Clinical Trials and Human Subject Protection

 

View Clinical Trials Guidance Documents

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.

Latest activity

• Processes and Practices Applicable to Bioresearch Monitoring Inspections
• Decentralized Clinical Trials for Drugs, Biological Products, and Devices
• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers, Draft Guidance for Industry
• Digital Health Technologies for Remote Data Acquisition in Clinical Investigations - Draft Guidance for Industry, Investigators, and Other Stakeholders
• FDA Takes Action For Failure to Submit Required Clinical Trial Results Information to ClinicalTrials.Gov
• FDA Publishes Guidance on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (August 2020)
• FDA Publishes Guidance on Institutional Review Board Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During COVID-19 Public Health Emergency
• FDA issues Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic

Bioresearch monitoring

View BIMO Compliance Programs

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.

Workshops, meetings, and conferences

• Conferences
• Workshops and meetings

Contacts

• Good clinical practice: gcpquestions@fda.hhs.gov
• IND/IDE contacts
• Bioresearch monitoring program contacts
• How to report complaints or problems about clinical trials to FDA

Report problems to FDA

• Reporting complaints related to FDA-regulated clinical trials
• Mandatory IRB reporting: FDA contacts

Resources

• Clinical trial forms
• ClinicalTrials.gov (NIH)
• Office of Clinical Policy
• Dockets management
• Approvals of FDA-Regulated Products