Clinical Researcher Coordinator Training Workshop
November 3, 2023
10 a.m. to 12 p.m.
More information will be provided
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.
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