OCTRI Navigating Monitored Visits and Audits for Clinical Trials
Clinical Researcher Coordinator Training
When |
April 2, 2024
12 p.m. to 2 p.m.
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Where |
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.