NIDDK Follow-up on Subjects and Immunological Assessments in The Environmental Determinants of Diabetes In The Young Study (TEDDY) (UC4)

摘要 南佛罗里达大学是唯一有资格进行在这个有限的竞争指定的活动 射频消融本申请的具体目的是描述协调免疫系统的招募的计划。 继续发挥DCC的职能，支持TEDDY受试者随访。 竞争将足以吸引有能力执行的合作者的申请 可靠的测量，并使数据提供给TEDDY研究人员进行合作， 综合分析。此外，该应用程序旨在支持TEDDY DCC进行受试者随访 在奖项的最后两年。第4年和第5年拟议的数据协调中心活动包括： 1)根据时间表执行研究方案，对TEDDY研究参与者进行随访， 研究操作手册中包含的程序，并与临床中心合作， 参加者和NIDDK工作人员。2)接收、管理和分析获得的数据 临床中心3）。通过进行研究中心访视以监测研究计划的依从性 记录保存的质量、源文件和数据输入的准确性，以及监督 数据质量控制。指导委员会、小组委员会和外部评价委员会会议， 4）。在整个研究过程中提供统计支持、专业知识和监督。5)提供研究- 广泛的沟通，传播研究材料，如协议，操作手册，表格或 其他研究文件，以及网站的开发和维护。6)在这一领域发挥着关键作用， TEDDY的运营，为临床中心提供培训和技术援助， 开展后续评估;协助方案执行;以及 与临床中心和NIDDK工作人员一起监督临床中心绩效的各个方面，包括 数据和生物样本提交的及时性和质量。7)分包合同的采购和管理 实验室服务，包括：中心人类白细胞抗原实验室;自身抗体实验室， mRNA实验室、传染病实验室和其他需要的实验室。8)提供 为TEDDY研究小组提供行政和后勤支持服务，包括编写出版物， 并为研究小组和小组委员会组织定期会议、讲习班和电话会议。九、 根据与下列人员制定的时间轴，将所有生物样本和数据转移至NIDDK中央储存库 NIDDK。和10）以协作和互动的方式与临床中心密切合作， 在指导委员会任职。

Abstract The University of South Florida is uniquely qualified to conduct the activities specified in this limited competition RFA. The specific aims of this application are to describe plans to coordinate the recruitment of immune markers collaborator(s) and to continue the DCC's functions in support of TEDDY subject follow-up. The competition will be sufficient to attract applications from collaborators with the capability to perform reliable measurements, and to make the data available to TEDDY investigators for collaborative, integrative analyses. In addition, this application is intended to support the TEDDY DCC for subject follow-up in the final two years of the award. The proposed Data Coordinating Center activities in years 4 and 5 include: 1) Executing the study protocol for follow-up of TEDDY study participants according to schedules and procedures contained in the study's Manual of Operations and in collaboration with the Clinical Centers at which participants are enrolled and with NIDDK staff. 2) Receiving, managing, and analyzing data obtained from the clinical centers 3). Monitoring of adherence to the research plan by conducting site visits to monitor the quality of record keeping, source documentation and the accuracy of data entry and also for overseeing data quality control. Steering Committee, subcommittee, and external evaluation committee meetings and workshops.4). Providing statistical support, expertise and oversight throughout the study. 5) Providing study- wide communications, dissemination of study materials such as protocols, Manual of Operations, forms or other study documents, and development and maintenance of the web site. 6) Playing a key role in the operational conduct of TEDDY, providing training and technical assistance to the Clinical Centers in performance of the follow-up assessments; assisting in protocol implementation; and working in conjunction with the Clinical Centers and NIDDK staff to oversee all aspects of Clinical Center performance, including timeliness and quality of data and biosample submission. 7) Procurement and administration of subcontracts for laboratory services, including: central human leukocyte antigen laboratory; the autoantibody laboratories, the mRNA laboratories, infectious disease laboratories, and other laboratories as needed. 8) Providing administrative and logistical support services for the TEDDY Study Group including preparation of publications, and organizing periodic meetings for the study group and subcommittees, workshops, and conference calls. 9) Transfer of all biosamples and data to the NIDDK central repositories according to a timeline developed with the NIDDK. and 10) Working closely with the Clinical Centers in a collaborative and interactive manner and serving on the Steering Committee.