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: 7478453
• 负责人: BRENDA MARIE SANDMAIER
• 金额: $ 52.64万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-08-01 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7478453
• 关键词: Address; Adverse event; Categories; Clinical; Clinical Data; Collaborations; Data; Data Analyses; Data Collection; Data Coordinating Center; Databases; Disease; Eligibility Determination; Feedback; Grant; Institution; Outcome; Patients; Process; Protocols documentation; Reporting; Research; Research Ethics Committees; Resources; Role; Sampling; Services; Specimen; Time; Transplant Recipients; Transplantation; base; follow-up; immune function; sample collection; statistics

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.

多中心试验方案管理和协调中心提供的服务包括： 多方面的首先，核心将提供方案监管管理机制，包括IRB批准流程。其次，它将决定病人 方案的资格和登记。第三，它将促进协议的实施，包括 协调方案特定的患者检查、研究标本采集和不良事件 以真实的时间为基础进行报告。第四，它将协调方案特定的临床数据收集。 最后，它将作为多中心试验的数据协调中心。多中心 这些研究对这些项目中提出的研究至关重要，因为计划的移植 协议针对相对罕见的疾病。这些疾病类别中的患者应计任何 一个中心可能是有限的，通过多中心可以实现更快的累积 协作这种合作需要协调数据收集，反馈参与 机构，以及IRB要求的多中心保证。该核心将提供资源， 分析这些试验的结果数据。该核心的作用是协调和收集来自 西雅图以外的协作网络，并整合来自中央患者数据库的数据 由临床统计部维护，仅为多中心研究收集数据。的 长期随访（LTFU）部门为所有西雅图移植患者提供随访， 该补助金的赞助，并在适当的情况下，这些数据，然后整合 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本。