Ⅰ期临床试验用药物的规范化管理  

Standardized drug management in phase I clinical trial

作　　者：赵彤芳[1] 叶宇婕 朱蕾蕾[1] 李珍[1] 元唯安[1] 蒋健[1] 

机构地区：[1]上海中医药大学附属曙光医院,上海201203

出　　处：《中国医院药学杂志》2015年第14期1325-1327,共3页Chinese Journal of Hospital Pharmacy

基　　金："十二五"重大新药创制<创新药物研究开发技术平台建设>(编号:2012ZX09303009-001)

摘　　要：通过介绍我院Ⅰ期临床试验研究室试验用药物管理制度和标准操作规程,为其他Ⅰ期药物临床试验机构提供参考。强调试验用药的科学管理是药物临床试验过程中重要环节,药品管理员及参与临床试验的研究人员在试验药物的接收、保存、发放、使用、回收、返还等各个环节中均应严格按照SOP规范执行操作,从而保证临床试验的质量,保障受试者的权益。This article was to give some advices on drug management for drug clinical trials by introducing investigational drug management system and standard operating procedures of phase I clinical trial center in our hospital.In order to ensure the quality of clinical trial and to protect rights of volunteers involved in clinical trial,the scientific investigational drug management,as a part of clinical trial,was of great importance.And all the drug administrators and researchers in clinical trials should operate strictly according to standard operation procedure during drug reception,storage,administration and recovery.

关 键 词：Ⅰ期临床试验 药物管理 标准操作规程 

分 类 号：R954[医药卫生—药学]