grant

Administrative Core

Organization RUTGERS BIOMEDICAL AND HEALTH SCIENCESLocation Newark, UNITED STATESPosted 23 Sept 2021Deadline 30 Jun 2027
NIHUS FederalResearch GrantFY2025AnimalsAwardBiological Specimen BanksBiological Substance BanksBlood SampleBlood specimenBrazilClinicalClinical DataClinical ProtocolsClinical ResearchClinical StudyCollaborationsCollectionCommunicationDataData Management CoreDedicationsDevelopment and ResearchGenomicsHeterogeneityInfrastructureInstitutionInvestigatorsLeadLogisticsMonitorNational Institutes of HealthPb elementPoliciesPrincipal InvestigatorProceduresProgress ReportsProtocolProtocols documentationPublic HealthR & DR&DResearchResearch PersonnelResearch ResourcesResearch SpecimenResearchersResolutionResourcesSiteSpecimenStructureSystemSystems BiologyTrainingUgandaUnited States National Institutes of HealthValidationWorkbiological specimen repositorybiosample repositorybiospecimen bankbiospecimen repositorydata centersdata managementdata management and coordinating centerdata management centerdata structureemerging pathogenexperienceheavy metal Pbheavy metal leadhuman subjectinternational centerinternet based platforminternet platformmeetingmeetingsnew pathogennovel pathogenoperationoperationsprogramsresearch and developmentresolutionsspecimen bankspecimen repositorystatistical analysis corestatistical corestatistics corestatistics research corevalidationsweb based platformweb based systemweb enabled platformweb platform
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Full Description

TBRU Administrative Core (Admin Core)
The proposed TBRU application will be supported by an Administrative Core structure to assist, coordinate

and maintain the TB Research Unit, the unit's research and development progress, communications, interactions

with internal and external partners and provide problem resolution. The Admin Core and Data Center will sit

physically within a dedicated suite and share infrastructure and facilities developed for TB research in the

International Center for Public Health (ICPH) building on the Rutgers-NJMS campus. Core lead is Dr. Alland,

with Co-Leads - Mr. David Hom and Ms. Francesca Escaleira.

Specific Aims:

1. Develop and operate an administrative (fiscal, regulatory), operational (scientific, logistics) infrastructure

and data management center capable of supporting proposed clinical, animal & translational protocols.

2. Maintain fiscal compliance and site reimbursement procedures per NIH policy.

3. Communicate and work with NIH program staff to monitor study progress and achieve milestones.

4. Coordinate and collaborate with other TBRU programs to leverage expertise across network.

A Management Plan and system will be deployed to maintain the operations of the TBRU, including the

financial, administrative/regulatory compliance activities, communications within the Unit, its committees and

with TBRU-N, programmatic DMID and TBRU meetings, sponsor interactions, progress reports, supplement

submissions, and assist Principal Investigators with project assessments. Appropriate and experienced

financial analyst, administrative coordinator are available for program conduct and post-awards management.

An existing Data Center - Data and Operations Management Center (DOMC) in the Center for Emerging

Pathogens (directed by Dr. David Alland) will provide a comprehensive Data Management Plan with

appropriate systems to organize, coordinate and validate the collection of clinical data, specimens (MTB

strains and blood samples) from the proposed clinical protocols. The DOMC houses trained, experienced

staff, who have worked in Uganda and Brazil in clinical studies. Validation and management of data collected

will be maintained by the Data Center, monitored by the Clinical Core. A specimen repository system

(FreezerPro web-based platform) will be maintained for collected MTB strains and blood samples (described

in Clinical Core). The DOMC will also assist with the collection of basic and translational data from TBRU

investigators to help with data management and structure required by the Systems Biology Core for statistical,

genomic, and systems biology analytic approaches.

Grant Number: 5U19AI162598-05
NIH Institute/Center: NIH

Principal Investigator: David Alland

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