# Research Design, Compliance, and Data Management Core

> **NIH NIH P20** · UNIVERSITY OF MONTANA · 2024 · $203,971

## Abstract

Research Design, Compliance, and Data Management Core Project Summary / Abstract.
Strong research design, data analysis, and study implementation expertise are key components of rigorous,
reproducible, and impactful clinical and translational (C&T) research. Large health datasets, including
electronic health records (EHR), combined with the procedures in place to ensure research is both ethical and
compliant with NIH and institutional policies, provide C&T investigators with the capability to address a wide
range of C&T research questions in a resource-efficient way. Although expertise and infrastructure are
growing, there are critical gaps in Montana in each of these areas that the Montana Clinical and Translational
Research Center (Montana CTRC), Research Design, Compliance, and Data Management (RDCD) Core is
tasked with filling. These activities are critical to address health research priorities in Montana, a rural state
with populations that experience substantial health disparities but who are underrepresented in C&T research.
The overall objective of the RDCD Core is to support Montana CTRC investigators by providing expertise and
resources in all phases of study protocol development and implementation with careful attention to adherence
to federal and institutional research policies, rules, and guidelines. With RDCD support, we hypothesize that
Montana CTRC investigators will produce rigorous and impactful research that addresses community priorities
and establishes further capacity for C&T research in Montana. IDeA-focused program resources at the
University of Montana (UM) provide an excellent platform to achieve goals and build C&T research capacity.
Within the past decade, UM has built valuable capacity through two IDeA-focused programs: the Centers of
Biomedical Research Excellence (CoBRE) Center for Population Health Research and the Montana site of the
Environmental Influences on Child Health Outcomes IDeA States Pediatric Clinical Trials Network (ECHO
ISPCTN). By collaborating closely with the Montana CTRC Cores and leveraging IDeA program-related
resources, the RDCD Core will achieve three specific aims. Aim 1: Provide Montana CTRC investigators with
the expertise needed to design and implement rigorous research protocols. Aim 2a: Leverage and enhance
existing EHR to address community, partner organization, and investigator C&T research priorities. Aim 2b:
Establish data navigation tools for clinical researchers that facilitate use of EHR and supporting datasets
relevant to health research in Montana. Aim 3: Ensure compliance with NIH and institutional policies related to
research in human participants and management of protected health information. In achieving these aims, the
RDCD Core will foster the design and conduct of high quality and impactful C&T research, support Montana
CTRC project success, and build capacity for future C&T research focused on health priorities in Montana.

## Key facts

- **NIH application ID:** 10984328
- **Project number:** 1P20GM155895-01
- **Recipient organization:** UNIVERSITY OF MONTANA
- **Principal Investigator:** Erin O'Brien Semmens
- **Activity code:** P20 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $203,971
- **Award type:** 1
- **Project period:** 2024-09-01 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10984328

## Citation

> US National Institutes of Health, RePORTER application 10984328, Research Design, Compliance, and Data Management Core (1P20GM155895-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10984328. Licensed CC0.

---

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