Preparing a Clinical Site for a Clinical Investigator Inspection by the FDA

The Food and Drug Administration (FDA) regularly inspects clinical investigators for a variety of reasons. Characteristics of a clinical study likely to trigger an FDA inspection are described. Items which are routinely examined during an FDA inspection are listed and discussed. Methods are suggested for early identification of clinical investigators who are likely to be inspected, and procedures and techniques are described for the sponsor to assist the clinic in attaining inspection-readiness.