The annual ACRP meeting will be held this upcoming weekend (27-30 April 2018) at the Gaylord National Resort and Convention Center in National Harbor, Maryland. This meeting presents an opportunity for clinical research professionals to meet and listen to/discuss the latest in clinical research. At this meeting, IMARC will be presenting on Saturday, 27 April 2018, from 11:30-12:30 on the topic of adverse event (AE) reporting for medical device clinical trials.
This session will include 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 a discussion on device AE reporting requirements from a monitoring and auditing mindset. There will be a review of AE definitions and requirements in 21CRF812, 21CFR312, ICH GCP, and ISO14155; a discussion about the FDA's current thinking on AE reporting in device trials and how this may impact which AEs are required to be reported in an investigational device study protocol; a critical thinking exercise 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.
We are excited for the opportunity to provide our experience and insight to this area and are looking forward to what we hope will be a lively discussion! Please let us know if you plan on attending or would like to know more about this topic!