Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

        Science and Research Special Topics

Clinical Trials and Human Subject Protection

                        
                BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


                Clinical Investigations Compliance & Enforcement
          FDA's Role: ClinicalTrials.gov Information
          Good Clinical Practice Educational Materials
          Report Problems to FDA
          Reporting Complaints Related to FDA-Regulated Clinical Trials
          Good Clinical Practice Inquiries Home
          Science & Research
          Science and Research Special Topics
          Clinical Trials and Human Subject ProtectionScience and Research Special Topics Clinical Trials and Human Subject Protection
  	
        Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintView 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

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 PandemicBioresearch 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 meetingsContacts

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

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

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

                                                                                  Content current as of:
      05/02/2023Clinical Trials and Human Subject Protection                
                          

                        BIMO Inspection Metrics
          HSP/BIMO Initiative
          Good Clinical Practice (GCP) Inspection Collaboration with International Regulators for Drug Development
          ICH Guidance Documents
          Regulations: Good Clinical Practice and Clinical Trials
          Clinical Trials Guidance Documents


                        Clinical Investigations Compliance & Enforcement
          FDA's Role: ClinicalTrials.gov Information
          Good Clinical Practice Educational Materials
          Report Problems to FDA
          Reporting Complaints Related to FDA-Regulated Clinical Trials
          Good Clinical Practice Inquiries
 Subscribe
                        Sign up for Good Clinical Practice/Human Subject Protection e-mail updates
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop