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1. 发明申请

US20130226610A1 DESIGN ASISTANCE FOR CLINICAL TRIAL PROTOCOLS 有权
标题翻译：临床试验方案的设计援助
公开(公告)号：US20130226610A1
公开(公告)日：2013-08-29
申请号：US13872460
申请日：2013-04-29
申请人： Medidata Solutions, Inc.
发明人： Carol A. Broverman , Peter L. Abramowitsch , Michael G. Kahn , Christopher Noon
IPC分类号： G06Q50/22
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. After 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。在协议数据库中实例化所有协议元素之后，它可以用于驱动研究的大多数下游方面的操作。

2. 发明申请

US20140039921A1 DESIGN ASSISTANCE FOR CLINICAL TRIAL PROTOCOLS 审中-公开
标题翻译：临床试验方案的设计援助
公开(公告)号：US20140039921A1
公开(公告)日：2014-02-06
申请号：US14054269
申请日：2013-10-15
申请人： MEDIDATA SOLUTIONS, INC.
发明人： Carol A. Broverman , Michael Gary Kahn , Christopher Noon , Peter Leonard Abramowitsch
IPC分类号： G06F19/00
CPC分类号： G06Q10/067 , G06F16/93 , G06F19/324 , 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. After 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。在协议数据库中实例化所有协议元素之后，它可以用于驱动研究的大多数下游方面的操作。

3. 发明授权

US08571891B2 Asistance for clinical trial protocols 有权
标题翻译：临床试验方案的设计援助
公开(公告)号：US08571891B2
公开(公告)日：2013-10-29
申请号：US13872460
申请日：2013-04-29
申请人： Medidata Solutions, Inc.
发明人： Carol A. Broverman , Peter Leonard Abramowitsch , Michael Gary Kahn , Christopher Noon
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. After 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。在协议数据库中实例化所有协议元素之后，它可以用于驱动研究的大多数下游方面的操作。

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