Lessons From a Rapid Project Management Exercise in the Time of Pandemic: Methodology for a Global COVID-19 VIRUS Registry Database.

Abstract

BackgroundThe rapid emergence of the COVID-19 pandemic globally collapsed health care organizations worldwide. Incomplete knowledge of best practices, progression of disease, and its impact could result in fallible care. Data on symptoms and advancement of the SARS-CoV-2 virus leading to critical care admission have not been captured or communicated well between international organizations experiencing the same impact from the virus. This led to the expedited need for establishing international communication and data collection on the critical care patients admitted with COVID-19.ObjectiveDeveloping a global registry to collect patient data in the critical care setting was imperative with the goal of analyzing and ameliorating outcomes.MethodsA prospective, observational global registry database was put together to record extensive deidentified clinical information for patients hospitalized with COVID-19.ResultsProject management was crucial for prompt implementation of the registry for synchronization, improving efficiency, increasing innovation, and fostering global collaboration for valuable data collection. The Society of Critical Care Medicine Discovery VIRUS (Viral Infection and Respiratory Illness Universal Study): COVID-19 Registry would compile data for crucial longitudinal outcomes for disease, treatment, and research. The agile project management approach expedited establishing the registry in 15 days and submission of institutional review board agreement for 250 participating sites. There has been enrollment of sites every month with a total of 306 sites from 28 countries and 64,114 patients enrolled (as of June 7, 2021).ConclusionsThis protocol addresses project management lessons in a time of crises which can be a precept for rapid project management for a large-scale health care data registry. We aim to discuss the approach and methodology for establishing the registry, the challenges faced, and the factors contributing to successful outcomes.Trial RegistrationClinicalTrials.gov NCT04323787; https://clinicaltrials.gov/ct2/show/NCT04323787