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FDA group to support combined EHR, electronic data capture systems

Clinical research and patient information captured during treatment are kept in different electronic systems and by separate organizations. The U.S. Food and Drug Administration (FDA) wants to support projects that bring point-of-care data and research data together by combining EHR and electronic data capture systems into a single structure.

The FDA’s Center for Drug Evaluation and Research (CDER) is asking for volunteers to experiment with how those two systems can be integrated in a clinical research setting to test new drug applications.

Organizations that want to conduct a demonstration may include EHR and electronic data capture vendors and academic medical centers. All projects should measure and assess the challenges and benefits of a single-point of capture EHR-to-electronic data capture system. The CDER wants project participants to “test the use of a standards-based technology solution to enable the collection of related healthcare and clinical research information.” Using a “standards-based technology solution” will reassure the CDER that the technology is reliable and will provide an example to share with vendors that want to duplicate a successful EHR and electronic data capture integration.

The FDA’s project notice in the Federal Register lists a few potential benefits of using standards-based technology during clinical trials, including:

  • Eliminating duplicate data by collecting it from a single source
  • Reducing transcription errors
  • Improving the technology to promote its wider adoption

The CDER believes streamlining the two electronic systems can improve the execution of clinical trials, hasten the research period and get medications on the market faster.

Interested groups must submit written or electronic requests for participation in the CDER project by Aug. 10, 2015.

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