Figure 1.
Establishing National COVID Cohort Collaborative (N3C) sociotechnical processes and infrastructure via community workstreams. Each workstream includes representatives from National Center for Advancing Translational Sciences (NCATS),25 the Clinical and Translational Science Awards hubs,23 the Center for Data to Health,26 sites contributing data, and other members of the research community. (1) Data Partnership and Governance: This workstream designs governance and makes regulatory recommendations to National Institutes of Health (NIH) for their execution. Organizations sign a Data Transfer Agreement (DTA) with NCATS and may use the central institutional review board. (2) Phenotype and Data Acquisition: The community defines inclusion criteria for the N3C COVID-19 (coronavirus disease 2019) cohort and supports organizations in customized data export. (3) Data Ingest and Harmonization: Data reside within different organizations in different common data models. This workstream quality-assures and harmonizes data from different sources and common data models into a unified dataset. (4) Collaborative Analytics workstream: Data are made accessible for collaborative use by the N3C community. A secure data enclave (N3C Enclave), from which data cannot be removed, houses analytical tools and supports reproducible and transparent workflows. Formulation of clinical research questions and development of prototype machine learning and statistical workflows is collaboratively coordinated; portals and dashboards support resource, data, expertise, and results navigation and reuse. (5) Synthetic Clinical Data: A pilot to determine the degree to which synthetic derivatives of the Limited Data Set are able to approximate analyses derived from original data, while enhancing shareable data outside the N3C Enclave. ACT: Accrual to Clinical Trials; OMOP: Observational Medical Outcomes Partnership; PCORnet: National Patient-Centered Clinical Research Network.