# The integrated Translational Health Research Institute of Virginia (iTHRIV): Using Data to Improve Health

> **NIH NIH UL1** · UNIVERSITY OF VIRGINIA · 2020 · $118,296

## Abstract

ABSTRACT
A new Human Subject Research prior approval submission process for Clinical Translational Science Award
hubs was implemented in early 2019. The activation of the new eRA Human Subjects System (HSS) provided
an opportunity to consolidate and simplify the submission, review and approval process for Prior Approval
requests involving human subjects research. Although, the HSS system afforded teams a centralized method
for submission, it did create new challenges at the NIH review level. In order to improve the process for our
researchers as well as the reviewers at the NIH, the integrated Translational Health Research Institute of
Virginia (iTHRIV), a collaboration of public and private institutions across the Commonwealth of Virginia,
proposes the addition of a dedicated quality assurance/ quality control position. The new iTHRIV Research
Quality Manager will perform quality reviews of CTSA-related submissions to NCATS, submissions to the eRA
Human Subjects System, and manage the overall prior approval process. Training the iTHRIV workforce in
quality and regulatory best practices of human subject submissions is another objective which we plan to
extend to include our partner sites, as well as share with the broad CTSA national network. The Research
Quality Manager will harmonize quality measures and processes across the iTHRIV partners including
incorporating best practices for all NCATS submission (Aim1), develop and disseminate training programs for
human subject research submission processes (Aim 2) and actively participate in the national working groups
sharing insights and best practices across the CTSA network (Aim 3). The addition of a Research Quality
Manager will provide training programs to fill a key educational need of our research community to further
develop the skills and knowledge of our workforce and enable iTHRIV to meet its primary aims of workforce
development, collaboration and integration, methods and processes and allow streamlining through the iTHRIV
Commons.

## Key facts

- **NIH application ID:** 10158925
- **Project number:** 3UL1TR003015-02S1
- **Recipient organization:** UNIVERSITY OF VIRGINIA
- **Principal Investigator:** Donald E Brown
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $118,296
- **Award type:** 3
- **Project period:** 2020-07-01 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10158925

## Citation

> US National Institutes of Health, RePORTER application 10158925, The integrated Translational Health Research Institute of Virginia (iTHRIV): Using Data to Improve Health (3UL1TR003015-02S1). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10158925. Licensed CC0.

---

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