This class will review federal and contractual obligations, monitoring visit/audit preparation, responses to findings/observations, interacting with monitors and auditors, and required reporting.
February 6, 2020
10 a.m. to 12 p.m.
3410 S.W. Bond Avenue
Portland, Oregon 97239
Room: A 1217
This is a series of classes sponsored by the Oregon Clinical and Translational Research Institute (OCTRI). The classes are designed for OHSU employees who are 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 overall objective of the OCTRI Study Coordinator Training Series is to increase working knowledge of conducting clinical research at OHSU.
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