# Stanford Center for Clinical & Translational Education and Research (Spectrum)

> **NIH NIH UL1** · STANFORD UNIVERSITY · 2021 · $139,058

## Abstract

Project Summary
The mission of Spectrum, Stanford’s CTSA-supported research Hub, is to transform clinical and translational
research and education at Stanford and across the Hub network to make it more effective at discovering and
implementing data-driven strategies to serve the health needs of individuals and the population and to
disseminate that knowledge to trainees and the public. Many Spectrum activities, such as our Pilot Programs
and KL2 Scholar Projects, require NCATS prior approval before grant funds can be spent on research. While
essential for ensuring compliance with federal policies and appropriate protections for human subjects research,
the prior approval process is also lengthy and plagued by inefficiencies. Another barrier to operational efficiency
is the lack of a dedicated staff member to oversee other Spectrum-related submissions to the eRA Human
Subjects System, obtain institutional approval for documents that are submitted to NCATS, and manage
communications with NCATS. Inefficiencies in Spectrum-related administrative interactions with NCATS delay
study start up and hamper progress towards our overall goal of transforming clinical and translational research.
With this Administrative Supplement, our overall goal is to facilitate consistency, efficiency and enhance the
submission of successful CTSA-related information packages to NCATS. Reporting to the CTSA Executive
Director, a QC/QA project manager will lead improvement initiatives within Spectrum to enhance the quality of
our submissions to NCATS and the eRA Human Subjects System and streamline communications within
Spectrum and between Spectrum and NCATS. Our Specific Aims are to: (1) Hire and onboard a full-time quality
assurance/quality control (QA/QC) project manager, (2) Develop and implement processes to improve the quality
of CTSA-related document submissions to NCATS and the eRA Human Subjects System, promote proactive
and timely communications, and enhance engagement and coordination with departments and their CTSA
faculty and staff to review and obtain institutional approvals for submitted documents. This includes performing
quality reviews and management of all CTSA-related submissions to NCATS, and (3) Use a data-driven
approach to evaluate the effectiveness of new processes and use the data to implement continuous and timely
improvement. Successful completion of these aims will substantially improve Spectrum’s communication and
coordination with NCATS, enable faster research progress, and ultimately help advance our overall mission.

## Key facts

- **NIH application ID:** 10261915
- **Project number:** 3UL1TR003142-02S2
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** Ruth M O'Hara
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $139,058
- **Award type:** 3
- **Project period:** 2020-10-01 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10261915

## Citation

> US National Institutes of Health, RePORTER application 10261915, Stanford Center for Clinical & Translational Education and Research (Spectrum) (3UL1TR003142-02S2). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10261915. Licensed CC0.

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