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First published August 21, 2007 as JAMIA PrePrint; doi:10.1197/jamia.M2470
Journal of the American Medical Informatics Association 2007;14(6):687-696
© 2007 American Medical Informatics Association


A more recent version of this article appeared on November 1, 2007
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Submitted on April 3, 2007
Accepted on August 7, 2007

Data Standards in Clinical Research: Gaps, Overlaps, Challenges and Future Directions

Rachel L. Richesson PhD, MPH1* and Jeffrey Krischer PhD1

Affiliation of the authors: 1 Pediatrics Epidemiology Center, University of South Florida, Tampa, FL

* To whom correspondence should be addressed.

Current efforts to define and implement health data standards are driven by issues related to the quality, cost and continuity of care, patient safety concerns, and desires to speed clinical research findings to the bedside. The President's goal for national adoption of electronic medical records in the next decade, coupled with the current emphasis on translational research, underscore the urgent need for data standards in clinical research. This paper reviews the motivations and requirements for standardized clinical research data, and the current state of standards development and adoption - including gaps and overlaps - in relevant areas. Unresolved issues and informatics challenges related to the adoption of clinical research data and terminology standards are mentioned, as are the collaborations and activities the authors perceive as most likely to address them.




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