It is important for research teams at all participating sites to be prepared in the event of an inspection by the Food and Drug Administration (FDA). Key factors to consider include:
When a research team member at U-M first learns that their site will be audited, this information should be immediately disseminated to other members of the research team including, where applicable, the investigator, MICHR IND/IDE Assistance Program (MIAP) staff member, study sponsor, U-M Institutional Review Board Medical School (IRBMED), Regulatory Affairs, Health System Legal Office, and Medical Records (in order to review electronic records if needed).
In addition, research team members should ensure all trial-related records are available and that a workspace for the FDA investigator(s) is provided. During the audit, it is also important that the designated liaison greets the FDA investigator(s) and verifies identification/credentials.
Contact us at MICHR-SPGSupport@umich.edu.