# SDMC; Statistical Data Mgmt Core

> **NIH NIH UM2** · FLORIDA STATE UNIVERSITY · 2023 · $3,527,930

## Abstract

PROJECT SUMMARY
As a mature research network, the ATN is well-poised to assemble innovative and experienced scholars,
providers and community partners that can deliver prevention and treatment technologies in the right
combinations at the right time and place for those who could benefit most. A strong Statistical and Data
Management Core (SDMC) is central to the successful planning, implementation, analysis, dissemination, and
stewardship of all ATN research projects, cross-network analyses, and contributions to the field of adolescent
and young adult HIV prevention and care. To provide SDMC services for this ATN funding cycle, we assembled
a leadership team from the University of North Carolina, Emmes, and Harvard University/Mass General. The
SDMC will provide comprehensive data management and analyses for all network clinical studies; leadership;
and services for regulatory aspects, biostatistics, study design, analysis, interpretation, and publication of results.
The SDMC will use innovative statistical methods and state-of-the-art clinical trial management systems and
laboratory information management systems to ensure complete, high-quality data. SDMC leaders are uniformly
committed to improving HIV prevention and care outcomes through excellence in evidence-based interventional
research. Our Core will provide scientific and analytic expertise, comprehensive data management and data
stewardship resources, and coordination, and supervision to the ATN and its individual and cross-network
protocols, as well as to the broader scientific and ATN stakeholder communities. The SDMC is responsible for
the integrity of study design, quality of data management and rigor and reproducibility of analyses for all clinical
studies proposed in this application and future emerging scientific priorities during this ATN project cycle. We
will ensure that all ATN studies meet data access and security protocols defined by institutional ethical review
requirements, federal regulatory standards, and applicable international guidelines. In addition, the SDMC will
lead efforts to standardize and harmonize data management and statistical activities within the ATN and in line
with other NIH-sponsored programs. Throughout the lifetime of an individual study, the SDMC will coordinate
services and systems for the clinical and laboratory data collection and management required to support the
research projects and the overall ATN research agenda. Across these activities, the SDMC will intentionally
promote more equitable use, accessibility, and dissemination of data through mentorship and involvement of
trainees, early-stage investigators, and under-represented minorities in SDMC activities. We have assembled a
diverse team with complementary leadership experience and expertise in statistical analyses, epidemiology of
HIV, statistical modeling and cost analysis, adolescent and young adult HIV intervention development and
evaluation, evidence-based clinical care, network sci...

## Key facts

- **NIH application ID:** 10595908
- **Project number:** 1UM2HD111102-01
- **Recipient organization:** FLORIDA STATE UNIVERSITY
- **Principal Investigator:** Kathryn E Muessig
- **Activity code:** UM2 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $3,527,930
- **Award type:** 1
- **Project period:** 2023-01-25 → 2029-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10595908

## Citation

> US National Institutes of Health, RePORTER application 10595908, SDMC; Statistical Data Mgmt Core (1UM2HD111102-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10595908. Licensed CC0.

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