The Food and Drug Administration (FDA) has developed the Bioresearch Monitoring Program (BIMO) to help ensure and monitor the protection of the rights, safety, and welfare of human research subjects involved in FDA-regulated clinical research studies. The BIMO program is also intended to verify the accuracy and reliability of clinical study data submitted to the FDA in support of research or marketing applications and to assess compliance with statutory requirements and FDA's regulations governing the conduct of clinical research studies.
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.
More information:
For additional assistance or inquiries, please contact the UCLA Office of Compliance Services at (310) 749-6763 and complianceeveryone@mednet.ucla.edu, the JCCC Office of Regulatory Compliance at (310) 206-5775 and jcccorc@mednet.ucla.edu, or the CTSI Office of Regulatory Affairs at (310) 794-8900 and ctsiora@mednet.ucla.edu.
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