FDA'S Inspections of Clinical Investigators

Abstract

The FDA's recently revised compliance program for inspections of clinical investigators now focuses on determining authority to control the clinical studies and responsibility for administration of every aspect of the trial. During these inspections, we compare raw data with case record forms and in the converse, case record forms with raw data. We look for drug accountability; adherence by the clinical investigator to the protocol, IRB approvals, and notification of study progress; informed consent; and proper reporting of adverse experiences. The revised compliance program enables FDA to conduct inspections of clinical investigators and to audit clinical studies to determine if the agency can place reliance on the integrity of reported study data.