FDA sets out investigator responsibilities for safety reporting in investigational drug and device studies

24th December 2025

FDA sets out investigator responsibilities for safety reporting in investigational drug and device studies

Summary: This FDA draft guidance explains investigators’ obligations to identify, assess and promptly report safety information that may represent an unanticipated problem involving risk to human subjects or others (for investigational drugs/biologics) or an unanticipated adverse device effect (UADE) (for investigational devices). It reinforces that investigators must protect participants, follow the investigational plan and applicable regulations, and ensure safety reporting is accurate, timely and appropriately escalated to sponsors and Institutional Review Boards (IRBs). The document aims to improve consistency in safety reporting, reduce unnecessary “noise” from non-meaningful reports, and ensure that serious, unexpected and clinically important safety issues are communicated quickly so that trials can be adjusted, paused or stopped if needed. 

Link: Investigator Responsibilities — Safety Reporting for Investigational Drugs and Devices

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