Common Rule Checklist

by Aarthi Iyer

Considerations for Use of Electronic Health Records in Clinical Investigations: A Review of FDA Guidance

With the issuance of draft guidance on the Use of Electronic Health Record Data in Clinical Investigations, the FDA hopes to facilitate the use of Electronic Health Record (EHR) data in clinical trials and streamline interoperability of EHRs and other electronic systems to support research. Specifically, the guidance provides key recommendations for running trials that rely on electronic data that are produced and housed in routine clinical care environments, including:

  • 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 integrity of EHR data
  • How to comply with FDA requirements for auditing, recordkeeping, and retention


The guidance defines EHRs as electronic platforms that contain individual electronic health records (e.g. medical history, allergies, laboratory test results, radiology images, treatment plans) for patients and are maintained by health care organizations and institutions. EHRs are not generally under the FDA’s purview; however, as trial sponsors are responsible for assessing the “validity, reliability, and integrity” of any data they use in FDA-regulated research, the new guidance clarifies FDA’s expectations on the proper use of EHR data in clinical investigations.


The guidance highlights interoperability of EHRs, including the potential for exchange of information between EHRs and research electronic data capture (EDC) systems, as an important benefit to running clinical trials. Interoperability of EHRs could:

  • Simplify data collection by automatically populating an EDC system with source data in near real-time during a subject’s 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

Indeed, FDA suggests that, “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.”

ONC-Certified Health Information Technology

The guidance encourages the use of EHR technology certified under the Office of the National Coordinator for Health Information Technology’s (ONC) Health IT Certification Program. Certified EHR technology is valuable because the certification’s requirements are intended to keep electronic data confidential and reliable. The agency states that the “use of such certified EHR technology would give FDA confidence during inspections that the EHR data is reliable and that the technical and software components of privacy and security protection requirements have been met.”

For non-ONC certified EHRs, the guidance advises sponsors to consider whether the systems in place ensure preservation of confidentiality, integrity, and reliability of data. This includes consideration of whether (i) system access is limited to authorized users; (ii) authors are identifiable; (iii) audit trails are available to track data changes; and (iv) records are maintained for FDA inspection as required by applicable regulations.

When non-ONC-certified EHRs provide data in a clinical investigation, sponsors should first evaluate whether the EHRs have capacity for providing the type of audit trails commonly requested during FDA inspections to ensure data replicability and reliability.

Part 11

The guidance articulates that FDA does not intend to assess overall compliance of EHRs with FDA’s regulation governing electronic records under 21 CFR Part 11. However, the agency still intends to assess compliance with Part 11 “at the point when EHR data enters the sponsor’s electronic system supporting the clinical investigation.”

For example, Part 11 requirements would be in effect once data from the EHR is entered into the EDC system for the trial. In studies where much of the source data stems from EHRs maintained by individual clinical sites, commentators suggest that the impact of the guidance will move Part 11 compliance “upstream” to EHR system users and / or developers, by way of sponsor requirements.

Best Practices

The following are the FDA’s suggested best practices for use of EHRs in clinical investigations.

  • Describing, in the study protocol, the intended use of EHRs during a clinical investigation
  • Ensuring that the EHR platforms provide electronic source data that are attributable, legible, contemporaneous, original, and accurate (ALCOA)
  • Including detailed information in consent forms that describe the extent to which confidentiality of subject-identifiable records will be maintained
  • Identifying, in consent forms, all entities with access to a subject’s EHRs relating to the investigation and describing the extent to which access will be granted
  • Ensuring that updates to the sponsor’s electronic system or EHR do not affect EHR data reliability or integrity as used in the investigation
  • Complying with any privacy and security requirements both applicable to an investigator’s organization and as a matter of law, including the ability to archive, backup, and retain EHR data for recordkeeping
  • Considering whether safeguards in place ensure privacy and confidentiality of data from subjects who later decide to withdraw participation in the clinical investigation

In instances where current EHRs may not be readily configurable to meet the parameters and best practices outlined in the guidance, researchers and sponsors should consider the use of enterprise data warehouses or translational data warehouses, including those that utilize a common data model, as these sources may have better interoperability and data integrity capabilities.

With EHRs becoming commonplace in healthcare settings, the FDA points to new opportunities to enhance data collection, improve patient safety, and clinical trial efficiency when data from EHRs are used in clinical investigations. However, while EHRs may provide increasing value in ongoing and new clinical trials, it will be crucial for researchers and sponsors to continually evaluate and address concerns about EHRs’ functionality and capacity to meet scientific and regulatory standards for data quality, reliability, integrity, and privacy.


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