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          FDA Webinar: Draft Guidance: Use of an Electronic Informed Consent in Clinical Investigations Questions and Answers – April 20, 2015Guidance Webinar Series FDA Webinar: Draft Guidance: Use of an Electronic Informed Consent in Clinical Investigations Questions and Answers – April 20, 2015
  
  	
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    PrintOn Monday, April 20, 2015, the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research (CDER), presented a webinar on the Draft Guidance: Use of an Electronic Informed Consent in Clinical Investigations Questions and Answers.

Summary:The Food and Drug Administration is announcing the availability of a draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” The purpose of this guidance is to provide recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.



Webinar link



Documents:



Draft Guidance: Use of an Electronic Informed Consent in Clinical Investigations Questions and Answers

Federal Register Notice (FRN)

Federal Register Publication Date:03/09/2015



Comments Date:05/08/2015



Docket Number:FDA-2015-05377



Speakers:

Leonard V. Sacks, M.D.

Associate Director for Clinical Methodology

OMP/CDER/FDA



Cheryl A. Grandinetti, Pharm.D.

Health Scientist Policy Analyst

OMP/CDER/FDA

                                                                                  Content current as of:
      04/30/2015Guidance Webinar Series
 
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