CDISC Transformer: a metadata-based transformation tool for clinical trial and research data into CDISC standards

• Yu Rang Park,
• Hye Hyeon Kim,
• Hwa Jeong Seo,
• Ju Han Kim,

Vol. 5, No. 10, October 30, 2011
10.3837/tiis.2011.10.009, Download Paper (Free):

• CDISC
• SDTM
• metadata registry
• clinical trial
• ISO/IEC 11179
• rule base

Abstract

CDISC (Clinical Data Interchanging Standards Consortium) standards are to support the acquisition, exchange, submission and archival of clinical trial and research data. SDTM (Study Data Tabulation Model) for Case Report Forms (CRFs) was recommended for U.S. Food and Drug Administration (FDA) regulatory submissions since 2004. Although the SDTM Implementation Guide gives a standardized and predefined collection of submission metadata _domains_ containing extensive variable collections, transforming CRFs to SDTM files for FDA submission is still a very hard and time-consuming task. For addressing this issue, we developed metadata based SDTM mapping rules. Using these mapping rules, we also developed a semi-automatic tool, named CDISC Transformer, for transforming clinical trial data to CDISC standard compliant data. The performance of CDISC Transformer with or without MDR support was evaluated using CDISC blank CRF as the _gold standard_. Both MDR and user inquiry-supported transformation substantially improved the accuracy of our transformation rules. CDISC Transformer will greatly reduce the workloads and enhance standardized data entry and integration for clinical trial and research in various healthcare domains.

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