# Core-004

> **NIH NIH UL1** · OREGON HEALTH & SCIENCE UNIVERSITY · 2021 · $700,773

## Abstract

The Research Methods section comprises two components focused on planning, operationalizing, and
implementing high quality Clinical and Translational Research (CTR) at OHSU and partnering institutions:
Biostatistics, Epidemiology and Research Design (BERD), and Regulatory Knowledge and support (RKS). In
OCTRI 2.0, each of these components has well-articulated goals, accompanied by relevant specific aims to
accomplish those goals. All the Research Methods aims are well aligned with the overarching aims for OCTRI;
contributions for each of the modules toward achievement of those aims will be measured and evaluated. Both
components capitalize on achievements in the prior OCTRI funding cycles, and leverage activities of
successful units that are essential to the OHSU infrastructure (in particular the Biostatistics & Design Program
[BDP] and the Office of Clinical Research), to ensure efficient and timely progress toward goals.
In recent years, great strides have been made tackling CTR challenges; however, the studies of complex
systems requires innovative methodologies and processes to effectively and efficiently translate discoveries
into interventions to improve health. Indispensable to the success of CTR are considerations in the areas of
research ethics, study design, data analyses, and interpretation. Thus, Cores dedicated to planning,
operationalizing, and implementing high quality CTR at OHSU are essential for achieving the overarching
goals of OCTRI 2.0. Responding to the challenges put forth in the IOM report to drive innovation in CTR,
OCTRI’s Biostatistics, Epidemiology and Research Design component (OCTRI-BERD) proposes initiatives
aimed at fostering methodology development, providing flexible personalized training experiences, and
promoting professional development of BERD practitioners. In addition, OCTRI-BERD will further enhance the
provision of collaborative and consultative services offered through our Biostatistics University Shared
Resource, Biostatistics & Design Program. The Regulatory Knowledge and Support component proposes
initiatives aimed at delivery of regulatory consultations services, training the workforce in human subjects’
protections, and alleviating regulatory-related bottlenecks in CTR. These efforts will further OCTRI’s missions
and catalyze CTR regionally and throughout the CTSA network.

## Key facts

- **NIH application ID:** 10198073
- **Project number:** 5UL1TR002369-05
- **Recipient organization:** OREGON HEALTH & SCIENCE UNIVERSITY
- **Principal Investigator:** David Hoadley Ellison
- **Activity code:** UL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $700,773
- **Award type:** 5
- **Project period:** 2017-09-02 → 2022-08-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10198073

## Citation

> US National Institutes of Health, RePORTER application 10198073, Core-004 (5UL1TR002369-05). Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/grant/nih/10198073. Licensed CC0.

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