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CLINICAL TRIAL SYSTEM FOR TREATMENT APPLICATION, CLINICAL TRIAL MANAGEMENT SERVER, AND CLINICAL TRIAL MANAGEMENT PROGRAM

机译:用于治疗应用的临床试验系统,临床试验管理服务器和临床试验管理程序

摘要

A clinical trial management server 300 assigns, at random, a subject to either a treatment group or a control group on the basis of assignment factor information of the subject inputted together with subject identification information from a doctor terminal 200, registers assignment information indicating the assignment result in an assignment database, and transmits the assignment information to a subject terminal 100. At the time of registering the subject identification information and the like in the assignment database, lock of access to the assignment database is released. When the assignment information read from the assignment database is transmitted to the subject terminal 100, the lock is set. Accordingly, assignment randomization and double-blindness can be achieved systematically, when performing a clinical trial which is for a treatment application and to which a placebo-controlled test is applied in the state where both of the subject and the doctor do not know to which of the treatment group and the control group the subject is assigned.
机译:临床试验管理服务器300基于与从医生终端200输入的被检体的识别信息一起输入的被检体的分配因子信息,将被检体随机分配到治疗组或对照组。结果产生分配数据库,并将分配信息发送到对象终端100。在将对象识别信息等登记在分配数据库中时,释放对分配数据库的访问锁定。当从分配数据库读取的分配信息被发送到对象终端100时,设置锁定。因此,当在受试者和医生都不知道哪个情况下进行针对治疗应用的临床试验并且对其进行安慰剂对照试验时,可以系统地实现分配随机化和双盲。在治疗组和对照组中分配受试者。

著录项

  • 公开/公告号WO2019142246A1

    专利类型

  • 公开/公告日2019-07-25

    原文格式PDF

  • 申请/专利权人 SUSTAINABLE MEDICINE INC.;

    申请/专利号WO2018JP01067

  • 发明设计人 UENO TARO;MOTOHASHI TOMOMITSU;

    申请日2018-01-16

  • 分类号G06Q50/22;

  • 国家 WO

  • 入库时间 2022-08-21 11:53:50

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