U.S. Food and Drug Administration
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Good Clinical Practice in FDA-Regulated Clinical Trials

Report to FDA:

Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.

The Good Clinical Practice Program is the focal point within FDA for Good Clinical Practice issues arising in human research trials regulated by FDA.

What We Do

 

Regulations

Guidances and Information Sheets

Current guidance on good clinical practice and the conduct of clinical trials.

Proposed Regulations and Draft Guidances

Details about these proposals and instructions for submitting comments.

Enforcement Information

Warning letters, disqualification proceedings, restricted list, adequate assurances list ...

Approved Products

Approvals of drugs, medical devices, biologicals, animal drugs, food additives.

Bioresearch Monitoring Program

Links to relevant Compliance Program Guidance Manuals.


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