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GUIDANCE DOCUMENT

Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry July 2018

Final

Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry

Docket Number:
FDA-2016-D-1224
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to assist sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties on the use of electronic health record data in FDA-regulated clinical investigations.2 For the purposes of this guidance, electronic health record (EHR) systems3are electronic platforms that contain individual health records for patients. EHR systems are generally maintained by health care providers, health care organizations, and health care institutions and are used to deliver care. EHR systems can be used to integrate real-time electronic health care information from medical devices and multiple health care providers involved in the care of patients.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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-2016-D-1224.