Draft Guidance – Use of Electronic Health Record Data in Clinical Investigations

 

FDA has announced the availability of a draft guidance for industry entitled “Use of Electronic Health Record Data in Clinical Investigations.“ The draft guidance is intended to assist sponsors, clinical investigators, contract research organizations (CROs), IRBs, and other interested parties on the use of EHR data in FDA- regulated clinical investigations. In particular, the draft guidance provides recommendations on the following: (1) Deciding whether and how to use EHRs as a source of data in clinical investigations; (2) using EHRs that are interoperable with electronic systems supporting clinical investigations; (3) ensuring the quality and the integrity of EHR data that are collected and used as electronic source data in clinical investigations; and (4) ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meet FDA’s inspection, recordkeeping, and record retention requirements. In an effort to modernize and streamline clinical investigations, the goals of the draft guidance are to facilitate use of EHR data in clinical investigations and to promote the interoperability of EHRs and electronic systems supporting the clinical investigation.

 

This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the use of EHR data in clinical investigations. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To read the entire Federal Register Notice and to make comments electronically.

 

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