The Association of Clinical Research Professionals

Adverse Event Reporting in Medical Device Trials: Requirements from a Monitoring and Auditing Perspective

Learn the ins and outs of adverse event (AE) reporting for medical device trials. Speakers will cover the differences between pharmaceutical and device AE reporting requirements, how to understand the AE reporting requirements for device trials based on the study protocol, and device AE reporting requirements from a monitoring and auditing mindset. Participate in an active discussion of AE requirements in 21CRF812 and 21CRF312, FDA’s current thinking on AE reporting in device trials and how this might impact which AEs are required to be reported, and how sites might need to delineate AE reporting between the protocol and their Institutional Review Board requirements. Hear several AE reporting case studies from monitoring and auditing perspectives.


This program is a recorded session from ACRP 2018