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Method of Facilitating Data-Exchange Between Clinical-Trial Sites and Clinical-Trial Sponsors

机译:促进临床试验站点和临床试验申办者之间数据交换的方法

摘要

A method of facilitating data-exchange between clinical-trial sites and clinical-trial sponsors, makes use of clinical site profiles and a remote server to manage the clinical-trial site's information. A set of trial-facilitation processes is stored on the remote server and is used to enable a clinical-trial sponsor to manage all the aspects of a clinical trial. To initiate the method of the present invention, the clinical-trial sponsor provides a set of inclusion-exclusion criteria that defines the parameters of a proposed clinical trial. The inclusion-exclusion criteria are then compared to the capabilities of each clinical-trial site profile to identify a list of clinical-trial sites capable of performing the proposed clinical trial. The list of clinical trial sites is then sent to the clinical-trial sponsor and the clinical-trial sponsor is given the opportunity to manage the proposed clinical trial.
机译:一种促进临床试验场所与临床试验申办者之间数据交换的方法,该方法利用临床场所配置文件和远程服务器来管理临床试验场所的信息。一组简化试验的过程存储在远程服务器上,用于使临床试验申办者能够管理临床试验的所有方面。为了启动本发明的方法,临床试验申办者提供了一组纳入-排除标准,其定义了所提议的临床试验的参数。然后将纳入-排除标准与每个临床试验位点配置文件的功能进行比较,以识别能够执行建议的临床试验的临床试验位点列表。然后将临床试验地点列表发送给临床试验申办者,使临床试验申办者有机会管理所提议的临床试验。

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