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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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