中医药临床试验信息化管理体系建设与实践

Construction and practice of informatization management system for clinical trials of traditional Chinese medicine

目的:探讨临床试验信息化管理体系建设及其在中医药临床试验过程管理中的实践,提高药物临床试验的管理效率。方法:与天津贝肯医疗科技有限公司合作,在成都中医药大学附属医院构建临床试验机构信息化管理平台,通过内网系统与医院原有的医院信息管理系统(HIS)、临床实验室检验系统(LIS)、放射信息管理系统(RIS)等闭合系统对接,经过加密传输后,与运行于互联网的信息系统完成数据交换和对接,将临床试验用户管理、项目管理、受试者信息管理、过程信息管理、试验药物管理等实现电子信息化,并对数据的安全、稳定和效率进行过程分析。结果:该系统在临床试验管理过程中实现了数据的安全、稳定和畅通,极大地提高了中医药临床试验项目管理效率。结论:引入临床试验研究信息化管理系统并与院内HIS,LIS整合是实现中医药临床试验机构现代化管理的必由之路,是践行中医药守正创新的重要途径之一。

Objective:To explore the construction of clinical trial information management system and its practice in the process management of traditional Chinese medicine clinical trials,so as to improve the management efficiency of drug clinical trials.Methods:In cooperation with Tianjin Abensu Science and Technology Co.,Ltd.,an information management platform for clinical trial institutions was constructed in the Affiliated Hospital of Chengdu University of traditional Chinese medicine.Through the intranet system,the hospital's original closed systems such as HIS,LIS and RIS were connected.After encrypted transmission,it completed data exchange and docking with the information system running on the internet.The electronic informatization of user management,project management,subject information management,process information management and experimental drug management of clinical trial realized.The security,stability and efficiency of the involved data were analyzed.Results:The system realized the safety,stability and smooth flow of data in the process of clinical trial management,and greatly improved the efficiency of traditional Chinese medicine(TCM)clinical trial project management.Conclusion:The introduction of information management system and its integration with internal systems like HIS and LIS is the road which must be taken to realize the modern management of TCM clinical trial institutions,and it is one of the most important ways to practice the innovation of TCM.