基于CDISC标准的中央随机分配管理系统的研发

发布时间：2018-10-22 11:24

【摘要】：目的研发中央随机分配管理系统(web-based central randomization management system,WCRMS)。方法采用软件研发中的生命周期法,将整个系统开发过程划分为系统规划、系统分析、系统设计、系统实施以及系统维护5个阶段进行系统研制。基于国际临床数据交换标准协会(Clinical Data Interchange Standards Consortium,CDISC)标准进行数据库设计,采用模型-视图-控制器(Model View Controller,MVC)模式架构,web服务器采用稳定的tomcat,数据库连接池技术采用Proxool。结果我们成功的研制了中央随机分配管理系统,并且经过多次测试,证明该系统具有稳定性、可靠性和实时性。目前该系统正稳定运行中,它可以支持多个研究设计(多中心/单中心、盲法/非盲)、样本量大小不一的临床研究同时进行,支持设盲研究紧急揭盲、动态药物管理。结论基于CDISC标准的数据库设计,保证了数据标准化与规范化,使系统能更好地与电子数据采集EDC系统进行对接。利用本系统,可使得随机分配隐藏更加可靠,也可使项目管理员通过实时监测项目各分中心进度,采取对应措施,缩短临床研究周期、保证试验质量,从而提高整个研究的效率。
[Abstract]:Objective to develop a central random distribution management system (web-based central randomization management system,WCRMS). Methods the whole system development process was divided into five stages: system planning, system analysis, system design, system implementation and system maintenance. The database is designed based on the International Association of Clinical data Exchange Standards (Clinical Data Interchange Standards Consortium,CDISC) standard. The model-view-controller (Model View Controller,MVC model is adopted. The web server adopts stable tomcat, database connection pool technology and Proxool.. Results We successfully developed the central random distribution management system, and after many tests, it is proved that the system is stable, reliable and real-time. At present, the system is running stably, it can support many research designs (multicenter / single center, blind method / non-blind), the clinical research of different sample size is carried out simultaneously, supports the blind research to expose the blindness urgently, the dynamic drug management. Conclusion the database design based on CDISC standard ensures the standardization and standardization of data and makes the system better connect with the electronic data acquisition EDC system. By using this system, the random allocation and hiding can be more reliable, and the project manager can monitor the progress of each sub-center of the project in real time, take corresponding measures, shorten the period of clinical research, and ensure the quality of the experiment. In order to improve the efficiency of the whole study.
【作者单位】：广州中医药大学第二附属医院;广东省中医院;广州中医药大学DME中心;
【基金】：广东省中医药局课题(20142060) 广东省中医院中医药科学技术研究专项课题(YN2015QN22)
【分类号】：TP315;R95

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