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FDA Provides Guidance for EHR Data Use in Clinical Investigations

FDA pushed for increased interoperability between EHR and EDC systems, clinical data standards, and certified EHR use to improve EHR data use in clinical investigations.

FDA advised clinical investigators to promote interoperability, integrity, and quality in EHR data use.

Source: Thinkstock

By Kate Monica

- FDA released new guidance this month intended to inform EHR data use in clinical investigations, ensure EHR data quality and integrity, promote interoperability between EHR systems and electronic data capture (EDC) systems, and relay FDA requirements for data collection.

In clinical investigations, EHR technology can allow researchers and investigators to access a variety of data types including clinical notes and physician orders, as well as radiology, laboratory, and pharmacy records.

 “EHRs may have the potential to provide clinical investigators and study personnel access to real-time data for review and can facilitate post-trial follow-up on patients to assess long-term safety and effectiveness of medical products,” wrote FDA officials in the industry guidance.

“In addition, there are opportunities for long-term follow up of large numbers of patients, which may be of particular importance in studies where the outcome of interest occurs rarely, such as in prophylaxis studies,” continued the authors.

By improving the accuracy of EHR data in prospective clinical investigations of human drugs and biological products, and medical devices, stakeholders can optimize the efficacy of clinical trials, FDA stated.

FDA officials offered recommendations for promoting interoperability between EHR systems and EDC systems. Lack of interoperability necessitates manual data entry to transfer information between systems or reports. Manual transcription heightens the risk of data entry errors.

The use of fully-integrated EHR and EDC systems allows clinical investigators to enter research data directly into the EHR to limit the risk of data entry errors.

“This may involve, for example, use of research modules, use of research tabs built into the EHR system, or use of custom research fields within the EHR system for data that are entered for research purposes,” wrote FDA officials.

“FDA encourages sponsors and clinical investigators to work with entities that control EHR systems, such as health care organizations, to use EHR and EDC systems that are interoperable or fully integrated. Moreover, diverse ownership of electronic systems and data may necessitate appropriate collaboration between the health care and clinical research communities,” the guidance continued.

Collaboration between healthcare organizations and system vendors may help to advance interoperability and enable EHR and EDC system integration.

FDA officials also acknowledged that problems with diverse clinical data standards may complicate interoperability between EHR and EDC systems. However, the increased adoption of open data standards through EHR data standardization requirements set forth by the ONC Health IT Certification Program and ONC’s Interoperability Standards Advisory (ISA) may help to address these challenges.

To promote repeated use of EHR data, FDA encouraged clinical investigators to engage in health data exchange of structured data.

“Sponsors should ensure that the structured data elements obtained from the EHR correspond with the protocol-defined data collection plan (e.g., time and method of measurement),” clarified guidance authors.

“In addition, for extraction of unstructured data, sponsors should consider the reliability and quality of unstructured EHR data and the appropriateness of using it as critical source data, such as study endpoints,” FDA officials continued.

FDA officials also provided best practices for using EHR systems in clinical investigations. Officials encouraged the use of EHR systems certified by the ONC Health IT Certification Program.

“Sponsors should include in their data management plan a list of EHR systems used by each clinical investigation site in the clinical investigation,” stated FDA officials. “Sponsors should document the manufacturer, model number, and version number of the EHR system and whether the EHR system is certified by ONC.”

If an EHR system is decertified by ONC, sponsors should assess the rationale behind the nonconformity and determine whether it will have a negative effect on the integrity of EHR data used in clinical investigations.

While FDA promotes the use of ONC certified health IT, sponsors may still utilize EHR systems not certified by ONC if controls are in place to ensure data integrity, confidentiality, and security.

In addition to recommendations about EHR data use, interoperability, and data integrity, FDA also offered guidance related to informed consent, blinded study designs, inspection, recordkeeping, record retention requirements, and other aspects of EHR data use in clinical investigations.



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