Achieving standardized medication data in clinical research studies: two approaches and applications for implementing RxNorm.
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.
Richesson
Rachel L
RL
Department of Pediatrics, University of South Florida, Tampa, FL, USA. richesrl@epi.usf.edu
Smith
Susan B
SB
Malloy
Jamie
J
Krischer
Jeffrey P
JP
D016303:Clinical Pharmacy Information Systems; D003625:Data Collection / Q000379:methods / Q000592:standards*; D006801:Humans; D033181:Information Dissemination / Q000379:methods*; D050316:Medical Order Entry Systems; D012042:Registries; D018875:Vocabulary, Controlled