Any time an audit of UT Southwestern study records is conducted by an external regulatory entity such as the US Food and Drug Administration (FDA), it is the responsibility of the Principal Investigator to inform the IRB promptly.  If the Principal Investigator is given advance notice of an audit by an external entity, the IRB staff can help the study team to 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" which 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.