit as the study proceeds, and to reconfirm consent or offer withdrawal where warranted. Research Ethics Boards (REBs) are directed to apply particular scrutiny to trust or dependency relationships (for example, physician-patient or professor-student) where the relationship itself could create undue influence on a prospective participant's decision to take part.
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GDPR Article 22 (Automated Decision-Making in Research) - CASRAI (2026)
GDPR Article 22(1) gives a data subject 'the right not to be subject to a decision based solely on automated processing, including profiling, which produces legal effects concerning him or her or similarly significantly affects him or her.' A research activity triggers Article 22 only if all three elements hold at once: (1) the decision is made solely by an automated system, with no meaningful human involvement in reaching the specific outcome – a human merely rubber-stamping an algorithmic output does not count as meaningful involvement, but a human who genuinely reviews the case and can depart from the system's recommendation does; (2) the processing includes profiling or another automated evaluation of the person, not just automated data collection or storage; and (3) the decision produces a legal effect or similarly significant effect on that individual – something that meaningfully affects their circumstances, behaviour, or choices, not a trivial or cosmetic outcome. In a research context this most commonly arises where an AI/ML system automatically screens, ranks, or excludes real individuals as part of a study – for example, a clinical-trial-eligibility screening tool that auto-rejects applicants, or an automated participant-selection or risk-stratification algorithm that determines who is invited, enrolled, or offered an intervention – as opposed to a model that only analyses aggregate or already-anonymised data with no decision made about a specific identifiable person. Article 22(2) narrows this to a qualified right rather than an absolute prohibition: solely automated decisions with legal/significant effect are permitted where (a) necessary for entering into or performing a contract, (b) authorised by Union or Member State law that also lays down suitable safeguards, or (c) based on the data subject's explicit consent. Where (a) or (c) applies, Article 22(3) requires the controller to implement suitable safeguards – at minimum the right to obtain human intervention, to express a point of view, and to contest the decision. Article 22(4) adds a further restriction: these decisions must not be based on special category data (Article 9(1) – including data concerning health, which covers most clinical and biomedical research) unless a specific Article 9(2)(a) or (g) exemption applies and suitable safeguards are in place. For research controllers, this means an automated eligibility or selection tool operating on health or genetic data faces a materially higher bar than one operating on non-sensitive data, even where a general Article 6 lawful basis for the underlying processing is otherwise sound.
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EU AI Act Article 53 (General-Purpose AI Model Obligations) - CASRAI (2026)
Article 53 of the EU AI Act (Regulation (EU) 2024/1689) sets the baseline obligations that apply to every provider of a general-purpose AI (GPAI) model placed on the EU market – a model trained on large amounts of data using self-supervision at scale, showing significant generality, and capable of competently performing a wide range of distinct tasks (Article 3(63)). A GPAI provider must, at minimum: (1) draw up and keep current technical documentation of the model per Annex XI, available on request to the AI Office and national authorities; (2) draw up and make available to downstream AI-system providers the information and documentation set out in Annex XII needed to understand the model's capabilities and limitations; (3) put in place a policy to comply with EU copyright law, including respecting rightsholders' text-and-data-mining opt-outs reserved under Article 4(3) of Directive (EU) 2019/790; and (4) draw up and publish a sufficiently detailed summary of the content used to train the model, following a template the AI Office provides. These obligations became applicable on 2 August 2025 (Article 113(b)). Models released under a genuinely free and open-source licence, with publicly available weights, architecture, and usage information, are exempt from obligations (1) and (2) above – but never from the copyright-policy or training-data-summary duties, and never at all if the model is also classified as carrying 'systemic risk.'
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EU AI Act Article 6 (High-Risk Classification Rules) - CASRAI (2026)
Article 6 of the EU AI Act (Regulation (EU) 2024/1689) is the classification test that determines whether an AI system counts as 'high-risk.' An AI system is high-risk if either: (1) under Article 6(1), it is a safety component of, or is itself, a product covered by EU harmonisation legislation listed in Annex I and that product requires third-party conformity assessment; or (2) under Article 6(2), it falls into one of the eight functional use-case categories listed in Annex III (biometrics; critical infrastructure; education/vocational training; employment/worker management; essential private and public services; law enforcement; migration/asylum/border control; administration of justice and democratic processes). Article 6(3) provides a narrow, documented exception for Annex III systems that perform only a narrow procedural task, improve a completed human activity's result, detect patterns without replacing human assessment, or perform preparatory tasks – unless the system profiles natural persons, in which case it is always high-risk. Classification under Article 6 is the trigger, not the substance: it determines whether the Title III, Chapter 2 obligations (risk management, data governance, technical documentation, human oversight, and more) apply at all.
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Tri-Agency Framework: Responsible Conduct of Research (RCR) - CASRAI (2026)
The Tri-Agency Framework: Responsible Conduct of Research is the joint policy of Canada's three federal research funding agencies – the Canadian Institutes of Health Research (CIHR), the Natural Sciences and Engineering Research Council of Canada (NSERC), and the Social Sciences and Humanities Research Council of Canada (SSHRC) – that defines researcher, institution, and Agency responsibilities for research integrity, sets minimum requirements for institutional RCR policies, defines what constitutes a breach of Agency policies, and specifies the process the Agencies follow when addressing allegations of a breach. It applies to research funded in whole or in part by any of the three Agencies, and is administered jointly by the Secretariat on Responsible Conduct of Research (SRCR) and the Interagency Advisory Panel on Responsible Conduct of Research (PRCR). The current edition took effect in 2021, replacing the 2016 version.
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EU AI Act Article 5 (Prohibited AI Practices) - CASRAI (2026)
Article 5 of Regulation (EU) 2024/1689 (the EU AI Act) lists AI practices that are banned outright across the EU, regardless of sector, risk classification, or intended purpose — including scientific research. A practice falls under Article 5 if it matches one of eight prohibited categories: (a) subliminal or purposefully manipulative/deceptive techniques that materially distort behaviour and cause significant harm; (b) exploitation of vulnerabilities tied to age, disability, or a specific social or economic situation; (c) social scoring by public or private actors leading to detrimental treatment in a context unrelated to the data that generated the score; (d) predictive policing based solely on profiling or personality-trait assessment, without objective, verifiable facts linked to a criminal activity; (e) untargeted scraping of facial images from the internet or CCTV footage to build or expand facial-recognition databases; (f) emotion inference in workplace or education settings, except for narrow medical or safety reasons; (g) biometric categorisation to infer race, political opinion, trade union membership, religion, sex life, or sexual orientation; and (h) real-time remote biometric identification in publicly accessible spaces for law enforcement, prohibited except for three narrowly defined purposes (searching for specific victims of trafficking or missing persons, preventing an imminent and specific terrorist threat, or locating a suspect in specific serious crimes carrying at least a 4-year custodial sentence), each requiring prior judicial or independent administrative authorisation. These provisions applied from 2 February 2025 — six months ahead of most of the rest of the Act — and unlike the Act's high-risk-system obligations, there is no proportionality test, self-assessment route, or conformity-assessment pathway around them: a matching practice is unlawful outright, and violations sit in the Act's highest penalty tier under Article 99 (administrative fines of up to €35 million or 7% of total worldwide annual turnover, whichever is higher).
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Favourable Opinion (NHS REC) - CASRAI (2026)
The formal outcome an NHS Research Ethics Committee (REC) in the UK issues after reviewing a research proposal, confirming the study raises no outstanding ethical objections – or only minor points that do not require re-review by the full committee – so that, subject to any standard conditions, the research may proceed toward HRA Approval (or HCRW Approval in Wales) and site-level activation.
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TCPS 2 Article 2.1 (REB Review Requirement) - CASRAI (2026)
Article 2.1 of Canada's Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2) is the threshold rule that triggers Research Ethics Board (REB) review: research involving living human participants, or research involving human biological materials (including embryos, fetuses, fetal tissue, reproductive materials, and stem cells related to human reproduction), must undergo REB review and receive REB approval before the research commences, and that approval must be maintained for the duration of the research. It is the operational test institutions apply to decide whether a proposed project needs to go to an REB at all – if a project meets the Article 2.1 description and no Article 2.2-2.4 exception applies, REB review is mandatory; if it does not meet the description (for example, because it is not 'research' as TCPS 2 defines the term, such as certain quality-assurance, quality-improvement, or program-evaluation activities), REB review under this article is not required.
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IEEE Plagiarism Policy and Prohibited Authors List (PAL) - CASRAI (2026)
IEEE (the Institute of Electrical and Electronics Engineers) investigates plagiarism complaints against its journals, transactions, and conference papers using a published five-level severity scale (Level One through Level Five) set out in IEEE's PSPB Operations Manual and its accompanying 'Plagiarism Levels and Corrective Actions' guidance. The scale grades a case by extent of uncredited or improperly credited verbatim copying, from Level One (an entire paper, or more than 50% of one, copied without credit, or verbatim reuse spanning more than one paper by the same author) down to Level Five (verbatim text copied from a credited source but not clearly marked as a direct quotation). Corrective actions scale with the level and with repeat-offense history, ranging from a required letter of apology through a suspension of an author's submission privileges to specific IEEE publications for a fixed period – commonly cited ranges run from about one to five years – up to a lifetime prohibition on publishing in any IEEE-copyrighted venue for the most serious or repeated Level One violations, administered at the discretion of the IEEE Publication Services and Products Board (PSPB) Chair. An author under an active submission suspension is added to IEEE's internal screening list – long known as the Prohibited Authors List (PAL) and, per more recent PSPB Operations Manual language, formally relabeled the PPL – which IEEE publication volunteers (editors, program chairs) check via an internal PAL Database tool before accepting a submission, to confirm a listed name is not attempting to submit to a venue it is currently barred from.
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IRB Noncompliance Determination - CASRAI (2026)
An IRB noncompliance determination is the formal process and written outcome by which an IRB, or an institution's Human Research Protection Program/compliance office acting on the IRB's behalf, investigates a report that an approved protocol or IRB requirement was not followed and classifies the finding as either administrative/minor noncompliance (handled at routine review) or serious or continuing noncompliance under 45 CFR 46.113 / 21 CFR 56.113, together with whatever corrective action or suspension/termination the finding requires. It is the upstream procedure that produces a serious-or-continuing finding; see the separate IRB Violations term for what that threshold means and OHRP's own compliance-oversight role once a finding is reported.
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IEEE Conflict of Interest Disclosure - CASRAI (2026)
IEEE conflict of interest (COI) disclosure refers to the author- and reviewer-facing conflict-of-interest rules IEEE applies across its journals, transactions, magazines, and conferences, set out through IEEE Author Center guidance and the editorial policies of individual IEEE technical societies. It is distinct from a generic conflict-of-interest disclosure in two ways specific to IEEE's editorial process: IEEE defines a conflict along three tiers – actual, perceived, and potential – rather than a single financial-interest dollar threshold, and IEEE devolves the operational specifics (what a reviewer must disclose, how far back a prior collaboration counts, how long a mentorship cooling-off period lasts) to the sponsoring technical society or specific journal rather than fixing one uniform disclosure form across all of IEEE, the same way the specific mechanics of IEEE's peer-review model are set at the society level rather than uniformly.
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GDPR Article 5(1)(b) Purpose Limitation (Compatible Research Use) - CASRAI (2026)
Article 5(1)(b) of the EU General Data Protection Regulation (GDPR) states the purpose limitation principle: personal data must be "collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes." The same provision then carves out a specific exception: "further processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes shall, in accordance with Article 89(1), not be considered to be incompatible with the initial purposes." In practice, this means a controller who wants to reuse personal data originally collected for another reason (clinical care, a prior study, an administrative register, a commercial service) for a new research purpose does not need to separately satisfy the compatibility test in Article 6(4) for that reuse, provided the processing genuinely falls within one of the four named purposes and Article 89(1) safeguards are in place. It is a compatibility fiction created by the Regulation itself, not a blanket exemption from the rest of the GDPR: the controller still needs a valid Article 6(1) lawful basis for the further processing, still needs an Article 9(2) condition if the data are special category, and still has to apply Article 89(1) safeguards - technical and organisational measures, and pseudonymisation or an equivalent minimisation measure wherever the research purpose can still be fulfilled that way.
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GDPR Article 6(1)(e) Public Task Legal Basis - CASRAI (2026)
GDPR Article 6(1)(e) is one of six lawful bases in Article 6(1) that can justify processing personal data. It applies where processing is 'necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.' A processing activity qualifies as an instance of this basis only if two conditions both hold: (1) the controller is carrying out a task that is genuinely public-interest or official-authority in nature – not merely a task the controller happens to think is worthwhile – and (2) per Article 6(3), that task is 'laid down by Union law or Member State law to which the controller is subject.' The second condition is the operative test: a public university or public research institute cannot simply assert 'research is in the public interest' and stop there. There must be an identifiable legal basis in national or EU law – a statute, charter, or regulation establishing the institution's research/education function, or (as is increasingly common) an explicit research-processing provision in a member state's GDPR-implementing legislation – that the controller can point to as the source of the task. Article 6(3) further requires that this legal basis meet an objective of public interest and be proportionate to the legitimate aim pursued, and it permits (but does not require) the law to specify further conditions such as who may process, purpose limitation, storage periods, and processing operations. Public task is distinct from Article 6(1)(f) legitimate interests, which is explicitly unavailable to public authorities 'in the performance of their tasks' (Article 6(1), final sentence) – meaning a public university carrying out research cannot fall back on legitimate interests if public task is unavailable or fails; it is also distinct from Article 6(1)(a) consent, which remains valid but carries the withdrawal risk described below.
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GDPR Recital 33 (Broad Consent for Scientific Research) - CASRAI (2026)
GDPR Recital 33 is the preambular text explaining how consent works for scientific research when the exact processing purpose cannot be fully specified at the time of data collection. It states that it is often not possible to fully identify the purpose of personal data processing for scientific research at the time of collection, and that data subjects should therefore be allowed to give consent to certain areas of scientific research, or to parts of a research project, when this is done in keeping with recognised ethical standards for scientific research. A data-processing activity satisfies Recital 33 when: (1) the research purpose genuinely could not be fully specified at collection because the research programme is exploratory, longitudinal, or intends future secondary uses that are not yet known; (2) the consent describes the research area, field, or project scope at a level a reasonable data subject can understand, rather than describing nothing at all; (3) the data controller applies recognised research-ethics oversight (e.g. an ethics committee or IRB/REC review) and appropriate safeguards under GDPR Article 89(1) (data minimisation, pseudonymisation where feasible); and (4) the data subject retains the ability to consent to only part of the described research, or to withdraw later. Recital 33 is not itself an operative legal obligation — recitals explain and interpret the numbered Articles but do not impose independent duties. In the consent context, the operative provisions are GDPR Article 6(1)(a) (consent as a lawful basis) and, for special category data such as health or genetic information, Article 9(2)(a) (explicit consent) or the Article 9(2)(j) research derogation as implemented in national law. Recital 33 is cited by regulators, ethics committees, and the European Data Protection Board to justify why research consent can be broader and more programme-level than the general GDPR consent standard, which otherwise requires a specific, informed, unambiguous indication of the data subject's wishes for a defined purpose.
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Human Fetal Tissue Research (NIH Policy Framework) - CASRAI (2026)
Human fetal tissue (HFT) research is research using tissue or cells obtained from a deceased human embryo or fetus, most often following a pregnancy loss. Where federal funding is involved and the tissue was obtained from an induced (elective) abortion, HFT research is governed by a distinct statutory and policy layer on top of the general Common Rule: the NIH Revitalization Act of 1993 (42 U.S.C. §§289g-1, 289g-2), which sets informed-consent and donation conditions and establishes a Human Fetal Tissue Research Ethics Advisory Board (EAB) mechanism for reviewing funding decisions on ethical grounds, plus successive HHS/NIH policy notices that have repeatedly changed whether and how such research may be federally funded.
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Subrecipient Risk Assessment - CASRAI (2026)
The evaluation a pass-through entity must perform on each proposed subrecipient before making a subaward of federal funds, under 2 CFR 200.332(c) — considering prior experience with similar subawards, results of previous audits, new or substantially changed personnel/systems, and the extent and results of any federal agency monitoring — performed specifically to set the intensity of the monitoring plan applied once the subaward is active.
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NREC (National Office for Research Ethics Committees, Ireland) - CASRAI (2026)
The NREC (National Office for Research Ethics Committees) is the statutory Irish body, hosted by the Health Research Board (HRB) since 2020, that establishes and administers Ireland's National Research Ethics Committees for legally regulated research: clinical trials of investigational medicinal products (NREC-CT) and clinical investigations of medical devices (NREC-MD), plus committees stood up for specific national needs such as the National Irish COVID-19 Biobank (NICB-REC) and COVID-19 research (NREC COVID-19). A study falls under NREC review, rather than a local HSE, hospital, or university Research Ethics Committee, when it is a Regulated Clinical Trial under the EU Clinical Trials Regulation (536/2014) or a regulated medical-device clinical investigation, in which case a single national ethics opinion from the relevant NREC is required, issued in a coordinated procedure alongside the scientific/regulatory assessment carried out by the Health Products Regulatory Authority (HPRA). Outside that regulated scope, most observational studies, most academic health and social-care research, and research within the HSE and HSE-funded hospitals, ethical review remains the responsibility of local HSE and Hospital Research Ethics Committees, not the NREC.
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Waiver of Informed Consent (45 CFR 46.116(f)) - CASRAI (2026)
A waiver of informed consent under 45 CFR 46.116(f) is an IRB determination that a study may enroll subjects, or use their identifiable private information or identifiable biospecimens, without obtaining informed consent at all – distinct from merely waiving the signed-form requirement under 46.117(c). An IRB (or, for research eligible for expedited review, an IRB chair or designated reviewer) may approve a full waiver or alteration of consent only after finding, and documenting in the study record, that all five criteria in 46.116(f)(3) are met: (i) the research involves no more than minimal risk to the subjects; (ii) the research could not practicably be carried out without the waiver or alteration; (iii) if the research uses identifiable private information or identifiable biospecimens, it could not practicably be carried out without using that information or those biospecimens in identifiable form; (iv) the waiver or alteration will not adversely affect the rights and welfare of the subjects; and (v) whenever appropriate, subjects or their legally authorized representatives will be provided with additional pertinent information after participation. This mechanism is the standard route for retrospective chart-review and secondary-database research, where re-contacting every prior patient to obtain prospective consent is often not feasible and would itself undermine the value or completeness of the dataset.
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Concordat to Support Research Integrity - CASRAI (2026)
The UK's sector-wide research integrity framework document, originally published by Universities UK in 2012, revised in 2019, and refreshed in 2025, that individual UK universities, funders, and sector bodies formally sign up to as named signatories. A signatory organisation commits to five thematic commitments and is expected to publish an annual public statement evidencing how it has acted on each one.
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ICH E2A (Clinical Safety Data Management: Definitions and Standards for Expedited Reporting) - CASRAI (2026)
ICH E2A is the ICH tripartite guideline (Step 4, 1994; adopted by FDA, EMA, and Japan) that defines Adverse Event, Adverse Reaction, Serious, and Unexpected, cascades those into the SUSAR (Suspected Unexpected Serious Adverse Reaction) category, and sets the expedited safety-reporting clock – 7 calendar days for fatal/life-threatening SUSARs, 15 calendar days for all other SUSARs, measured from sponsor awareness. It is the regulatory-standard-level source that IND Safety Reports, Safety Letters, and national expedited-reporting rules (21 CFR 312.32 in the US; EU Regulation (EU) No 536/2014) all implement.
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2 CFR 200 Subpart B (General Provisions) - CASRAI (2026)
2 CFR 200 Subpart B ("General Provisions," 2 CFR 200.100-200.113) is the foundational, scope-setting subpart of the OMB Uniform Guidance. It does not itself create administrative, cost, or audit requirements the way Subparts C through F do; instead it establishes the purpose and legal authority behind the whole of 2 CFR 200, defines who and what it applies to (and what is excepted), fixes how it interacts with prior and future agency guidance, assigns OMB and federal-agency implementation responsibilities, and sets two obligations that apply across every award regardless of subject matter: a written conflict-of-interest standard (200.112) and mandatory disclosure of certain violations of federal criminal law (200.113). A requirement belongs to Subpart B if it concerns whether and how the Uniform Guidance applies at all, rather than a specific administrative, cost, or audit rule once it does apply.
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NSF AI Dear Colleague Letter (DCL) - CASRAI (2026)
An NSF AI Dear Colleague Letter (DCL) is any of several topic-specific Dear Colleague Letters the National Science Foundation has issued that have artificial intelligence as their explicit subject – typically flagging a funding priority and directing proposers toward an existing mechanism (RAPID, Planning Grant, EAGER, or a standing program) rather than creating an independent competition. To count as one, a document must (a) be formally issued as a DCL under NSF's Proposal & Award Policies & Procedures Guide (PAPPG) Chapter I definition, carrying an NSF publication number in the nsf.gov DCL series, and (b) name AI/generative AI as the letter's subject. This is a narrower category than 'NSF AI policy' generally, and it explicitly excludes NSF's December 2023 guidance on generative-AI use in the merit review process, which was issued as a Notice to the Research Community, not a DCL – a distinction searchers frequently get wrong and this page exists to clarify.
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Translated Informed Consent Materials - CASRAI (2026)
Consent materials count as compliant "translated informed consent" when they make the required disclosure elements of 45 CFR 46.116 (and, for FDA-regulated research, 21 CFR 50.25) understandable to a prospective participant who does not read or speak English proficiently — satisfied through one of two IRB-approved pathways: (1) a fully translated long-form consent document, reviewed and approved by the IRB before use, or (2) the short-form written consent process under 45 CFR 46.117(b)(2) / 21 CFR 50.27(b)(2), in which a brief document in the participant's language states that the required elements were presented orally, backed by a bilingual witness and the English-language summary the person obtaining consent signs. Neither pathway is optional paperwork — both require prospective IRB approval, and neither can be improvised at the bedside or in the field without one.
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Safety Letter (Dear Investigator Letter) - CASRAI (2026)
A Safety Letter — almost universally called a Dear Investigator Letter (DIL) in practice — is the direct, investigator-facing document a trial sponsor sends to every participating site in a multi-site clinical trial when new safety information emerges that could affect subjects' welfare, the risk-benefit assessment of the investigational product, or how the trial is conducted. It is the notification artifact itself: the letter (or attached safety report) an investigator physically receives, reads, and is expected to act on — distinct from the underlying regulatory reporting mechanisms (an IND Safety Report to FDA, or a periodic DSUR) that may trigger it. Under US law, the obligation traces to 21 CFR 312.55 ("Informing investigators"), which requires a sponsor to keep every participating investigator informed of new observations on the drug — particularly adverse effects and safe use — "as the overall investigation proceeds," and specifically to ensure investigators are promptly informed of significant new adverse effects or risks. The regulation names periodically revised Investigator's Brochure updates, reprints of published studies, and "reports or letters to clinical investigators" as acceptable means of distribution — the Dear Investigator Letter is that last category in standard industry practice. ICH E6(R2) Sections 5.16–5.18 place the parallel expectation on sponsors internationally: ongoing safety evaluation, and prompt notification of investigators, IRBs/ECs, and regulators when new information could affect the conduct of the trial or the risk to subjects.
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Export Control and AI (EAR/ITAR Applied to AI Models and Systems) - CASRAI (2026)
Export control and AI refers to how the US Export Administration Regulations (EAR, 15 CFR Parts 730-774, administered by the Commerce Department's Bureau of Industry and Security, or BIS) and the International Traffic in Arms Regulations (ITAR, 22 CFR Parts 120-130, administered by the State Department) apply to artificial intelligence and machine learning software, trained models, model weights, training datasets, and the underlying computing hardware used in research. An AI-related item, dataset, or system is subject to export control analysis if it is US-origin, meets an EAR or ITAR jurisdictional trigger, and either physically leaves the United States, is transmitted electronically to a destination abroad, or is released ('deemed exported') to a foreign national inside the United States who is not a US citizen, lawful permanent resident, or protected individual.
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Medicare Clinical Trial Policy (NCD 310.1) - CASRAI (2026)
The Medicare Clinical Trial Policy is the national coverage framework, codified as National Coverage Determination (NCD) 310.1 ("Routine Costs in Clinical Trials"), under which Medicare pays the routine patient-care costs of a beneficiary enrolled in a qualifying clinical trial, plus reasonable and necessary costs of treating complications from participation. A trial only qualifies if it meets three threshold criteria (the studied intervention falls within a Medicare benefit category, the trial has therapeutic intent, and trials of a therapeutic intervention enroll patients with a diagnosed disease) and satisfies at least one deeming criterion: funding or endorsement by NIH, CDC, AHRQ, CMS, DOD, or VA (or by a cooperative group/center they support); conduct under an FDA Investigational New Drug (IND) application; or exemption from IND requirements as a drug trial under 21 CFR 312.2(b)(1). A trial that meets none of these is not automatically excluded, but its sponsor must instead complete CMS's qualifying-trial checklist demonstrating the trial's scientific validity and integrity. Separately, since Change Request 5790 (Transmittal 310, effective 2008), Medicare claims for routine costs under a qualifying trial must report the trial's ClinicalTrials.gov identifier (the NCT number) alongside condition code 30 – so registration in the National Library of Medicine's public registry functions, in practice, as a billing prerequisite: a claim without a valid NCT number is at risk of denial even if the trial itself otherwise qualifies.
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Cognizant Federal Agency - CASRAI (2026)
A cognizant federal agency (for indirect costs) is the single federal agency assigned, under 2 CFR 200 Appendix III (institutions of higher education) or Appendix IV (nonprofit organizations), to negotiate and approve a given institution's indirect (F&A) cost rate and to review certain institution-wide compliance matters on that institution's behalf for all federal awarding agencies. It is assigned to the institution as a whole, generally based on which agency has provided the largest share of that institution's federal funding over a recent multi-year period – it is not chosen by the institution, and it is not the same thing as the awarding agency on any single grant.
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Pilot Study - CASRAI (2026)
A small-scale study that runs a scaled-down but methodologically faithful version of a planned future study’s actual protocol — same recruitment approach, same intervention delivery, same outcome measures and data-collection procedures — in order to test whether the full-scale study is workable, refine its methods and instruments, and generate preliminary parameter estimates (recruitment rate, adherence, rough effect size or outcome variance) before committing to the definitive study. A pilot study is one specific subtype of feasibility study — the one that tests feasibility by actually running the intended methods, rather than assessing feasibility through other means (surveys, record review, capacity audits). It is not designed to formally test whether an intervention works, and it is a distinct concept from a Phase I clinical trial, which is a defined stage in the drug-development regulatory pathway rather than a general research-methodology device.
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Section 117 Foreign Gift and Contract Reporting - CASRAI (2026)
An institution triggers Section 117 of the Higher Education Act (20 U.S.C. § 1011f) reporting when it is a covered institution — offering a bachelor's degree or higher (or an at-least-two-year transfer program toward one), accredited by a nationally recognized accrediting agency, and receiving federal financial assistance — and it receives a gift from, or enters a contract with, a foreign source valued at $250,000 or more, either alone or cumulatively with all other gifts and contracts from that same foreign source, within a calendar year. Institutions owned or controlled by a foreign source must separately disclose that relationship, with no dollar threshold. Covered institutions report semiannually to the U.S. Department of Education (historically due January 31 and July 31, for the preceding six-month period); as of January 2026, filings go through ED's new foreignfundinghighered.gov reporting portal.
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Research Security Officer (RSO) - CASRAI (2026)
The Research Security Officer (RSO) is the institutional official or office that coordinates a research institution's research security program under NSPM-33 and the CHIPS and Science Act of 2022 – owning export control review, foreign-influence and foreign talent recruitment program disclosure, cybersecurity coordination for federally funded research, insider-threat and travel-security policy, training rollout, and certification to funding agencies that the required program is in place. "Research Security Officer" is not a title NSPM-33 itself mandates verbatim – it is the role most covered institutions have created to hold that accountability.
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NIH Closeout - CASRAI (2026)
NIH closeout is the agency-specific implementation of the federal closeout requirements at 2 CFR 200.344, layered with NIH's own reporting mechanics: a recipient institution must submit a Final Research Performance Progress Report (Final RPPR), a Final Federal Financial Report (FFR, SF-425), and, where applicable, a Final Invention Statement and Certification (FIS), all within 120 calendar days of the end of the project period. The Final RPPR and any Final Progress Report Additional Materials (FRAM) are submitted through eRA Commons; the FFR is submitted through the federal Payment Management System (PMS), which eRA Commons' FFR module routes recipients to. An award is not considered closed until NIH has received and accepted all three documents and reconciled the award's financial status – late or missing documents can trigger NIH's unilateral closeout process, in which NIH closes the award administratively without the recipient's final reports, which can result in disallowed costs and complicate future award processing for the institution.
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HSE Research Ethics Committee - CASRAI (2026)
An HSE Research Ethics Committee (REC) is one of the independent ethics review bodies operating within Ireland's Health Service Executive (HSE) and HSE-funded hospitals to provide ethical approval for health research conducted in the Irish public health system. HSE/Hospital RECs review studies that recruit participants through publicly funded health services, use personal healthcare data or biological samples from service users, involve health and social care staff as participants or researchers, or are hosted within publicly funded healthcare infrastructure. They are distinct from Ireland's National Office for Research Ethics Committees (NREC), a separate statutory body under the Department of Health that provides single national ethical approval only for regulated clinical trials of investigational medicinal products, regulated medical device investigations, and regulated performance studies of in-vitro diagnostic devices. Research falling outside NREC's narrower statutory scope – including most observational, data-driven, and non-regulated clinical research – is reviewed by an HSE or Hospital REC instead. The HSE is currently reforming this system, moving from a fragmented set of local committees toward six regional HSE Reference RECs aligned with Sláintecare Regional Health Areas, each operating to a Standard Code of Governance and Management and supported by the HSE Research Ethics Committees Support and Coordination Office, which reports to the National Committee for the Governance, Management and Support of Research.
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CARE Case Report Guidelines - CASRAI (2026)
The CARE (CAse REport) Guidelines are a 13-item reporting checklist, developed by an international consensus group and published in 2013, that specifies what a clinical case report must include – patient information, timeline, diagnostic assessment, intervention, and outcome – for it to be complete, transparent, and usable by other clinicians and reviewers.
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