ABSTRACT
Since the Investigational New Drug Regulations went into effect in 1963, the Food and Drug Administration (FDA) has conducted more than 5900 clinical investigator and 2000 Institutional Review Board audits. The FDA Bioresearch Monitoring Program conducts site visits of clinical investigators, sponsors, and contract research organizations, nonclinicallaboratories, as well as Institutional Review Boards. All FDA product area, i.e., drugs, biologics, medical devices, radiological products, foods, and veterinary drugs, are involved in the Bioresearch Monitoring Program. The objectives of FDA audit procedures are (1) to assure adherence to the regulations 1-5, (2) to determine the integrity of scientific testing and the reliability of the data in support of pending product approval by the FDA, and (3) to determine that the rights and safety of the patient have been adequately protected.
