EHR Data in Clinical Trials: New FDA Draft Guidance

Regulatory NewsRegulatory News | 16 May 2016 |  By 

The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations.

The 12-page guidance is meant to facilitate the use of EHR data in clinical trials and “promote the interoperability of EHRs and electronic systems supporting such trials.”

Prepared by the Office of Medical Policy and the Office of Translational Sciences in FDA’s Center for Drug Evaluation and Research (CDER), in coordination with the Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH), as well as the Office of the National Coordinator for Health Information Technology (ONC), the guidance offers recommendations on:

  • Deciding whether and how to use EHRs as a source of data in clinical trials;
  • Use of interoperable EHRs that produce electronic records and support clinical investigations;
  • Ensuring the quality and the integrity of EHR data collected and used as electronic source data in clinical trials;
  • Ensuring that the EHR data used as electronic source data meets FDA’s inspection, recordkeeping and record-retention requirements;

“With the widespread use of EHRs, there are opportunities to improve patient safety, data accuracy, and clinical trial efficiency when data from these systems are used in clinical investigations,” FDA says. “EHRs may enable clinical investigators and study personnel to more easily combine, aggregate, and analyze data from many different sources (e.g., clinical notes; physician orders; and radiology, laboratory and pharmacy records).”


For the purposes of this guidance, FDA defines EHRs as “electronic platforms that contain individual electronic health records for patients and are maintained by health care organizations and institutions.”

For example, the agency says, a typical EHR may include a patient’s medical history, diagnoses, treatment plans, immunization dates, allergies, radiology images, pharmacy records and laboratory and test results. EHRs can also be used to integrate real-time electronic health care information from medical devices and different health care providers.

In general, however, FDA notes that 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.”

However, sponsors of trials should include (e.g., in the protocol or the data management plan) information about the intended use of the EHR during a clinical investigation and a description or diagram of the electronic data flow between the EHR and the sponsor’s electronic system supporting the clinical investigation.

“This should include a description of how the relevant EHR data are extracted and subsequently imported into the sponsor’s electronic system. Sponsors should check the extracted data for consistency and completeness with the source data obtained from the EHR, and make corrections when errors are found to properly align the source data with the extracted data. In addition, sponsors should ensure that data obtained from the EHRs are consistent with the data collection specified in the clinical protocol.”

Sponsors should also make sure software updates to the sponsor’s electronic system or the EHR do not affect the reliability and the integrity of EHR data, FDA says. Sponsors should also consider the clinical investigator’s ability to appropriately archive and back up any EHR data that may be used for the clinical investigation so that data are not lost before the record retention period.

Study monitors should have suitable access to all relevant subject information pertaining to a clinical investigation as appropriate and such access must be described in the informed consent.

“The informed consent for clinical investigations in which EHRs will be used must include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and must also identify all entities who may gain access to the patient’s electronic health record relating to the clinical investigation, including access to EHRs granted to other parties,” such as sponsors, CROs and study monitors, FDA notes.

Data Integrity

Similarly to the manufacturing of drugs (FDA last month put out new guidance on data integrity and cGMP manufacturing), FDA’s acceptance of data from clinical trials, which has been an issue for other regulators like the European Medicines Agency, depends on its ability to verify the quality and the integrity of data during on-site inspections and audits, and sponsors are responsible for “assessing the validity, reliability, and integrity of any data used to support a marketing application for a medical product.

“When EHRs are used as a source of data in clinical investigations, sponsors should ensure that the EHRs they use and the processes and policies for their use provide electronic source data that are attributable, legible, contemporaneous, original, and accurate (ALCOA),” the draft says.

And for EHRs not certified by ONC, which FDA says “can also provide adequate data to inform FDA’s regulatory decisions provided that adequate controls are in place to ensure the confidentiality, integrity, and reliability of data,” sponsors should consider whether such systems have adequate controls in place to ensure that data maintain their confidentiality, integrity and reliability. Sponsors should evaluate whether such EHR systems can:

  • Limit access to electronic systems for only authorized users
  • Identify authors of records
  • Make audit trails available to track changes to data
  • Ensure records are available and retained for FDA inspection for as long as the records are required by applicable regulations.

“When health care professionals who are not part of the clinical investigation make modifications or corrections to data in the EHR that will be used for the clinical investigation, it is important to ensure that these modifications are made without obscuring previous entries,” FDA says. “Furthermore, sponsors should discuss with the relevant FDA review division any unique issues or challenges encountered that are related to the data collection from the EHRs.”

Sponsors also should consider the safeguards to ensure the privacy and confidentiality of data from subjects who participate, discontinue participation, who are withdrawn by a legally authorized representative, or who are discontinued from participation by the clinical investigator.


The ability of EHR and other electronic systems to exchange data is an important priority for FDA, which encourages sponsors and clinical investigators to work with the entities that control the EHRs to use interoperable systems.

EHRs may be interoperable with EDC systems in myriad ways, FDA says, including via the electronic transmission of relevant EHR data to an EDC system.

“For example, data elements originating in an EHR (e.g., demographics, vital signs, past medical history, past surgical history, social history, medications, adverse reactions) may automatically populate the eCRFs [electronic case report forms] within an EDC system,” FDA says.

But there are also practical challenges with the interoperability of EHRs and EDC systems due to the “complex and diverse clinical data standards used by the health careand clinical research communities, which may hinder the exchange of information between different electronic systems,” FDA says.

Collaborations between the health care and clinical research communities may be necessary in some cases, though many of these challenges are being addressed “by the adoption of data standards as well as through standardization requirements as part of the ONC Health Information Technology (Health IT) Certification Program,” FDA says.

This guidance expands on two previous guidance documents: “Computerized Systems Used in Clinical Investigations,” and “Electronic Source Data in Clinical Investigations,” and FDA says it does not apply to the use of EHR data in postmarket observational pharmacoepidemiologic studies designed to assess the risk associated with a drug exposure or designed to test pre-specified hypotheses for such studies, or when used as a recruitment tool for clinical investigations.

FDA Draft Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations


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