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Establishment of a data management scheme in clinical research combined with useful tools

Research Project

Project/Area Number 17K01438
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical engineering assessment
Research InstitutionNational Institute of Public Health (2018-2021)
Wakayama Medical University (2017)

Principal Investigator

Doi Mariko  国立保健医療科学院, その他部局等, 主任研究官 (70636860)

Co-Investigator(Kenkyū-buntansha) 岡田 昌史  東京大学, 医学部附属病院, 特任講師 (70375492)
上野 悟  国立保健医療科学院, その他部局等, 上席主任研究官 (20595706)
Project Period (FY) 2017-04-01 – 2022-03-31
Project Status Completed (Fiscal Year 2021)
Budget Amount *help
¥4,680,000 (Direct Cost: ¥3,600,000、Indirect Cost: ¥1,080,000)
Fiscal Year 2019: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2018: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2017: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Keywords効率化 / データマネジメント / 臨床研究 / データ管理 / 症例報告書の検討 / データ取集モデル
Outline of Final Research Achievements

In this study, we created programs for data checking for clinical research data using the statistical analysis software R. We also constructed an efficient inquiry flow for data queries and built a report generation program using the R studio report generation function, which is R-related software. The data checking using R statistical analysis software and the report generation function of R studio was considered to be applicable and reusable for data management in other clinical trials. In those cases, it would be favorable to standardize the names of data items.

Academic Significance and Societal Importance of the Research Achievements

臨床研究のデータマネジメントの手法が再利用されることで、コストも含めた効率的なデータマネジメントが可能になると考えられる。

Report

(6 results)
  • 2021 Annual Research Report   Final Research Report ( PDF )
  • 2020 Research-status Report
  • 2019 Research-status Report
  • 2018 Research-status Report
  • 2017 Research-status Report
  • Research Products

    (7 results)

All 2020 2019 2018

All Presentation (7 results) (of which Int'l Joint Research: 1 results)

  • [Presentation] 頭頸部悪性腫瘍登録データを利用した臨床研究における症例登録とデータマネジメントに関する検討.2020

    • Author(s)
      土井麻理子,岡田昌史,中溝宗永,吉本世一,谷岡健資,北山恵,丹生健一,家根旦有,林隆一.
    • Organizer
      日本臨床試験学会 第11回学術集会総会
    • Related Report
      2019 Research-status Report
  • [Presentation] 疫学研究へのCDISC標準の利用可能性の検討.2019

    • Author(s)
      上野悟,星佳芳,土井麻理子,佐藤洋子,水島洋.
    • Organizer
      第78回日本公衆衛生学会総会
    • Related Report
      2019 Research-status Report
  • [Presentation] オープンサイエンスを考慮した医療情報の利活用を促進するCDISC標準の検討.2019

    • Author(s)
      上野悟,星佳芳,土井麻理子,佐藤洋子,水島洋.
    • Organizer
      第39回医療情報学連合大会(第20回日本医療情報学会学術大会)
    • Related Report
      2019 Research-status Report
  • [Presentation] 日本頭頸部悪性腫瘍登録レジストリにおけるデータの収集と管理方法の検討.2019

    • Author(s)
      北山恵,谷岡健資,中溝宗永,吉本世一,土井麻理子,下川敏雄,丹生健一,林隆一.
    • Organizer
      日本計算機統計学会第33回シンポジウム
    • Related Report
      2019 Research-status Report
  • [Presentation] 日本頭頸部悪性腫瘍登録レジストリにおけるデータの収集と管理方法の検討.2019

    • Author(s)
      土井麻理子,岡田昌史,中溝宗永,吉本世一,谷岡健資,北山恵,丹生健一,林隆一.
    • Organizer
      日本臨床疫学会 第3回年次学術大会
    • Related Report
      2019 Research-status Report
  • [Presentation] Promoting the Use of CDISC Standards for Open Data Utilization.2019

    • Author(s)
      Ueno S, Doi M.
    • Organizer
      2019 CDISC U.S. Interchange
    • Related Report
      2019 Research-status Report
    • Int'l Joint Research
  • [Presentation] 疫学研究の推進に向けたCDISC標準の利用2018

    • Author(s)
      上野悟
    • Organizer
      第77回日本公衆衛生学会総会
    • Related Report
      2018 Research-status Report

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Published: 2017-04-28   Modified: 2023-01-30  

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