Michigan Institute for Clinical and Health Research (MICHR)

项目摘要 拟议补编的目的是支持人权专员办事处向国家人权委员会提供数据的能力。 COVID Cohort Collaborative（N3 C）倡议。国家转化科学推进中心（National Center for Advancing Translational Science） 支持的倡议正在请求包含COVID-19电子健康记录（EHR）的完整数据集 积极和测试的案例。该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，使用新的数据组件进行扩展，并具有机构 修订政策，以适应如何安全地共享、合并和共享此类数据的创新愿景 与其他机构的数据，并以符合患者隐私的方式进行分析。策展和 管理这种独特的UM EHR实例还需要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）团队， 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。人权专员办事处将从处理独特的监管， 法规遵从性和治理挑战，以创建与降低 未来项目的障碍。N3 C平台很可能成为未来如何应对 国家危机是可以解决的。

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.