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INSAFEDARE: INNOVATIVE APPLICATIONS OF ASSESSMENT AND ASSURANCE OF DATA AND SYNTHETIC DATA FOR REGULATORY DECISION SUPPORT

INSAFEDARE：用于监管决策支持的数据和合成数据评估和保证的创新应用

基本信息

批准号：
10066712
负责人：
金额：
$ 36.06万
依托单位：
UNIVERSITY OF BIRMINGHAM
依托单位国家：
英国
项目类别：
EU-Funded
财政年份：
2023
资助国家：
英国
起止时间：
2023 至无数据
项目状态：
未结题

来源：
https://gtr.ukri.org/projects?ref=10066712
关键词：
INSAFEDARE INNOVATIVE APPLICATIONS ASSESSMENT ASSURANCE

项目摘要

INSAFEDARE aims to provide a toolkit to enable cost-effective and high assurance decision-making in the context of the processes that all stakeholders may follow as part of regulation of medical devices. The toolkit consists of scientific guidance on assurance, tools to retrieve datasets and assist application validation and a publicly available guidance work-group for sustainable support of the discipline. INSAFEDARE will investigate use, challenges, and opportunities real world and synthetic data-driven validation of devices. The project will provide guidance on quality and safety assurance of datasets as a tool for validation, and devices that have validated using data driven approaches. INSAFEDARE will investigate use of synthetic datasets and will identify how they can be used to establish assurance before the formal, established certification process, reducing the risk for developers and waste for regulatory bodies. Furthermore, the project will publish the findings as a public guidance, laying the ground for a standard development working group; and develop training and syllabus that can enhance the skills of stakeholders. Finally, the project will develop a tool for the discovery, integration, and query of multiple datasets, and a tool for supporting the sustainable, dynamic, and through-life surveillance of devices, capturing the impact of new evidence offered by newly published datasets.

INSAFEDARE旨在提供一个工具包，以便在所有利益相关者可能遵循的过程中，实现具有成本效益和高保证的决策，作为医疗器械监管的一部分。该工具包包括关于保证的科学指南、检索数据集和协助应用程序验证的工具，以及一个公开提供的指导工作组，以持续支持该学科。INSAFEDARE将调查真实的世界和合成数据驱动的设备验证的使用、挑战和机遇。该项目将为作为验证工具的数据集的质量和安全保证以及使用数据驱动方法验证的设备提供指导。INSAFEDARE将调查合成数据集的使用情况，并确定如何在正式的既定认证流程之前使用它们来建立保证，从而减少开发人员的风险和监管机构的浪费。此外，该项目将公布调查结果，作为公共指南，为标准制定工作组奠定基础;并制定培训和教学大纲，以提高利益攸关方的技能。最后，该项目将开发一种用于发现、整合和查询多个数据集的工具，以及一种用于支持设备的可持续、动态和终身监测的工具，以捕捉新发布的数据集提供的新证据的影响。