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v2026.1714 entries · CC-BY 4.0

Compliance vocabulary

Compliance mapping

External compliance frameworks — NSPM-33, GDPR, IRB/REC review, ICH-GCP — mapped onto the CASRAI dictionary so that institutional systems can carry a single normalised representation.

Research compliance vocabularies are not interchangeable. NSPM-33 disclosure fields are not identical to the EU’s GDPR data-processing fields; ethics-review terminology differs between IRBs and RECs; the ICH guideline uses its own controlled vocabulary for clinical-trial documentation. The CASRAI dictionary federates these vocabularies, providing a normalised internal representation that institutional CRIS, ethics-review systems and trial-management systems can share. Where the canonical vocabulary lives at NSF, the WHO, the EMA, the ICH or the European Commission, we cross-walk rather than reinvent.

The pages below set out the operational mapping for each of the four most-asked-about frameworks. For richer treatment of the underlying dictionary domains, follow the in-line links to the CASRAI dictionary.

External framework

NSPM-33 (US research security)

National Security Presidential Memorandum-33 covers research-security disclosure for US-federally-funded research. The OSTP implementation guidance (2022, updated through 2024–2025) requires structured disclosure of current and pending support, foreign components, in-kind contributions and outside positions. NSF and NIH have each implemented agency-specific disclosure portals; the underlying data model is consistent across agencies.

The CASRAI dictionary’s research-security domain provides the controlled vocabulary for the institutional side of this work: current support, pending support, foreign component, in-kind contribution, outside position, conflict of commitment, conflict of interest. These terms map directly onto the NSF and NIH form fields.

CASRAI dictionary mapping

External fieldCASRAI term
NSF current & pending support — activecasrai:support/active
NSF current & pending support — pendingcasrai:support/pending
NIH Other Support — foreign componentcasrai:support/foreign-component
NIH Other Support — in-kind contributioncasrai:support/in-kind
NSF biographical sketch — appointmentcasrai:position/appointment
NSF biographical sketch — affiliationcasrai:affiliation

External framework

GDPR (EU data protection)

The General Data Protection Regulation governs the processing of personal data by EU-based institutions and by non-EU institutions processing data on EU residents. For research workflows, the operational fields are consent type, lawful basis, retention period, data-sharing scope, data-protection impact assessment status, and pseudonymisation level.

The CASRAI dictionary aligns its personal-data terms with the GDPR vocabulary (data subject, data controller, data processor, lawful basis, special-category data) and provides the cross-walk to the CODATA data-stewardship terms used in the international data-sharing literature.

CASRAI dictionary mapping

External fieldCASRAI term
GDPR Article 6 lawful basiscasrai:legal-basis
GDPR Article 9 special-category datacasrai:special-category-data
Data Protection Impact Assessment (DPIA)casrai:dpia
Data Processing Agreement (DPA)casrai:dpa
Data subject access request (DSAR)casrai:dsar
Pseudonymisation levelcasrai:pseudonymisation

External framework

IRB / REC review terms

Institutional Review Board (US, under 45 CFR 46), Research Ethics Committee (UK and most of Europe), and the comparable bodies in Australia, Canada and elsewhere share a common vocabulary for protocol review, informed consent, vulnerable populations, and risk classification. The CASRAI dictionary federates these terms with the WHO research-ethics framework and the CIOMS International Ethical Guidelines.

CASRAI dictionary mapping

External fieldCASRAI term
IRB / REC protocol numbercasrai:ethics-approval
Informed consent typecasrai:consent-type
Vulnerable population designationcasrai:vulnerable-population
Risk classification (minimal / greater than minimal)casrai:risk-classification
Continuing review intervalcasrai:continuing-review
Adverse event reporting categorycasrai:adverse-event

External framework

ICH-GCP (Good Clinical Practice)

The International Council for Harmonisation Good Clinical Practice guideline (ICH E6 R3, finalised 2024) is the operative international standard for clinical-trial conduct. The CASRAI dictionary’s clinical-research domain aligns with the ICH E6 vocabulary for trial protocol, investigator brochure, case report form, adverse event reporting and trial master file structure.

For trial registration, CASRAI cross-walks ClinicalTrials.gov, ISRCTN and EudraCT identifiers into a single registration field.

CASRAI dictionary mapping

External fieldCASRAI term
Trial protocol identifiercasrai:trial-protocol-id
Investigator brochure versioncasrai:investigator-brochure
Case report form (CRF) versioncasrai:crf-version
Serious adverse event (SAE)casrai:sae
Trial master file (TMF) statuscasrai:tmf-status
ClinicalTrials.gov / ISRCTN / EudraCT registrationcasrai:trial-registration

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