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

PROJECT SUMMARY/ABSTRACTWe 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 withas part of the Biomedical Data Translator program ('Translator'), funded by the National Centerfor Advancing Translational Sciences (NCATS), to research and develop the Integrated Clinicaland Environmental Exposures Service (ICEES). ICEES represents a unique, disease-agnosticframework and approach to support open sharing of and research on sensitive patient data thathave 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 willextend this effort to instantiate an ICEES+ COVID-19 open infrastructure, focused on patients atUNC Health who have been tested (positive or negative) for COVID-19. The proposed work willleverage not only our prior Translator work, but also new work that our team has been engagedwith as part of the NCATS Center for Data to Health (CD2H) National Covid CohortCollaborative (N3C). Indeed, the North Carolina Translational and Clinical Sciences Institute(home to UNC's CTSA) was selected by CD2H leadership to lead the technical implementationof significant portions of the N3C initiative. We will adopt the N3C COVID-19 consensusphenotype for the proposed work and extend the captured data fields to include relevant datafields that were intentionally excluded by the N3C collaborative in their effort to promoteuniformity and participation, but are available via our local clinical data warehouse, such astemperature, oxygen saturation, isolation flags, and other potentially relevant clinical features(e.g., blood type). We also have partnered with investigators affiliated with the EnvironmentalPolymorphisms Registry at the National Institute for Environmental Health Sciences and will beexposing 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 promotewidespread use of ICEES+ COVID-19, largely through our engagement with the Translatorprogram, CD2H N3C, and other large-scale collaboratives. A key aspect of the proposed work isthat ICEES+COVID-19 will be open source, which will allow other institutions to rapidly adoptour approach and expose their data for open analysis of COVID-19 data by a much largercommunity. Collectively, the proposed work will catalyze efforts to respond to the COVID-19pandemic and position society to be better prepared for the next one.