• Journal of KIISE:Computing Practices and Letters
• /
• v.15 no.8
• /
• pp.566-575
• /
• 2009

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.

• Proceedings of the KAIS Fall Conference
• /
• 2010.11b
• /
• pp.673-676
• /
• 2010

본 연구에서는 임상시험 데이터를 수집하는 CRF를 웹의 표준인 XML 기반으로 설계하고, 임상시험데이터 표준인 SDTM으로 변환된 eCRF를 생성하는 XML 기반 프로세스을 개발했다. 데이터구조와 폼이 분리되는 XML 기반 개발 프로세스는 XML Schema로 eCRF를 개발하고, SDTM을 적용한 XML 문서를 생성한다. 생성된 XML 문서에서 SDTM 규약에 맞는 도메인별로 변환방법을 제시한다. 이에 eCRF 분석과 데이터베이스 설계 및 구현이 동시에 이루어진다.