FDA Releases Guidelines for the Use of Electronic Health Record Data in Clinical Trials

The Food and Drug Administration (FDA) recently published an updated draft on guidelines for using electronic health record (EHR) data in clinical investigations to collect comments from the industry.  Released in May, these proposed industry guidelines are meant to address the issues resulting from the ever-changing technology-based tools that allow ease of data collection in healthcare fields. The guidelines specifically address the following as it relates to clinical investigations:

• If and how to use EHRs as a source of data
• Ensuring EHRs are interoperable with electronic data capture (EDC) systems
• Maintaining quality and integrity of EHR data collected and used in clinical investigations
• Meeting FDA inspection, record-keeping, and record-retention requirements

EHRs as a Data Source

EHRs are defined in this guidance as: “electronic platforms that contain individual electronic health records for patients and are maintained by health care organizations and institutions.”

The EHR itself is in general not under the jurisdiction of the FDA; however, when conducting clinical trials, the data used must be verifiable for quality and integrity by the FDA. Using EHRs as a data source supplies several benefits, including improved patient safety, data accuracy, and clinical trial efficiency. For example, EHRs could allow investigators to access real-time longitudinal data, or to get additional insights into long-term safety and accuracy without dedicated data collection and human labor.

Interoperability with Other Systems

It is important EHRs are interoperable with Electronic Data Capture (EDC) systems to simplify data collection and reduce the risk of errors. Several challenges can hamper the interoperability of both systems such as the diverse clinical data standards between the healthcare and clinical research communities, or diverse ownership of the electronic systems with an organization.

Meeting FDA Requirements

EHR data sources must meet FDA requirements and ensure data is “attributable, legible, contemporaneous, original, and accurate” (referred to as ALCOA). EHRs do not have to be certified by the ONC Health IT Certification Program. However, if they are not certified, the sponsors using the EHR for a study need to set-up control systems that guarantee the confidentiality, integrity, and reliability of the data. Such internal control systems include:

• A limited access to the electronic system for authorized users
• Identifiable authors of records
• Audit trail to track changes to data
• Records being kept available for FDA inspection for a duration required by applicable regulations

CommCare can Serve as an EHR to Collect  Data used in Clinical Trials

CommCare, our software platform, is being used in numerous clinical trials. It plays the role of an integrated platform that can digitally manage the clinical trial: from the informed-consent process, the storage of the ICH documentation to the collection of clinical data and its integration to EDC.  We are happy to see this guidance from the FDA which means CommCare source data can be used in FDA-approved clinical trials.  CommCare has already been deployed in the following use cases:

• Real-time monitoring of patients enrolled in clinical trials.
• Provider to patients communication systems, such as sending SMS reminders to ensure protocol adherence.
• Implementing CDISC ODM standards for integration with EDC systems in clinical platforms like  OpenClinica.  This enabled automated creation of applications based on the CRF definition in the EDC system, with full electronic data capture from the CommCare application to the EDC system.
• Enabling data collected and hosted on our cloud to meet the essential security and availability requirements for HIPAA compliance and this FDA guidance.
• Enabling data collection in remote areas without cell service or Wi-Fi access.

CommCare is used by a network of 500 partners throughout 50 emerging countries. This network is a valuable resource for investigators who can leverage professionals who are already equipped and trained on CommCare.  If you are interested in learning more about CommCare for Clinical Trials, please get in touch with our team.