The Biostatistical Core's (BSC) primary goal remains the same as the last submission which is to closelyinteract with the Principal Investigators (Pis) of the three projects, the Investigators of the clinical sitesparticipating in Project I, the CLEARER trial, the Investigators of the clinical sites that will enroll patients inProject 2, the STOP-IT trial, and the Investigators in the basic science project, Project 3, TRUST, as wellas NIH personnel.
The specific aims of the BSC are to:1. Collaborate with all the investigators in the design of the investigations.2. Prepare programs for adaptive randomization for the CLEARER and STOP-IT trials and monitor each ona continuous basis.3. Provide a centralized information management system for collecting, entering, editing, storing, andanalyzing data. This includes development of data collection forms on a web-based data entry system, amanual of operations, quality control procedures, security and confidentiality of data, and long-term storagefor all projects. The web-based data-entry and communication system for the two SPOTRIAS clinical trials isa new addition from the previous five years.4. Produce scheduled reports to the clinical sites and also prepare reports to the Data and SafetyMonitoring Boards (DSMB).5. Analyze each trial data, Projects 1 and 2, in collaboration with the Investigators including performing aninterim analysis for Project 1, CLEARER.6. Analyze the data from Project 3 in collaboration with the Principal Investigator and other participatinginvestigators.7. Participate in the closeout of each clinical trial.8. Maintain the shared SPOTRIAS clinical subject database at UC for the SPOTRIAS Network andcoordinate regular submission of data to the Central Data Storage facility.
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