Biomarkers of Dietary Intake and Exposure Data Coordinating Center

膳食摄入和暴露生物标志物数据协调中心

• 批准号: 10286935
• 负责人: Hrishikesh Chakraborty
• 金额: $ 56.35万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-16 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10286935
• 关键词: Address; Ancillary Study; Biological Markers; Biomarker of Dietary Intake; Biometry; Certification; Clinical Research; Clinical Trials Data Monitoring Committees; Collaborations; Common Core; Communication; Communities; Complement; Confidentiality of Patient Information; Congresses; Consensus; Consent Forms; Data; Data Aggregation; Data Analyses; Data Collection; Data Coordinating Center; Data Files; Data Set; Development; Dietary Administration; Dietary intake; Documentation; Enrollment; Ensure; Food; Goals; Guidelines; Health Insurance Portability and Accountability Act; Individual; Infrastructure; Institutes; Institutional Review Boards; Knowledge; Leadership; Link; Logistics; Manuals; Manuscripts; Metabolic; Metabolism; Methodology; Methods; Monitor; National Institute of Diabetes and Digestive and Kidney Diseases; Nature; Office of Administrative Management; Online Systems; Outcome; Performance; Positioning Attribute; Preparation; Privacy; Productivity; Protocols documentation; Publications; Reporting; Research; Research Institute; Research Project Grants; Resources; Risk; Safety; Science; Secure; Services; Site; Standardization; Statistical Data Interpretation; Structure; Teleconferences; TimeLine; Training; United States Department of Agriculture; Vision; Visual; Work; Writing; biomarker development; biomarker performance; biomarker validation; catalyst; cloud storage; data anonymization; data dissemination; data exchange; data harmonization; data integration; data management; data modeling; data quality; data repository; data sharing; data submission; dietary; dietary constituent; electronic data capture system; evidence base; experience; improved; innovation; meetings; member; microbial; multidisciplinary; operation; recruit; repository; tool; transmission process; user-friendly; webinar; working group

Project Summary/Abstract The purpose of the Dietary Biomarker Development Centers (DBDCs) Consortium is to identify biomarkers of dietary intake that can serve as independent markers of dietary intake and complement current dietary intake assessment methods and the continually evolving evidence base for addressing metabolic transformation of dietary constituents, especially the non- nutrients by host and microbial metabolism. The Data Coordinating Center (DCC) aims to: 1) provide a robust administrative management structure that enhances communication and collaboration and improves the DBDC’s Consortium productivity and quality, 2) provide data transfers, harmonization, integration, processing, and management, 3) develop a self-service analytics platform and interactive reporting for users and conduct analyses, and 4) communicate and disseminate knowledge within and beyond the Consortium. Operationally, the DCC will develop manuals of operations, provide protocol training, establish and monitor timelines, organize meetings with the Steering Committee (SC), NIDDK/USDA, and Data Safety and Monitoring Board (DSMB). For data management, the DCC will establish a federally-compliant online electronic data capture system to support the direct submission of data and a web-based consortium communication and collaboration platform (CCCP) for secure data sharing and dissemination of tools and results. The CCCP will have a link to access the self-service analytics and interactive reporting to facilitate easy access to the data. The DCC will periodically assess data quality, perform checks for data completeness, develop data documentation, ensure protection of patient confidentiality, prepare reports for the SC and DSMB, and prepare de-identified public use data files for submission into the NIDDK repository. Finally, the DCC will provide thought leadership, biostatistical support, and methodological innovation to account for the multi-faceted nature of dietary biomarker development, and facilitate the preparation and dissemination of study results through multiple high-impact manuscripts and presentations. Our team’s nationally recognized expertise in data management, harmonization, and coordination of large networks, and our experience in biomarker research uniquely positions the DCRI to provide all of the services and support required by the Consortium.

项目概要/摘要 膳食生物标志物开发中心 (DBDC) 联盟的目的是确定 膳食摄入的生物标志物可以作为膳食摄入的独立标志物 补充当前的膳食摄入评估方法和不断发展的证据 解决膳食成分（尤其是非膳食成分）代谢转化的基础 数据协调中心 (DCC) 的目标是：1) 提供健全的行政管理结构，加强沟通和 协作并提高 DBDC 联盟的生产力和质量，2) 提供数据 传输、协调、集成、处理和管理，3) 开发自助服务 分析平台和交互式报告，供用户进行分析，以及 4) 沟通 DCC 将在联盟内部和外部传播知识。 制定操作手册，提供协议培训，建立和监控时间表， 与指导委员会 (SC)、NIDDK/USDA 以及数据安全和 对于数据管理，DCC 将建立一个符合联邦标准的监测委员会 (DSMB)。 在线电子数据采集系统，支持直接提交数据和基于网络的 用于安全数据共享的联盟通信和协作平台（CCCP） CCCP 将有一个访问自助服务的链接。 DCC 将定期进行分析和交互式报告，以方便访问数据。 评估数据质量，检查数据完整性，开发数据文档， 确保保护患者机密，为 SC 和 DSMB 准备报告，并准备 最后，DCC 将取消识别的公共使用数据文件提交到 NIDDK 存​​储库。 提供思想领导、生物统计支持和方法创新来解释 膳食生物标志物开发的多面性，并促进制备和 通过多份高影响力的手稿和演示文稿传播研究结果。 团队在数据管理、统一和协调方面拥有全国公认的专业知识 大型网络，以及我们在生物标志物研究方面的经验，使 DCRI 能够 提供联盟所需的所有服务和支持。