FDA proposes instructions on utilizing EHR data in clinical trials

New draft instructions from the Food and Drug Administration (FDA)) cover deciding whether and how to utilize EHRs as an information source in the clinical trials.

While the new instruction offers general guidance on EHR abilities, the new draft doesn’t involve provisions under which the FDA would assess agreement of records systems.

The agency’s draft covers utilizing EHRs that interoperate with electronic networks supporting trials, and explains ensuring the quality and integrity of information accumulated and used. FDA will agree to the comment on draft recommendations for sixty days before establishing final guidance.

The FDA’s lead in this place is significant because facilitating the correlation between EHRs and clinical trials would offer important benefits in speeding and cutting the prices of clinical trials, as well as streamlining the procedure of finding sufferers for research.

FDA initially released the separate guidance on electronic source information in clinical investigations, which appreciated that data can come from several sources and be entered into the trial sponsor’s Case Report Form (CRF), which is a paper or electronic questionnaire. This could involve information from EHRs—this latest proposed instruction concentrates on such data.

The agency doesn’t intend to actively assess agreement of EHRs used in trials with its rules. “Although, FDA’s acceptance of data from clinical investigations for decision-making purposes relies on FDA’s capability to verify the quality and integrity of data during FDA on-site inspections and audits,” in accordance to the guidance. Consequently, the agency is clarifying few hopes when EHRs are utilized as a source of data.

For example, FDA points out that interoperability of EHRs and a trial sponsor’s electronic data capture system (EDC) can simplify information collection by getting correct source data when a patient gets care. Such interoperability also can decrease the transcription errors and ease interpretation of data.

“FDA motivates the sponsors and clinical investigators to work with the entities that control the EHRs, like healthcare agencies, to use EHRs and EDC systems that are interoperable,” the draft guidance claims.

Another best practice for utilizing the EHR data in clinical trials is making sure the data is attributable, legible, contemporaneous, original and accurate. Further, FDA suggests utilization of ONC-certified EHRs and other health IT due to clear differences in interoperability and keeping data confidential.

Non-certified EHRs may be utilized, but should be assessed to determine if adequate controls are in place to make certain the data confidentiality, integrity and reliability. The assessment should involve limited access to electronic networks; identification of authors of records; audit trails to track changes to information; and availability and retention of records required for FDA inspection.

Moreover, trial sponsors should outline data flow between the EHR and the electronic data capture system, in accordance to FDA.

Other highlights of the instructions involve:

• When healthcare experts not part of the investigation modify or accurate EHR data that will be utilized in a trial, ensure modifications don’t obscure previous entries.


• Audit trail documentation of HER information should be retained at least as long as the time period needed for the subject’s electronic records, and should be present for FDA to review and copy.


• Informed consent must involve the extent to which subject confidentiality will be maintained and recognize entire entities who might have access to the subject information.


• Sponsors should consider safeguards to secure information from subjects who participate, decide to discontinue involvement or are discontinued from involvement by the clinical investigator.