FDA CDER Overview: Certificates of Confidentiality

May 8, 2025

In this two-part course, participants will learn 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.

Resources

• Certificates of Confidentiality: Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff 
• Center for Drug Evaluation and Research (CDER) CoC Contact: 
  [email protected] 
• Center for Biologics Evaluation and Research (CBER) CoC Contact: 
  [email protected] 
• Center for Devices and Radiological Health (CDRH) CoC Contact: 
  [email protected] 
• Center for Tobacco Products (CTP) CoC Contact: 
  [email protected] 
• Human Foods Program (HFP) CoC Contact: 
  [email protected] 

visit the FDA.gov webpage