Trial management and protection of human subjects
A. J. K.
BLOOD, HEART, LUNG
The trial is led by three principal investigators, C. K. G., R. S., and R. H., in a co-principal investigator management plan with a Coordinating Council that includes co-investigators L. L., I. D. P., A. J. K., C. W., and D.W. The Coordinating Council oversees the clinical effectiveness core, implementation science core, and the data and statistical core. The Coordinating Council has monthly or bimonthly meetings with two representatives from the National Institutes of Health, National Heart, Lung, and Blood Institute: Mihaela Stefan, program officer, and Karen Bienstock, clinical trials specialist. The Data Coordinating Center (DCC) is housed at the University of Utah under the direction of RH. A Data Safety and Monitoring Board (DSMB) has been convened (charter in Additional File This study protocol was approved by the Intermountain Health Institutional Review Board with waiver of informed consent on 7/28/2022 (no. 1051681).