TMF-RM IRB or IEC Trial Approval Section

**Semantic type:** Intellectual Product

**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.

**Synonyms:** - IRB or IEC Trial Approval - IRB-IEC Doc Subcat - IRB-IEC Documents Subcategory - IRB/IEC Trial Approval - Institutional Review Board Independent Ethics Committee Documents