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GUIDANCE DOCUMENT

Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers October 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2017-D-1105
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Office of the Commissioner, Office of Clinical Policy and Programs

This 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.  The guidance provides recommendations regarding the requirements in our regulations, pursuant to 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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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-1105.

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