# Clinical Core

> **NIH NIH U19** · EMORY UNIVERSITY · 2020 · $615,050

## Abstract

The goal of the Clinical Core (Core C) is to provide centralized expertise and capacity to enroll well-characterized 
cohorts of participants infected with M. tuberculosis to meet the aims of the TBRU. 
Coordination by the Clinical Core will create internal consistency across cohorts and improve the efficiency 
of enrollment for the TBRU projects involving human subjects, as well as for TBRU "Collaborative Projects." 
Subjects will be enrolled at two highly experienced and established sites: the Kenya Medical Research 
Institute (KEMRI) / U.S. Centers for Disease Control and Prevention (CDC), in Nyanza Province, and at the 
DeKalb County Board of Health in Atlanta, Georgia. Infrastructure at these sites for conducting TB clinical 
and translational studies is among the best in the world. Since 2007, the KEMRI TB Branch has enrolled 
over 28,000 adults and children into research studies, including 8,000 followed in longitudinal cohorts. The 
BSL3 TB research laboratory has state-of-the-art capacity for mycobacteriology, immunology, specimen 
archiving and international shipping. KEMRI/CDC conducts ongoing population-based, active surveillance for 
infectious diseases that will be leveraged for TBRU studies. The DeKalb/Atlanta site has collaborated with 
Emory and CDC in TB research for over a decade. More than 2,500 newly arrived refugees from high-burden 
TB countries are seen annually and over 1,500 adults with LTBI are identified and offered treatment 
each year. Data management, quality assurance and regulatory procedures in Kenya and Atlanta are of the 
highest quality, making these exceptional sites to achieve TBRU Project aims. 
The Clinical Core will be a major resource for the TBRU by providing: 1) expertise in clinical and 
translational research that spans more than a decade and includes over 15 TB endemic settings; 2) 
coordination of participant enrollment and follow-up to achieve maximal efficiency and synergy between 
projects; 3) centralized specimen collection, processing and shipping through the TBRU Data Management 
Center; and 4) assurance of high-quality, ethical research conducted in accordance with U.S. and 
international regulatory requirements.

## Key facts

- **NIH application ID:** 9989028
- **Project number:** 5U19AI111211-07
- **Recipient organization:** EMORY UNIVERSITY
- **Principal Investigator:** Neel Rajnikant Gandhi
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $615,050
- **Award type:** 5
- **Project period:** 2014-08-11 → 2022-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9989028

## Citation

> US National Institutes of Health, RePORTER application 9989028, Clinical Core (5U19AI111211-07). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9989028. Licensed CC0.

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