FREQUENTLY Asked Questions

When are IRB inspections conducted?

View All FAQs
About the Author
Proxima CRO Team
Alisa Hamilton
Mgr. of Ops, Marketing & Comms.
Alisa’s overall goal through everything she has achieved at Proxima is to make it one of the most enjoyable places to work. ‍

IRB inspections do not always occur, but if they do, they are meant to determine if IRBs are operating in compliance with current FDA regulations and statutory requirements and if the IRBs are following their own written procedures.

The two FDA inspections of IRBs that could occur:

  • Surveillance inspections – periodic, scheduled inspections to review the overall operations and procedures of the IRBs .
  • Directed inspections – unscheduled inspections focused on the IRB's review of a specific clinical trial or trials. Directed inspections generally result from a complaint, clinical investigator misconduct, or safety issues pertaining to a trial or site.

 

Related FAQs:
More Questions? We're here to help!
SPEAK WITH A SPECIALIST