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Mitigating the impact of disasters and emergencies on clinical trials site conduct: A site perspective following major and minor unforeseen events

机译:减轻灾难和紧急情况对临床试验现场行为的影响:重大和次要不可预见事件发生后的现场观点

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摘要

Internationally, the frequency of emergencies and disasters affecting the built environment is increasing. Clinical trials sites that experience an event that affects their clinical trials research infrastructure and site functionality, may find their ability to follow optimal clinical trials conduct is compromised. There is however minimal published information on how clinical trials sites should best undertake emergency planning and develop resilience. We provide a description (case study) from a site perspective of two unforeseen events, one major and one minor, and discuss ‘lessons learnt’.
机译:在国际上,影响建筑环境的紧急情况和灾难的频率在增加。发生影响其临床试验研究基础设施和站点功能的事件的临床试验站点可能会发现其遵循最佳临床试验行为的能力受到了损害。但是,关于临床试验场所应如何最好地进行应急计划并增强适应力的信息很少。我们从现场的角度提供了两个重大事件和一个次要事件两个不可预见事件的描述(案例研究),并讨论了“经验教训”。

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