What is electronic informed consent?
Topics: Informed Consent, FDA, Electronic
You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
What is electronic informed consent?
Topics: Informed Consent, FDA, Electronic
In March, 2015, FDA released a new draft guidance: Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.
FDA defines electronic informed consent (eIC) as using electronic systems and processes that may employ multiple electronic media (e.g., text, graphics, audio, video, podcasts and interactive Web sites, biological recognition devices, and card readers) to convey information related to the study and to obtain and document informed consent.
Topics: Informed Consent, FDA, Electronic