Art
J-GLOBAL ID：202102218155520039   Reference number：21A0085973

Role of the Study Managers in Investigator Initiated Trials Conducted in Accordance with GCP Guidelines

医師主導治験におけるスタディマネジャーの役割
Author (1)：
KASAI HIROI

About KASAI HIROI

(京大 医 病院 先端医療研究開発機構)

About 京大 医 病院 先端医療研究開発機構


Material：
薬理と治療  (日本臨床試験学会雑誌)

About 薬理と治療


Volume： 48  Issue： Suppl.2  Page： s87-s89  Publication year： Dec. 18, 2020 
JST Material Number： Z0947A  ISSN： 0386-3603  Document type： Article
Article type： 解説  Country of issue： Japan (JPN)  Language： JAPANESE (JA)
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human(primates)

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,...
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*doctor initiated clinical trial

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,...
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Medicine in general 
(GA01010Y)

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Reference (3)：
  • 独立行政法人医薬品医療機器総合機構 令和元事業年度業務実績 (数値データ集).
  • 医師主導治験スタディマネジャーのためのオペレーション支援ツール, 2020年7月. http://www.jmacct.med.or.jp/information/stm.html
  • 平成23年度 医師主導治験における治験調整事務局の標準化・効率化に関する研究 「笠井班」, 医師主導治験はじめて医師主導治験に関わるすべてのスタッフの方へ, 2017年1月. http://www.jmacct.med.or.jp/project_d2011/2011/kyoiku.html
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医師主導治験

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, 
役割

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