Data Coordinating Center (DCC) for the Consortium for Identification of Environmental Determinants of Diabetes in the Young (TEDDY) Study

 描述(由申请者提供)：南佛罗里达大学是唯一有资格开展这项有限比赛中规定的活动的机构。此应用程序的具体目标是为大数据分析领域的合作者建立公开竞争，包括 能够集成多种类型的数据，包括多组学、饮食记录、临床数据、环境分析和其他数据。数据和数据分析工具将需要提供给Teddy调查人员，使用最佳的共享手段，其中可能包括安全的云环境。此外，此应用程序旨在支持Teddy DCC在奖项的最后一年进行主题跟踪。拟议的数据协调中心在第5年的活动包括：1)根据研究操作手册中包含的时间表和程序，并与参与者登记的临床中心和NIDDK工作人员合作，执行对Teddy研究参与者的后续研究方案。2)接收、管理和分析从临床中心获得的数据。监测研究计划的遵守情况，方法是进行实地考察，以监测记录保存、原始文件和数据输入的准确性，并监督数据质量控制。指导委员会、小组委员会和外部评价委员会的会议和研讨会。在整个研究过程中提供统计支持、专门知识和监督。5)提供全研究范围的交流，传播研究材料，如方案、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TEDDY的运作中发挥关键作用，在后续评估方面向临床中心提供培训和技术援助；协助执行方案；并与临床中心和NIDDK工作人员合作，监督临床中心业绩的所有方面，包括数据和生物样本提交的及时性和质量。7)采购和管理实验室服务分包合同，包括：人类白细胞抗原中央实验室、自身抗体实验室、信使核糖核酸实验室、传染病实验室和必要的其他实验室。8)为Teddy研究小组提供行政和后勤支助服务，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。9)。根据与NIDDK共同制定的时间表，将所有生物样本和数据转移到NIDDK中央储存库。和10)以协作和互动的方式与临床中心密切合作，并在指导委员会提供服务。

 DESCRIPTION (provided by applicant): 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 establish an open competition for collaborators for Big Data analysis, including the capability to integrate data across many types, including multi-omics, diet records, clinical data, environmental analytes, and other data. The data and the data analytics tools will need to be available to TEDDY investigators using optimal means for sharing that could include a secure cloud environment. In addition, this application is intended to support the TEDDY DCC for subject follow-up in the final year of the award. The proposed Data Coordinating Center activities in year 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.