This policy describes the required actions to be taken when a member of a UW–Madison study team conducting Food and Drug Administration (FDA)-regulated human subjects research is notified of an inspection by the FDA or audit by another external agency (e.g., National Institute of Health [NIH], Office for Human Research Protections [OHRP], U.S. Department of Agriculture [USDA], etc.).
Financial audits are out of the scope of this policy.
Successful handling and completion of FDA on-site inspections (or that of other federal agencies evaluating the conduct of FDA-regulated research) are vital to the university’s research mission. Often perceived as an arduous process and time-sensitive event, the FDA Regulated Research Oversight Program helps support and guide involved investigators and study teams prior to, during, and following such federal inspection. Notification and involvement of the program not only help individual investigators being audited, but they also: assure federal agencies that the university is appropriately engaged in FDA-regulated research oversight; enable individual inspection observations to be trended over time; and allow appropriate cross-campus process improvement opportunities to be identified and implemented.