National COVID Cohort Collaborative (N3C) Institutional Review Board (IRB) protocol.

This document details N3C's Institutional Review Board (IRB) protocol. The National COVID Cohort Collaborative (N3C) proposes to establish a central registry of patients who have been tested for COVID or have a clinical diagnosis of COVID. This will be derived by harmonizing COVID clinical data extracted from the federated clinical repositories associated with the Common Data Model (CDM) programs, enumerated in this document. Creating the N3C registry of individual-level (containing information specific to individual patients, sometimes called row-level) data as a limited--albeit protected--dataset of EHR data at a national level will be unprecedented in US clinical research. It will support novel machine learning analytics and discovery of important predictors associated with emergency visits, hospitalizations, ICU transfer, ventilator dependency, and death, amongst a myriad of related outcomes. It will have the scale, statistical power, and computing platform to address most questions the clinical and research communities seek to answer