FDA CDER Overview: Certificates of Confidentiality

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About this Event (Hosted by CDER SBIA)

At the end of this two-part webinar, participants will understand the purpose of a Certificate of Confidentiality (CoC), be able to identify when mandatory CoCs are issued, and know when to consider requesting a discretionary CoC. Attendees will also learn how to request a discretionary CoC, the statutory responsibilities associated with possessing a CoC, and the limitations to the disclosure protections afforded by a CoC.

Intended Audience

Sponsors, Sponsor-Investigators, and Researchers conducting research involving FDA regulated drug products in which identifiable, sensitive information is collected from human research participants.

Topics Covered

• Definition of identifiable, sensitive information 
• Overview of mandatory and discretionary certificates of confidentiality (CoC) 
• CoC disclosure protections and exceptions
• Process to request a discretionary CoC from FDA CDER
• FDA CDER review of discretionary CoC requests and issuance.

Speakers 

Certificates of Confidentiality 
Part 1: General Overview
Irene Rwakazina, Pharm.D., CCRP
Consumer Safety Officer
Office of Scientific Investigations (OSI) | Office of Compliance (OC) | CDER | FDA

Certificates of Confidentiality
Part 2: FDA | CDER Issuance of Discretionary Certificates of Confidentiality
Kelly M. K. Nolen, Ph.D.
Senior Pharmacologist
OSI | OC | CDER | FDA

FDA Resources

• Content current as of:

  05/07/2025

Source