Data management
Data management and analysis activities will occur via a collaboration between the Intermountain data management team and the University of Utah DCC. Under the subcontract agreement with the DCC and consistent with prior studies, the Intermountain study team is responsible for cleaning, aggregating, and exporting all data captured at the study sites and delivering to the University of Utah DCC for analysis via a secure server.The DCC will present relevant study data and other trial issues to the DSMB, including the statistical trial design at the initial DSMB meeting, and the finalized trial statistical analysis plan at the end of the 6-month baseline measurement period prior to initiation of the clinical trial. The DCC will also perform two interim efficacy analyses (further described below) to consider early stopping for superiority if compelling evidence of a treatment effect is seen when comparing the two treatment arms. While the clinical trial is proceeding, the principal investigators will not have access to interim data regarding overall treatment efficacy by study arm.