Quality Improvement

What to Do During an Audit

During the audit

• Verify credentials of auditor.
• If federal audit, request to see “notice to inspect."
• Provide adequate space for auditor(s) to conduct inspection.
• Ensure the availability of equipment requested by auditor, if applicable.
• Identify the key point person and ensure that the key point person is available during the audit to address the auditor’s question/concern or find requested documentation.
• Answer all questions honestly. If you do not know, don’t guess, indicate you will find the answer and provide the information to the auditor.
• Supply all requested materials. Do not allow auditor to retrieve documents/materials.
• Make copies of documents as requested by auditor. Make 2nd copy for the record of items provided to auditor.
• Have Institutional Standard Operating Procedures and, if applicable, Department/Division/Center policies and procedures available.
• Do not volunteer information.
• Do not offer anything of significant value to the auditor.

Upon completion of the audit

• Attend debriefing meeting with auditor(s) for summary and discussion of audit findings and identify what subsequent activities may be expected.
  • Attendees of debriefing meeting should minimally include principal investigator and senior study coordinator/research nurse manager.
  • Review audit findings during the debriefing meeting. In the event a documented deficiency was corrected during the audit, review your concern with the auditor and request deletion of the deficiency from the report.
• Begin preparation of written response to audit findings. 

 v. 06/18/07