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Controlled Terminology for Clinical Research: A Collaboration between CDISC and NCI Enterprise Vocabulary Services

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Abstract

Over the past decade, the Clinical Data Interchange Standards Consortium (CDISC) has developed international standards to improve the efficiency with which research data are collected, exchanged, and managed. The Study Data Tabulation Model (SDTM), used for regulatory submissions, is the most widely adopted CDISC standard to date. Recognizing the essential role of controlled terminology in ensuring interoperability of such standards, CDISC launched its controlled terminology initiative and has partnered with the US National Cancer Institute Enterprise Vocabulary Services to develop both the terminology and collaborative processes that can meet these needs. Completion of the controlled terminology for SDTM and building on the methods and lessons from this project will significantly advance the usefulness of CDISC data standards and move closer toward achieving full semantic interoperability.

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Authors and Affiliations

  1. National Cancer Institute Enterprise Vocabulary Services, Rockville, Maryland, USA

    Margaret W. Haber (Co-Director) & Lawrence W. Wright (Co-Director)

  2. Terminology and Strategic Alliances, CDISC, Texas, Austin, USA

    Bron W. Kisler (Director)

  3. Octagon Research Solutions, Inc., Wayne, Pennsylvania, USA

    Mary Lenzen (Principal Consultant)

Authors
  1. Margaret W. Haber
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  2. Bron W. Kisler
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  3. Mary Lenzen
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  4. Lawrence W. Wright
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Corresponding author

Correspondence to Bron W. Kisler.

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Haber, M.W., Kisler, B.W., Lenzen, M. et al. Controlled Terminology for Clinical Research: A Collaboration between CDISC and NCI Enterprise Vocabulary Services. Ther Innov Regul Sci 41, 405–412 (2007). https://doi.org/10.1177/009286150704100314

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  • DOI: https://doi.org/10.1177/009286150704100314

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