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.
- FDA Inspections of Clinical Investigators: Information Sheet Guidance
- FDA Compliance Program Guidance Manual and Guidance for the FDA Staff
- Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
- FDA Guidance: Electronic Source Data in Clinical Investigations
- FDA Form 483 Frequently Asked Questions
- FDA Guidance: Computerized Systems Used in Clinical Investigations