ComplianceOnline

FDA Issues Final Guidance on the Use of Electronic Informed Consent

  • By: Staff Editor
  • Date: April 11, 2017
  • Source: http://www.fda.gov
Abstract:

FDA Issues Final Guidance on the Use of Electronic Informed Consent

The informed consent process has been an area of debate over the past few years. Regulations and guidelines controlling the conduct of clinical trials require informed consent to be obtained from each study subject prior to initiation of clinical investigation. In December 2016, FDA published its final guidance on the use of electronic informed consent. This guidance document finalizes the draft guidance entitled “Use of Electronic Informed Consent in Clinical Investigations--Questions and Answers” published in March 2015.

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