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

Research output: Contribution to journalArticleResearchpeer-review

1 Citation (Scopus)

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.

Original languageEnglish
Pages (from-to)1830-1840
Number of pages11
JournalKSII Transactions on Internet and Information Systems
Volume5
Issue number10
DOIs
StatePublished - 31 Oct 2011

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Metadata
Data integration
Data acquisition

Keywords

  • CDISC
  • Clinical trial
  • ISO/IEC 11179
  • Metadata registry
  • Rule base
  • SDTM

Cite this

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CDISC Transformer : A metadata-based transformation tool for clinical trial and research data into CDISC standards. / Park, Yu Rang; Kim, Hye Hyeon; Seo, Hwa Jeong; Kim, Ju Han.

In: KSII Transactions on Internet and Information Systems, Vol. 5, No. 10, 31.10.2011, p. 1830-1840.

Research output: Contribution to journalArticleResearchpeer-review

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