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Research for developing new continuous education curriculum for clinical researchers and specialists.

Research Project

Project/Area Number 15K15164
Research Category

Grant-in-Aid for Challenging Exploratory Research

Allocation TypeMulti-year Fund
Research Field Medical sociology
Research InstitutionThe University of Tokyo

Principal Investigator

Svensson Kishi Akiko  東京大学, 医学部附属病院, 特任助教 (40750633)

Co-Investigator(Kenkyū-buntansha) 河原崎 秀一  東京大学, 医学部附属病院, 登録診療員 (90722265)
高田 宗典  東京大学, 医学部附属病院, 助教 (70746841)
上村 夕香理  東京大学, 医学部附属病院, 助教 (80548537)
上田 哲也  東京大学, 医学部附属病院, 助教 (40272562)
Project Period (FY) 2015-04-01 – 2017-03-31
Project Status Completed (Fiscal Year 2016)
Budget Amount *help
¥3,770,000 (Direct Cost: ¥2,900,000、Indirect Cost: ¥870,000)
Fiscal Year 2016: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2015: ¥2,210,000 (Direct Cost: ¥1,700,000、Indirect Cost: ¥510,000)
Keywords臨床研究 / 臨床試験 / 治験 / 研究者育成 / 教育 / トランスレーショナルリサーチ / 研修 / 倫理
Outline of Final Research Achievements

The Ethical Guidelines for Medical and Health Research Involving Human Subjects (2015) emphasized education and training for clinical researchers and specialists in the field. Due to the increased stringency and complexity of regulations, clinical researchers are required to increase not only knowledge of ethics, but also know-how of conducting research such as methodological, regulatory, and organizational expertise.
To ensure the quality and reliability of the clinical research, there is an urgent need for developing a continuous and systematic education. Therefore, this research sets as its overall goal to develop a systematic educational curriculum for global standard researchers by defining the necessary knowledge and ability required. We have until now met the following goals: 1) Defined the needs for education in the clinical research, 2) Conducted investigations of domestic/international education, and 3) Developed a comprehensive curriculum based on the acquired information.

Report

(3 results)
  • 2016 Annual Research Report   Final Research Report ( PDF )
  • 2015 Research-status Report
  • Research Products

    (9 results)

All 2017 2016 2015 Other

All Journal Article (3 results) (of which Int'l Joint Research: 1 results,  Peer Reviewed: 1 results) Presentation (4 results) (of which Int'l Joint Research: 1 results,  Invited: 2 results) Book (1 results) Remarks (1 results)

  • [Journal Article] Japanese Initiative for Education in Pharmaceutical Medicine and Clinical Research Training.2017

    • Author(s)
      Akiko Kishi, Ichiro Uchida, Daisuke Koide, Kyoko Imamura
    • Journal Title

      Journal of Medicine Development Sciences

      Volume: なし

    • Related Report
      2016 Annual Research Report
    • Peer Reviewed / Int'l Joint Research
  • [Journal Article] 徹底分析シリーズ 薬が承認されるまで 「人を対象とする医学系研究に関する倫理指針」と臨床現場での対応-臨床研究の質と透明性確保のための歩み2016

    • Author(s)
      岸 暁子
    • Journal Title

      LiSA

      Volume: 23 Issue: 6 Pages: 532-536

    • DOI

      10.11477/mf.3101200584

    • ISSN
      1340-8836, 1883-5511
    • Year and Date
      2016-06-01
    • Related Report
      2016 Annual Research Report
  • [Journal Article] 東大病院における臨床研究者育成生涯教育研修の現状とそのカリキュラム構築 -「系統的臨床研究者・専門家の生涯教育」カリキュラム-2015

    • Author(s)
      岸暁子、上村夕香理
    • Journal Title

      化学療法の領域

      Volume: Vol.31

    • Related Report
      2015 Research-status Report
  • [Presentation] スタンフォード大学の創薬・診断法開発教育プログラム "SPARK"の東京大学における導入の取り組み2017

    • Author(s)
      福島正哉 、岸暁子、木村紘子、前田佑二郎 、吉本真、加藤益弘 、木村廣道
    • Organizer
      日本臨床試験学会
    • Place of Presentation
      大阪
    • Related Report
      2016 Annual Research Report
  • [Presentation] Global collaboration and Education, Current Summary of curriculum development for clinical researchers and expansion of international collaboration2015

    • Author(s)
      Akiko Kishi Svensson
    • Organizer
      The 2015 REACTA FORUM, REGIONAL ASIAN CLNICAL TRIAL ANNUAL FORUM
    • Place of Presentation
      Chiba, Japan
    • Year and Date
      2015-11-26
    • Related Report
      2015 Research-status Report
    • Int'l Joint Research / Invited
  • [Presentation] 東京大学における臨床研究者・専門スタッフ養成プログラム構築の活動報告2015

    • Author(s)
      岸 暁子
    • Organizer
      ARO協議会第3回学術集会
    • Place of Presentation
      東京
    • Year and Date
      2015-09-17
    • Related Report
      2015 Research-status Report
  • [Presentation] 東大での臨床試験研究者教育の取り組み2015

    • Author(s)
      岸 暁子
    • Organizer
      第6回 日本製薬医学会 年次総会
    • Place of Presentation
      東京
    • Year and Date
      2015-07-24
    • Related Report
      2015 Research-status Report
    • Invited
  • [Book] アカデミア創薬の実践ガイド2017

    • Author(s)
      ダリア モックリー=ローゼン 編, ケビン グリムス 編, 加藤 益弘 総監訳, 木村 廣道 総監訳, 木村 紘子岸 暁子 監訳.
    • Total Pages
      260
    • Publisher
      東大出版
    • Related Report
      2016 Annual Research Report
  • [Remarks] 「系統的臨床研究者・専門家の生涯学習・研修」カリキュラム

    • URL

      https://www.uhcta.com/uth/member/index.cfm

    • Related Report
      2016 Annual Research Report 2015 Research-status Report

URL: 

Published: 2015-04-16   Modified: 2018-03-22  

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