Frequently Asked Questions

When are IRB inspections conducted?

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IRB: General

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.