Frequently Asked Questions

How are IRB inspections conducted?

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IRB: General

The FDA must contact a responsible individual at the institution and typically that would be the IRB chairperson. The FDA inspector and chosen individual of the institution will schedule a day/time to visit. The FDA investigator will issue a notice of inspection (Form FDA 482) and present their credentials. The inspection will begin with interviewing appropriate people and obtaining information about the IRB's policies and procedures. Usually, the IRB's performance is evaluated by tracking one or more studies that are subject to IRB review under FDA regulations. The IRB's procedures and membership rosters are examined to determine whether they conform to current FDA regulations.

Throughout the IRB inspection, the FDA personnel typically review and copy:

  • Records of IRB membership
  • IRB procedures and guidelines
  • Minutes of IRB meetings for the past year
  • Documents related to the studies given by the clinical investigator to the IRB
  • Documents related to the studies sent by the IRB to the clinical investigator
  • Any other materials about these studies