临床试验管理信息系统设计与实践

Design and practice of clinical trial management information system

目的:基于我国现有法规和指导原则,在保障受试者信息安全的前提下,探讨临床试验全过程的信息化管理。方法:从角色管理信息安全的角度出发,设计开发供研究者使用的临床试验信息化管理平台(CTMS)以及供申办者使用的临床试验网络服务系统,用于实现临床试验的全过程管理。结果:我院临床试验信息化管理平台和网络服务系统的联合应用,实现了对项目立项、合同签署、伦理审查、项目启动、筛选/入组、受试者管理、结题全过程的实时监控和信息化管理。结论:申办者和研究者分开设计保证了受试者的信息安全,方便申办者、研究者和机构管理人员实时查看项目进度和相关资料,并对所产生的数据进行有效统计,可大幅度提高临床试验管理的工作效率。

AIM:To explore the information management of the whole process of clinical trials based on the laws and guidelines.METHODS:Taking the clinical trial management of our hospital as an example,we designed the clinical trial management information systems separately for researcher and sponsor to realize the whole process management of clinical trial in our hospital.RESULTS:The application of the clinical trial information management systems realized the real-time monitoring and information management of the whole process of project initiation,contract signing,ethical review,start-up,project selection/enrollment,subject management and conclusion.CONCLUSION:The separate design can ensure the information security of subjects,make effective statistics on the data generated,which can greatly improve the work efficiency of clinical trial management.