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          Decentralized Clinical Trials for Drugs, Biological Products, and DevicesSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Decentralized Clinical Trials for Drugs, Biological Products, and Devices
					
		
		May 2023


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft
		
		    		Level 1 Guidance

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2022-D-2870
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health
          Oncology Center of Excellence


This draft guidance provides recommendations for sponsors, investigators, and other stakeholders regarding the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and devices. In this guidance, a DCT refers to a clinical trial where some or all of the trial-related activities occur at locations other than traditional clinical trial sites.  In fully decentralized clinical trials, all activities take place at locations other than traditional trial sites.  These trial-related activities may take place at the homes of trial participants or in local health care facilities that are convenient for trial participants.  In hybrid DCTs, some trial activities involve in-person visits by trial participants to traditional clinical trial sites, and other activities are conducted at locations other than traditional clinical trial sites, such as participants’ homes.


 
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						All written comments should be identified with this document's docket number: FDA-2022-D-2870.

                                                                                  Content current as of:
      05/01/2023
         
                  
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