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: 10649583
• 负责人: Hrishikesh Chakraborty
• 金额: $ 43.98万
• 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/10649583
• 关键词: Address; Agreement; 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; Creativeness; 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; Institutional Review Boards; Knowledge; Leadership; Link; 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; Training; United States Department of Agriculture; Vision; Visual; Work; Writing; biomarker development; biomarker identification; 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; dietary requirement; electronic data capture system; evidence base; experience; improved; innovation; meetings; member; microbial; multidisciplinary; operation; recruit; repository; timeline; 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.

项目总结/摘要 膳食生物标志物开发中心（DBDC）联盟的目的是确定 饮食摄入的生物标志物，可以作为饮食摄入的独立标志物， 补充目前的膳食摄入量评估方法和不断发展的证据 为解决膳食成分的代谢转化问题奠定了基础，特别是非 营养物质的宿主和微生物代谢。数据协调中心（DCC）的目标是：1） 提供一个强有力的行政管理结构，加强沟通， 协作并提高DBDC联盟的生产力和质量，2）提供数据 转移、协调、整合、处理和管理，3）开发自助服务 分析平台和用户交互式报告，并进行分析，以及4）沟通 并在联盟内外传播知识。在业务上，DCC将 制定业务手册，提供方案培训，建立和监测时间表， 组织与指导委员会（SC）、NIDDK/USDA和数据安全部门的会议， 监查委员会（DSMB）。对于数据管理，DCC将建立一个符合联邦标准的 支持直接提交数据的在线电子数据采集系统，以及 用于安全数据共享的联盟通信和协作平台（CCCP）， 传播工具和成果。CCCP将具有访问自助服务的链接 分析和交互式报告，以方便轻松访问数据。DCC将定期 评估数据质量，检查数据完整性，编制数据文件， 确保保护患者机密，为SC和DSMB准备报告，并准备 去识别的公共使用数据文件提交到NIDDK存储库。最后，DCC将 提供思想领导、生物统计支持和方法创新， 饮食生物标志物开发的多方面性质，并促进制备和 通过多个高影响力的手稿和演讲传播研究结果。我们 团队在数据管理、统一和协调方面的国家公认的专业知识， 大型网络，我们在生物标志物研究方面的经验使DCRI处于独特的地位， 提供联盟所需的所有服务和支持。