News Feature | May 20, 2016

FDA Issues Draft Guidance On EHR Use In Clinical Trials

By Jof Enriquez,
Follow me on Twitter @jofenriq

FDA Draft Guidance

The U.S. Food and Drug Administration (FDA) has released draft guidance on the use of electronic health record (EHR) data by sponsors, clinical investigators, contract research organizations (CROs), institutional review boards (IRBs), and other interested parties who conduct clinical trials.

In issuing the draft guidance, FDA aims to facilitate the use of EHR data in clinical investigations of medical devices, human drugs and biological products, and combination products, and to promote the interoperability of EHRs and electronic systems supporting such studies. Further, the draft guidance contains non-binding recommendations on: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 EHR data used as electronic source data meets FDA’s inspection, record-keeping, and record-retention requirements

FDA acknowledges that EHRs in general belong to health care organizations and institutions, but notes that "FDA’s acceptance of data from clinical investigations for decision-making purposes depends on FDA’s ability to verify the quality and the integrity of data during FDA on-site inspections and audits. Sponsors are responsible for assessing the validity, reliability, and integrity of any data used to support a marketing application for a medical product. Therefore, this guidance clarifies FDA’s expectations when EHRs are used as a source of data in clinical investigations."

FDA encourages sponsors and clinical investigators to ensure that EHRs are interoperable with electronic data capture (EDC) systems to reduce errors in data transcription and allow automated data transfer. The agency cites as an 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 within an EDC system."

In order to ensure the quality and the integrity of EHR data collected, FDA reminds sponsors to follow the ALCOA quality standard for evidence whenever possible.

"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)," states FDA.

FDA encourages sponsors to use EHR technology certified under the ONC Health IT Certification Program to give FDA during inspections confidence that the collected EHR data is reliable and that the technical and software components of privacy and security protection requirements have been met. If certification is unmet, sponsors should provide FDA information on adequate controls and internal safeguards to ensure the confidentiality, integrity and reliability of data.

The agency encourages sponsors and clinical investigators to adhere to other best practices in the use of EHR data, by ensuring:

  • that software updates to the sponsor’s electronic system or the EHR do not affect the reliability and the integrity of EHR data entering the sponsor’s electronic system, and consider the ability to appropriately archive and backup any EHR data used
  • that modifications to EHR data for use in trials made by health care professionals who are not part of the clinical investigation are made without obscuring previous entries
  • that there are adequate methods to monitor, track, and document all changes made to information in the EHR, and that the audit trail documentation of the EHR should be retained for a time period and should be available for FDA to review and copy
  • that informed consent must contain a statement of confidentiality, a list of entities granted access to EHR data, and description of foreseeable risks with the use of EHRs, such as data breaches
  • consider the safeguards that are in place to ensure the privacy and confidentiality of data from subjects who participate, who decide to discontinue participation in a clinical investigation, who are withdrawn by their legally authorized representative, as applicable, or who are discontinued from participation by the clinical investigator
  • that FDA has access to all relevant data within the EHR pertaining to the clinical investigation

"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. 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). 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," states FDA.

According to RAPS, the draft 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.

The draft guidance, however, does include 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.

FDA is accepting comments on the draft guidance until July 18, 2016.