Core--Protocol Management and Coordination of Multi-center Trials

核心--多中心试验的方案管理和协调

• 批准号: 7304871
• 负责人: BRENDA MARIE SANDMAIER
• 金额: $ 50.94万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-15 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7304871
• 关键词: biomedical facility; data collection; health science research analysis /evaluation; hematopoietic stem cells; hematopoietic tissue transplantation; medical outreach /case finding; sample collection; stem cell transplantation

The services provided by the Protocol Management and Coordination of Multi-Center Trials Core, are multifaceted. First, the Core will provide the mechanism for the regulatory management of protocols including the process for IRB approval. Second, it will determine patient eligibility and registration to protocols. Third, it will facilitate protocol implementation including the coordination of protocol-specific patient workups, research specimen collections, and adverse event reporting on a real time basis. Fourth, it will coordinate clinical data collection that is protocol-specific. Finally, it will serve as the data coordination center for the multi-center trials proposed. Multi-center studies are critical for the studies proposed in these projects because the planned transplantation protocols address relatively uncommon diseases. Accrual of patients in these disease categories to any one center is likely to be limited, and more rapid accrual can be achieved through multi-center collaboration. Such collaborations require coordination of data collection, feedback to participating institutions, and multi-center assurances of IRB requirements. This Core will provide resources to obtain outcome data for analysis of these trials. The role of this Core is to coordinate and gather data from the collaborative network outside of Seattle, and to integrate data from the central patient database maintained by Clinical Statistics with data collected solely for the multi-center studies. The Long-Term Follow-Up (LTFU) department provides follow-up on all Seattle patients transplanted under the auspices of this grant, and, where appropriate, these data are then integrated into the multi-center database. This Core is also responsible for coordinating the acquisition of research samples for the Immune Function Studies Core.

协议管理和多中心试验核心协调提供的服务是 多方面。首先，核心将为包括IRB批准的过程（包括IRB批准过程）提供监管管理机制。其次，它将确定病人 资格和注册协议。第三，它将促进协议实施，包括 协议特定的患者检查，研究标本收集​​和不良事件的协调 实时报告。第四，它将协调特定于方案的临床数据收集。 最后，它将作为提出的多中心试验的数据协调中心。多中心 研究对于这些项目提出的研究至关重要，因为计划的移植 协议解决了相对罕见的疾病。这些疾病类别中的患者应计 一个中心可能受到限制，并且可以通过多中心实现更快的应计 合作。此类合作需要协调数据收集，反馈参与 机构以及对IRB要求的多中心保证。该核心将提供资源以获取 结果数据用于分析这些试验。该核心的作用是协调和收集来自 西雅图以外的协作网络，并集成了中央患者数据库的数据 通过临床统计数据与仅针对多中心研究收集的数据保持。这 长期随访（LTFU）部门对所有移植的西雅图患者进行了随访 然后在适当的情况下集成了这笔赠款的主持人，然后将这些数据集成 进入多中心数据库。该核心还负责协调研究的获取 免疫功能研究核心的样品。