Preferred Label : TMF-RM IRB or IEC Trial Approval Section;
NCIt related terms : IRB-IEC Doc Subcat; IRB/IEC Trial Approval; Institutional Review Board Independent Ethics Committee Documents; IRB-IEC Documents Subcategory; IRB or IEC Trial Approval;
NCIt definition : The Trial Master File Reference Model section that contains a collection of documents
related to the Institutional Review Board or Independent Ethics Committee decisions
for the clinical trial.;
Alternative definition : CareLex: Subcategory name for the eTMF domain containing documentation between an
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) and a Study
Site regarding human subjects in biomedical or behavioral research.; CDISC: A collection of documents related to the Institutional Review Board or Independent
Ethics Committee decisions for the clinical trial.;
Origin ID : C115696;
UMLS CUI : C3898752;
Semantic type(s)
concept_is_in_subset