基于医院数据中心的临床试验智能化质量管理系统的构建  

Establishment of clinical trial intelligent quality management system based on hospital date center

作　　者：刘丽雅[1] 袁华慧 程潇[1] LIU Li-ya;YUAN Hua-hui;CHENG Xiao(Drug Clinical Trials Institution,Shanghai Jiao Tong University Affiliated Sixth People’s Hospital,SHANGHAI 200233,China;Shanghai Medical Data Information Technology Co.Ltd.,SHANGHAI 200233,China)

机构地区：[1]上海交通大学附属第六人民医院药物临床试验机构,上海200233 [2]上海米帝信息技术有限公司,上海200233

出　　处：《中国新药与临床杂志》2020年第6期349-352,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：为提升临床试验质量,加强临床试验实施过程中的质量管理,本机构依托于医院数据中心构建了临床试验智能化质量管理系统。该系统基于医院日常诊疗数据,通过专家知识库、临床数据处理系统和临床决策系统这三个核心组件,实现临床试验实施全过程中对于重要质量控制环节数据的动态化智能化监测功能,以期辅助研究者决策,进一步完善质量控制与保障体系,提高机构临床试验质量管理水平。In order to improve the quality of clinical trials and strengthen the quality management during the implementation of clinical trials,our institution built a clinical trials intelligent quality management system relying on the hospital’s data center.Through the three core components of expert knowledge base,clinical data processing system and clinical decision system,it realizes the dynamic and intelligent monitoring function of the data of important quality control links in the whole process of clinical trial implementation.It can assist researchers in decision-making,further improve the quality control and guarantee system,and improve the level of clinical trial quality management.

关 键 词：临床试验 临床试验质量管理规范 信息系统 智能化 药学 

分 类 号：R95[医药卫生—药学]