| Project/Area Number |
15K15218
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| Research Category |
Grant-in-Aid for Challenging Exploratory Research
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| Allocation Type | Multi-year Fund |
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| Research Field |
Epidemiology and preventive medicine
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| Research Institution | The University of Tokyo |
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Principal Investigator |
Okada Masafumi 東京大学, 医学部附属病院, 特任講師 (70375492)
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| 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)
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| Project Period (FY) |
2015-04-01 – 2018-03-31
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| Project Status |
Completed (Fiscal Year 2017)
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| Budget Amount *help |
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2017: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2016: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2015: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
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| Keywords | データマネジメント / 臨床研究 / CDISC / R言語 / R / Define-XML / 標準化 / 臨床試験 / メタデータ / CDISC標準 / CDASH |
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| 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.
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