Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers March 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2017-D-1105
• Issued by: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health; Center for Tobacco Products; Center for Veterinary Medicine; Office of Regulatory Affairs; Office of the Commissioner, Office of Clinical Policy and Programs

This draft guidance provides information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs under FDA regulations. This draft guidance revises the draft guidance for industry issued in June 2017 entitled Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 — Questions and Answers and, when finalized, will supersede the guidance for industry entitled Computerized Systems Used in Clinical Investigations (May 2007). The guidance provides recommendations regarding the requirements, including the requirements under 21 CFR part 11, under which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

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