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.
If you are scheduled for an FDA Site Inspection or if you have any questions about HSO involvement in an FDA inspection, contact the HSO/IRB Compliance Program at firstname.lastname@example.org.
Access a recorded presentation about FDA Site Inspection Guidance for UI Researchers in the IRB ICON Course for Researchers. This presentation was originally given for the ICTS Clinical Lecture Series on March 3, 2016.
[Note: You must install VLC Media Player to view the recording.]
- The portal to the IRB ICON Course for Researchers is on the Education and Training page
- Log in with your HawkID and password
- The recording and slides are posted in the “Additional Topics” section
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