我院临床试验药房的建设与管理  

Construction and Management of Clinical Trial Pharmacy in Our Hospital

作　　者：王彦荣[1] 李卫红 郭鹏 陈然[1] 白锡波[1] WANG Yanrong;LI Weihong;GUO Peng;CHEN Ran;BAI Xibo(Cangzhou Central Hospital,Cangzhou,Hebei,China 061001)

机构地区：[1]河北省沧州市中心医院,河北沧州061001

出　　处：《中国药业》2021年第1期24-27,共4页China Pharmaceuticals

基　　金：河北省重点研发计划健康医疗与生物医药专项[18273004]。

摘　　要：目的探讨临床试验药房的建设、管理与应用。方法从医院临床试验药房的软硬件建设,人员、设备、文件、环境与安全管理,以及对试验项目的支持与质量保障三方面进行分析。结果医院临床试验药房充分发挥了药学人员的学科优势,大幅度提高了试验用药品管理的科学性和规范性,减轻了临床试验项目组的工作量,增进了药物临床试验机构和项目组的契合度,推动了整个药物临床试验机构的全面规范化建设。结论临床试验药房除了具有管理试验用药品的功能外,在临床试验项目管理与协调、药物临床试验机构规范化建设等方面也能发挥重要作用。Objective To investigate the construction,management and application of clinical trial pharmacy.Methods The construction of software and hardware,the comprehensive management mode including personnel,equipment,documents,environment and safety,as well as the support and quality assurance of clinical trials in the clinical trial pharmacy were analyzed.Results The clinical trial pharmacy of the hospital has gave full play to the discipline advantages of pharmaceutical personnel,greatly improved the scientificity and standardization of the investigational product management,reduced the workload of the clinical trial project team,improved the compatibility between the clinical trial institution and project teams,and promoted the overall standardized construction of the clinical trial institutions.Conclusion Clinical trial pharmacy not only has the function of managing investigational products,but also plays an important role in the management and coordination of clinical trials and the construction of a clinical trial institution.

关 键 词：临床试验药房 试验用药品 建设 药事管理 

分 类 号：R952[医药卫生—药学]