FDA ClinicalTrials.gov audit – Clinical Research Made Simple

FDA Compliance Monitoring for ClinicalTrials.gov Registration and Results

August 16, 2025

FDA Compliance Monitoring for ClinicalTrials.gov Registration and Results How FDA Monitors Compliance with Clinical Trial Registration and Results Posting Overview of FDA’s Role in Trial Registration Compliance The U.S. Food and Drug Administration (FDA) actively oversees compliance with clinical trial registration and result disclosure obligations under the FDA Amendments Act of 2007 (FDAAA 801) and…

Clinical Trial Registries and Result Disclosure, ClinicalTrials.gov Registration