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          E6(R3) GOOD CLINICAL PRACTICE (GCP)Search for FDA Guidance Documents GUIDANCE DOCUMENT
	E6(R3) GOOD CLINICAL PRACTICE (GCP)
					
		
		June 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	Download the  Draft  Guidance Document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	  	    Not for implementation.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-2023-D-1955
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research


ICH Website

Explanatory Video - ICH E6(R3) Guideline - Good Clinical Practice
	PDF - E6(R3) Guidline Availability Notice
	Webpage - ICH Guidelines \ Efficacy Guidelines


The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “E6(R3) Guideline for Good Clinical Practice.”  The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).  The draft guidance outlines modernized Good Clinical Practice considerations to guide thoughtful design and responsible conduct of clinical trials in a manner that ensures participant safety and the reliability of trial results.  This draft guidance encourages innovation, focuses on quality, and establishes proportionate and risk-based approaches for conducting clinical trials, while minimizing unnecessary complexities.  The draft guidance is intended to provide flexible, modern, and clear Good Clinical Practice for conducting clinical trials

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					You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
						If unable to submit comments online, please mail written comments to:
						Dockets Management
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							5630 Fishers Lane, Rm 1061
							Rockville, MD 20852
						All written comments should be identified with this document's docket number: FDA-2023-D-1955.

                                                                                  Content current as of:
      06/08/2023
         
                  
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