Fundamental software library for clinical data management with standard-based data models.

2017 Fiscal Year Final Research Report

• Project/Area Number: 15K15218
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Multi-year Fund
• Research Field: Epidemiology and preventive medicine
• Research Institution: The University of Tokyo
• Principal Investigator: Okada Masafumi 東京大学, 医学部附属病院, 特任講師 (70375492)
• Co-Investigator(Kenkyū-buntansha): 土井 麻理子 和歌山県立医科大学, 医学部, 講師 (70636860) ; 上野 悟 国立研究開発法人国立精神・神経医療研究センター, 臨床研究支援部, 科研費研究員 (20595706) ; 木内 貴弘 東京大学, 医学部附属病院, 教授 (10260481)
• Project Period (FY): 2015-04-01 – 2018-03-31
• Keywords: データマネジメント / 臨床研究 / CDISC / R言語

Outline of Final Research Achievements

We developed a software tool to help data management process for clinical research: Define2Validate. When the research will be conducted using CDISC standards, one can apply validation rule for collected data with standard-based rule description, by converting the rules into re-usable script of R statistical language.

Free Research Field

データマネジメント, 疫学, 医療情報学