FDA Issues New Draft Guidance on Investigator Responsibilities for Safety Reporting Requirements and Safety Assessment in Certain Research Studies

This draft guidance reflects FDA's current thinking on how investigators must report adverse events to help protect patients participating i

Receive this email as a forward? Subscribe to CDER SBIA industry updates. FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS . FDA Issues New Draft Guidance on Investigator Responsibilities for Safety Reporting Requirements and Safety Assessment in Certain Research Studies   The U.S. Food and Drug Administration has issued the draft guidance for industry, Investigator Responsibilities—Safety Reporting for Investigational Drugs and Devices.  This draft guidance reflects FDA's current thinking on how investigators must report adverse events to help protect patients participating in clinical research studies.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 The draft guidance issued today includes concepts from previous guidances that are related to investigators' responsibilities: Safety Reporting Requirements for INDs and BA/BE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 This draft guidance focuses on investigator's safety reporting requirements in investigational new drug (IND) studies, bioavailability and bioequivalence studies that are exempt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. When finalized, this guidance (in conjunction with the above referenced "Sponsor Responsibilities" guidance) will replace the referenced 2009 and 2012 guidances. To learn more about IND safety reporting and this guidance, please watch FDA's Small Business and Industry Assistance (SBIA) webinar, Investigator Responsibilities — Safety Reporting for Investigational Drugs and Device. . The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research  provides guidance, education and updates for regulated industry. Subscribe to CDER SBIA Email Updates Register for Upcoming Training View 2021 Recordings on YouTube Follow on LinkedIn Follow on Twitter This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, contact us at CDERSBIA@fda.hhs.gov or 1-866-405-5367 or (301) 796-6707.  SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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