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Guidance on using electronic health record data in clinical trials issued by FDA

Guidance on using electronic health record data in clinical trials issued by FDA

Electronic Health Records provide real-time data for review to the clinical investigators and study personnel and also leads to post-trial follow up on patients to assess long-term safety and effectiveness of medical products.

While EHR systems themselves are not under the control of the FDA or its regulated entities, FDA said that it does not intend to assess the compliance of EHRs with federal regulations. FDA makes it clear that its overall acceptance of a submission depends on its ability to verify the quality and integrity of the data which includes audit trails with identifiable authors, retaining records as long as required, having policies and procedures in place to secure the data such as limited access to authorized users, sponsor consideration of using an EHR to unblind a study.

The Food and Drug Administration has issued guidance to the industry on how to use electronic health record data in clinical trials including drugs meant for humans as well as biological products as well as studies conducted in clinical practice settings.

The main points laid down by the guidance include:

1) Recommendations on deciding whether and how to use EHRs as a source of data in clinical investigations

2) Facilitating and ensuring quality and integrity of data while using EHR system interoperable with electronic data capture (EDC) systems in clinical investigations

3) Ensuring the use of EHR data collected and used as source data in clinical investigations meeting the FDA criteria of inspection, recordkeeping and record retention.

4) Opportunities for long-term follow up of large numbers of interest that occurs rarely such as prophylaxis studies.

5) Encouragement to sponsors and clinical investigators to work with entities that control EHR systems such as health care organizations to use EHR and EDC systems interoperably or with full integration.

6) Recommendation on 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.

7) Recommendation on using the EHR systems certified through the Office of the National Coordinator for Health IT which meet certain privacy and security protection requirements.

The guidance does not apply to:

1) Use of EHR data in post marketing observational pharmaco-epidemiologic studies wherein the focus is to assess the adverse events and risks associated with drug exposure or designed to test prespecified hypotheses for such studies

2) Use of EHR data for evaluation of feasibility of trial design

3) Use of EHR data as a recruitment tool for clinical investigations

4) Use of EHR data collected for registries and natural history studies.