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Development and evaluation of a clinical data repository supporting CDISC-conformant dataset.

Research Project

Project/Area Number 26670346
Research Category

Grant-in-Aid for Challenging Exploratory Research

Allocation TypeMulti-year Fund
Research Field Medical and hospital managemen
Research InstitutionThe University of Tokyo

Principal Investigator

Kiuchi Takahiro  東京大学, 医学部附属病院, 教授 (10260481)

Co-Investigator(Kenkyū-buntansha) OHTSU HIROSHI  国立国際医療研究センター, 医療情報解析研究部・臨床疫学研究室, 室長 (40372388)
OKADA MASAFUMI  東京大学, 医学部附属病院, 講師 (70375492)
Co-Investigator(Renkei-kenkyūsha) ISHIKAWA HIRONO  東京大学, 医学部附属病院, 准教授 (40384846)
Project Period (FY) 2014-04-01 – 2016-03-31
Project Status Completed (Fiscal Year 2015)
Budget Amount *help
¥3,640,000 (Direct Cost: ¥2,800,000、Indirect Cost: ¥840,000)
Fiscal Year 2015: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
Fiscal Year 2014: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
KeywordsCDISC / 症例データレポジトリ
Outline of Final Research Achievements

In this year, we built some example datasets of a clinical trial including case reports of individual subjects, in CDISC ODM format. Then we confirmed that we can import the example dataset into XML database which was deployed in last year. We tested some of variations in the method of expression for clinical data, and got successful results in much of cases.
Then we developed a web interface and a desktop application for the XML database. With this application, clinical researchers can search complex data structure from the XML database, without experiences of XQuery XML query language. The search results can also be re-import into the XML database. As the result, clinical researchers can use the XML database as a reliable and easy-to-use network storage, which can be an infrastructure of reproducible research.

Report

(3 results)
  • 2015 Annual Research Report   Final Research Report ( PDF )
  • 2014 Research-status Report
  • Research Products

    (5 results)

All 2016 2015 2014

All Journal Article (1 results) Presentation (4 results) (of which Int'l Joint Research: 1 results)

  • [Journal Article] CDISC標準の概要と実装の留意点2014

    • Author(s)
      木内貴弘
    • Journal Title

      PHARMSTAGE

      Volume: 5 Pages: 4-8

    • Related Report
      2014 Research-status Report
  • [Presentation] 臨床研究におけるICT標準化の取り組みと現状・将来像について2016

    • Author(s)
      大津洋
    • Organizer
      第7回日本臨床試験学会学術総会
    • Place of Presentation
      名古屋国際会議場(名古屋)
    • Year and Date
      2016-03-11
    • Related Report
      2015 Annual Research Report
  • [Presentation] Trial Development of Clinical Resarch Date Using CDISC ODM2015

    • Author(s)
      木内貴弘
    • Organizer
      2015 CDISC International Interchange
    • Place of Presentation
      Chicago(USA)
    • Year and Date
      2015-11-09
    • Related Report
      2015 Annual Research Report
    • Int'l Joint Research
  • [Presentation] Trial development of clinical and epidemiological data repository system using CDISC ODM.2014

    • Author(s)
      木内貴弘
    • Organizer
      CDISC Interchange North America
    • Place of Presentation
      North Bethesda, MD
    • Year and Date
      2014-11-10 – 2014-11-14
    • Related Report
      2014 Research-status Report
  • [Presentation] 「医療・臨床研究領域でのCDISC標準」2014

    • Author(s)
      大津洋
    • Organizer
      SASユーザー総会
    • Place of Presentation
      東京大学伊藤国際学術研究センター
    • Year and Date
      2014-07-25
    • Related Report
      2014 Research-status Report

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Published: 2014-04-04   Modified: 2017-05-10  

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