临床试验用药品的中心化管理  

Centralized management of clinical trial drugs

作　　者：黄义昆[1] 毛晓丽 李红梅 谢玲[1] 钟晓燕 HUANG Yikun;MAO Xiaoli;LI Hongmei;XIE Ling;ZHONG Xiaoyan(Office of Drug Clinical Trial Organization,Liuzhou People's Hospital Affiliated to Guangxi Medical University,Guangxi,Liuzhou 545006,China)

机构地区：[1]广西医科大学附属柳州市人民医院药物临床试验机构办公室,广西柳州545006

出　　处：《中国医药科学》2021年第18期228-230,共3页China Medicine And Pharmacy

摘　　要：介绍本院建立药物临床试验(GCP)中心药房对试验用药品实行中心化管理的条件及方法。试验用药品中心化管理模式,分别从硬件设施与人员、管理制度与标准操作规程、管理流程、卫星药房的管理、质量管理等方面的工作实践来论述。建立GCP中心药房后,使试验用药品的管理规范有序,GCP药师在试验用药品管理中的优势能够得到充分的发挥,GCP药师可以通过对试验用药品的管理,深深融入临床试验项目的质量管理中。中心化管理模式是规范试验用药品管理的有效方法,有助于提高临床试验的整体质量。The conditions and methods of centralized management of clinical trial drugs in the central pharmacy of drug clinical trials(GCP)in our hospital will be introduced.The model of centralized management of trial drugs is discussed in terms of hardware facilities and personnel,management system and standard operating procedures,management process,management of satellite pharmacy,quality management and other work practices,respectively.After the establishment of GCP central pharmacy,the management of trial drugs can be standardized and orderly.The advantages of the GCP pharmacists in the management of trial drugs can be fully utilized,and the GCP pharmacists can be deeply involved in the quality management of clinical trial projects by managing trial drugs.The centralized management model is an effective way to standardize the managem ent of trial drugs,which helps to improve the overall quality of clinical trials.

关 键 词：药物临床试验 试验用药品 药库管理 GCP中心药房 

分 类 号：R95[医药卫生—药学]