我院药物临床试验管理系统的构架、功能及运行实践  

Structure,Function and Operation Practice of Clinical Trial Management System in Our Hospital

作　　者：赵佳[1,2] 姜春梅[1] 李明明[1] 郭媛[1] 温雯[1] 郎丽杰[1] 李国信[1] 

机构地区：[1]辽宁省中医药研究院/辽宁中医药大学附属第二医院,沈阳110034 [2]第四军医大学军事预防系卫生统计学教研室,西安710032

出　　处：《中国药房》2015年第34期4759-4762,共4页China Pharmacy

基　　金：国家科技重大专项课题(No.2012zx09303017);国家临床重点专科建设项目;国家中医药管理局临床中药学重点学科;辽宁中医药大学杏林学者青蓝工程

摘　　要：目的:提高机构对药物临床试验过程的监控和管理水平。方法:分析我院与其他公司合作研发的药物临床试验管理系统(CTMS)的构架及功能,评价其在临床试验过程中的应用及运行效果。结果与结论:我院的CTMS由基础、效能和战略3层组成构架,具备角色配置、信息交流和报告、信息提醒、药物追踪、临床试验的进程控制、电子化记录的质量控制、电子签名及与其他系统整合连接功能等,并通过建立相应的标准操作规程使其运行更加规范化、制度化。该系统正式运行后,机构各部门之间的协作更加流畅,日常管理、药物管理、受试者管理和文件管理的水平都得到了较大的提高,各试验记录和表格的自动生成简化了研究者的工作、减少了人工操作误差,使监控范围覆盖整个临床试验过程。OBJECTIVE：To promote the supervision and management of clinical trial by institution. METHODS：The structure and function of clinical trial management system（CTMS）developed by our hospital and other enterprise together were analyzed to evaluate the application and operation result of CTMS. RESULTS CONCLUSIONS：CTMS of our hospital is made up of foundation,efficiency and strategy. It is equipped with role allocation,information exchange and report,information warning,drug tracking,clinical trial process control,quality control of electronic record,electronic signature and integration and connection with other system,etc. Relevant operation procedure is established to promote standardization and institutionalization of CTMS. Due to the application of CTMS,the cooperation among departments become smoother,and management level have been enhanced in daily management,pharmacy management,subjects and document administration. It also simplifies the work of researcher and reduces the human error by the autogeneration of trial records and tables with the system. Consequently,the monitor coveraged throughout all the trial process.

关 键 词：药物临床试验管理系统 构架 功能 运行效果 

分 类 号：R95[医药卫生—药学]