FDA Site Inspection Guidance

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 a 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.  Please refer to the Guide below for details.

Access a recording of a presentation about the UI FDA Site Inspection Guidance for Researchers via our ICON Course for Researchers. 

  • Click here for the log-in screen.  
  • Log into ICON and "enroll" in the course.  
  • Then, select "content" on the top toolbar. 
  • Next, choose "FDA Site Inspection Guidance" from the left side navigation bar.

The following links provide additional information for researchers preparing for a FDA site inspection.