# Southern California Clinical and Translational Science Institute

> **NIH NIH UL1** · UNIVERSITY OF SOUTHERN CALIFORNIA · 2023 · $49,860

## Abstract

ABSTRACT
The Southern California Clinical and Translational Science Institute (SC CTSI) is committed to ensuring safe,
efficient, and high-quality research to improve health. As part of ongoing operational review within the SC
CTSI, we have identified the process of obtaining NCATS approval to conduct research involving human
subjects as an important opportunity for enhancing efficiency. Assessment of this process has revealed that
lack of knowledge on the part of investigators and lack of a single individual dedicated to this specialized and
labor-intensive process contribute to delays, which slow translational research overall. We propose to hire a
new Quality Assurance (QA) Specialist who will specialize in the human subjects' prior approval process and
associated training and facilitation. The Specialist will (a) implement and maintain a streamlined quality
assurance and control program that is aligned with institutional and federal regulatory processes for human
subject protections and (b) engage in regular training to increase local capacity for preparing high-quality
submissions. The overarching goal will be to enhance efficiency and quality through consultations, process
improvement, communication, and training. The immediate outcomes will be shorter activation times for clinical
studies, a better informed and more efficient CTR workforce, and reduced administrative burdens on other SC
CTSI staff, the IRBs and NCATS. The long-term impacts will be more trials completed successfully and faster,
as well better administrative integration of the SC CTSI with our IRBs, NCATS and other hubs. Innovative
approaches such as use in this setting of the Kaizen method and a scalable project management tool,
Monday.com will be shared with the NCATS QA/QC group to help improve efficiency and quality across the
CTSA network.

## Key facts

- **NIH application ID:** 10700623
- **Project number:** 3UL1TR001855-06A1S1
- **Recipient organization:** UNIVERSITY OF SOUTHERN CALIFORNIA
- **Principal Investigator:** Thomas A Buchanan
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $49,860
- **Award type:** 3
- **Project period:** 2023-01-01 → 2027-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10700623

## Citation

> US National Institutes of Health, RePORTER application 10700623, Southern California Clinical and Translational Science Institute (3UL1TR001855-06A1S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10700623. Licensed CC0.

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