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COMPUTER-ASSISTED METHOD FOR ADAPTIVE, RISK-BASED MONITORING OF CLINICAL STUDIES

机译:计算机辅助的基于风险的临床研究自适应监测方法

摘要

A method and system are described for continuously assessing the quality of field data in a clinical study, identifying clinical sites with weaker performance than other sites, and flexibly allocating resources to address the problems, including the need to send field monitors to a site. The sites are compared with respect to the number of database entries requiring verification, and a higher priority (for allocation of management resources) is given to sites that have generated higher numbers of unverified database entries. The invention is particularly useful in the conduct of adaptive clinical trials of pharmaceutical products.
机译:描述了一种方法和系统,用于连续评估临床研究中的现场数据质量,识别性能比其他站点弱的临床站点,并灵活分配资源以解决问题,包括需要将现场监控器发送到站点。将站点与需要验证的数据库条目的数量进行比较,并为生成了更多未验证数据库条目的站点赋予更高的优先级(用于分配管理资源)。本发明在进行药​​物产品的适应性临床试验中特别有用。

著录项

  • 公开/公告号US2016328439A1

    专利类型

  • 公开/公告日2016-11-10

    原文格式PDF

  • 申请/专利权人 ALICIA W PALADIN;

    申请/专利号US201615205179

  • 发明设计人 MICHAEL JOSEPH ROSENBERG;

    申请日2016-07-08

  • 分类号G06F17/30;G06F19;

  • 国家 US

  • 入库时间 2022-08-21 14:36:35

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