摘要
目的:探讨综合性医院的临床试验药物中心化的管理模式。方法:结合本院实际情况,从标准操作规程的制定、硬件设施建设、人员培训,以及信息化系统的应用等方面,介绍试验药物中心化管理方法。结果:此种管理具有明显优势,充分发挥了药师专业特长,专人专职集中管理,有效地提高了试验药物管理质量。结论:各医院需要结合自身条件,改进和完善试验药物中心化管理方法,提高信息化管理水平,这对于构建规范化、精细化的试验药物中心化管理模式具有重要意义。
Objective: To discuss the centralized management mode of clinical trial drugs for a general hospital. Method: Combining with the actual situation of our hospital, the centralized management of clinical trial drugs was introduced in terms of the formulation of system and standard operating procedures,the construction of hardware facilities, the personnel training and the application of information system, etc.Results: The centralized management of clinical trial drugs showed obvious advantages. The establishment of the clinical trial drug central pharmacy gave full play to the professional expertise of pharmacists.Centralized management by designated personnel effectively improved the quality of management of clinical trial drugs. Conclusion: Institutions need to refer to their own conditions to improve the management methods and the level of information management. It’s important for the normal and detail centralized management mode of clinical trial drugs.
作者
王璐璐
刘慧
朱青
葛卫红
王健
WANG Lulu;LIU Hui;ZHU Qing;GE Weihong;WANG Jian(Department of Pharmacy,the Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China;the Institution Office,Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School,Nanjing 210008,China)
出处
《药学与临床研究》
2020年第1期78-80,共3页
Pharmaceutical and Clinical Research
基金
南京大学医学院管理研究所课题研究项目(NDYG2017010)
关键词
临床试验
药物管理
中心化管理
GCP
Clinical trial
Drug management
Centralized management
GCP
