FDA To Test EHRs, Electronic Data Capture for Clinical Research

July 2, 2015 in News

FDA is seeking demonstration projects to analyze how electronic health records with electronic data capture capabilities could bolster clinical research involving new and investigational drugs, according to a notice published last week in the Federal Register, FierceEMR reports (Durben Hirsch, FierceEMR, 6/29).

Initiative Details

In the notice, FDA said it is looking to support demonstration projects to analyze how a single-point, end-to-end EHR-to-electronic data capture approach would perform in clinical research settings (Slabodkin, Health Data Management, 6/29). Specifically, the demonstration projects would test standards-based technology as a way to facilitate the collection of health and clinical research data within one system and workflow.

According to the notice, the need for single-point data capture has emerged amid the proliferation of disparate health information systems (Jayanthi, Becker’s Health IT CIO Review, 6/29).

FDA noted that the process could potentially help:

  • Eliminate the duplication of data;
  • Improve data quality; and
  • Reduce transcription errors.

FDA’s Center for Drug Evaluation and Research will accept requests for participation until Aug. 10. Participants could include:

  • Academic medical centers;
  • EHR and electronic data capture vendors; and
  • Other stakeholders.

According to Health Data Management, projects would last about 12 months and could be extended if necessary (Health Data Management, 6/29).

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