Core--Clinical

核心--临床

• 批准号: 7154581
• 负责人: George Stamatoyannopoulos
• 金额: $ 44.52万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-29 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7154581
• 关键词: biomedical facility; biotechnology; clinical research; cooperative study; data management; experimental designs; gene therapy; health science research analysis /evaluation; human subject; medical outreach /case finding; patient safety /medical error; statistics /biometry

The Clinical Core will support investigators of the Program for Excellence in Gene Therapy with the formulation, execution, and analysis of their clinical gene transfer trials, with the goals of ensuring patient safety, facilitating study implementation, and achieving regulatory compliance. During protocol development, the Clinical Core will provide study design, biostatistical, and regulatory support in preparing the clinical protocol. The Clinical Core will assist investigators in preparing submissions to the Institutional Review Board, Institutional Biosafety Committee, General Clinical Research Center, the Recombinant DNA Advisory Committee of the NIH, the FDA, and internal institutional committees. The Core will also assist investigators in preparing their protocols for presentation to the Data and Safety Monitoring Board (DSMB). Prior to implementing the protocol the Clinical Core will play an active role in the preparation of study manuals, case report forms, and related study documents, standard operating procedures related to study conduct, statistical analysis plans, and monitoring plans. During execution of the trial the Clinical Core will provide logistical support for study procedures, specimen collections and processing, and patient travel arrangements. The Clinical Core will facilitate interactions between investigators and the UW General Clinical Research Center and the Gene and Cell Therapy Laboratory. The Clinical Core will verify informed consent, complete case report forms, and assist with data management. A key function of the Clinical Core will be to contract with external monitors for each of the clinical protocols to assure that studies are conducted in accordance with the study protocol. A quality assurance auditor will assure that all trials are conducted strictly in compliance with institutional and governmental regulations. The Clinical Core will also provide ongoing training in Good Clinical Practice, and will assist investigators with submission of adverse event reports and annual reports to the institutional committees, the NIH, and the FDA. Following study completion the Clinical Core will assist with data management and analysis and long-term follow-up.

临床核心将支持其临床基因转移试验的制定，执行和分析基因治疗方案的研究人员，并具有目标 确保患者安全，促进研究实施并实现监管合规性。在协议开发过程中，临床核心将在准备临床方案时提供研究设计，生物统计和监管支持。临床核心将协助调查人员为机构审查委员会，机构生物安全委员会，一般临床研究中心，NIH重组DNA咨询委员会，FDA和内部机构委员会的准备准备。核心还将帮助调查人员准备其协议，以介绍数据和安全监控委员会（DSMB）。在实施协议之前 与研究行为，统计分析计划和监视计划有关的程序。在执行试验期间，临床核心将为研究程序，标本收集和处理以及患者旅行安排提供后勤支持。临床核心将促进研究人员与大学一般临床研究中心以及基因和细胞治疗实验室之间的相互作用。临床核心将验证知情同意书，完整的案例报告表并协助数据管理。临床核心的关键功能将是与外部监视器签约，以确保根据研究方案进行研究。质量保证审核员将确保所有试验都严格遵守机构和政府法规。这 临床核心还将在良好的临床实践中提供持续的培训，并将协助调查人员向机构委员会，NIH和FDA提交不良事件报告和年度报告。研究完成后，临床核心将有助于数据管理和分析以及长期随访。