# NIH Prior Approval Process Professional

> **NIH NIH UL1** · UNIVERSITY OF COLORADO DENVER · 2020 · $91,829

## Abstract

PROJECT SUMMARY/ABSTRACT
The Colorado Clinical and Translational Sciences Institute (CCTSI) provides a wide variety of
resources, education and training, personnel, quality improvement, regulatory support and
funding opportunities for faculty and trainees at all of the partner institutions. Two of the major
objectives of the parent UL1 NIH CTSA award are to 1) support investigator initiated translational
research in the form of funding pilot grant projects and to 2) support junior investigator career
development through the CTSA KL2 program. Both CCTSI programs involve funding of human
subject and vertebrate animal research subject to the NIH delay onset prior approval policy.
Supplemental funds requested in this proposal will support the efforts of an experienced
regulatory professional who will be dedicated to work directly with investigators to prepare and
submit the required prior approval documentation to NCATS for their projects. With this
administrative supplement funding, the CCTSI will recruit and appoint a new .75 FTE (9 calendar
months) QA/QC NIH prior approval professional with experience in human subjects and animal
research regulations and familiarity with CU-Anschutz institutional policies and procedures, as
well as ClinicalTrials.gov. and other federal policies. The dedicated professional will have
familiarity with the concepts of quality assurance, quality control, and process improvement. This
individual will be responsible for understanding the regulatory environment governing human
subject and vertebrate animal research and the documentation required for scientific evaluation
and regulatory approval of such proposed research. The QA/QC NIH prior approval professional
will understand the NIH /NCATS processes and electronic systems used to submit proposals for
review and approval. This professional will also initiate improved training of researchers at our
institution regarding NIH requirements for prior approval. Dedicating effort specifically to the
management of the NIH delayed onset prior approval processes at the Colorado CTSA hub will
address the shortcomings identified by NCATS in many of the proposals being submitted for
approval: 1) Inaccurate/incomplete HSS fields; 2) Incomplete submissions (missing, inaccurate,
or inconsistent documents; inadequate information); 3) Overall quality of the materials; and 4)
Adherence to NIH and NCATS policies. Successful implementation of this position will create
efficiencies in the system, reduce overall errors, and decrease the cost of preparing and reviewing
applications.

## Key facts

- **NIH application ID:** 10158652
- **Project number:** 3UL1TR002535-03S1
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** RONALD J. SOKOL
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $91,829
- **Award type:** 3
- **Project period:** 2018-05-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10158652

## Citation

> US National Institutes of Health, RePORTER application 10158652, NIH Prior Approval Process Professional (3UL1TR002535-03S1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10158652. Licensed CC0.

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