Preferred Label : TMF-RM Institutional Review Board or Independent Ethics Committee and Other Approvals
Zone;
NCIt related terms : IRB-IEC Sponsor Communication Category; General IRB/IEC; Institutional Review Board - Independent Ethics Committee; IRB-IEC Comm Cat; IRB/IEC and other Approvals; IRB or IEC and Other Approvals;
Alternative definition : CareLex: A Category name for the eTMF domain used to classify a set of documents shared
between an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or
other committee and a sponsor or designee regarding the conduct of a trial. General
IRB documents are trial level documents, not site specific documents. Local IRB-IEC
are filed under Site Management, IRB-IEC Documents category.; CDISC: The Trial Master File Reference Model zone that contains the collection of
documents relating to the interactions with the Institutional Review Board (IRB)/Independent
Ethics Committee (IEC), including submissions, decisions, acknowledgments, and oversight
information about the IRB/IEC for the clinical trial.;
Origin ID : C115691;
UMLS CUI : C3890567;
Semantic type(s)
- concept_is_in_subset
