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Documentation to the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) related to subject safety. Notifications may include but are not limited to serious adverse events, quarterly line listings, suspected unexpected serious adverse reactions (SUSARs), Council for International Organizations of Medical Sciences (CIOMS), MedWatch, Analysis of Similar Events, cover letters and/or IRB/IEC-specific reporting forms. [Adapted from TMF-RM]
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