Institutional Review Board Independent Ethics Committee Notification of Safety Information Document

Preferred Label : Institutional Review Board Independent Ethics Committee Notification of Safety Information Document;

NCIt related terms : Notification to IRB-IEC of Safety Information; Notification to Regulatory Authority of Safety/Trial Information; Safety Report; Notf IRB-IEC Safe Info; Notification to Institutional Review Board Independent Ethics Committee of Safety Information;

NCIt definition : Records submitted to the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) detailing the safety of subjects in a clinical trial.;

Alternative definition : CareLex: Documentation to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) related to subject safety. Notifications may include but are not limited to serious adverse events, quarterly line listings, suspected unexpected serious adverse reactions (SUSARs), Council for International Organizations of Medical Sciences (CIOMS), MedWatch, Analysis of Similar Events, cover letters and/or IRB/IEC-specific reporting forms. [Adapted from TMF-RM];

Details

Origin ID

C115698;

UMLS CUI

C3889273;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- CareLex eTMF Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

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