C115616Level 5
Institutional Review Board Independent Ethics Committee Submission Documentation
**Semantic type:** Intellectual Product
**Definition:** Documentation submitted to an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for approval of the details of a clinical trial, and any changes or updates made to that trial.
**Synonyms:** - IRB or IEC Submission - IRB-IEC Subm - IRB-IEC Submission - IRB/IEC Submission - Institutional Review Board Independent Ethics Committee Submission
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