Preferred Label : Institutional Review Board Independent Ethics Committee Compliance Documentation;
NCIt related terms : IRB-IEC Attestation Form; IRB-IEC GCP Compliance Statement; IRB-IEC GCP Stmt; Institutional Review Board Independent Ethics Committee Good Clinical Practices Compliance
Statement; IRB or IEC Compliance Documentation;
Alternative definition : CareLex: Study Site-specific documentation that states the Institutional Review Board
(IRB) or Independent Ethics Committee (IEC) is performing its function according to
written operating procedures and is in compliance with Good Clinical Practices (GCP)
or applicable regulatory requirements.; CDISC: Documentation confirming the Institutional Review Board or Independent Ethics
Committee is in compliance with written operating procedures, Good Clinical Practices,
and applicable regulatory requirements.;
Origin ID : C115594;
UMLS CUI : C3898753;
Semantic type(s)
- concept_is_in_subset
