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# Guidance on Use of E Health Records in Trials
- URL: https://www.fdaweb.com/guidance-on-use-of-e-health-records-in-trials/
- Published: 2016-05-17T12:00:00.000Z
- Updated: 2026-09-14T21:03:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135691

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Use of Electronic Health Record Data in Clinical Investigations*. It is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards, and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations. To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM501068.pdf?ref=fdaweb.com). To view this notice, click[here](https://www.gpo.gov/fdsys/pkg/FR-2016-05-17/pdf/2016-11564.pdf?ref=fdaweb.com).