介绍了药物临床试验管理系统的研究与实践，阐明系统总体功能、架构,从项目管理、受试者信息、医嘱管理、药品管理、通知公告、等方面分析系统功能,指出系统的优势，应用其可以对药物临床试验实现全方位、规范化的信息管理。

The paper introduced the practice and thinking of drugs clinical trial management system, illuminated the function and framework of management system, analyzed the function from the aspects of project management，subject information, doctors’ advice management，drug administration，announcements, and pointed out the advantage of the system which can achieve the comprehensive and standardized management for drugs clinical trial.