Preferred Label : Institutional Review Board - Independent Ethics Committee Sponsor Communication;
NCIt related terms : IRB-IEC Spons Comm Track Subcat; IRB/IEC and other Approvals; IRB-IEC Sponsor Communications and Tracking Subcategory;
NCIt definition : Records detailing all trial related communication between the Institutional Review
Board (IRB) and/or the independent ethics committee (IEC), and the trial sponsor.;
Alternative definition : CareLex: Local IRB-IEC documents are filed under Site Management. Subcategory name
for the eTMF domain containing documentation related to communications with the Sponsor,
Institutional Review Board (IRB) and/or the Independent Ethics Committee (IEC), including
communications, tracking, and documents not otherwise specified.;
Origin ID : C115480;
UMLS CUI : C3889673;
Semantic type(s)
concept_is_in_subset