CDISC Extension for Supporting Multinational Clinical Trials

Clinical Data Interchange Standards Consortium (CDISC) developed global and platform-independent data standards to improve ineffective processes of clinical trial studies. Regardless of its objective toward global cooperation, the current version of the CDISC standard cannot describe clinical trial data in various languages for multi-national investigators or reviewers. This problem applies not only to tabulated datasets in Study Data Tabulation Model (SDTM) but also to extensible markup language representation of the datasets in Operational Data Model (ODM) instances. In order to address this issue, we propose to extend the current version of SDTM and ODM to collect clinical data for multi-national clinical trials. SDTM needs to have new special-purpose domain for multi-language representation purpose. Additionally, ODM is recommended to extend its XML schema using subtyping or type inheritance mechanism respectively. Our extension of SDTM and ODM enable to represent any granule of study data tabulation model or XML data entities to describe in efficient languages. This result will contribute to collect multi-language data easily for multi-national clinical trials.