Michigan Institute for Clinical and Health Research (MICHR)

项目摘要 拟议补编的目的是支持人权高专办向国家数据中心提供数据的能力。 COVID Cohort Collaborative(N3C)倡议。国家翻译科学促进中心 支持的计划是请求包含新冠肺炎电子健康记录的完整数据集 阳性和检测病例。此数据集将是一个独立于整体CDM的CDM，需要 单独维护、更频繁地刷新、使用新数据组件进行扩展，并拥有 修订政策，以适应如何安全地共享、组合此类数据的创新愿景 与其他机构的数据进行比较，并以符合患者隐私的方式进行分析。策划人和 管理这一独特的UM EHR实例还需要两个MICHR工作人员的额外努力 作为MICHR以外的工作人员，包括卫生信息技术和服务(HITS)小组， 研究，临床和转化研究数据办公室(DOCTR)，机构审查委员会 (IRB)和合规办公室。MICHR将从解决独特的监管问题中吸取教训， 合规性和治理挑战，以创建与降低成本相关的最佳实践 未来项目的障碍。N3C平台很可能成为未来如何应对 国家危机是可以实现的。

Project Summary The purpose of the proposed supplement is to support MICHR’s ability to contribute data to the National COVID Cohort Collaborative (N3C) initiative. This National Center for Advancing Translational Science supported initiative is requesting a complete dataset containing electronic health records (EHR) of COVID-19 positive and tested cases. This dataset will be a separate CDM from the overall CDM, that will need to be separately maintained, refreshed more frequently, expanded with new data components, and have institutional policies revised to accommodate the innovative vision of how such data can be securely shared, combined with other institutions’ data, and analyzed in a manner consistent with patient privacy. The curation and governance of this unique instance of the UM EHR will require additional effort from both MICHR staff as well as staff outside of MICHR including the Health Information Technology & Services (HITS) team, the Office of Research, the Data Office for Clinical and Translational Research (DOCTR), the institutional review board (IRB), and the Office of Compliance. MICHR will take the lessons learned from tackling the unique regulatory, compliance, and governance challenges that arise from this project to create best practices related to lowering the barriers of future projects. The N3C platform is likely to serve as a model for how future responses to national crises can be accomplished.