F03 - The IRB’s Critical Role in Understanding Sponsor and Investigator Responsibilities for Investigational New Drug Application (IND) Safety Reporting in Order to Assure the Protection of Human Subjects
Friday, November 19, 2021
1:30 PM – 2:30 PM ET
Location: Livestreamed
This session will provide an overview of FDA IND safety reporting responsibilities for the sponsor and clinical investigator in the safety reporting process of clinical trials. This overview will provide IRB staff and members with information to understand the obligations that both sponsors and investigators have in relation to IND safety reporting. Further, this session will emphasize the critical role that the IRB plays in identifying the type of safety information that requires submission to the IRB as an unanticipated problem and developing oversight procedures to ensure the protection of human subjects.
Learning Objectives:
Review the responsibilities that sponsors, investigators, and the IRB have in relation to IND safety reporting
Consider how the IRB’s written procedures for unanticipated problems impacts successful identification and submission of safety information to the IRB
Discuss what type of safety data must be reported to the IRB as an unanticipated problem and the strategies and procedures the IRB should employ to assure the protection of the rights and welfare of human subjects
