federal_register: 2015-05377

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-05377 Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers; Draft Guidance for Industry, Clinical Investigators, and Institutional Review Boards; Availability Notice The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled "Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers." The guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) 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. 2015-03-09 2015 3 https://www.federalregister.gov/documents/2015/03/09/2015-05377/use-of-an-electronic-informed-consent-in-clinical-investigations-questions-and-answers-draft https://www.govinfo.gov/content/pkg/FR-2015-03-09/pdf/2015-05377.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry, clinical investigators, and institutional review boards entitled "Use of Electronic Informed Consent in Clinical Investigations:...  

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