New draft guidance from the Food and Drug Administration covers deciding whether and how to use EHRs as a data source in clinical trials.

While the new guidance provides general guidance on EHR capabilities, the new draft does not include provisions under which the FDA would assess compliance of records systems.

The agency’s draft covers using EHRs that interoperate with electronic systems supporting trials, and discusses ensuring the quality and integrity of data collected and used. FDA will accept comment on draft recommendations for 60 days before developing final guidance.

The FDA’s lead in this area is important because facilitating the correlation between EHRs and clinical trials would provide significant benefits in speeding and cutting the costs of clinical trials, as well as streamlining the process of finding patients for research.

FDA previously issued separate guidance on electronic source data in clinical investigations, which acknowledged that data can come from various sources and be entered into the trial sponsor’s Case Report Form (CRF), which is a paper or electronic questionnaire. This could include data from EHRs—this latest proposed guidance focuses on such data.

The agency does not intend to actively assess compliance of EHRs used in trials with its rules. “However, FDA’s acceptance of data from clinical investigations for decision-making purposes depends on FDA’s ability to verify the quality and integrity of data during FDA on-site inspections and audits,” according to the guidance. Consequently, the agency is clarifying certain expectations when EHRs are used as a source of data.

For instance, FDA notes that interoperability of EHRs and a trial sponsor’s electronic data capture system (EDC) can simplify data collection by getting accurate source data when a patient receives care. Such interoperability also can reduce transcription errors and ease interpretation of data.

“FDA encourages sponsors and clinical investigators to work with the entities that control the EHRs, such as healthcare organizations, to use EHRs and EDC systems that are interoperable,” the draft guidance says.

Another best practice for using EHR data in clinical trials is ensuring the data is attributable, legible, contemporaneous, original and accurate. Further, FDA recommends use of ONC-certified EHRs and other health information technology because of clear differences in interoperability and keeping data confidential.

Non-certified EHRs may be used, but should be assessed to determine if adequate controls are in place to ensure data confidentiality, integrity and reliability. The assessment should include limited access to electronic systems; identification of authors of records; audit trails to track changes to data; and availability and retention of records needed for FDA inspection.

Further, trial sponsors should outline data flow between the EHR and the electronic data capture system, according to FDA.

“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 EHRs are consistent with the data collection specified in the clinical protocol.”

Other highlights of the guidance include:

  • When healthcare professionals not part of the investigation modify or correct EHR data that will be used in a trial, ensure modifications do not obscure previous entries.
  • Audit trail documentation of EHR data should be retained at least as long as the time period required for the subject’s electronic records, and should be available for FDA to review and copy.
  • Informed consent must include the extent to which subject confidentiality will be maintained and identify all entities who may have access to the subject data.
  • Sponsors should consider safeguards to protect data from subjects who participate, decide to discontinue participation or are discontinued from participation by the clinical investigator.

The complete draft guidance is available here.

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