药物临床试验机构办公室运行管理与评价

Operation management and evaluation of drug clinical trial institution office

近年来国家多项举措推动了我国临床试验的飞速发展。药物临床试验机构备案制即将实施,对我国药物临床试验机构办公室的运行管理模式提出了新的挑战。机构办公室运行效率和服务能力是否能够匹配和适应形势,是机构管理人员需要思考的问题。本文分享本院机构办公室运行管理经验,包括设立项目运营组和质量保障组细分职责,完善操作指南及搭建信息化平台以优化运行管理措施,建立质量、效率、成本效益、持续发展4个运行效果评价指标等,为药物临床试验机构办公室的运行管理与评价提供参考。

In recent years,many national initiatives have promoted the rapid development of clinical trials in China.Clinical trial institution office will face a new challenge of its operational management model when drug clinical trial institution’s register system will be implemented.Managers should think about whether clinical trial institution office’s operational efficiency and service capability can match and adapt to the situation.We shared the experience of the operation and management of our institution office in this paper,including the establishment of project operation group and quality assurance group to segment the responsibilities,the improvement of operation guide and building an information platform to optimize operation management,and the establishment of four evaluation indexes of quality,efficiency,cost-effectiveness and sustainable development.We hope to provide reference for the operation management and evaluation of the drug clinical trial institution office.