Coordinating-Center

标题：外科特发性颅内高压数据协调和生物统计中心 治疗试验（SiihTT） 总结 外科特发性颅内出血的数据协调和生物统计中心（DCBC）组成部分 高血压治疗试验（SiihTT）将在提供数据管理、生物统计 在试验的项目管理、研究中心和安全性监测中发挥辅助作用。SiihTT DCBC将建立并维护一个符合法规的研究特定电子数据库，以确保高效 在SiihTT组件之间进行数据收集和传输。生物统计支持将包括以下方面的投入 试验设计的完善，随机化计划的制定， 统计分析计划，主要和次要分析的执行， 研究结果，并为数据和安全性监查委员会编写中期报告。SiihTT DCBC 将监督药品供应链管理和中心实验室服务，并协助SIihTT 招募中心具有项目管理职责，包括培训研究人员、收集 监管文件，以及管理中心和研究中心机构审查委员会文件（方案， 同意书）。SiihTT DCBC将向SiihTT招生中心提供有助于研究中心的报告 监测、安全监测和现场付款。SiihTT DCBC拥有超过25年的经验， 在110多项研究中协调和实施这些角色，包括最近完成的特发性 颅内高压治疗试验。SiihTT DCBC将与研究主席（Dr. Wall）、SiihTT招生和资源中心（Kupersmith博士）、SiihTT视野阅读中心 (Dr.墙），SihTT摄影阅读中心（费尔登博士），和SihTT OCT阅读中心（博士。 Keltner）。

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).