药物临床试验系统ECTS的构建和特点

Construction and characteristics of electronic clinical trial system(ECTS)for drugs

目的:拟解决我国多中心药物临床试验传统纸质管理方式落后、缺乏信息共享及协同管理等问题。方法:研究开发以"Microsoft Visual Studio"为技术支撑的药物临床试验管理信息系统,并介绍其系统功能、技术架构及流程特点。结果与结论:该系统可实现药物临床试验项目、受试者、药品管理、质量控制等主要环节的信息化管理,对确保药物临床试验管理的时效性、规范性和提高管理效率具有重要意义。

OBJECTIVE To solve problems in the multicenter clinical drug trials in China in traditional paper managements,information sharing and collaborative managements.METHODS An electronic clinical trial system（ECTS）was developed based on Microsoft Visual Studio technology.Function,technology architecture and demonstrations were introduced.RESULTS and CONCLUSION The system realizes information management in key links,such as project information management,ECTS of information management,drug management,quality control.It is important to ensure the timeliness,normalization and management effectiveness.