OCTRI Navigating Monitoring Visits and Audits for Clinical Trials

This class will review federal and contractual obligations, monitoring visit/audit preparation, responses to findings/observations, interacting with monitors and auditors, and required reporting.

When	February 6, 2020 10 a.m. to 12 p.m. Add to Calendar 2020-02-06 10:00:00 2020-02-06 12:00:00 OCTRI Navigating Monitoring Visits and Audits for Clinical Trials Class description 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 Contact: Bridget Adams 503-494-5077 adamsb@ohsu.edu Register in Compass - Search "OCTRI" <p></p><p><a href="https://www.ohsu.edu/node/434266">OCTRI Navigating Monitoring Visits and Audits for Clinical Trials</a></p> Campus: South Waterfront Campus Building: Rood Family Pavilion Bridget Adams adamsb@ohsu.edu America/Los_Angeles public
Where	Campus: South Waterfront Campus Building: Rood Family Pavilion 3410 S. Bond Avenue Portland, Oregon 97239 Room: A 1217
Contact Information	Bridget Adams 503-494-5077 adamsb@ohsu.edu Register in Compass - Search "OCTRI"

Class description

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