The Food and Drug Administration has issued guidance to industry on using electronic health record data in clinical investigations including those involving human drugs and biological products, as well as studies conducted in clinical practice settings.
“EHRs may have the potential to provide clinical investigators and study personnel access to real-time data for review and can facilitate post-trial follow-up on patients to assess long-term safety and effectiveness of medical products,” the FDA’s guidance states. “In addition, there are opportunities for long-term follow up of large numbers of patients, which may be of particular importance in studies where the outcome of interest occurs rarely, such as in prophylaxis studies.”
At the same time, however, the FDA warns that “there are opportunities to improve data accuracy and promote clinical trial efficiency when EHRs are used in clinical investigations.”
In particular, the agency guidance provides recommendations on: deciding whether and how to use EHRs as a source of data in clinical investigations; using EHR systems that are interoperable with electronic data capture (EDC) systems in clinical investigations; making sure the quality and integrity of EHR data collected and used as electronic source data in clinical investigations; and ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA inspection, recordkeeping, and record retention requirements.
“Interoperable systems allow electronic transmission of relevant EHR data to the EDC system,” the agency points out. “FDA encourages sponsors and clinical investigators to work with entities that control EHR systems, such as health care organizations, to use EHR and EDC systems that are interoperable or fully integrated.”
The FDA’s guidance also recommends the exchange of structured data between EHR and EDC systems so that data may be entered once at the point-of-care and used many times without manual re-entry or manual source data verification.
The agency notes that its guidance does not apply to: the use of EHR data in post-marketing observational pharmaco-epidemiologic studies designed to assess adverse events and risks associated with drug exposure or designed to test prespecified hypotheses for such studies; the use of EHR data to evaluate feasibility of the trial design or as a recruitment tool for clinical investigations; as well as data collected for registries and natural history studies.
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