FDA Inspection? Here's what to do:
If you are notified that your research will be reviewed of audited by the FDA or any other external agency except the sponsor, you must inform the Office of Regulatory Compliance immediately of the impending audit/evaluation. Alison Lakin must be invited to the exit interview.
For guidance or assistance in preparing for an outside audit, please contact the QA Team at clinicalresearchsupportcenter@ucdenver.edu.