FDA Guidance Defines Proper Usage of eHealth Records in Clinical Trials

FDA Guidance Provides Direction on When, How to Use EHRs as Data Source

The U.S. Food and Drug Administration (FDA) hopes to “modernize and streamline” clinical investigations by promoting use of electronic health records (EHRs) in clinical trials with a new guidance providing direction on when and how to use EHRs as a data source in a trial, among other areas.

The guidance is aimed at sponsors, clinical investigators, contract research organizations (CROs), and institutional review boards (IRBs). The guidance calls on industry meet a number of new standards, including:

  • Sponsors should include in their data management plan a list of EHR systems used by each clinical investigation site. They should also document the manufacturer, model number, and version number and whether it is certified by the Office of the National Coordinator for Health Information Technology (ONC).
  • Because many foreign studies don’t use EHR systems certified by ONC, FDA expects to see policies and processes in place that demonstrate appropriate security measures have been employed to protect data. This includes limiting access to authorized users and ensuring that authors of records are identified, that audit trails are available to track changes to data, and that records are available for FDA inspection for as long as required by applicable regulations.

Turning to eSource principles for EHRs, FDA’s guidance says:

  • Identifying the EHR as the data originator may be sufficient because sponsors are not expected to know details about all users who contribute information to the patient’s EHR.
  • After data are transferred to the electronic case report form, the clinical investigator should be the only individual authorized to make modifications or corrections. Those changes should include data elements showing the date, time, data originator, and reason for the change.

EHRs can also adversely impact blinded study designs, FDA says. If a potential for unblinding is identified, sponsors should determine whether the use of interoperable systems is appropriate, or whether other controls should be put in place to prevent inadvertent compromises to the study.


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The guidance also addresses the important issue of informed consent. “When informed consent is required, the consent must include a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and should identify entities, such as healthcare providers, clinical investigators, sponsors, [contract research organizations], study monitors, and regulatory agencies who may gain access to the patient’s [EHRs] relating to the investigation.”

The consent process must also indicate that FDA may inspect records and should not state or imply FDA needs permission from the subject for access to the records.

The guidance does not cover use of EHR data in postmarketing observational pharmacoepidemiologic studies, use of EHRs to evaluate feasibility of trial designs or as a recruitment tool for clinical investigations, or data collected for registries and natural history studies.

Author: Michael Causey