# Methodologic Core

> **NIH NIH P30** · NORTHWESTERN UNIVERSITY · 2023 · $333,046

## Abstract

The mission of the CCCR Methodologic Core is – in the COVID era – to accelerate clinical research
in
musculoskeletal and rheumatic diseases by providing state-of-art expertise to design and develop impactful
studies and innovative interventions, and execute rigorous data collection, management, and analysis
. While
most COVID-19 impacts were negative, many responses have been positive, leading to creative solutions for
informed consent, study visits, and use of electronic health record and remote data. In the transition to a new
normal, our support of the Research Community specifically addresses vulnerable groups, e.g., early-stage
investigators (ESIs) and translational researchers without access to clinical research infrastructure. This Core
will support approaches that can be nimble in response to rapid changes and are more resilient than before the
pandemic. To advance the next generation of clinical research, we propose to catalyze the work of our
Research Community through the following aims: 1) Provide expertise in study design, methodology,
outcomes, and statistical analysis planning, a) address elements relevant to all projects (e.g., inclusion, safety,
recruitment, assessment, retention, and a priori analysis plan development) and contingency plans in a project
specific Virtual Playbook, b) work closely with the Community Advisory Board (CAB) and the Resource Core to
help users design research that incorporates patient and other stakeholders' perspectives, c) integrate, as
needed, expert input on adaptive/pragmatic study design, epidemiology, behavioral science, nutritional
science, economic evaluation, policy analysis, genomics, bioinformatics, and clinical informatics; 2) Facilitate
access to and utilization of existing disease-specific databases, registries, and clinical cohorts; 3) Promote safe
and responsible data management, a) provide access to database specialists who can advise or lead database
construction and serve as a hub to organize institutional resources for database management, b) provide
recommendations for data management, addressing complexities involved in combining different data streams
(e.g., neighborhood- and individual-level; self-reported and performance-based; data from mobile devices,
web-based interfaces, and wearable sensors), c) develop specific data flow plans and complete data
management checklists for each project; 4) Assist research teams in completing rigorous statistical analyses
that maximize the potential of study data, a) execute statistical analysis plans and collaborate with teams to
interpret results, b) support manuscript and grant development, c) refine and apply sophisticated analytic
approaches tailored to data that are the focus of the Resource Core; 5) Enhance the methodologic training
environment, a) mentor and collaborate to enhance the capabilities ESIs and established investigators, b)
provide formal educational activities and events for our Research Community and all CCCRs. This Cor...

## Key facts

- **NIH application ID:** 10708109
- **Project number:** 5P30AR072579-07
- **Recipient organization:** NORTHWESTERN UNIVERSITY
- **Principal Investigator:** Jungwha Julia Lee
- **Activity code:** P30 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $333,046
- **Award type:** 5
- **Project period:** 2017-09-19 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10708109

## Citation

> US National Institutes of Health, RePORTER application 10708109, Methodologic Core (5P30AR072579-07). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10708109. Licensed CC0.

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