# Clinical and Translational Science Award

> **NIH NIH UL1** · COLUMBIA UNIVERSITY HEALTH SCIENCES · 2022 · $100,172

## Abstract

Project Summary
The Irving Institute for Clinical and Translational Research (Irving Institute) is home to Columbia University’s
(CU) Clinical and Translational Science Award (CTSA) Program hub. Our vision is to transform the health and
wellbeing of our communities in New York City, the nation, and the world. We aim to catalyze all phases of
clinical and translational science (T0-T4), synergize with our partners and stakeholders, and integrate activities
within our hub and across the national CTSA Program. As a comprehensive CTSA, we offer a broad array of
support for trainees, scholars and investigators across our entire hub, which includes Columbia University, the
Columbia University Irving Medical Center, the New York Psychiatric Institute, and New York Presbyterian
Hospital. We seek to continuously create and refine innovations for an integrated research- and user-friendly
translational research environment at our hub. Among our successful programs are TRANSFORM (TRaining
And Nurturing Scholars FOr Research that is Multidisciplinary), our workforce development resource that
oversees the Institutional Career Development (KL2) program, and the Pilot and Collaborative Studies Resource
(PCSR), our pilot funding program. Both functions have built robust programs to provide innovative resources,
and combined they support over twenty projects a year for junior investigators and collaborative translational
research. However, these programs must also navigate the complex regulatory approvals needed to begin
research studies. The requirement that new KL2 scholar projects and pilot projects receive prior approval from
the National Center for Advancing Translational Science (NCATS) has resulted in numerous inefficiencies and
delays. The goal of this supplement is to develop regulatory and administrative expertise and structures to better
manage the prior approval process and accelerate the movement of discoveries through the translational pipeline
toward improving health. To achieve this goal, we propose to 1. Develop a dedicated quality assurance/quality
control (QA/QC) position to oversee management of prior approval requests to NCATS: 1.1. Develop and
implement an efficient process to collect material for NCATS prior approval submissions and perform QA/QC
reviews for UL1- and KL2-related NCATS submissions, 1.2. Develop trainings and tools to enhance the quality
and efficiency of prior approval submissions to NCATS and obtain trainings from NCATS and CTSA consortium
members to ensure ongoing compliance; 2. Demonstrate the effectiveness of new processes and tools in
producing timely, high-quality submissions to NCATS and apply the data to support continuous improvement;
and 3. Disseminate innovative QA/QC methods for the prior approval process across the CTSA Program
consortium and adopt best practices from the QA/QC Group and consortium members. This project will improve
the quality of our prior approval submissions, accelerate the start of important r...

## Key facts

- **NIH application ID:** 10486496
- **Project number:** 3UL1TR001873-07S1
- **Recipient organization:** COLUMBIA UNIVERSITY HEALTH SCIENCES
- **Principal Investigator:** Muredach P Reilly
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $100,172
- **Award type:** 3
- **Project period:** 2022-08-01 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10486496

## Citation

> US National Institutes of Health, RePORTER application 10486496, Clinical and Translational Science Award (3UL1TR001873-07S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10486496. Licensed CC0.

---

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