FDA Inspections of Clinical Investigators Policy

Institutional Review Board
Human Research Protections (HRP)

FDA Inspections of Clinical
Investigators Policy

October 29, 2024

To promote our institution’s commitment to compliance with Food and Drug Administration (FDA) requirements, UCI Health has developed a new FDA Inspections of Clinical Investigators Policy<![if !vml]>Image of needle and vial<![endif]>

The policy’s primary purpose is to establish and enforce expectations for investigators conducting FDA-regulated research.

Furthering this commitment, UCI has formed a new workgroup dedicated to advancing our organizational efforts in FDA-regulated research.  This initiative aims to enhance compliance, streamline processes, and foster innovation at UCI.

The workgroup brings together experts from various departments, including HRP, to collaborate on best practices, address regulatory challenges, and support ongoing and future FDA-regulated research.  This interdisciplinary approach will benefit the research enterprise by ensuring that UCI’s research meets the highest standards of quality and integrity.

UCI faculty and staff engaged in the conduct of FDA-regulated research must adhere to the procedures indicated in the policy.

To obtain additional information regarding FDA Inspections:

Stay informed! Sign up for our HRP / IRB Listserv: To subscribe to HRP News & Announcements, send a blank email to: or-irb-hrp+subscribe@uci.edu

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