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

多中心试验核心方案管理和协调提供的服务包括 多面性。首先，核心将为方案的监管管理提供机制，包括内部审查委员会的批准程序。其次，它将决定患者 协议的资格和注册。第三，它将促进协议的实施，包括 协调特定方案的患者检查、研究样本收集和不良事件 实时报道。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 研究对这些项目中提出的研究至关重要，因为计划中的移植 协议针对的是相对不常见的疾病。这些疾病类别中的患者对任何 一个中心可能是有限的，通过多个中心可以实现更快的收益 协作。这样的协作需要协调数据收集、向参与者反馈 机构，以及IRB要求的多中心保证。该核心将提供资源以获得 用于分析这些试验的结果数据。此核心的作用是协调和收集来自 西雅图以外的协作网络，并集成来自中心患者数据库的数据 由临床统计部维护，数据仅为多中心研究收集。这个 长期随访(LTFU)部门为所有西雅图移植的患者提供随访 这笔赠款的赞助，以及在适当的情况下，这些数据然后被整合 输入到多中心数据库中。该核心还负责协调研究的获取 免疫功能研究核心的样本。

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.