The Biostatistical Core's (BSC) primary goal remains the same as the last submission which is to closely interact with the Principal Investigators (Pis) of the three projects, the Investigators of the clinical sites participating in Project I, the CLEARER trial, the Investigators of the clinical sites that will enroll patients in Project 2, the STOP-IT trial, and the Investigators in the basic science project, Project 3, TRUST, as well as 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 on a continuous basis. 3. Provide a centralized information management system for collecting, entering, editing, storing, and analyzing data. This includes development of data collection forms on a web-based data entry system, a manual of operations, quality control procedures, security and confidentiality of data, and long-term storage for all projects. The web-based data-entry and communication system for the two SPOTRIAS clinical trials is a new addition from the previous five years. 4. Produce scheduled reports to the clinical sites and also prepare reports to the Data and Safety Monitoring Boards (DSMB). 5. Analyze each trial data, Projects 1 and 2, in collaboration with the Investigators including performing an interim analysis for Project 1, CLEARER. 6. Analyze the data from Project 3 in collaboration with the Principal Investigator and other participating investigators. 7. Participate in the closeout of each clinical trial. 8. Maintain the shared SPOTRIAS clinical subject database at UC for the SPOTRIAS Network and coordinate regular submission of data to the Central Data Storage facility.
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