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          E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)Search for FDA Guidance Documents GUIDANCE DOCUMENT
	E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1)
					
		
		March 2018


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

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    PrintDocket Number:
		    FDA-2018-D-0719
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Biologics Evaluation and Research
          Center for Drug Evaluation and Research


**OMB Control Number: 0910-0014
Expiration Date: 09/30/2026**

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

The objective of this ICH GCP guidance is to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.


 
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						All written comments should be identified with this document's docket number: FDA-2018-D-0719.

                                                                                  Content current as of:
      11/09/2023
         
                  
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