基于质量机能展开（QFD）方法的临床试验机构管理系统需求分析研究

The Analysis Based on Quality Function Deployment （QFD） Method of Clinical Trial Management System Requirements

为保证药物临床试验质量,规范化管理,提高工作效率,将信息技术引入药物临床研究机构的管理势在必行.本研究应用了以质量机能展开（QFD）方法为基础的管理信息系统需求分析方法,对卫生部某直属三甲医院药物临床试验机构管理系统进行了详尽的需求分析,保证了用户参与程度,同时提高了分析质量,为软件工程师进行系统设计奠定坚实的基础.

It is imperative to apply information technology in the area of management of clinical research so as to ensure the quality of clinical trials and to improve management efficiency. In this study, the based analysis method was the quality function deployment （QFD）. This methodology is used to analysis the clinical trials management information system on a hospital directly under the Ministry of Health. It ensured user participation, lay a solid foundation for software engineers on system design.