FDA recently published a draft guidance, "Use of Electronic Health Record Data in Clinical Investigation," which is intended to guide sponsors, clinical investigators, contract research organizations, and institutional review boards in the use of electronic health record ("EHR") data as part of investigations of FDA-regulated products. Through its recommendations, FDA hopes to facilitate the use of EHR data in clinical trials and promote interoperability between EHRs and electronic systems supporting clinical investigations. The draft guidance provides FDA's current thinking on the decision to use and how to use EHRs as a source of clinical investigation data, using EHRs that are interoperable with systems that produce electronic records supporting clinical investigations, ensuring the quality and integrity of data collected and used, and ensuring that use of EHR data meets inspection, recordkeeping, and record retention requirements.
The draft guidance is intended to apply to the use of EHR data in prospective clinical trials of medical products (human drugs and biological products, medical devices, and combination products regulated by the Centers for Drug Evaluation and Research, for Biologics Evaluation and Research, and for Devices and Radiological Health), including foreign clinical studies not conducted under an investigational new drug application or investigational device exemption that are submitted to support a marketing application. The draft guidance does not apply to the use of EHR data in postmarketing observational pharmacoepidemiologic studies designed to assess drug exposure risk or test prespecified hypotheses. The draft guidance document includes best practices for the use of EHR data in clinical investigations, stating that sponsors should ensure the EHRs used and the policies and processes for their employment supply electronic source data that is "attributable, legible, contemporaneous, original, and accurate (ALCOA)." It also includes general considerations for the use of EHR in clinical investigations, data modifications, audit trails, informed consent, and the privacy and security of data. FDA is requesting comments on the draft guidance by July 18, 2016.
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