CDISC Transformer:
meta-data driven semi-automatic transformation of eCRF to CDISC SDTM standard

● CONTENT
● OVERVIEW

  • Escalating interests of clinical trials and multi-national and multi-institutional clinical trials are increasing.
  • ClinicalTrials.gov trial registry contain and open information on more than 100,000 clinical studies, and even provides summary result data. It aims to improve the clinical resesarch enterprise.
  • However, clinical trial enterprise in domestic is difficult to be advanced due to heterogeneous data formats and controlled vocabularies
  • Based on the international standard Clinical Data Interchange Standards Consortium (CDISC), we develop clinical trial data transforming modules and model to integrate clinical trial information.
● STRUCURE OF CDISC TRANSFORMER  (top)

 
1 Part : Development of integrated clinical information registry and integrated analysis system
  • Analysis of standard model for clinical trial information
  • Design of databases and datawarehouse for managing and integrating clinical trial information
  • Development of databases and datawarehouse
  • Development of statistical analysis system and mining tool
2 Part : Development of CDISC transformer base on CDISC standard model for clincal trial data interoperability
  • Understand CDISC standard models
  • Research controlled vocabulary used in CDISC model
  • Design and development of the mapping rules for interacting among clinical trial data and standard model structure
  • Mapping clinical trial data into controlled vocabulary
  • Development of CDISC Transformer system based on mapping rule
  • Development of clinical trial data transmitting protocol based on standard formet
● RESEARCH GOAL AT EACH YEAR  (top)
 
Year Goal Research Content
1st

Year
  • Understand and analysis of standard model for clinical trial information
  • Design of databases and datawarehouse for managing and integrating clinical trial information
  • Research controlled vocabularies used in CDISC model
  • Development of CDISC Transformer system based on mapping rule
  • Research of CDISC models (ODM, SDTM, ADaM, LAB and etc.)
  • Research the status of clinical trial enterprise and how CDISC models are utilized in international/domestic
  • Understand clinical trial process and general term used
  • Design of databases to represent and cover entire CDISC models and relative controlled terminologies
  • Desgin of a datawarehouse for analysis on clincl trial information
2nd

Year
  • Development of databases and datawarehouse for managing and integrating clinical trial information
  • Development of statistical analysis system and mining tool
  • Mapping clinical trial data with controlled vocabulary
  • Development of CDISC Transformer system based on mapping rule
  • Development of clinical trial data transmitting protocol based on standard formet
  • Development of databases and datawarehouse for managing and integrating clinical trial information
  • Development of statistical analysis system based on CDISC ADaM model (using ClinicalTrials.gov summary result data)
  • Mapping clinical trial data with controlled vocabularies (UMLS)
  • Development of CDISC Transformer system (compliant with CDISC SDTM and ODM models)
  • Development of clinical trial data transmitting protocol based on standard formet
 
● RESULTS  (top)
 
Year Result Publication
1st

Year
  • 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* KSII Transactions on Internet and Information Systems 2011;5; 1830-184
2nd

Year
  • CDISC Transformer: meta-data driven semi-automatic transformation of CDISC ODM standard model to CDISC SDTM standard model
  • Understand clinical trial analysis data as converting ClinicalTrials.gov summary result data to CDISC ADaM standard model