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Development of CRC Training Program to Improve the International Competitiveness in Drug Development

Research Project

Project/Area Number 26670272
Research Category

Grant-in-Aid for Challenging Exploratory Research

Allocation TypeMulti-year Fund
Research Field Applied pharmacology
Research InstitutionKeio University

Principal Investigator

Matsushima Yukiko  慶應義塾大学, 医学部, 特任講師 (10618531)

Co-Investigator(Kenkyū-buntansha) Hisashi Urushihara  慶應義塾大学, 薬学部, 准教授 (10511917)
Research Collaborator Daisuke Utsui  慶應義塾大学, 薬学部
Akiko Yoshitani  慶應義塾大学, 医学部, 研究員
Aki Iguchi  慶應義塾大学, 医学部, 特任助教
Kyoko Matsuda  国立病院機構大阪南医療センター, 薬剤部・治験管理室, CRC
Mayumi Watanabe  日本大学医学部附属板橋病院, 臨床研究推進センター, CRC
Junko Yamasaki  神戸大学医学部附属病院, 臨床研究推進センター, CRC
Brosnan Katrina  Queensland Department of Health, Principal Policy Officer
Hall Cindy  Princess Alexandra hospital, Cardiology department
Lee Steph  Princess Alexandra hospital, Cancer Trial unit
Project Period (FY) 2014-04-01 – 2016-03-31
Project Status Completed (Fiscal Year 2015)
Budget Amount *help
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2015: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2014: ¥2,600,000 (Direct Cost: ¥2,000,000、Indirect Cost: ¥600,000)
KeywordsCRC / 人材育成 / 国際共同治験 / 医薬品臨床開発 / 医療 / 国際共同臨床試験 / 医薬品開発 / 臨床試験 / 臨床研究コーディネーター / 専門職教育 / 国際情報交換
Outline of Final Research Achievements

In this study, we performed comparative analysis on the operations and the education contents of Clinical Research Coordinator (CRC) in Japan and Australia where global clinical trials are frequently performed. We clarified the operations that are additionally needed for the CRC duties in Japan and evaluated an appropriate education content to train such necessary options aiming to improve the global competitiveness of Japan in the drug development area. We elucidated that the operation additionally needed is ‘Total Clinical trial management at Site’ and the education contents for this should include the training programs for ‘Formulating Research Question’ and ‘Development of clinical trials reports, results and publications’ and ‘Budget building and financial management’.

Report

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

    (5 results)

All 2015 2014

All Presentation (5 results) (of which Invited: 4 results)

  • [Presentation] CRCの視点からみた、オーストラリアと日本の違い2015

    • Author(s)
      吉谷 安紀子
    • Organizer
      第15回CRCと臨床試験のあり方を考える会議
    • Place of Presentation
      神戸国際展示場(兵庫県神戸市)
    • Year and Date
      2015-09-12
    • Related Report
      2015 Annual Research Report
    • Invited
  • [Presentation] 治験事務局・CRC兼任者の視点からみた、オーストラリアと日本の違い2015

    • Author(s)
      松田 恭子
    • Organizer
      第15回CRCと臨床試験のあり方を考える会議
    • Place of Presentation
      神戸国際展示場(兵庫県神戸市)
    • Year and Date
      2015-09-12
    • Related Report
      2015 Annual Research Report
    • Invited
  • [Presentation] Establishment of a comprehensive cancer clinical trials unit results in access to novel cancer treatments and improved patient outcomes2015

    • Author(s)
      Steph Lee
    • Organizer
      第15回CRCと臨床試験のあり方を考える会議
    • Place of Presentation
      神戸国際展示場(兵庫県神戸市)
    • Year and Date
      2015-09-12
    • Related Report
      2015 Annual Research Report
    • Invited
  • [Presentation] 医師主導治験におけるリスクに関する調査研究2014

    • Author(s)
      宇津井 大祐, 風見 葉子、川島 弓枝、菊地 佳代子、松嶋 由紀子、岩崎 幸司、今野 浩一、笠井 宏委
    • Organizer
      第35回日本臨床薬理学会学術総会
    • Place of Presentation
      ひめぎんホール、松山
    • Year and Date
      2014-12-04 – 2014-12-06
    • Related Report
      2014 Research-status Report
  • [Presentation] Association of Clinical Research Professionals(ACRP)による臨床試験プロフェッショナル育成と認定.2014

    • Author(s)
      松嶋 由紀子
    • Organizer
      日本製薬医学会第5回年次大会
    • Place of Presentation
      東京大学 山上会館、東京
    • Year and Date
      2014-07-04 – 2014-07-05
    • Related Report
      2014 Research-status Report
    • Invited

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

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