摘要
药物临床试验资料管理是临床试验质量管理中的重要组成部分,规范化临床试验资料管理对于新药申报注册、评价临床试验质量、保护受试者权益十分关键。PDCA循环法是质量管理活动的基本方法,本文就作者单位在药物临床试验资料管理中运用PDCA循环法实践过程就行论述。
TThe data management of drug clinical trail is an important part of the clinical trail quality management. The standardized data management of drug clinical trail is the key to new drug application ＆ registration, clinical trail quality evaluation and the pro- tection of subject＇s rights and interests. PDCA circle method is the basic method in quality management activity. This article discussed the practical use of PDCA circle method in drug clinical data management of the author＇s own affiliation.
作者
仲丽
殷佩浩
杨帆平
张贇贇
卢方
邢丽娜
ZHONG Li YIN Peihao YANG Fanping ZHANG Yunyun LU Fang XING Lina(Institute for Drug Clinical Trail, Putuo District Centre Hospital of Shanghai/Putuo Hospital affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200062, Chin)
出处
《中国中医药现代远程教育》
2017年第1期39-41,共3页
Chinese Medicine Modern Distance Education of China
基金
上海市普陀区中心医院/上海中医药大学附属普陀医院科研基金资助项目【No:2013PT047】
