Coordinating-Center

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TITLE: Data Coordination and Biostatistics Center for the Surgical Idiopathic Intracranial Hypertension Treatment Trial (SiihTT) SUMMARY The Data Coordination and Biostatistics Center (DCBC) component of the Surgical Idiopathic Intracranial Hypertension Treatment Trial (SiihTT) will have a primary role in providing data management, biostatistical support, and secondary roles in project management and site and safety monitoring for the trial. The SiihTT DCBC will build and maintain a regulatory-compliant, study-specific electronic database that ensures efficient data collection and transfer among the SiihTT components. Biostatistical support will include input on refinements of trial design, development of the randomization plan, refinement and implementation of the statistical analysis plan, execution of primary and secondary analyses, timely presentation and reporting of study results, and preparation of interim reports for the Data and Safety Monitoring Board. The SiihTT DCBC will oversee drug supply chain management and central laboratory services, as well as assist the SiihTT Enrollment Center with project management duties, including training of study personnel, collection of regulatory documents, and management of central and site Institutional Review Board documents (protocols, consent forms). The SiihTT DCBC will provide the SiihTT Enrollment Center with reports that facilitate site monitoring, safety monitoring, and site payments. The SiihTT DCBC has more than 25 years of experience in orchestrating and operationalizing these roles in over 110 studies, including the recently completed Idiopathic Intracranial Hypertension Treatment Trial. The SiihTT DCBC will work collaboratively with the Study Chair (Dr. Wall), the SiihTT Enrollment and Resource Centers (Dr. Kupersmith), the SiihTT Visual Field Reading Center (Dr. Wall), the SiihTT Photography Reading Center (Dr. Feldon), and the SiihTT OCT Reading Center (Dr. Keltner).