Investigator Responsibilities for Safety Reporting for Investigational Drugs and Devices: FDA's Final Guidance 2025

Course Description In response to IRB's concerns regarding the reporting of relevant safety information, the FDA released safety reporting guidance in 2009. Last updated in 2012, the subsequent guidance documents continued to focus on reporting requirements for IND and BA/BE studies. In December 2025, FDA released its most recent update, along with its companion guidance for Sponsors, includes safety reporting guidance for pharmaceutical/biologics and medical device studies and provides clarifying definitions and examples to assist Clinical Investigators in meeting their regulatory obligations for safety reporting. This webinar will explore the FDA's current thinking on requirements for reporting safety events as evidenced in the final guidance. Learning Objectives Review the FDA's definitions of "reasonable possibility", "serious", and other terms Evaluate clarifications for who makes decisions regarding causality and classification Discuss examples of UPIRTSOs and plans for reporting Assess expectations for Investigator review of safety reports Consider FDA's alternative pathway for reporting responsibilities Explore FDA's examples of what is reportable and what is not Investigate the complementary elements of the FDA's Final Guidance for Sponsor Responsibilities for safety reporting Who Should Attend This course is intended for Clinical Investigators, and IRB and Sponsor/CRO representatives who require an understanding safety reporting regulations and requirements. Instructor Elizabeth Ronk Nelson, M.P.H. Click here for complete trainer biographies AccreditationBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 2.0 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.ACPE#: 0778-0000-26-001-L99-P Released: 5/26. Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.