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中国药物评价 ›› 2020, Vol. 37 ›› Issue (5): 391-393.

• 药物管理 • 上一篇    下一篇

药物临床试验过程中试验用药品管理的实践体会

   刘金永, 李子玥   

  1. 南京医科大学附属淮安第一医院药物临床试验机构, 江苏 淮安 223300
  • 收稿日期:2020-05-07 修回日期:2020-07-16 出版日期:2020-10-28 发布日期:2020-10-28

Practical Experience in the Management of Investigational Product in Clinical Trials

  1. Drug Clinical Trial Institution,The Affiliated Huaian NO.1 People′s Hospital of Nanjing Medical University,
         Jiangsu Huai′an 223300, China
  • Received:2020-05-07 Revised:2020-07-16 Online:2020-10-28 Published:2020-10-28

摘要: 目的:探讨试验用药品管理过程中的关键环节和存在的主要问题,为规范试验用药品的管理提供参考。方法:以《药物临床试验质量管理规范》(GCP)、《药物临床试验数据现场核查要点》为参照,查阅国内文献,结合本机构试验用药品管理实践经验,对试验用药品管理过程中的关键环节和存在的主要问题进行探讨分析。结果与结论:药物临床试验机构应重视试验用药品管理,多措并举,重视试验用药品管理过程中的关键环节,发现问题,解决问题,持续改进试验用药品管理的质量,保证药物临床试验质量。
 

关键词: font-size:medium, ">药物临床试验;试验用药品;管理

Abstract: Objective: To explore the key links and main problems in the process of investigational product management in clinical trials,and provide reference for regulating the management of investigational products.Methods: Taking the Good Clinical Practice(GCP) and Data On-site Verification Points of Drugs Clinical Trial as a reference,consulting the domestic literature and combining with the practical experience of investigational product management in clinical trials,this paper discusses and analyzes the key links and main problems in the process of investigational product management in clinical trials.Results and Conclusions: Drug clinical trial institutions should pay attention to the management of investigational product, take multiple measures simultaneously,pay attention to the key links in the process of investigational product management,find and solve problems,continuously improve the quality of investigational product management and ensure the quality of drug clinical trials.

Key words: font-size:medium, ">Drug clinical trial; Investigational product; Management

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