ICEES+ COVID-19 Open Infrastructure to Democratize and Accelerate Cross-Institutional Clinical Data Sharing and Research

项目摘要/摘要 我们提出了一种新的技术、法规和文化解决方案来支持对COVID的研究- 19并建立应对下一次大流行所需的开放基础设施：冰川+ 新冠肺炎。拟议的工作将建立在我们团队参与的先前工作的基础上 作为生物医学数据翻译器计划的一部分，由国家中心资助 推进翻译科学(NCATS)研究开发综合临床 和环境暴露服务(ICES)。冰川代表着一种独特的、与疾病无关的 支持开放共享和研究敏感患者数据的框架和方法 已经在患者和就诊层面与公共暴露数据进行了整合。重要的是 ICES已经在我们最初的哮喘驾驶用例中得到了验证。我们会 将这一努力扩展到实例化ICES+新冠肺炎开放基础设施，重点放在 已进行新冠肺炎检测(阳性或阴性)的北卡罗来纳大学卫生部长。拟议的工作将 不仅利用我们以前的翻译工作，而且还利用我们团队已经参与的新工作 作为NCATS健康数据中心(CD2H)国家Covid队列的一部分 协作型(N3C)。事实上，北卡罗来纳州翻译和临床科学研究所 (北卡罗来纳大学CTSA总部)被CD2H领导层选中领导技术实施 N3C倡议的重要部分。我们将采纳N3C·新冠肺炎共识 建议工作的表型，并扩展捕获的数据字段以包括相关数据 被N3C协作性组织故意排除在外的领域 一致性和参与性，但可通过我们本地的临床数据仓库获得，例如 体温、血氧饱和度、隔离标志和其他可能相关的临床特征 (例如，血型)。我们还与隶属于环境保护局的调查人员合作 在国家环境健康科学研究所的多态注册，并将 暴露其注册表参与者的数据。我们的总体目标是开发和部署Icees+ 新冠肺炎，应用冰+新冠肺炎支持新冠肺炎研究，推动 冰雪+新冠肺炎的广泛使用，主要是通过我们与翻译的互动 计划、CD2H N3C等大型协作。拟议工作的一个关键方面是 ICES+新冠肺炎将是开源的，这将允许其他机构迅速采用 我们的方法和公开他们的数据，以开放分析新冠肺炎的数据要大得多 社区。总体而言，拟议的工作将促进响应新冠肺炎的努力 并使社会为下一次疫情做好更好的准备。

PROJECT SUMMARY/ABSTRACT We propose a novel technical, regulatory, and cultural solution to support research on COVID- 19 and establish the open infrastructure required to respond to the next pandemic: ICEES+ COVID-19. The proposed work will build on the prior work that our team has been engaged with as part of the Biomedical Data Translator program (‘Translator’), funded by the National Center for Advancing Translational Sciences (NCATS), to research and develop the Integrated Clinical and Environmental Exposures Service (ICEES). ICEES represents a unique, disease-agnostic framework and approach to support open sharing of and research on sensitive patient data that have been integrated at the patient and visit level with public exposures data. Importantly, ICEES has been validated in the context of our initial driving use case on asthma. We will extend this effort to instantiate an ICEES+ COVID-19 open infrastructure, focused on patients at UNC Health who have been tested (positive or negative) for COVID-19. The proposed work will leverage not only our prior Translator work, but also new work that our team has been engaged with as part of the NCATS Center for Data to Health (CD2H) National Covid Cohort Collaborative (N3C). Indeed, the North Carolina Translational and Clinical Sciences Institute (home to UNC’s CTSA) was selected by CD2H leadership to lead the technical implementation of significant portions of the N3C initiative. We will adopt the N3C COVID-19 consensus phenotype for the proposed work and extend the captured data fields to include relevant data fields that were intentionally excluded by the N3C collaborative in their effort to promote uniformity and participation, but are available via our local clinical data warehouse, such as temperature, oxygen saturation, isolation flags, and other potentially relevant clinical features (e.g., blood type). We also have partnered with investigators affiliated with the Environmental Polymorphisms Registry at the National Institute for Environmental Health Sciences and will be exposing data on their registry participants. Our overall aims are to develop and deploy ICEES+ COVID-19, apply ICEES+ COVID-19 to support research on COVID-19, and promote widespread use of ICEES+ COVID-19, largely through our engagement with the Translator program, CD2H N3C, and other large-scale collaboratives. A key aspect of the proposed work is that ICEES+COVID-19 will be open source, which will allow other institutions to rapidly adopt our approach and expose their data for open analysis of COVID-19 data by a much larger community. Collectively, the proposed work will catalyze efforts to respond to the COVID-19 pandemic and position society to be better prepared for the next one.