New FDA Guidance on Certificates of Confidentiality

Investigators can request discretionary Certificates of Confidentiality (CoCs) from the U.S. Food and Drug Administration (FDA) for non-federally funded research that is subject to FDA regulations. The FDA recently announced new guidance on Certificates of Confidentiality that explains the Agency’s implementation of discretionary CoCs.

See “Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.”

CITI Program’s Related Courses of Interest

GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus)
This course is suitable for individuals proposing to conduct clinical trials of drugs, biologics, and devices primarily in the U.S. and/or who would prefer a more U.S. FDA-centric curriculum.
View Course Details

FDA Inspections: From Site Preparation to Response
Covers regulatory inspections of clinical investigators and sites, including mock inspections, 482s, 483s, warning letters, communication, and CAPA plans.
View Course Details

Biomedical Principal Investigator (PI)
Focuses on key topics essential to the biomedical investigator’s role and responsibilities in conducting a clinical investigation of a product regulated by the U.S. Food and Drug Administration (FDA).
View Course Details