Biomarkers of Dietary Intake and Exposure Data Coordinating Center

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.