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) 摘要 外科特发性颅内疾病的数据协调和生物统计中心(DCBC)部分 高血压治疗试验(SiihTT)将在提供数据管理、生物统计方面发挥主要作用 在试验的项目管理、现场和安全监测方面发挥辅助和辅助作用。SiihTT DCBC将建立和维护一个符合法规的、特定于研究的电子数据库，以确保高效 SiihTT各组成部分之间的数据收集和传输。生物统计学支持将包括以下内容 完善试验设计，制定随机化计划，完善和实施 统计分析计划、执行一次和二次分析、及时提交和报告 研究结果，并为数据和安全监测委员会编写中期报告。SiihTT DCBC 将监督药品供应链管理和中央实验室服务，并协助信息和通信技术研究所 招生中心负责项目管理职责，包括培训学习人员，收集 管理文件，以及中央和现场机构审查委员会文件的管理(协议， 同意书)。SiihTT DCBC将向SiihTT招生中心提供报告，以方便网站 监控、安全监控和现场支付。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 颅内压升高治疗试验。SiihTT DCBC将与研究主席(Dr。 墙)、SiihTT招生和资源中心(Kupersmith博士)、SiihTT视野阅读中心 (沃尔博士)、SiihTT摄影阅读中心(Feldon博士)和SiihTT OCT阅读中心(Dr。 凯尔特纳)。

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).