This session will cover adverse event (AE) reporting for medical device clinical trials, including the following topics: the differences between pharmaceutical and device AE reporting requirements, how to understand the AE reporting requirements for device trials based on a study protocol, and a discussion on device AE reporting requirements from a monitoring and auditing mindset. There will be an overview of AE requirements in 21CRF812 and 21CFR312; a discussion about the FDA's current thinking on AE reporting in device trials and how this may impact what AEs are required to be reported in an investigational device study protocol; a discussion on how sites may need to delineate AE reporting between the protocol and their IRB requirements; and an overview of several AE reporting case studies from monitoring and auditing perspectives.
Understand the differences between adverse event (AE) reporting requirements under 21 CFR 812 vs. 312.
Determine appropriate AE reporting requirements for your medical device trial based on the study protocol.
Critically examine AE reporting requirements and processes for medical device trials, with a focus on monitoring and auditing perspectives.
Associate Director of Clinical Monitoring Services,
IMARC Research Inc.