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          Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations:  Questions and AnswersSearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations:  Questions and Answers
					
		
		March 2023


	Download the  Draft  Guidance Document
	    
      	      		Read the Federal Register Notice 

    Draft

	  	    Not for implementation. Contains non-binding recommendations.
	  
	  
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    PrintDocket Number:
		    FDA-2017-D-1105
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Drug Evaluation and Research
          Center for Biologics Evaluation and Research
          Center for Devices and Radiological Health
          Center for Tobacco Products
          Center for Veterinary Medicine
          Office of Regulatory Affairs
          Office of the Commissioner, Office of Clinical Policy and Programs


This draft guidance provides information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs under FDA regulations. This draft guidance revises the draft guidance for industry issued in June 2017 entitled *Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 — Questions and Answers* and, when finalized, will supersede the guidance for industry entitled *Computerized Systems Used in Clinical Investigations* (May 2007). The guidance provides recommendations regarding the requirements, including the requirements under 21 CFR part 11, under which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.


 
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						All written comments should be identified with this document's docket number: FDA-2017-D-1105.

                                                                                  Content current as of:
      03/15/2023
         
                  
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