摘要
药物临床试验管理是医院管理中非常重要的组成部分,药物临床试验机构是对医院药物临床试验相关活动进行管理的独立的职能部门。本文根据该院机构10余年的发展状况,结合我国各医院机构的整体运行情况,从药物临床试验机构的组织架构和质量保证体系、归档资料管理体系、试验药物管理体系等3个方面进行阐述,旨在推进药物临床试验的医学控制。
Drug clinical trials management is a very important component of hospital management.Drug clinical trial institution is an independent department managing the drug clinical trials related activities in hospital.Based on more than ten years of development,combined with the overall running conditions of drug clinical trials institution in our country,in this paper,the author discusses on the drug clinical trials institution organizational structure and quality assurance system,file data management system,drugs management system,in order to promote the medical control of drug clinical trials.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2013年第4期311-313,共3页
The Chinese Journal of Clinical Pharmacology
基金
陕西省科技攻关基金资助项目(2008K15-04)
关键词
药物临床试验机构
规范管理
质量控制
drug clinical trials institution
standardized management
quality control
