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Risk management approach to oversight of institutional review boards

机译:监督机构审查委员会的风险管理方法

摘要

A computer system receives, before a start of a trial of a medical therapy, data that configure the computer system to detect alert conditions indicative of occurrences of failure modes identified as being potentially associated with an institutional ethics committee such as an Institutional Review Board (IRB) that reviews the trial. Respective mitigation procedures are defined for the failure modes before the start of the trial. The mitigation procedures indicate procedures to mitigate occurrences of the failure modes. Furthermore, the computer system receives IRB activity data indicative of activities performed by the IRB. The computer system detects, based on the IRB activity data that one of the alert conditions has occurred. The alert condition is indicative of an occurrence of a given one of the failure modes. In response to detecting that the alert condition has occurred, the computer system outputs an alert.
机译:在开始进行医学治疗之前,计算机系统接收将计算机系统配置为检测指示出现故障模式的警报条件的数据,这些故障模式的发生被标识为与诸如机构审查委员会(IRB) ),以审核该试验。在试验开始之前,针对故障模式定义了相应的缓解程序。缓解过程指示减轻故障模式的发生的过程。此外,计算机系统接收指示由IRB执行的活动的IRB活动数据。计算机系统基于IRB活动数据检测到警报条件之一已发生。警报条件指示给定的一种故障模式的发生。响应于检测到已经发生警报状况,计算机系统输出警报。

著录项

  • 公开/公告号EP2887244A1

    专利类型

  • 公开/公告日2015-06-24

    原文格式PDF

  • 申请/专利权人 MEDTRONIC INC.;

    申请/专利号EP20140198253

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

    申请日2014-12-16

  • 分类号G06F19;G06Q50/22;

  • 国家 EP

  • 入库时间 2022-08-21 15:02:32

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