# Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval Process

> **NIH NIH UL1** · INDIANA UNIVERSITY INDIANAPOLIS · 2020 · $114,838

## Abstract

PROJECT SUMMARY
The NCATS Human Subjects Research (HSR) Prior Approval (PA) process for KL2 Scholar
Projects and certain Pilot Projects has been challenging for CTSA institutions to navigate. The
Indiana CTSI will create a dedicated Quality Assurance/Quality Control (QA/QC) Project
Manager role to improve quality and facilitate the HSRPA process. The long-term goal is to
improve the quality of human subjects research submissions, make the overall process more
efficient, and provide quality assurance for the ongoing conduct of research at the Indiana CTSI,
with a particular emphasis on young investigators. The objectives are to decrease the review
timeline from the time of award to study startup by supporting the education of young
investigators and to ensure research conducted is at the highest quality so that important clinical
research discoveries can positively impact patient outcomes more quickly. The specific aims are
to: (1) Create a dedicated QA/QC position within the Indiana CTSI to perform quality reviews of
CTSA-related submissions to NCATS, submit to the HSS, and manage the overall process; (2)
Support applications by interfacing with KL2 Scholars and Pilot Project awardees throughout the
IRB submission process; (3) Monitor funded projects once approved to ensure data quality and
compliance; and (4) Offer QA/QC support to other K-funded young investigators. Accomplishing
the above aims will enable measurable improvements in all stages of the HSRPA process and
study conduct for KL2 Scholar Projects and certain Pilot Projects. In particular, individualized
support to young investigators throughout their project will greatly enhance their training and
preparation for a productive career in clinical research.

## Key facts

- **NIH application ID:** 10157125
- **Project number:** 3UL1TR002529-03S1
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Sharon M Moe
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $114,838
- **Award type:** 3
- **Project period:** 2020-07-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10157125

## Citation

> US National Institutes of Health, RePORTER application 10157125, Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval Process (3UL1TR002529-03S1). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10157125. Licensed CC0.

---

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