我院临床试验用药品管理模式的构建  

Construction of Management Model of Clinical Trial Drugs in Our Hospital

作　　者：刘韬[1] 王艺[1] 邓丽婷[1] 叶娟平[1] 张方予[1] 黄红兵[1] 

机构地区：[1]华南肿瘤学国家重点实验室/肿瘤医学协同创新中心/中山大学肿瘤防治中心,广州510060

出　　处：《中国药房》2015年第34期4766-4769,共4页China Pharmacy

摘　　要：目的:探讨建立科学和规范化的临床试验用药品管理方法。方法:采用理论分析与实证分析相结合的方法,从临床试验药房的软硬件建设、药品管理制度和标准操作规程的制订、定期质控和药品信息化管理平台建设等方面,介绍我院临床试验用药品的管理模式。结果:从我院实践情况来看,建立专门的临床试验用药品中心化管理药房,配置齐备的药品管理设施设备,由专职药学专业人员依据国家的法律法规、管理制度和标准操作规程集中管理试验用药品,并由质控小组定期对药品管理进行质控监督检查,可有效保障受试者用药安全,保证药物临床试验结果严谨科学。结论:药物临床试验机构严格遵照《药物临床试验质量管理规范》的要求,加强对试验用药品的管理,并不断提升信息化管理水平,对于构建规范化、精细化、高效能的临床试验用药品中心化管理药房具有重要意义。OBJECTIVE：To explore the method for the scientific and standard management of clinical trial drugs. METHODS：By theory analysis and empirical analysis,the management model of clinical trial drugs in our hospital was introduced in terms of software and hardware construction of clinical trial pharmacy,the formulation of drug management system and standard operation procedure,regular quality control and drug information management platform construction,etc. RESULTS：In the experience of our hospital,it could safeguard the safety of drug use in subjects and scientificity and preciseness of drug clinical trial results through the concentrated administration trial drugs by full-time pharmacists according to national laws and regulations,management system and standard operation procedure,and regular quality control inspection by quality control group. CONCLUSIONS：Drug clinical trial institute strictly abide the requirements of Good Clinical Practice,strengthen the management of trial drugs and improve information management continuously,which is of important significance to construct standardized,detailed and high-efficiency centralized management system of clinical trial drugs.

关 键 词：临床试验用药品 管理模式 临床试验药房 抗肿瘤药 

分 类 号：R95[医药卫生—药学]