Event Reporting in Human Subjects Research

It’s inevitable: research doesn’t always go as planned. The Office of Responsible Research Practices and the Center for Clinical and Translational Science are offering a session on when to notify the IRB about unexpected events or other problems. The session will:

• Provide an overview of the newly revised event reporting policy
• Differentiate between investigator, sponsor, and IRB reporting requirements
• Provide definitions and discuss case examples

While the session will be tailored to medical researchers and research staff, anyone preparing IRB submissions is welcome.