The U.S. Food and Drug Administration published guidance meant to give clarity to clinical investigators, research organizations, IRBs and others on the use of electronic health record data in FDA-regulated clinical investigations.
The draft gives FDA recommendations on: whether and how to use EHRs as a data source in clinical investigations; using EHRs that are interoperable with other electronic systems supporting clinical trials; ensuring the quality and the integrity of EHR data; and making sure electronic source data meets FDA requirement for record keeping and retention.
"In general, EHRs are not under the control of FDA-regulated entities (e.g., sponsors, clinical investigators), because in most instances, these systems belong to health care organizations and institutions," according to the document.
"However, FDA’s acceptance of data from clinical investigations for decision-making purposes depends on FDA’s ability to verify the quality and the integrity of data during FDA on-site inspections and audits. Sponsors are responsible for assessing the validity, reliability, and integrity of any data used to support a marketing application for a medical product."
With EHRs now near ubiquitous in care settings, the FDA said there are new opportunities to improve patient safety, clinical trial efficiency, and to enable investigators to combine data from a range of sources including clinical notes, physician orders, pharmacy records as well as radiology and lab results.
Electronic health records "may have the potential to provide clinical investigators and study personnel access to real-time and longitudinal health care data for review and can facilitate post-trial follow-up on patients to assess long-term safety and efficacy of medical products," according to the draft guidance.
Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com
