The US FDA has issued the draft guidance for industry, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices. This draft guidance reflects FDA’s current thinking on how investigators must report adverse events to help protect patients participating in clinical research studies. The guidance also streamlines and merges materials from previous FDA guidances so stakeholders can easily reference relevant information.
Previously, FDA had grouped together reporting requirement recommendations for investigators and sponsors. The agency has now separated these recommendations. Sponsor recommendations for safety reporting are included in the FDA guidance, Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies, which the agency issued in June 2021.
The draft guidance issued today includes concepts from previous guidances that are related to investigators’ responsibilities: Safety Reporting Requirements for INDs and BA/BE Studies (December 2012) and the guidance for clinical investigators, sponsors, and IRBs Adverse Event Reporting to IRBs—Improving Human Subject Protection (January 2009).
This draft guidance focuses on investigator’s safety reporting requirements in investigational new drug (IND) studies, bioavailability and bioequivalence studies that are exempt from the IND requirements, and clinical trials involving an investigational device exemption. In addition, this guidance makes recommendations regarding the investigator’s responsibility to promptly report to the institutional review board all unanticipated problems that involve risk to human research participants or others.
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