FDA Expands on Recommendations Regarding Use of EHR Data in Clinical Trials, Part One: Overview of Recent Draft Guidance

May 18, 2016

FDA Draft Guidance on Use of Electronic Health Record (EHR) Data in Clinical Trials

On Tuesday, May 17, FDA announced the availability of a new draft guidance, entitled “Use of Electronic Health Record Data in Clinical Investigations.”  The document, which expands on the recommendations found in two previous guidance documents (“Computerized Systems Used in Clinical Investigations” and “Electronic Source Data in Clinical Investigations”), was published in an attempt to update and simplify clinical investigations.

The draft guidance applies to sponsors, clinical investigators, contract research organizations, institutional review boards (IRBs), and other interested parties, and provides assistance regarding the use of electronic health record (EHR) data in FDA-regulated clinical trials.  The document provides recommendations on:

  • “Deciding whether and how to use EHRs as a source of data in clinical investigations.”
  • “Using EHRs that are interoperable with electronic systems supporting clinical investigations.”
  • “Ensuring the quality and the integrity of EHR data that are collected and used as electronic source data in clinical investigations.”
  • “Ensuring that the use of EHR data collected and used as electronic source data in clinical investigations meets FDA’s inspection, recordkeeping, and record retention requirements.”

FDA’s recommendations “apply to the use of EHR data in prospective clinical investigations of human drugs and biological products, medical devices, and combination products.  This includes foreign clinical studies not conducted under an investigational new drug application (IND) or an investigational device exemption (IDE) that are submitted to FDA in support of an application for the marketing approval of a medical product.”  However, FDA notes that its recommendations do NOT apply to the use of EHR data:

  • “In postmarketing observational pharmacoepidemiologic studies designed to assess the risk associated with a drug exposure or designed to test prespecified hypotheses for such studies.”
  • “When used as a recruitment tool for clinical investigations.”

What is an EHR?

In its draft guidance, FDA states that “EHRs are electronic platforms that contain individual electronic health records for patients and are maintained by health care organizations and institutions.”  Typically, EHRs include the following information (as applicable): medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records, and lab and test results.

Many health care institutions use EHRs, allowing them to integrate real-time electronic health care information and import data from medical devices and other health care providers involved in the care of patients.

Advantages of EHRs

Widespread EHR use provides the opportunity to make improvements in a number of areas, such as patient safety, data accuracy, and clinical trial efficiency.  FDA notes that “EHRs may enable clinical investigators and study personnel to more easily combine, aggregate, and analyze data from many different sources.”  In addition, “EHRs 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. There are also opportunities for long-term follow-up of large numbers of patients in studies where primary endpoints are rare, such as in prophylaxis studies.”


The interoperability, or “the ability of two or more systems or components to exchange information and to use the information that has been exchanged,” paired with automatic exchange of information between the EHR and the sponsor’s electronic data capture (EDC) system, may benefit the clinical trial, patients, and other health care provider.  As such, the interoperability of EHRs and EDC systems may:

  • “Simplify data collection for a clinical investigation by enabling clinical investigators and study personnel to capture source data at the time of a subject’s point-of-care visit.”
  • “Reduce errors in data transcription.”
  • “Provide data that is more accurate and complete allowing for improvement in the quality of clinical investigations and the interpretation of data.”

Additionally, the use of interoperable technology may allow the EDC system to fully integrate with the EHR, enabling both the clinical investigator and the patient’s other health care providers to access all of the research and clinical care data as appropriate.  “Full integration of both systems may reduce the use of stand-alone EDC systems by health care providers who are participating as investigators in clinical investigations.”

Challenges of Interoperability

Along with a number of benefits, there can also be many practical challenges associated with the interoperability of EHRs and EDC systems, which may include:

  • “Complex and diverse clinical data standards used by the health care and clinical research communities, which may hinder the exchange of information between different electronic systems.”
  • “Diverse ownership of electronic systems and data can necessitate appropriate collaboration between the health care and clinical research communities.”

Inspection, Recordkeeping, & Record Retention Requirements

The draft guidance states that “FDA must have access to records and may inspect and copy all records pertaining to a clinical investigation in accordance with 21 CFR 312.57, 312.58, 312.62, 312.68, 812.140, and 812.145.”  When identifying an EHR as the source, all relevant data pertaining to the clinical trial within the EHR must be made available to the Agency upon request.  During an inspection, FDA may also request additional paper or electronic records to support data provided in the eCRF.

Clinical investigators of human drugs and biological products must retain all records for two years “following the date a marketing application is approved for the drug for the indication for which it is being investigated.”  Medical device investigators or sponsors must retain all records for two years “after the latter of the following two dates: the date on which the investigation is terminated or completed or the date that the records are no longer required for the purposes of supporting a premarket approval application or a notice of completion of a product development protocol.”

Best Practices & Other Considerations

The draft guidance also provides a number of best practices and other considerations regarding the use of EHRs in clinical trials.

Interested in learning more about FDA’s recommendations? Part two is available now with additional information about the Agency’s draft guidance.

Are you developing an FDA-regulated product?  Do you need to submit an application to FDA that involves clinical data?  We can help you achieve a successful interaction with FDA.  To learn more about our services and how we can help you, contact us today.


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