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How to Prepare for an Audit

Congratulations, you’ve been chosen for an FDA Audit! Now let the fear, anxiety, and panic set in along with your litany of questions. What do you do? Where do you turn for answers? What does the FDA want to see? How should you prepare for their visit? STOP-take a deep breath, there are many resources already available to you. The Human Research Protection Program has outlined a course of action that will make the audit process clearer and easier to follow, allowing members of the Department of Medicine research teams to successfully prepare and participate in the audit process.

(Taken from MCW Human Research Protection Program’s web page: How to Prepare for an Audit)

Steps to Take Upon Notification of Pending Audit

  • Confirm the date and time for the audit, its anticipated duration, and composition of the audit team. Ascertain whether the audit team will require the use of any specific equipment.

  • Notify the principal investigator and research team members.

  • Ensure that the principal investigator and senior study coordinator are available for the audit.

  • Notify the IRB.

  • If your study includes the use of electronically captured data, check with your institution regarding its policy for review of electronically captured data by outside personnel. Be prepared to provide hard copies of the electronically captured data for the auditor's use.

  • Have the Institutional Standard Operating Procedures, and if applicable, your department/division/center's policies and procedures pertaining to the conduct of research available.

  • Meet with the individuals responsible for the receipt, storage, or dispensing of investigational product for the study. Ensure that all of the records are available for review and the storage area is available for review/tour.

  • Consider contacting Quality Improvement to assist in the preparation for the audit.

  • Review all of the signed informed consents. Verify dates and signature in addition to the version of the document that was used.                                                       

  • Verify reconsenting occurred when applicable. Ensure that all study subjects met inclusion/exclusion criteria.


Ensure and confirm that all documentation and records
are available for review and
are in order. This may
include but is not limited to
the following documents
and documentation: clinic
charts, medical records,
radiographic images, diaries, questionnaires, and research data records, and study participant files if applicable.


  • Ensure that the sponsor and IRB were contacted regarding protocol deviations and the documentation
  • Ensure that investigational product was stored and dispensed properly. Records should adequately reflect the quantity received the date of the arrival, the condition of receipt, the serial numbers or other unique identification codes assigned to the product, product was stored accordant to protocol, quantity dispensed, quantity used by the subject and quantity returned to the sponsor/manufacturer or disposed of in an appropriate manner.

Ensure these documents are completed, accurate and available for review:

  • Ensure that logs and tracking records are accurate, complete and available for review.

  • Ensure that all case report forms are available and complete, including investigator's signature and date.

  • Ensure that all regulatory documentation and correspondence is present, complete and current.

  • In the event a document is missing, request a copy of the document from the IRB.

Preparing for an audit by the FDA or another from an external source can be a daunting task without a plan. With the help of MCW and the Human Research Protection Program, preparing for one doesn’t have to be. This process has been laid out to make being audited less fearful than it may have seemed when you first heard you were going to be audited.

Article written by Antonio Grasso, Nephrology
© 2015 Medical College of Wisconsin
Page Updated 07/18/2011