Establish a Data Coordinating Center (DCC) for the Consortium for Identification

描述（由申请人提供）：南佛罗里达大学是唯一有资格开展这个有限竞争RFA中指定的活动的大学。所描述的拟议数据协调中心活动包括：1)根据研究操作手册中包含的时间表和程序，并与参与者入组的临床中心和NIDDK工作人员合作，执行TEDDY研究参与者的随访研究方案。2)接收、管理和分析从临床中心获得的数据通过实地考察监测记录保存的质量、来源文件和数据输入的准确性，以及监督数据质量控制，监测研究计划的执行情况；指导委员会、小组委员会和外部评价委员会会议和讲习班。4)。在整个研究过程中提供统计支持、专业知识和监督。5)提供研究范围内的交流，传播研究材料，如协议、操作手册、表格或其他研究文件，以及开发和维护网站。6)在TEDDY的运作中发挥关键作用，为临床中心的后续评估提供培训和技术援助；协助协议实施；并与临床中心和NIDDK工作人员合作，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)实验室服务分包合同的采购和管理，包括：中央人类白细胞抗原实验室；自身抗体实验室、信使rna实验室、传染病实验室和其他必要的实验室。8)为TEDDY研究小组提供行政和后勤支持服务，包括准备出版物，为研究小组和小组委员会组织定期会议，研讨会和电话会议。9)。根据NIDDK制定的时间表，将所有生物样本和数据转移到NIDDK中央存储库。10)以协作和互动的方式与临床中心密切合作，并担任指导委员会成员。

DESCRIPTION (provided by applicant): The University of South Florida is uniquely qualified to conduct the activities specified in this limited competition RFA. The proposed Data Coordinating Center activities described 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 bio-sample 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 bio-samples 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.