Food and Drug Administration (FDA) Audit

Any time an audit of UT Southwestern Medical Center study records is conducted by an external regulatory entity such as the U.S. Food and Drug Administration (FDA), it is the responsibility of the Principal Investigator to inform the Institutional Review Board (IRB) promptly. If the PI is given advance notice of an audit by an external entity, IRB staff can help the study team gather essential documents, and can be available to help answer the auditor's questions about human subject protections at UT Southwestern. 

The IRB also may wish to send a representative to observe proceedings of any "exit interview" that may occur. Finally, the written report of any audit findings by FDA or other regulatory agencies must be forwarded to the IRB for their records.

Please review additional information regarding FDA Inspections, Compliance, Enforcement, and Criminal Investigations.

UT Southwestern IRB also recommends the use of the FDA Inspection Preparation Guide and the Compliance Program Guidance Manual for FDA Staff.