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Method and system for managing electronic informed consent process in clinical trials

机译:在临床试验中管理电子知情知情同意过程的方法和系统

摘要

A method and a system for managing an electronic informed consent process in a clinical trial are provided. The method includes tracking (704) time spent by a participant on reading content associated with an electronic informed consent process in a clinical trial. The time spent on reading the content is compared (706) with a pre-defined expected time for reading the content. A deviation in the time spent is detected (708) if difference between the time spent and the pre-defined expected time does not meet a time difference threshold. Furthermore, the method includes triggering (710) an action to mitigate impact of the deviation on the electronic informed consent process.
机译:提供了在临床试验中管理电子知情同意过程的方法和系统。 该方法包括参与者在临床试验中读取与电子知情同意过程相关联的读取内容的参与者所花费的跟踪(704)时间。 将在读取内容上花费的时间进行比较(706),其中预定义的预期时间用于读取内容。 检测时间花费的偏差(708)如果花费的时间和预定义的预期时间之间的差异不符合时间差阈值。 此外,该方法包括触发(710)一个动作,以减轻偏离对电子知情同意过程的影响。

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