PPDs Application for the Transplantation Statistical and Clinical Coordinating Center (T-SCCC) (U01 Clinical Trial Not Allowed)

项目总结/摘要 为了支持DAIT努力提高对导致疾病的原因和机制的认识， 免疫疾病的发展，并扩大知识，可以应用于改善技术， 诊断，治疗和预防，T-SCCC将提供经验丰富的工作人员，标准化的程序， 最佳设施和综合系统，以过渡和支持统计和临床协调 NIAID/DAIT的临床研究项目、制药商发起的临床试验和其他 NIAID资助的移植临床项目。T-SCCC将为DAIT的移植提供支持 研究人员解决关键的科学问题，并通过有效地管理项目和 研究资源，促进利益相关者之间的沟通和合作， 协议概念到同行评审的手稿。 T-SCCC将：1）提供经验丰富的科学家和统计学家与临床研究者合作 和DAIT开发创新的统计设计和分析计划的概念和全面的研究建议; 对临床和机制研究数据进行中期和最终统计分析， 为科学手稿和报告的出版和展示提供最佳结果; 2）提供高 支持数据和安全监测委员会的高质量不良事件/严重不良事件报告，其他 安全委员会/机构和卫生监管机构确保研究受试者安全; 3）提供 专门的、经验丰富的方案团队，以帮助制定、审查和修订方案以及方案相关的 在启动时和整个过程中记录并提供研究中心方案相关流程和程序培训 研究以适应变化; 4）建立和维护生物样本跟踪数据库， 运送检测试剂盒和/或散装供应品，包括用于机理研究的生物样本标记包（配套）; 5)通过支持数据管理计划，帮助确保完整、准确的临床数据收集和安全性 与CDSMC、研究者、SMT和DAIT合作开发和设计研究数据库; 6） 与CDSMC、SMT和DAIT合作，监测研究受试者的安全性， 程序，并遵守安全监督和报告要求; 7）提供和维护安全，用户- 经许可的、基于互联网的临床研究协作门户网站，用于存储临床试验信息和研究- 特定文件，并提供从CDSMC安全接收研究数据的机制，以进行分析、报告 8）制定和实施合作项目管理、沟通和 支持参与交付T-SCCC的利益相关者和流程的复杂网络，以确保 有效、有效和符合伦理的研究监督、报告和开展;以及9）使用完善的标准， 建立和实施全面的跨职能质量保证/质量控制计划的方法， 在可交付成果中验证质量流程，并促进T-SCCC绩效评估。

Project Summary/Abstract To support DAIT's efforts to increase understanding of the causes and mechanisms that lead to the development of immunologic diseases and to expand knowledge that can be applied to improving techniques of diagnosis, treatment, and prevention, the T-SCCC will provide experienced staff, standardized procedures, optimal facilities, and integrated systems to transition-in and support statistical and clinical coordinating center deliverables for NIAID/DAIT's clinical research programs, investigator-initiated clinical trials, and other NIAID-funded clinical programs in transplantation. The T-SCCC will empower DAIT's transplantation researchers to address key scientific questions and share resultant data by efficiently managing program and study resources and facilitating communication and collaboration among stakeholders from initial study and protocol concepts through to peer-reviewed manuscripts. The T-SCCC will: 1) provide experienced scientists and statisticians to collaborate with clinical investigators and DAIT to develop innovative statistical design and analysis plans for concept and full study proposals; conduct interim and final statistical analyses of clinical and mechanistic study data that will be used to that yield optimal results for scientific manuscripts and reports for publication and presentation; 2) provide high- quality adverse event/serious adverse event reporting that supports Data and Safety Monitoring Boards, other safety committees/bodies, and regulatory health authorities in ensuring study participant safety; 3) provide dedicated, experienced protocol teams to help develop, review, and revise protocols and protocol-related documents and provide site training on protocol-related processes and procedures at startup and throughout studies to accommodate changes; 4) establish and maintain a biospecimen tracking database and assemble and ship assay kits and/or bulk supplies that include biospecimen labeling packets (kitting) for mechanistic studies; 5) help ensure complete, accurate clinical data collection and security by supporting data management plan development and study database design in collaboration with the CDSMC, investigators, SMTs, and DAIT; 6) collaborate with the CDSMC, SMTs, and DAIT to monitor study participant safety, implement of safety procedures and adhere to safety oversight and reporting requirements; 7) provide and maintain secure, user- permissioned, internet-based clinical study collaboration portals, to house clinical trial information and study- specific files and provide a mechanism to receive study data securely from the CDSMC for analysis, reporting, and sharing; 8) develop and implement plans for collaborative project management, communications, and support of the complex web of stakeholders and processes involved in delivering the T-SCCC to ensure efficient, valid, and ethical study oversight, reporting, and conduct; and 9) use well-developed standards and methods to build and implement a comprehensive, cross-functional quality assurance/quality control plan that standardizes quality processes across deliverables and facilitates assessments of T-SCCC performance.