Institute for Medical Informatics (IMISE), University of Leipzig, Germany.
Heidelberg Institute for Theoretical Studies (HITS), Heidelberg, Germany.
Stud Health Technol Inform. 2024 Aug 22;316:1413-1417. doi: 10.3233/SHTI240676.
The National Research Data Infrastructure for Personal Health Data (NFDI4Health) uses Local Data Hubs (LDHs) to manage locally research studies, documents and sensitive personal data to support controlled data sharing. While research data management (RDM) systems facilitate the storage and preparation of data and metadata as well as organizational access, they often lack support for interoperability standards of the application domain. To support the exchange with external registries of research studies, we chose 17 attributes to characterize the most relevant aspects of clinical trials (in the following named "metadata profile"). We implemented the metadata profile in the RDM system FAIRDOM SEEK using core attributes and SEEK's extended metadata feature and created a mapping conforming to the Health Level 7 Fast Healthcare Interoperability Resources (FHIR) standard version R4. Finally, we implemented a prototype application interface for exports in FHIR-JSON format. We plan to extend the interface to serve central registries and support specific FHIR Implementation Guides from various use cases.
国家个人健康数据研究数据基础设施 (NFDI4Health) 使用本地数据中心 (LDH) 来管理本地研究、文档和敏感个人数据，以支持受控的数据共享。虽然研究数据管理 (RDM) 系统便于存储和准备数据和元数据以及组织访问，但它们通常缺乏对应用领域互操作性标准的支持。为了支持与外部研究注册机构的交换，我们选择了 17 个属性来描述临床试验最相关的方面（以下称为“元数据配置文件”）。我们在 RDM 系统 FAIRDOM SEEK 中使用核心属性和 SEEK 的扩展元数据功能实现了元数据配置文件，并创建了符合健康水平 7 快速医疗互操作性资源 (FHIR) 标准版本 R4 的映射。最后，我们为 FHIR-JSON 格式的导出实现了一个原型应用接口。我们计划扩展该接口，以服务于中央注册中心，并支持来自各种用例的特定 FHIR 实施指南。
