Class Description

This is one in a series of classes designed for OHSU employees working as research coordinators.  The intent of the program is to provide in depth education through lecture, examples and exercises on clinical research coordinator activities.

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. 

Class Objective

• 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