# UC San Diego Clinical and Translational Research Institute

> **NIH NIH UL1** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2021 · $145,499

## Abstract

PROJECT SUMMARY/ABSTRACT
This administrative supplemental funding request is in response to the NOT-TR-20-014 opportunity, and it is
linked to the UC San Diego Altman Clinical and Translational Research Institute (ACTRI) Hub. Our hub, which
was successfully renewed in 2020 for 5 years, has experienced increasing challenges in managing efficiency
in the NCATS Prior Approval process. These challenges include interactions among a complex group of
stakeholders, including the applicant, ACTRI administration, Office of Grants and Contracts Administration
(OCGA), the Institutional Review Board (IRB), and the NIH. The consequences of delayed onset of projects
are substantial, in particular that delays in a phase of Prior Approval detract from our hub’s ability to advance
research for the 10-15 annual Pilot Awards and 8 KL2 awards we administer. Therefore, we welcome the
opportunity to apply for funding to support a new full-time role at the ACTRI, a Quality Assurance/Quality
Control (QA) Officer. The QA/QC Officer will work under the supervision of the Clinical Research Strategic
Initiatives Office, PI, and key Program Directors involved in Prior Approval submissions. The QA/QC officer will
undertake a variety of process improvement responsibilities directly aimed at increasing efficiency in Prior
Approval procedures. After formal process mapping and programming planning, the QA/QC’s responsibilities
will include: 1) Pre-award/Applicant Community Support in the form of web-based resource development, in
service presentations, and consultation services aimed at prospective applicants to programs and increasing
awareness of the Prior Approval process and its timelines, 2) Prior Approval Submission support, including
tracking and project management of awarded applicants, document QA, and linkage between stakeholders,
and 3) Post-Approval Management of processes including timeliness of updates to regulatory documents and
tracking of work products such as publications and related compliance assurance. The QA/QC Officer will
develop, adapt, and implement project management tools, with which our hub is experienced, such as project
management dashboards, time tracking software, and process mapping. As directed by the NOT, the QA/QC
Officer will collaborate with the national QA/QC network and will be active in resource sharing and adoption
with other hubs in our region and nationwide.

## Key facts

- **NIH application ID:** 10378449
- **Project number:** 3UL1TR001442-07S1
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** GARY S FIRESTEIN
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $145,499
- **Award type:** 3
- **Project period:** 2015-08-13 → 2025-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10378449

## Citation

> US National Institutes of Health, RePORTER application 10378449, UC San Diego Clinical and Translational Research Institute (3UL1TR001442-07S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10378449. Licensed CC0.

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