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DIRECT REPORTING OF ADVERSE EVENTS

机译:直接报告不良事件

摘要

Systems, methods, and computer readable media are described for communicating an adverse event report directly to an end-user receiving party and tracking one or more adverse event reports. An adverse event may be detected manually or automatically by a system and an electronic adverse event reporting form presented to a user with one or more data fields pre-populated with data from a patient's electronic health record (EHR). The user may enter and edit data in the electronic form and may submit the data in the electronic form directly to an end-user receiving party such as the U.S. Food and Drug Administration. One or more receipts may be received from the receiving party and indicia from the receipts recorded to one or more records. The submitted adverse event reports may be tracked, accessed, and interacted with through a user interface and additional information may be provided to a user therein.
机译:描述了用于将不良事件报告直接传递给终端用户接收方并跟踪一个或多个不良事件报告的系统,方法和计算机可读介质。不良事件可以由系统手动或自动检测,并且电子不良事件报告表格会通过一个或多个数据字段预先显示给用户,其中一个或多个数据字段已预先填充了来自患者电子健康记录(EHR)的数据。用户可以电子形式输入和编辑数据,并且可以将电子形式的数据直接提交给最终用户接收方,例如美国食品和药物管理局。可以从接收方接收一张或多张收据,并从记录在一张或多张记录中的收据中标记。所提交的不良事件报告可以通过用户界面进行跟踪,访问和交互,并且可以在其中向用户提供附加信息。

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