# Clinical Core

> **NIH NIH U19** · RBHS-NEW JERSEY MEDICAL SCHOOL · 2021 · $153,455

## Abstract

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.

## Key facts

- **NIH application ID:** 10271646
- **Project number:** 1U19AI162598-01
- **Recipient organization:** RBHS-NEW JERSEY MEDICAL SCHOOL
- **Principal Investigator:** Christopher C. Whalen
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $153,455
- **Award type:** 1
- **Project period:** 2021-09-23 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10271646

## Citation

> US National Institutes of Health, RePORTER application 10271646, Clinical Core (1U19AI162598-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10271646. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*