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ESTABLISHING RISK-BASED STUDY CONDUCT

机译:建立基于风险的研究行为

摘要

A computer system is configured before a start of a trial of a medical therapy to detect alert conditions. The alert conditions are indicative of occurrences of failure modes identified as being potentially associated with the trial. During the trial, the computer system receives trial data. The computer system detects, based on the trial data, that one or more of the alert conditions have occurred. In response to detecting that an alert condition has occurred, the computer system outputs an alert associated with a mitigation procedure defined for the given failure mode before the start of the trial. The mitigation procedure indicates a procedure to mitigate the occurrence of the given failure mode.
机译:在开始医学治疗试验之前配置计算机系统以检测警报状况。警报条件指示故障模式的发生,这些故障模式被标识为可能与试验相关。在试用期间,计算机系统接收试用数据。该计算机系统基于试验数据检测已经发生一种或多种警报条件。响应于检测到已经发生警报状况,计算机系统在试验开始之前输出与针对给定故障模式定义的缓解过程相关的警报。缓解过程指示减轻给定故障模式的发生的过程。

著录项

  • 公开/公告号EP2850548A1

    专利类型

  • 公开/公告日2015-03-25

    原文格式PDF

  • 申请/专利权人 MEDTRONIC INC.;

    申请/专利号EP20130726637

  • 发明设计人 FAY MARGARET F.;OLESON KIMBERLY A.;

    申请日2013-05-17

  • 分类号G06F19;G06Q50/22;

  • 国家 EP

  • 入库时间 2022-08-21 15:03:12

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