Electronic Informed Consent Form (eICF)

There’s increasing interest in using electronic media to supplement or replace paper-based informed consent processes. An electronic informed consent form (eICF) may be used to provide information usually contained within the written ICF, evaluate the subject’s understanding of the information provided, and document that the subject (or the subject’s legally acceptable representative) provides voluntary consent to participate in a clinical study. Electronic informed consent (eIC) processes may use interactive electronic-based technology (including diagrams, images, graphics, videos, narration, quizzes) to facilitate the subject’s ability to comprehend the information and to assess the subject’s understanding of the information being presented during the eIC process.

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“I can really trust the Emtex writers to deliver a quality document on time, to reach out to me or team members when appropriate, and to adapt to our changes in process/template over time. The consistent quality of work– and that this is true of all the writers. The willingness and ability to learn and improve. The good balance between independent work and reaching out to me or the team when appropriate. The effective and friendly communication.”

Senior Medical Writing Leader

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