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# Clinical Investigation Electronic Systems Guidance
- URL: https://www.fdaweb.com/clinical-investigation-electronic-systems-guidance/
- Published: 2023-03-15T12:00:00.000Z
- Updated: 2026-09-14T18:19:42.000Z
- Author: David McFarland
- Tags: FDA Policy/General, Drugs, Devices, #legacy-id-D5153980

FDA has published a draft guidance, *Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers*, with guidance for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on using electronic systems, records, and signatures in clinical investigations of medical products, food, tobacco products, and new animal drugs. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-systems-electronic-records-and-electronic-signatures-clinical-investigations-questions?ref=fdaweb.com) has recommendations on the requirements under which FDA considers electronic systems, records, and signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures on paper.

The agency says this guidance revises a 6/2017 guidance. When finalized, it will supersede a 5/2007 guidance.