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ALARM AND REPORT SYSTEM FOR ADVERSE EVENTS OF CLINICAL TRIALS BASED ON HOSPITAL MEDICAL RECORD SYSTEMS

机译:基于医院医疗记录系统的临床试验不良事件报警和报告系统

摘要

In connection with a clinical research management system and a hospital information system, the present invention relates to an apparatus which informs a clinical research manager, a carer, or related institutions of a corresponding fact when patients participating in the clinical research visit a hospital. More particularly, the present invention relates to the clinical research management system for differentiating steps according to the type of the clinical research in which the patients participate, the type of an event that occurs during the visit, and the like, and specifying a receiver scope of a notification differently. Accordingly, the present invention can quickly inform a clinical research coordinator, a principal investigator, and an institutional review board of a serious adverse event.
机译:结合临床研究管理系统和医院信息系统,本发明涉及一种装置,当参与临床研究的患者访问医院时,该装置将相应的事实通知临床研究经理,护理人员或相关机构。更具体地,本发明涉及一种临床研究管理系统,其用于根据患者参与的临床研究的类型,就诊期间发生的事件的类型等来区分步骤,并指定接收者的范围。通知的方式有所不同。因此,本发明可以将严重的不良事件迅速通知临床研究协调员,主要研究人员和机构审查委员会。

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