May 8, 2025
Enroll in the Certificates of Confidentiality Course
Enroll in the Certificates of Confidentiality course to access all lessons and resources.
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Supporting Resources – Access with FREE Enrollment (above)
Presentations
About This Course
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]