?:definition
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Study Site-specific documents that describe the clinical trial changes and/or updates to the trial which are submitted to a committee other than the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) for approval. Such committees include but are not limited to scientific, institutional, financial, data protection, and/or biobank; includes non-IRB-IEC related submissions and correspondence. [Adapted from TMF-RM]
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