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公开(公告)号：US07444293B1
公开(公告)日：2008-10-28
申请号：US09974781
申请日：2001-10-10
IPC分类号： G06Q50/00
CPC分类号： G06Q50/24 , G06F19/00 , G06Q50/22 , G16H10/20 , Y10S707/99945
摘要： Structure and methodology for reducing risk of protocol ambiguities that could lead to operational failures in the conduct of clinical trials. Roughly described, an analyst encodes the features of a protocol into a highly structured, formal model created specifically to capture issues that tend to cause operational difficulties. The process forces the analyst to look for specific parameters in the text version of the protocol. The system creates a database of the protocol as encoded, and can display the protocol schema as a graphical network of protocol events and temporal links. In one aspect, the database includes an object class into which an analyst encodes descriptions of operational uncertainties. The system can display the network in graphical-visual form, with a human-perceptible indication of objects that have operational uncertainties associated therewith. Advantageously, the formal protocol model includes slots for encoding temporal constraints among protocol events.
摘要翻译： 用于降低协议模糊度风险的结构和方法，这可能导致临床试验进行中的操作失败。 大致描述，分析师将协议的特征编码成一个高度结构化的正式模型，专门用于捕获容易导致操作困难的问题。 该过程强制分析人员在协议的文本版本中查找特定参数。 该系统创建协议的数据库编码，并可以将协议模式显示为协议事件和时间链接的图形网络。 在一个方面，数据库包括对象类，分类器对其进行编码操作不确定性的描述。 该系统可以以图形视觉形式显示网络，具有与之相关的具有操作不确定性的对象的人为可察觉的指示。 有利地，正式协议模型包括用于协议协议事件之间的时间约束的时隙。
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公开(公告)号：US08504380B2
公开(公告)日：2013-08-06
申请号：US10454954
申请日：2003-06-05
IPC分类号： G06Q10/00
CPC分类号： G06F19/363 , G06F17/30011 , G06F19/00 , G06F19/324 , G06Q10/067 , G06Q50/22 , G16H10/20
摘要： Roughly described, a user instantiates protocol elements in a structured clinical trial protocol database and then draws from them in the development of one or more protocol related documents. The system helps the user select tasks to be performed during the study by reference to a historical database of tasks previously associated with similar protocols. The system automatically generates complex content from protocol elements in the database, and can render overlapping sets of protocol elements differently at different locations in the document. The system can automatically provide advisories indicating aspects of the document that still require completion or highlighting other issues that a sponsoring authority deems important for the document type. Alter all protocol elements are instantiated in the protocol database, it can then be used to drive the operation of most downstream aspects of the study.
摘要翻译： 粗略地描述，用户在结构化临床试验协议数据库中实例化协议元素，然后从它们中抽出开发一个或多个协议相关文档。 该系统帮助用户通过参考先前与类似协议相关联的任务的历史数据库来选择在研究期间执行的任务。 该系统自动从数据库中的协议元素生成复杂的内容，并且可以在文档的不同位置呈现不同的协议元素的重叠集合。 该系统可以自动提供指示文档方面的建议，该方面仍然需要完成，或突出显示赞助机构认为对文档类型重要的其他问题。 更改所有协议元素在协议数据库中实例化，然后可以用于驱动研究的大多数下游方面的操作。
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