Participants will learn how to identify, evaluate, and report Reportable New Information (RNI) in human research studies, including understanding RNI categories, reporting requirements, submission timelines, and when an event does or does not require IRB reporting. They will also learn how RNIs relate to modifications (MODs) and Corrective and Preventive Action Plans (CAPAs), enabling them to protect participant rights, safety, welfare, and study integrity while maintaining regulatory compliance.
If you are obtaining PSNA credits, you can miss no more than 10 minutes of the presentation and your camera must remain on.
