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:

                News & Events for Human Drugs

News & Events for Human Drugs

                        CDER Conversations
          Q&A with FDA
          Spotlight on CDER Science


                        From Our Perspective Home
          Drugs
          News & Events for Human Drugs
          Decentralized Clinical Trials (DCT) Draft Guidance - 06/20/2023News & Events for Human Drugs Virtual
    Event Title
              Decentralized Clinical Trials (DCT) Draft Guidance


                  June 20, 2023

  

    
  Share
    Post
    Linkedin

    Email
    PrintOn This Page
      Meeting Information
                Event MaterialsDate:
          
  


     
           

June 20, 2023   

 
 
        
                                      Time: 
                                      
3:00 PM
    - 4:00 PM
ET

 

  

Topic & Presentations
			SpeakersDecentralized Clinical Trials (DCT) Draft GuidanceIntro - Decentralized Clinical Trials for Drugs, Biological Products, and Devices
			**Leonard Sacks, MBBCh***Associate Director*
			Clinical Methodologies
			Office of Medical Policy (OMP) | CDER | FDAOverview of the DCT Draft Guidance
			**Ryan Robinson, MD***Medical Officer*
			Clinical Methodologies
			OMP | CDER | FDAQ&A Discussion Panel
			Same as above

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

The FDA sees important potential benefits and value in DCTs. Advances in clinical care using electronic communications and information technology to interact with trial participants in different locations (i.e., telehealth) allow for fewer in-person visits to clinical trial sites and facilitate decentralization. In addition, digital health technologies have expanded the types of trial-related data that can be obtained remotely from trial participants. By enabling remote participation, DCTs may enhance convenience for trial participants, reduce the burden on caregivers, expand access to more diverse patient populations, improve trial efficiencies, and facilitate research on rare diseases and diseases affecting populations with limited mobility. As part of the FDA’s efforts to be responsive to the rapidly evolving clinical trial landscape and clarify the Agency’s recommendations on the conduct of DCTs, the FDA will provide an overview of the draft guidance titled Decentralized Clinical Trials for Drugs, Biological Products, and Devices.

TOPICS COVERED

Design of a DCT
	Conduct of remote clinical trial visits and clinical trial-related activities in a DCT
	Use of digital health technologies to remotely acquire data in a DCT
	Roles and responsibilities of the sponsor and investigators in a DCT
	Obtaining informed consent and institutional review board oversight of the informed consent process in a DCT
	Determination of the appropriateness of investigational products for use in a DCT
	Packaging and shipping of investigational products in a DCT
	Safety monitoring of trial participants in a DCT
	Software used to support the conduct of a DCTINTENDED AUDIENCE

Entities (e.g. sponsors, contract research organizations) designing clinical investigations which incorporate decentralized elements or who submit INDs/IDEs
	Developers of DCT software or digital health technologies
	Clinical trial personnel or other healthcare professionals involved in clinical investigations using decentralized elements
	Patients (or caregivers of patients) participating in DCTs
	Regulators involved in the use of DCT data to support marketing applicationsFDA RESOURCES

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Guidance for Industry, Investigators, and Other Stakeholders
	DHTs for Drug Development Mailbox


Event Materials

  Title
            File Type/SizeDecentralized Clinical Trials (DCT) Draft Guidance_June_30_2023.pdf
              pdf               (318.37 KB)

                                                                                  Content current as of:
      08/08/2023
         
                   
Regulated Product(s)
		 DrugsMore Meetings,
      Conferences, and
      Workshops
        
        News & Events for Human Drugs

          
                        CDER Conversations
          Q&A with FDA
          Spotlight on CDER Science


                        From Our Perspective
 
 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