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  1. Science and Research Special Topics

Clinical Trials and Human Subject Protection


Protecting the rights, safety and welfare of people who participate in clinical trials is a critical aspect of the FDA’s mission. FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. FDA’s regulations and guidances for clinical trials help support efficient medical product development, while assuring trials generate the robust evidence needed to assess product safety and efficacy. The agency works to ensure its GCP policies continue to facilitate new approaches to generating quality clinical evidence.

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Bioresearch monitoring

FDA’s bioresearch monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA-regulated research.

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