# Clinical Trials Logistics Core

> **NIH NIH P20** · UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA · 2020 · $283,402

## Abstract

The prevalence rates for children’s mental, emotional, and behavioral disorders, as well as for childhood
obesity, are at alarmingly high levels and need to be systematically addressed through effective prevention
strategies. Early-stage scientists in the Research Center for Child Well-Being are conducting intensive
prevention trials that are supported in part by the Center’s Clinical Trials Logistics Core research facility (CTL
Core). The CTL Core seeks to bolster the scientific rigor and transparency of the Center’s preventive
intervention clinical trials, which involve the prospective assignment of human participants to an intervention
and evaluate behavioral and health-related outcomes. The CTL Core is essential to ensure compliance with
NIH’s most recent Clinical Trials Policies. Early-stage investigators, central to the Center’s mission and goals,
do not yet have the experience and infrastructure support to incorporate the newest Clinical Trial requirements
into the conceptualization, conduct, and reporting of their intervention trials. The evaluation of interventions for
the prevention and reduction of mental, emotional, behavioral, and unhealthy lifestyle-related risk factors in
childhood requires substantial support and guidance with respect to preparatory steps, community and school
engagement, trial reporting demands, state-of-the-art measurement of primary and secondary outcomes, and
focused evaluation of intervention implementation processes. The CTL Core provides the requisite
infrastructure, instrumentation, and technical expertise to support the prevention trials and related studies
conducted by the early-stage investigators to rigorously implement interventions within real-world settings. The
CTL Core draws on the Center’s local Community Advisory Board and experienced staff to promote effective
community and school engagement. Overall, the CTL Core enhances the integrity of the independent and
dependent variables measured in Center sponsored research by ensuring: state-of-the-art measures; well-
specified and deployed intervention and measurement protocols; and diligent attention to human subjects’
protocols and issues. The CTL Core aims include: AIM 1: Deploy a cogent team to provide technical expertise
and state-of-the-art instrumentation to the Center’s early-stage investigators to conduct high-quality prevention
trials; AIM 2: Provide support and guidance for: (a) the research projects led by Center early-stage
investigators with respect to the preparation, conduct, and reporting of their prevention trials; (b) pilot seed
projects; and, (c) the preparation of R01-level research projects by transitioning early-stage investigators; and
AIM 3: Conduct technical training workshops for early-stage investigators, faculty, and staff in the Center, and
other university faculty who conduct prevention trials involving children, on (1) community participation and
engagement; and (2) requirements, compliance, and best practices for clin...

## Key facts

- **NIH application ID:** 9852056
- **Project number:** 1P20GM130420-01A1
- **Recipient organization:** UNIVERSITY OF SOUTH CAROLINA AT COLUMBIA
- **Principal Investigator:** MICHAEL W BEETS
- **Activity code:** P20 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $283,402
- **Award type:** 1
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9852056

## Citation

> US National Institutes of Health, RePORTER application 9852056, Clinical Trials Logistics Core (1P20GM130420-01A1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/9852056. Licensed CC0.

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