grant

Biomarkers of Dietary Intake and Exposure Data Coordinating Center

Organization DUKE UNIVERSITYLocation DURHAM, UNITED STATESPosted 16 Aug 2021Deadline 30 Jun 2027
NIHUS FederalResearch GrantFY2025AddressAdministrative ManagementAggregated DataAgreementAncillary StudyBiological MarkersBiomarker of Dietary IntakeBiometricsBiometryBiostatisticsCertificationClinical ResearchClinical StudyClinical Trials Data Monitoring CommitteesCollaborationsCommon CoreCommunicationCommunitiesComplementComplement ProteinsConfidentiality of Patient InformationConsensusConsent DocumentsConsent FormsCreativenessDataData AggregationData AnalysesData AnalysisData BanksData CollectionData Coordinating CenterData Coordination CenterData FilesData Management CoreData Monitoring CommitteesData SetData and Safety Monitoring BoardsDatabanksDevelopmentDietary AdministrationDietary biomarkersDietary intakeDocumentationEnrollmentEnsureFoodGoalsGuidelinesHIPAAHealth Insurance Portability and Accountability ActIRBIRBsIndividualInformed Consent DocumentsInformed Consent FormsInfrastructureInstitutional Review BoardsIntermediary MetabolismKennedy Kassebaum ActKnowledgeLeadershipLinkManualsManuscriptsMetabolicMetabolic ProcessesMetabolismMethodologyMethodsMonitorNIDDKNational Institute of Diabetes and Digestive and Kidney DiseasesNatureNutritional biomarkersOffice of Administrative ManagementOn-Line SystemsOnline SystemsOutcomePL 104-191PL104-191PerformancePositionPositioning AttributePreparationPrivacyProductivityProtocolProtocols documentationPublic Law 104-191PublicationsR-Series Research ProjectsR01 MechanismR01 ProgramReportingResearchResearch GrantsResearch InstituteResearch Project GrantsResearch ProjectsResearch ResourcesResourcesRiskSafetySafety Monitoring BoardsScienceScientific PublicationSecureServicesSightSiteStandardizationStatistical Data AnalysesStatistical Data AnalysisStatistical Data InterpretationStructureTeleconferencesTrainingTransmissionUS Department of AgricultureUSDAUnited States Department of AgricultureUnited States Health Insurance Portability and Accountability ActVisionVisualWorkWritinganonymous databio-markersbiologic markerbiomarkerbiomarker developmentbiomarker identificationbiomarker performancebiomarker utilitybiomarker validationcatalystcloud storagecloud-based storagecomplementationcreativitydata anonymizationdata depositiondata depositorydata disseminationdata exchangedata harmonizationdata integrationdata interpretationdata managementdata management and coordinating centerdata management centerdata modelingdata qualitydata repositorydata set repositorydata sharingdata submissiondata transferdata transmissiondataset repositorydepositorydevelopmentaldietary constituentdietary requirementelectronic data capture systemenrollevidence baseexperienceharmonized dataidentification of biomarkersidentification of new biomarkersimprovedinnovateinnovationinnovativemarker identificationmarker validationmeetingmeeting reportsmeetingsmembermicrobialmodel of datamodel the datamodeling of the datamultidisciplinarynutrition biomarkeronline computeroperationoperationspatient confidentialitypreparationsrecruitrepositorystatistical analysistimelinetooltransmission processuser-friendlyvisual functionweb basedwebinarwork groupworking group
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Full Description

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.

Grant Number: 5U24DK129557-05
NIH Institute/Center: NIH

Principal Investigator: Hrishikesh Chakraborty

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