The FDA BIMO Program involves site visits to clinical investigators, sponsors, monitors, contract research organizations (CROs), Institutional Review Boards (IRBs), non-clinical (animal) laboratories, and bioequivalence analytical laboratories. The FDA conducts both announced and unannounced inspections of clinical investigator sites.
In the event a UCLA faculty or staff member is notified of an upcoming FDA inspection, or if the inspector arrives onsite for an unannounced inspection, please refer to UCLA HS Policy 9441 for guidance regarding notifications to be sent to UCLA Officials and the study sponsor, as well as the prospective post-inspection response and corrective actions that may be required. This policy applies to all UCLA faculty and staff involved in the implementation, conduct, and coordination of FDA-regulated clinical research studies.
For additional assistance or inquiries, please contact the UCLA Office of Compliance Services at (310) 749-6763 and firstname.lastname@example.org, the JCCC Office of Regulatory Compliance at (310) 206-5775 and email@example.com, or the CTSI Office of Regulatory Affairs at (310) 794-8900 and firstname.lastname@example.org.