Class Description

The Navigating Monitoring Visits and Study Audits for Clinical Trials class will review federal and contractual obligations, monitoring visit/audit preparation, responses to findings/observations, interacting with monitors and auditors,  and required reporting before and after monitoring visits and audits at OHSU. 

Objectives

At the end of the class the students should know:

• Differences between monitoring and auditing
• Best practices for monitoring visit/audit preparation
• Who to notify in the event of an FDA audit
• Potential outcomes of NIH/FDA audits
• How to interact with and respond to FDA
• What notifications are required before and after an FDA audit