Administrative Core

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.