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Achieving Standardized Medication Data in Clinical Research Studies: Two Approaches and Applications for Implementing RxNorm

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Abstract

The National Institutes of Health has proposed a roadmap for clinical research. Test projects of this roadmap include centralized data management for distributed research, the harmonization of clinical and research data, and the use of data standards throughout the research process. In 2003, RxNorm was named as a standard for codifying clinical drugs. Clinical researchers looking to implement RxNorm have few template implementation plans. Epidemiological studies and clinical trials (types of clinical research) have different requirements for model standards and best implementation tools. This paper highlights two different (epidemiological and intervention) clinical research projects, their unique requirements for a medication standard, the suitability of RxNorm as a standard for each, and application and process requirements for implementation. It is hoped that our experience of selecting and implementing the RxNorm standard to address varying study requirements in both domestic and international settings will be of value to other efforts.

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Acknowledgements

The authors wish to thank Cristina McCarthy, Wendy McCleod, Lori Ballard, and Kim Hunt for their contributions. The authors also wish to thank Dr. Stuart Nelson of the NLM for his support. This research is funded by the National Institutes of Health DK63790 and RR019259, the National Center for Research Resources (NCRR). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of NCRR or NIH. We also thank the NIH Office of Rare Diseases for its support of the RDCRN. The terminology server hosted by Apelon, Inc. (http://www.apelon.com). The TEDDY study is funded by DK 63829, 63861, 63821, 63865, 63863, 63836 and 63790 and Contract No. HHSN267200700014C from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Child Health and Human Development (NICHD), National Institute of Environmental Health Sciences (NIEHS), Juvenile Diabetes Research Foundation (JDRF), and Centers for Disease Control and Prevention (CDC). We also thank Ken Young and Heather Guillette for technical support of RxNorm browsers.

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  1. Department of Pediatrics, College of Medicine, University of South Florida, Tampa, FL, USA

    Rachel L. Richesson, Susan B. Smith, Jamie Malloy & Jeffrey P. Krischer

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  1. Rachel L. Richesson
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  2. Susan B. Smith
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  3. Jamie Malloy
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  4. Jeffrey P. Krischer
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Correspondence to Rachel L. Richesson.

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Richesson, R.L., Smith, S.B., Malloy, J. et al. Achieving Standardized Medication Data in Clinical Research Studies: Two Approaches and Applications for Implementing RxNorm. J Med Syst 34, 651–657 (2010). https://doi.org/10.1007/s10916-009-9278-5

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  • DOI: https://doi.org/10.1007/s10916-009-9278-5

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