# Tufts Clinical and Translational Science Institute

> **NIH NIH UL1** · TUFTS UNIVERSITY BOSTON · 2020 · $229,314

## Abstract

SUMMARY
The proposed project will bring together Tufts Clinical and Translational Science Institute (CTSI)
faculty and staff to address translational roadblocks associated with managing National Center
for Advancing Translational Science (NCATS) Prior Approval requests. Tufts CTSI will build on
our long-standing Research Process Improvement (RPI) and Pilot Studies programs to develop
new tools, strategies, quality improvement metrics, and to deploy dedicated personnel to
perform quality reviews of hub Prior Approval request submissions to NCATS and the eRA
Human Subjects System. We will also create tools and processes to more effectively
collaborate with investigators on preparing Prior Approval packages to request approval for
CTSA-funded research and to liaise with institutional and NCATS representatives to manage
Prior Approval-related processes. Relevant Prior Approval requests include, but are not limited
to: 1) changes in key personnel, 2) addition of a foreign component, 3) request to carryover
funds, and 4) requests to conduct animal- and human-subjects research by all new Mentored
Clinical Research Scholar (KL2) projects and certain Pilot Studies projects. The preliminary
focus of our efforts will be an increased monitoring of Prior Approval request packages for
CTSA-funded animal- and human-subjects research projects, which have been particularly
challenging and time-consuming for our hub. To achieve these goals, we propose expanding
the roles and responsibilities of RPI and Pilot Studies program personnel to develop tools and
processes for preparing Prior Approval packages, perform enhanced quality assurance/quality
control (QA/QC) reviews of packages prior to submission, and to share evidence-based best
practices for submission of NCATS Prior Approval requests with the goal of improving the
quality, consistency, and efficiency of NCATS Prior Approval requests. With Tufts CTSI's
experience leading national quality and process improvement initiatives, we anticipate the
proposed work will have a significant impact on improving NCATS Prior Approval requests
locally at our hub, but also nationally as we contribute resources and provide trainings to the
CTSA Consortium.

## Key facts

- **NIH application ID:** 10153069
- **Project number:** 3UL1TR002544-03S2
- **Recipient organization:** TUFTS UNIVERSITY BOSTON
- **Principal Investigator:** Harry P. Selker
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $229,314
- **Award type:** 3
- **Project period:** 2018-05-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10153069

## Citation

> US National Institutes of Health, RePORTER application 10153069, Tufts Clinical and Translational Science Institute (3UL1TR002544-03S2). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10153069. Licensed CC0.

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