The Food and Drug Administration (FDA) conducts site inspections of clinical investigators involved in FDA-regulated clinical trials to determine compliance with applicable regulations. The HSO’s FDA Site Inspection Guide provides practical advice for Principal Investigators (PI) and research staff undergoing an FDA inspection. The Guide outlines step-by-step pre-inspection preparations, recommended study team conduct during the inspection, potential post-inspection outcomes, and directions for post-inspection activities. This presentation will illustrate where to find the Guide, provide a high-level review of its contents, and how to use it to prepare for an FDA Site Inspection.

Pre-registration is recommended.