# Core-004

> **NIH NIH UL1** · UNIVERSITY OF COLORADO DENVER · 2022 · $877,616

## Abstract

The Research Methods Program is constructed to support with innovative solutions the design, analysis, ethics,
and regulatory challenges that face clinical and translational research (CTR) teams in the complex ecosystem
in which CTR research is now conducted. The Research Methods Program is comprised of two Cores: 1) the
Biostatistics, Epidemiology and Research Design (BERD) core and 2) the Regulatory Knowledge and
Support (RKS) core. This program will build upon, share leadership with and collaborate with the corresponding
campus-wide infrastructure programs, extending the reach and impact of the CCTSI by leveraging other campus
resources to transform our CTR research enterprise. BERD and RKS programs will have co-created activities
(Aim 1) that will form a seamless resource for new study design and start-up support for our investigators. The
BERD and RKS programs have also identified specific barriers to translation and will develop solutions for
removing these barriers, demonstrate the efficacy of these new solutions and disseminate our best practices
both within our institution and to the CTSA Consortium (Aims 2-5). The Research Methods goals will be achieved
through the following Specific Aims: Aim 1: Develop a multidisciplinary Study Jump-Start Clinic to improve the
design and analysis rigor and ensure that ethics and regulatory aspects are responsibly addressed in clinical
and translational research. Aim 2: Develop and disseminate new Methodologies for data analysis including
development of new software. Aim 3: Develop and promote innovative training and educational resources to
encourage rigorous and reproducible designs and analyses in clinical and translational research. Aim 4: Promote
an efficient, responsible and safe research environment across the lifespan of each study and facilitate
improvements in the research enterprise to promote: Efficiency, Quality, and Ethics. Aim 5: Develop, adapt and
disseminate innovative research tools using a regulatory science framework to promote competency. Innovative
aspects of this program are an efficient approach to getting investigators together with critical team members
prior to submitting a proposal for review, a software development team to enhance analysis methods
dissemination, a novel research results dissemination tool kit focused on improving the rate at which study teams
provide study results to participants. In addition, BERD and RKS, as our Research Methods Program, will
facilitate interactions with the Informatics, Ethics, Community Engagement & Research (CE&R) and TIN Liaison
Team to assist investigators in optimal use of these resources. The overall result will be an efficient system to
enhance research design and analysis and to accelerate the efficiency of the design-to-implementation phase
of the translational research process. Successful completion of the aims will transform the clinical and
translational landscape, improve the research rigor, and create innovative solutions t...

## Key facts

- **NIH application ID:** 10414771
- **Project number:** 5UL1TR002535-05
- **Recipient organization:** UNIVERSITY OF COLORADO DENVER
- **Principal Investigator:** RONALD J. SOKOL
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $877,616
- **Award type:** 5
- **Project period:** 2018-05-01 → 2023-11-15

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10414771

## Citation

> US National Institutes of Health, RePORTER application 10414771, Core-004 (5UL1TR002535-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10414771. Licensed CC0.

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