浅谈我院GCP药房信息管理系统的建立与应用  

Discussion on the Establishment and Application of GCP Pharmacy Information Management System in Our Hospital

作　　者：黄芳玲 林小倩 郑玲 丘宏强[2] HUANG Fang-ling;LIN Xiao-qian;ZHENG Ling;QIU Hong-qiang(GCP Office of Meng Chao Hepatobiliary Hospital,Fujian Medical University,Fuzhou 350028,China;Pharmacy Department of Union Hospital Affiliated to Fujian Medical University,Fuzhou 350001,China)

机构地区：[1]福建医科大学孟超肝胆医院GCP办公室,福建福州350028 [2]福建医科大学附属协和医院药学部,福建福州350001

出　　处：《海峡药学》2023年第8期120-123,共4页Strait Pharmaceutical Journal

基　　金：福州市卫生健康系统科技计划项目:2022-S-wz3。

摘　　要：目的 通过建立GCP药房信息管理系统,提高临床试验管理质量与效率,加强规范GCP药房信息化管理,保障医院药物临床试验的过程科学且可靠。方法 引进临床试验信息化管理系统,根据福建医科大学孟超肝胆医院GCP药房的实际需求进行功能改造,并进行效果评价。结果 GCP药房建立相对完善的电子信息管理,实现临床试验用药物的接收、发放、使用、保存与回收等方面的全方位细节管理。结论 电子管理信息系统使GCP药房管理更加科学与规范,可进一步提高临床试验用药品管理效率,提升药物临床试验质量。OBJECTIVE To establish a GCP pharmacy information management system,improve the quality and efficiency of clinical trial management,strengthen standardized GCP pharmacy information management,and ensure the scientific and reliable process of hospital drug clinical trials.METHODS The information management system of clinical trials in Hangzhou Yikov was introduced,and the functional transformation was carried out according to the actual needs of the GCP pharmacy of Meng Chao Hepatobiliary Hospital of Fujian Medical University,and the effect was evaluated.RESULTS The GCP pharmacy has established a relatively complete electronic information management system,achieving comprehensive and detailed management of the receipt,distribution,use,preservation,and recycling of clinical trial drugs.CONCLUSION The electronic management information system makes GCP pharmacy management more scientific and standardized,which can further improve the efficiency of drug management in clinical trials and improve the quality of drug clinical trials.

关 键 词：GCP药房 临床试验 信息化管理 

分 类 号：R969.4[医药卫生—药理学]