The Research Site’s Role in Supporting Patient Centricity with eConsent

摘要

In “Use of Electronic Informed Consent Questions and Answers: Guidance for Institutional Review Boards, Investigators and Sponsors” (2016), the FDA described eConsent as “the use of electronic systems and processes that may employ multiple electronic media…to convey information related to the study and to obtain and document informed consent.” 1 In 2017, TransCelerate Biopharma published “eConsent: Implementation Guidance” for sponsors and CROs and “Introduction to eConsent for Sites” for research sites. 2,3 These are the three foundational documents of eConsent.