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# Trial Electronic Systems, Records, Signatures Guide
- URL: https://www.fdaweb.com/trial-electronic-systems-records-signatures-guide/
- Published: 2024-10-01T12:00:00.000Z
- Updated: 2026-09-14T14:42:53.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5157894

FDA has published a guidance, *Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers*, with help 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, new animal drugs, foods, and tobacco. The [document](https://www.fda.gov/media/166215/download?ref=fdaweb.com) provides recommendations about the regulatory requirements that FDA uses to consider electronic systems, records, and signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

The guidance expands on recommendations in an 8/2003 guidance, FDA says.