浜松医科大学附属病院治験管理センターの活動状況に対する治験依頼者へのアンケート調査 A Questionnaire Study of the Clinical Trial Sponsor's View for the Activities in the Center for Clinical Trials of Hamamatsu University Hospital

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著者

    • 山田 浩 YAMADA Hiroshi
    • 浜松医科大学附属病院治験管理センター Center for Clinical Trials, Hamamatsu University School of Medicine
    • 姉崎 健 ANEZAKI Ken
    • 浜松医科大学附属病院治験管理センター Center for Clinical Trials, Hamamatsu University School of Medicine
    • 大橋 京一 OHASHI Kyoichi
    • 浜松医科大学附属病院治験管理センター Center for Clinical Trials, Hamamatsu University School of Medicine

抄録

We investigated the clinical trial sponsor's view for the activities of the center for clinical trials of Hamamastu University Hospital, under the revised good clinical practice (GCP) guidelines in Japan for the evaluation of its current supporting systems. Unsigned questionnaire-survey by mail was sent out between October 2001 and November 2001, to a total of 30 clinical trial sponsors. Twenty-five clinical trial sponsors including 28 responders replied to the questionnaire. Seventy-five percent of the responders had a favorable feeling towards receiving the monitoring or audit. Sixty-one percent were not satisfied with the activities of the clinical research coordinators, and wished to have assistance for recording the case report files or the participant's recruitment. For the contract, ninety-three percent had a feeling of abolition of repeated contract on each fiscal year and seventy-one percent were against advance payment. Both speedy and simple processes of contract making were also requested. University hospitals have a responsibility of promoting highly advanced medical services as clinical trials, therefore the solution of the problems presented by the clinical trial sponsors should be considered to achieve high quality and warranted clinical trials.

収録刊行物

  • 臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS

    臨床薬理 = JAPANESE JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS 33(4), 131-135, 2002-07-31

    一般社団法人 日本臨床薬理学会

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各種コード

  • NII論文ID(NAID)
    10013250179
  • NII書誌ID(NCID)
    AN0025404X
  • 本文言語コード
    JPN
  • 資料種別
    REV
  • ISSN
    03881601
  • データ提供元
    CJP書誌  CJP引用  J-STAGE 
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