# Core-005

> **NIH NIH UL1** · UNIVERSITY OF COLORADO DENVER · 2020 · $2,026,280

## Abstract

The goal of the Hub Research Capacity program of the CCTSI is to support clinical and translational research
(CTR) that engages diverse communities in projects conducted by investigators from a broad spectrum of
disciplines across the CCTSI affiliated institutions. As outlined in the FOA, this component includes cores
focused on Integrating Special Populations (ISP) and Participant and Clinical Interactions (PCI). The ISP
core will build on and expand the extensive existing resources and adopt new strategies to engage volunteers
in research, with an overarching goal of ensuring appropriate inclusion by age, sex, gender, race, and ethnicity,
and from underserved communities. This will be accomplished through the following Specific Aims: Aim 1:
ensure that infants, children, and adolescents continue to be an important focus of CTR within the CCTSI by
supporting research on both common and rare childhood diseases. Aim 2: evaluate and promote the appropriate
inclusion of older adults in CTR and raise awareness of age bias in research. Aim 3: develop a standardized
approach for monitoring recruitment success in CTR protocols and strategies to enhance the inclusion of
underrepresented minorities. Examples of the approaches to accomplish these aims include: engaging Patient
and Advocacy Groups to assist with study design and patient recruitment; supporting research networks focused
on improving care for the most vulnerable elderly; and expanding resources, such as tele-technology, to connect
with hard-to-reach populations. The PCI core will focus its efforts on improving infrastructure and processes that
enhance the safety, efficiency, and merit of CTR. This will be accomplished through the following specific aims:
Aim 4: implement OnCore, a Clinical Research Management System, for all CTR protocols that involve more
than minimal risk to human subjects to improve tracking and evaluation of benchmarks of success. Aim 5:
develop the PCI Management Program, which will provide oversight of centralized research facilities and staff
and expand resources to improve the safety, efficiency, and merit of CTR. Aim 6: ensure the high quality and
scientific impact of the CTR portfolio through rigorous review of scientific merit, monitoring of protocol
benchmarks of success, and tracking of dissemination of results. Examples of the approaches to accomplish
these aims include: centralize the management of protocol documents for coordinated reviews by the Scientific
Advisory and Review Committee, Colorado Multiple Institutional Review Board, and other entities; expand the
pool of centrally-trained and –managed research personnel under a fee-for-service model, including research
coordinators, budget specialists, and regulatory specialists; and utilize OnCore to monitor protocol-specific
benchmarks of success in participant accrual and retention, compliance to the protocol, and safety. The Hub
Research Capacity component of the CCTSI is fully committed to building infras...

## Key facts

- **NIH application ID:** 10142898
- **Project number:** 5UL1TR002535-03
- **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:** $2,026,280
- **Award type:** 5
- **Project period:** — → —

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10142898

## Citation

> US National Institutes of Health, RePORTER application 10142898, Core-005 (5UL1TR002535-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10142898. Licensed CC0.

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