开源电子图像试验管理系统的法规合规要求。
Regulatory compliance requirements for an open source electronic image trial management system.
作者信息
Rhodes Colin, Moore Steve, Clark Ken, Maffitt David, Perry John, Handzel Toni, Prior Fred
机构信息
VirtualScopics Inc., Rochester, NY 14625, USA.
出版信息
Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:3475-8. doi: 10.1109/IEMBS.2010.5627838.
There is a global need for software to manage imaging based clinical trials to speed basic research and drug development. Such a system must comply with regulatory requirements. The U.S. Food and Drug Administration (FDA) has regulations regarding software development process controls and data provenance tracking. A key unanswered problem is the identification of which data changes are significant given a workflow model for image trial management. We report on the results of our study of provenance tracking requirements and define an architecture and software development process that meets U.S. regulatory requirements using open source software components.
全球都需要用于管理基于成像的临床试验的软件，以加速基础研究和药物开发。这样的系统必须符合监管要求。美国食品药品监督管理局（FDA）对软件开发过程控制和数据来源跟踪有相关规定。一个关键的未解决问题是，在图像试验管理的工作流程模型下，确定哪些数据变化是重要的。我们报告了我们对来源跟踪要求的研究结果，并使用开源软件组件定义了一种符合美国监管要求的架构和软件开发过程。
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