OCTRI Navigating Monitored Visits and Audits for Clinical Trials

Clinical Researcher Coordinator Training

April 2, 2024
12 p.m. to 2 p.m.

In-person (register in Compass)

Contact Information

Study Coordinator Training Descripton:

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

If you have a disability and need an accommodation to attend or participate in this event, please contact an OCTRI Navigator (octri@ohsu.edu, 503-418-9790) at least five business days before the event.