№ lp_1_09853
This document is a guidance publication outlining the procedures and recommendations for the implementation of electronic informed consent (eIC) in clinical trials regulated by the FDA and HHS.
Year: 2016
Region / City: United States
Topic: Electronic Informed Consent (eIC)
Document Type: Guidance
Agency / Institution: Office for Human Research Protection (OHRP), Food and Drug Administration (FDA)
Author: Office for Human Research Protection (OHRP), FDA
Target Audience: Researchers, IRBs, Clinical Investigators, and Study Participants
Period of Validity: Ongoing
Approval Date: December 2016
Date of Revisions: Not specified
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