# iTech - Analytic-Core

> **NIH NIH U19** · UNIV OF NORTH CAROLINA CHAPEL HILL · 2020 · $988,767

## Abstract

The Analytic Core (AC) will provide expertise and systems for the conduct of qualitative studies,
randomized controlled trials (RCT), and economic studies to support the aims of the iTech and its
research and pilot studies, interactions within the ATN, and with NICHD. This work is organized across
three aims that follow the research project lifecycle. Throughout the development (Aim 1), execution (Aim 2),
analysis, and dissemination (Aim 3) phases of each study activity, the AC will responsibly and strategically
manage its resources to foster a collaborative environment, maintain scientific rigor, and ensure timely work
completion.It is composed of a Leadership Team, co-directed by Drs. Eli Rosenberg and Kathryn Muessig, and
three subteams: the Randomized Controlled Trial (RCT), Cost Analysis, and Qualitative Teams.
The first aim supports the development of iTech studies' qualitative, RCT, and costing activities by
consulting on valid study design and establishing best-practice data collection systems and procedures. The
Qualitative Team will work with research project PIs to develop valid and consistent (between-study) protocols,
secure IRB approval, and design systems for qualitative data collection, storage, and analysis. The RCT Team
will implement web-based recruitment screener and computer audio-assisted interview tools, design case
report forms and collection system, develop and implement randomization plans and systems, and implement
data capture and storage systems for study app usage, laboratory, and retention data. The Cost Analysis
Team will work with project PIs to develop cost input parameters and collection tools. The second aim
supports protocol implementation through the collection and maintenance of high-quality study data and
real-time monitoring of study progress. For all research activities, the AC will provide data to the Management
Core to monitor accrual on a weekly basis during active enrollment, to ensure each study is meeting enrollment
targets within estimated timeframes. The RCT Team will routinely summarize study data to monitor all key
domains of RCT activities, in the form of study progress reports, data quality reports, and research data
reports. When recommended by NICHD for a given RCT protocol, the AC will act to assemble a DSMB. The
third aim is to ensure that data analyses are conducted to the highest scientific standards and that results are
dissemination in a timely way. In addition to supporting the iTech research and pilots studies, the AC will
work collaboratively with the Management Core to ensure project and subject recruitment venue (SRV)
milestones are met, data standards are upheld and dissemination is timely. Collaboration with the
Technology Core will serve to ensure participant Recruitment and Retention and analysis of self-collected
testing specimens. The AC will also serve as a resource to other funded U19s providing technical assistance
on measurement and analysis of technology-based data syst...

## Key facts

- **NIH application ID:** 9955292
- **Project number:** 5U19HD089881-05
- **Recipient organization:** UNIV OF NORTH CAROLINA CHAPEL HILL
- **Principal Investigator:** Kathryn E Muessig
- **Activity code:** U19 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $988,767
- **Award type:** 5
- **Project period:** — → 2022-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9955292

## Citation

> US National Institutes of Health, RePORTER application 9955292, iTech - Analytic-Core (5U19HD089881-05). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/9955292. Licensed CC0.

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