This session will cover identifying, assessing, and reporting adverse events (AEs) for medical device studies at the site level. An overview of the possible sources for potential events will be provided along with best practices for establishing a process of assessing events and a workflow for reporting events to sponsors and IRBs. Common hurdles that sites face and possible solutions will be provided. This course will explain how to apply 21CFR812, ICH-GCP E6, ISO 14155, protocol requirements and IRB policies. Actual questions from FDA investigators during site audits will be included.

Learning Objectives:

1. Understand the different methods and possible sources for identifying adverse events.
   
2. Examine the importance of establishing a process for timely assessment of events once identified.
3. Understand the reporting requirements and recommended procedures for AE reports to sponsors and IRBs.