Follow-up on Subjects, Integrative Data Analysis and Measurement of Viral Antibodies in The Environmental Determinants of Diabetes in The Young Study (TEDDY)
青年糖尿病环境决定因素研究(TEDDY)中的受试者跟踪、综合数据分析和病毒抗体测量
基本信息
- 批准号:10392400
- 负责人:
- 金额:$ 999.99万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-04-13 至 2024-03-31
- 项目状态:已结题
- 来源:
- 关键词:AdherenceAntibodiesArchitectureAutoantibodiesAutoimmunityAwardBig DataBiologicalBiological MarkersCeliac DiseaseCharacteristicsClinical InvestigatorCollaborationsCommunicationConfidentiality of Patient InformationDataData AnalysesData CollectionData Coordinating CenterData Management ResourcesData SecurityData SetDevelopmentDiabetes MellitusDietary FactorsDiseaseDocumentationEducational workshopEnrollmentEnsureEvaluationFloridaFundingGene ExpressionGoalsHLA AntigensHealthImmune systemImmunologic MarkersIndividualInfectious AgentInfectious Diseases ResearchInformaticsInsulin-Dependent Diabetes MellitusLaboratoriesLiteratureLogisticsMaintenanceManualsMeasurementMessenger RNAMonitorNational Institute of Diabetes and Digestive and Kidney DiseasesPaperParticipantPathogenesisPerformancePeriodicityPlayPreparationProceduresProtocols documentationPsychosocial FactorPublicationsQuality ControlReportingResearchResearch PersonnelRoleSamplingSampling StudiesScheduleSecureServicesSite VisitSourceSpecific qualifier valueSpecimenStatistical Data InterpretationStudy SubjectTimeTimeLineTrainingUniversitiesViralViral AntibodiesViral MarkersVisitWorkclinical centerdata de-identificationdata qualitydata repositorydata sharingdata warehousediabetes riskdietaryendocrine pancreas developmentenvironmental agentfollow up assessmentfollow-upislet autoimmunitymeetingsmetabolomicsmicrobiomeoperationpreventprimary endpointrepositorysymposiumweb site
项目摘要
Project Summary/Abstract
The University of South Florida is uniquely qualified to conduct the activities specified in this limited competition
RFA. The purpose of the RFA is to fund the continuation of the Data Coordinating Center's (DCC's) functions
in support of TEDDY subject follow-up and to add funds for studies of viral markers (antibodies) and the
integrative analysis of omics data. Competition will be sufficient to attract applications from collaborators with
the capability to perform reliable measurements of viral markers, and to make the data available to TEDDY
investigators for collaborative, integrative analyses. The proposed Data Coordinating Center activities 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. The solicitation of external collaborators for studies of viral markers and
integrative analyses will follow established mechanisms for soliciting and evaluating proposals. The DCC has
successfully done this for several core TEDDY labs and this would be the third solicitation for integrative data
analysis.
项目概要/摘要
南佛罗里达大学拥有开展本次有限竞赛中指定活动的独特资格
射频消融。 RFA 的目的是资助数据协调中心 (DCC) 职能的延续
支持 TEDDY 受试者后续行动,并为病毒标记物(抗体)和
组学数据的综合分析。竞争将足以吸引合作者的申请
能够对病毒标记进行可靠的测量,并将数据提供给 TEDDY
研究人员进行协作、综合分析。拟议的数据协调中心活动包括:
1) 根据时间表和执行TEDDY研究参与者随访的研究方案
程序包含在该研究的操作手册中并与临床中心合作
哪些参与者已注册以及 NIDDK 工作人员。 2) 接收、管理和分析获得的数据
来自临床中心3)。通过实地考察来监测研究计划的遵守情况
记录保存、源文件的质量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估委员会会议和
研讨会.4).在整个研究过程中提供统计支持、专业知识和监督。 5)提供学习-
广泛的沟通、传播研究材料,例如方案、操作手册、表格或
其他学习文档以及网站的开发和维护。 6) 发挥关键作用
TEDDY 的运营行为,为以下地区的临床中心提供培训和技术援助
后续评估的表现;协助协议实施;并协同工作
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,包括准备出版物、
组织研究组和小组委员会的定期会议、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
NIDDK。 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。征求外部合作者进行病毒标记物和
综合分析将遵循既定的提案征集和评估机制。 DCC 有
成功为几个核心 TEDDY 实验室完成了这项工作,这将是第三次征集综合数据
分析。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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JEFFREY P KRISCHER其他文献
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{{ truncateString('JEFFREY P KRISCHER', 18)}}的其他基金
Limited Competition: Continued Follow-up of Subjects and Initiation of a Second Case-control Cohort in The Environmental Determinants of Diabetes in The Young Study (TEDDY)
有限的竞争:在年轻研究中糖尿病的环境决定因素(TEDDY)中继续对受试者进行随访并启动第二个病例对照队列
- 批准号:
10398923 - 财政年份:2021
- 资助金额:
$ 999.99万 - 项目类别:
Human gene transfer & macrophage cell transplantation therapy of hereditary PAP (hPAP)
人类基因转移
- 批准号:
10403442 - 财政年份:2021
- 资助金额:
$ 999.99万 - 项目类别:
Human gene transfer & macrophage cell transplantation therapy of hereditary PAP (hPAP)
人类基因转移
- 批准号:
10179934 - 财政年份:2021
- 资助金额:
$ 999.99万 - 项目类别:
Limited Competition: Continued Follow-up of Subjects and Initiation of a Second Case-control Cohort in The Environmental Determinants of Diabetes in The Young Study (TEDDY)
有限的竞争:在年轻研究中糖尿病的环境决定因素(TEDDY)中继续对受试者进行随访并启动第二个病例对照队列
- 批准号:
10227415 - 财政年份:2021
- 资助金额:
$ 999.99万 - 项目类别:
Human gene transfer & macrophage cell transplantation therapy of hereditary PAP (hPAP)
人类基因转移
- 批准号:
10702185 - 财政年份:2021
- 资助金额:
$ 999.99万 - 项目类别:
Follow-up on Subjects, Integrative Data Analysis and Measurement of Viral Antibodies in The Environmental Determinants of Diabetes in The Young Study (TEDDY)
青年糖尿病环境决定因素研究(TEDDY)中的受试者跟踪、综合数据分析和病毒抗体测量
- 批准号:
10260891 - 财政年份:2020
- 资助金额:
$ 999.99万 - 项目类别:
NIDDK Follow-up on Subjects and Immunological Assessments in The Environmental Determinants of Diabetes In The Young Study (TEDDY) (UC4)
NIDDK 青年糖尿病环境决定因素研究 (TEDDY) (UC4) 中受试者和免疫学评估的后续行动
- 批准号:
10088137 - 财政年份:2017
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$ 999.99万 - 项目类别:
Data Coordinating Center for Type 1 Diabetes TrialNet (UC4)USF: TrialNet UC4-3
1 型糖尿病数据协调中心 TrialNet (UC4)USF:TrialNet UC4-3
- 批准号:
9506924 - 财政年份:2017
- 资助金额:
$ 999.99万 - 项目类别:
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多中心介入性淋巴管平滑肌瘤病早期疾病试验 (MILED) - DCC
- 批准号:
10249943 - 财政年份:2016
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多中心介入性淋巴管平滑肌瘤病早期疾病试验 (MILED) - DCC
- 批准号:
9743827 - 财政年份:2016
- 资助金额:
$ 999.99万 - 项目类别:
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