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  • Documentation of prompt notification to investigators of all findings of a clinical trial, including but not limited to new, important information on serious adverse events and/or safety concerns that could adversely affect the safety of subjects, impact the conduct of the trial, or alter the approval/favorable opinion of the Institutional Review Board (IRB)/Independent Ethics Committee (IEC), to continue the trial. Notifications may include but are not limited to 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 country-specific reporting forms. [Adapted from TMF-RM]
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