TMF-RM Institutional Review Board or Independent Ethics Committee and Other Approvals Zone

**Semantic type:** Intellectual Product

**Definition:** 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.

**Synonyms:** - General IRB/IEC - IRB or IEC and Other Approvals - IRB-IEC Comm Cat - IRB-IEC Sponsor Communication Category - IRB/IEC and other Approvals - Institutional Review Board - Independent Ethics Committee