Clinical Core

The TBRU Clinical Core will take overall responsibility for all human subjects? studies in the proposed TBRU protocols, and will work closely with the Data and Operations Management Center (DOMC) in the Administrative Core to coordinate approved protocols and unit-wide scientific activities in concert with scientific decisions of the TBRU.

The primary objective of the Clinical Core is to ensure the implementation and conduct of the clinical research studies align with the scientific and translational aims of the TBRU projects and scientific cores by providing support for; 1. Protocol development, 2. Implementation and operations, 3. Quality assurance and control, 4.

Sample banking and inventory; 5. Data collection, and 6. Epidemiological and statistical analysis.

The Clinical Core will monitor the clinical operations, sample collection and processing, and data collection from study initiation through close out, to ensure that all activities are conducted in compliance with local and international regulations and ethical standards.

The clinical studies will be conducted at Makerere University in Kampala, Uganda and the Núcleo de Doenças Infecciosas (NDI) in Vitória, Brazil. The Core leads Dr. Whalen and Ms.

Douglass will work closely with the Lead Investigators at each site to ensure timely completion of all project milestones.

In a prospective cohort of HHC of TB patients in Uganda and a retrospective cohort study in Brazil (Projects 1 and 2) and one in Uganda (Project 1) we will characterize the immediate and long-term consequences and interactive effects of bacterial and host heterogeneity with a focus on the underlying immune mechanisms that we hypothesize to be critical determinants of the natural history of TB.

These studies involving human participants must be conducted with careful design and oversight with our Brazilian and Ugandan partners to guarantee the safety and protection of all participants, the study team, and the integrity of the data.

The Clinical Core will coordinate with the Administrative and Systems Biology Core, and under the direction of the Principal Investigators, to accomplish these objectives, implement the clinical protocols for projects 1 and 2 at the collaborating sites in Brazil and Uganda, and to establish an inventory of human clinical specimens, isolates of Mtb and clinical epidemiological data to be utilized across projects 1, 2, 3 and 4.