The FDA’s updated IND safety reporting guidance has clarified reporting responsibilities for sponsors, investigators, and IRBs, but implementing those requirements remains challenging. Questions about what qualifies as an IND safety report, when information must be reported to the IRB, and how to manage reporting efficiently continue to create confusion across clinical trials.
Join experts from WCG IRB, Indiana University, and the National Institutes of Health (NIH) for a discussion of the updated guidance, common reporting pitfalls, and real-world approaches to maintaining compliance while supporting participant safety. Attendees will gain practical insights into reporting responsibilities, IRB expectations, and strategies for navigating evolving regulatory requirements.
Learning Objectives
After attending this webinar, participants will be able to:
- Explain the IND safety reporting responsibilities of sponsors, investigators, and IRBs.
- Distinguish between serious adverse events, SUSARs, IND safety reports, and unanticipated problems.
- Identify common reporting challenges and compliance risks.
- Apply practical strategies for meeting FDA and IRB reporting expectations.
Please fill out the following form to register for this webinar:
Speakers:
Purna Garimella, MS, CIP, RAC-US
Executive Director, Human Research Protection Program & IRB, Indiana University
Nicole Grant
Acting Director & Executive IRB Chair, Office of Human Subjects Research Protection, National Institutes of Health (NIH)