我院药物临床试验管理系统的构架、功能及运行实践

发布时间：2018-03-24 15:06

本文选题：药物临床试验管理系统　切入点：构架　出处：《中国药房》2015年34期

【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。
[Abstract]:Objective: to improve the level of monitoring and management of drug clinical trial process. Methods: the framework and function of CTMS, a drug clinical trial management system developed by our hospital in cooperation with other companies, were analyzed. Results and conclusions: the CTMS of our hospital consists of three layers: basic, efficiency and strategy, with role configuration, information exchange and report, information reminding, drug tracking, and so on. The process control of clinical trial, the quality control of electronic record, electronic signature and the function of integrating with other systems, etc., and make the operation more standardized and systematized by establishing the corresponding standard operating procedures. The collaboration between agencies and departments is more fluid, the level of daily management, drug management, subject management and document management has been greatly improved, and the automatic generation of test records and tables simplifies the work of researchers. The manual operation error is reduced and the monitoring scope covers the whole clinical trial process.
【作者单位】：辽宁省中医药研究院/辽宁中医药大学附属第二医院;第四军医大学军事预防系卫生统计学教研室;
【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
【分类号】：R95

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