The proposed Administrative Core under the direction of Dr. Ellner (PI) and Mr. David Hom (Director) will take overall responsibility of management (fiscal, regulatory, operational), coordinating (operational, logistics), and oversight of all TBRU activities. The Administrative Core will assist proposed sites with study development (biostatistics, protocol, operating procedures), implementation and performance monitoring. The Core will also communicate and work with NIH program staff to monitor study progress and achieve proposed milestones. Lastly, the Administrative Core will work to leverage expertise across other TBRU programs with collaborative projects proposed by TBRU investigators. The Core will also operate a Data Management Center (DMC) to coordinate approved protocol and unit-wide scientific activities in concert with scientific decisions of the TBRU. The DMC will oversee the collection, storage, quality control, and evaluation of all study data. It will provide support and coordination for the statistical and data processing functions for proposed studies at all sites - clinical, animal, and translational. A detailed Management Plan will outline general activities, leadership structure, typical work-flow, chain of responsibility, review/approval processes, review committees and management activities across the TBRU members. Dr. Ellner has overall responsibility for the scientific, administrative, and fiscal activities of the TBRU and will provide vertical integration by directly interacting with leadership at each site. He will be ultimately responsible for scientific conduct and management of the TBRU.
TB remains a global public health emergency compounded by increasing drug resistance. Better tools are needed to control TB. Discovery of new markers for the development of TB and adequacy of treatment would allow evidence-based determination of treatment options for prevention and cure. The Administrative Core/Data Management Center will provide coordination, management of the proposed TBRU.