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Guidance on Electronic Informed Consent in Clinical Trials

03/09/2015

Federal Register Notice: FDA is making available a draft guidance for industry, clinical investigators, and institutional review boards entitled Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers. It provides recommendations for clinical investigators, sponsors, and institutional review boards on the use of electronic media and processes to obtain informed consent for FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. To download this draft guidance, click here. To view this notice, click here.

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