Clinical and Population Science

About the Core

The focus of the Clinical & Population Science Core (CPS Core) is to foster TB investigators interested in conducting scientifically rigorous, impactful clinical and epidemiologic research along the full spectrum of TB exposure, infection, and disease.

The CPS Core provides a home for TB research resources for the current large cadre of TB scientists and growing pool of investigators interested in TB research. Leveraging the unique bridge between science, public health, and policy that is reflected in the Emory/Georgia TRAC is an ideal embodiment of bench to bedside to community that will ensure maximal public health impact. The CPS Core’s overarching goal is to increase multi-disciplinary collaborations by building awareness of TRAC clinical research sites, facilitating connections between investigators and Clinical Core faculty based on research interests, and supporting bidirectional travel.

CPS Core Services

Obtaining input from community advisory board (CAB) on research needs, engagement with potential study population, evaluating proposed study procedures and informed consent processes, and evaluating study implementation and impact.

Development of study aims; selecting study population; sample size determination; power calculations; randomization schema; interim safety/efficacy monitoring

Exemplar protocols; operationalization of grant activities into study procedures and assistance with protocol development; creation of study visit schedule, including planning for unscheduled visits; formatting protocol into required IRB template

Library of SOPs to be modified/adapted for specific study: TB specific, HIV specific, and general study procedures

Library of data collection forms:

TB specific forms: measuring exposure, screening for signs and symptoms, latent TB infection, TB disease and drug-resistance, chest radiography, treatment adherence, treatment outcomes, close contacts.
General test result forms: HbA1c, pregnancy, HIV, vital signs, malaria, parasites.
HIV specific results forms: CD4, viral load, ART prescription and adherence.
General study forms: screening, enrollment/consent, medical history questionnaire, locator information, specimen tracking, study exit.

Adult and child informed consent forms; child assent forms; supporting documentation; human subjects research ethics and GCP training certificates, navigating institutional board review and approval, such as biosafety (if applicable).

Sample regulatory binders; links to required trainings, e.g., Biomedical and/or CRC- CITI, GCP-ICH, HIPAA, COI, GCLP; support in understanding the regulations and applying them to research projects; data safety and monitoring board (if applicable).

Diagnosis (or exclusion) of TB infection and disease; informed consent training; airborne infection control procedures.

Tracking visit schedule; ensuring retention; supporting treatment adherence; measuring TB outcomes; study exit.

Training in sputum sample collection and processing; tuberculin skin test application and reading; interferon gamma release assay blood collection; HIV testing; specimen handling, storage and shipping, including infection control procedures.

Exemplar databases; database design consultation and development support; data management plan SOPs for electronic and/or hard copy data collection forms and source documents

Training of quality control (QC) best practices for informed consent documents and data collection forms; consultation on QC procedures for electronic forms and data entered into databases; guidance on security and confidentiality considerations for direct data entry and/or paper-based data collection

Exemplar statistical analysis plans (SAP); reproducible coding practices; code verification; table/figure shells for DSMB reporting; basic statistical methods, including training in R, Python and SAS; data visualization; guidance on interpretation and appropriate reporting of methods.

Expert consultation and review of abstract, poster and manuscript drafts; dissemination of study outcomes to stakeholders