A clinical trial data capture system has clinical site computers (6), each registered with a site and having thick client software, and a server (2) programmed to receive clinical data from the site computers and to analyse said data in real time. The server (2) automatically determines if a site computer is outside of an allowed region, indicating unauthorised use, and takes an action such as clearing the computer's data. Each site computer performs cycle management by maintaining a workflow (14) per patient, and imposes a consent gate through to subsequent workflow stages of patient treatment with n visits Vl ... Vi ... Vn, and treatment follow-up. A distribution plot is generated (27) for parameters when data is close to thresholds and a threshold may be automatically modified accordingly.
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机译:临床试验数据捕获系统具有临床站点计算机(6),每个服务器都在站点上注册并具有胖客户端软件,以及服务器(2),该服务器被编程为从站点计算机接收临床数据并实时分析所述数据。服务器(2)自动确定站点计算机是否在允许的区域之外,表示未经授权的使用,并采取诸如清除计算机数据的操作。每台站点计算机都通过维护每个患者的工作流程(14)来执行周期管理,并在访问n次访问V l I> Sub>的患者治疗的后续工作流程阶段强加同意门。 V i I> Sub> ... V n I> Sub>,并进行治疗随访。当数据接近阈值并且可以相应地自动修改阈值时,为参数生成分布图(27)。
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