浅谈临床试验项目管理系统的设计和应用  

Construction and application of clinical trial management system

作　　者：郝梅[1] 丛翠翠 王瓅珏[2] 张东湖[1] 黄锋[1,4] 王天兵[3,4] HAO Mei;CONG Cui-cui;WANG Li-jue;ZHANG Dong-hu;HUANG Feng;WANG Tian-bing(Medical Information Center,Peking University People’s Hospital,Beijing 100044,China;Department of Scientific Research,Peking University People’s Hospital,Beijing 100044,China;Trauma Center,Peking University People’s Hospital,Beijing 100044,China;Ministry of Education Engineering Research Center for Mobile Digital Hospital System,Peking University,Beijing 100871,China)

机构地区：[1]北京大学人民医院医学信息中心,北京100044 [2]北京大学人民医院科研处,北京100044 [3]北京大学人民医院创伤救治中心,北京100044 [4]北京大学移动数字医院系统教育部工程研究中心,北京100871

出　　处：《中国临床药理学杂志》2020年第14期2136-2139,共4页The Chinese Journal of Clinical Pharmacology

基　　金：国家重点研发计划基金资助项目(2016YFC0901703)。

摘　　要：目的拟解决临床试验传统纸质管理方式工作效率低、质控难度大及协同管理难等问题。方法在医院现有信息化基础上,依据国际通用规则、药物临床试验管理规范和医院标准操作规程,设计并搭建了临床试验项目管理系统。结果该系统已完成一期实施,实现了立项审查、伦理审查、协议审查、试验实施、中心药房管理、结题审查等主要环节的信息化管理。经过4年的实际应用,提高了工作效率,提升了服务质量,获得了研究者、申办方、管理部门等的高度认可。结论临床试验项目管理系统有助于实现临床试验项目统一、规范、专业的管理,为临床试验的顺利实施提供了有力保障。Objective To solve problems in traditional paper management in the clinical trials,such as low work efficiency,difficult quality control and collaboration management.Methods On the basis of hospital informationization,clinical trials management system(CTMS)is designed and developed according to international general rules,Good Clinical Practice(GCP)and hospital Standard Operating Procedures(SOP).Results It has completed PhaseⅠ,which realized information management in key link,such as initiation,ethical review,agreement review,implementation,investigational products pharmacy management and concluding examination.After four years of application,the work efficiency and service quality have been improved,which has been highly approved by researchers,sponsors and management departments.Conclusion The system is helpful to realize the unified,standardized and professional management of clinical trial,and provides a strong guarantee for the smooth implementation of clinical trial.

关 键 词：传统纸质管理方式 临床试验项目管理系统 效率 质量 

分 类 号：R97[医药卫生—药品]