FDA audits of clinical studies: policy and procedure.

The Food and Drug Administration has been conducting audits of the work of clinical investigators since 1962, and has done so on a routine basis since 1977. Since 1977 the work of approximately 2,800 drug investigators has been subject to inspection; approximately 500 of these have been "for cause," including 49 performed outside of the United States. The routine audits are done on studies important to the FDA's approval of therapeutic claims, and are thus not targeted at the investigator, but at the validity of the study.

FDA's conduct, review, and evaluation of inspections of clinical investigators.

This review of the Food and Drug Administration's Bioresearch Monitoring Program focuses on the inspection of clinical investigators who study investigational drugs. The differences between routine, "for-cause," and bioequivalency/bioavailability inspections are examined, with emphasis on the responsibilities of the clinical investigator, reasons for conducting the inspections, and problems found. Important aspects of the inspection report, such as protocol adherence, records maintenance, informed consent, institutional review board approval, and drug accountability, are outlined.