YAKUGAKU ZASSHI
Online ISSN : 1347-5231
Print ISSN : 0031-6903
ISSN-L : 0031-6903
一般論文
依頼者による医療施設の治験実施体制の評価と問題点
萩森 奈央子田﨑 正信清松 和子富安 真由美長澤 浩平藤戸 博遠藤 恵理華高橋 浩二郎玉利 一也牛島 由美子白石 和代竹内 綾子北村 美奈子末廣 勉大西 利彦
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2009 年 129 巻 5 号 p. 537-548

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  With the revision of the Good Clinical Practice (GCP) in 1997, the Clinical Trial Center was established at Saga University Hospital in 1999, where clinical research coordinators (CRC) of nurses and pharmacists have been carrying out support for clinical trials since June 2000. At present, two pharmacists, two nurses, and three clerical work assistants support the execution of clinical trials; however, in recent years the number of clinical trial commissions has been gradually decreasing. On this occasion, in order to carry out even higher quality and smoother clinical trials, we conducted a questionnaire targeting the sponsors of clinical trials (head monitors) to evaluate this hospital's system for the execution of clinical trials from the sponsor's standpoint. Moreover, for the purpose of comparison with the systems of other institutions, the same questionnaire was conducted on two other hospitals-the University of Occupational and Environmental Health, Japan and the Social Insurance Shimonoseki Kousei Hospital. The problems of the clinical trial execution in our team turned out lack of knowledge concerning GCP and our complex system from the result of the questionnaire.

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© 2009 by the PHARMACEUTICAL SOCIETY OF JAPAN
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