摘要
目的:探索临床试验用药品中心化管理质量与效率共赢的工作模式。方法:药物临床试验机构设计并构建具有我院特色的临床试验中心药房信息化系统(investigational drug service,IDS)。结果:我院临床试验中心药房实现了试验用药品管理、临床试验项目管理、中心药房管理的一体化管理模式,服务能力与服务质量显著提升,工作效率显著提高、人力成本显著降低,获得研究者、申办方、监管部门等的高度认可。结论:具有我院特色的信息化系统指导临床试验中心药房药师高质量、高效率地完成了试验用药品管理工作,为临床试验的顺利实施提供了有力保障。
Objective： To explore central investigational products management mode of high quality and high efficiency. Methods： Drug clinical trial center designed and developed special information system,investigational drug service（ IDS）, for investigational products pharmacy. Results： Investigational products pharmacy has implemented the integrated management mode of investigational products management,clinical trial management and central pharmacy management. Service capacity and service quality have been significantly increased,working efficiency has been improved while labor cost has been significantly reduced. We get high praise from investigators,sponsors and the government. Conclusion： Pharmacists of investigational products pharmacy can accomplish their work with high quality and high efficiency. And investigational products pharmacy also provides strong support for the clinical trials.
作者
牛晓也
张晓婷
高玉玲
肖奎静
张丹宁
杨丽
陈凤荣
李海燕
NIU Xiao-ye;ZHANG Xiao-ting;GAO Yu-ling;XIAO Kui-jing;ZHANG Dan-ning;YANG Li;CHEN Feng-rong;LI Hai-yan(Peking University Third Hospital Drug Clinical Trial Center,Beijing 100191,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2018年第19期2281-2285,共5页
Chinese Journal of New Drugs
基金
国家"重大新药创制"科技重大专项资助项目(2012ZX09303007-001)
关键词
试验用药品管理
中心化
信息化系统
质量
效率
investigational products management
centralization
information system
quality
efficiency
