# HEAL ERN: Data Coordinating Resource Center

> **NIH NIH U24** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2024 · $3,350,650

## Abstract

Project Summary
 The NIH created the Helping to End Addiction Long-term (HEAL) initiative to speed scientiﬁc solutions to the
national opioid public health crisis. As part of the HEAL initiative, the HEAL Effectiveness Research Network
(ERN) was established to conduct comparative effectiveness trials for prevention and management of pain, while
reducing risk of addiction. Five ERN trials have been implemented with data coordination support from the
University of Utah Trial Innovation Center. This proposal is written in response to RFA-TR-22-012 to provide
continued support for these ﬁve trials, as well as two additional trials that may be funded in response to RFA-AT-22-
005 (“HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness
Research Network Cooperative Agreement”). The University of Utah is responding to be the Data Coordination
Resource Center (DCRC).
 We will continue to work collaboratively with each ERN study team and the other HEAL ERN Resource
Centers to 1) develop, implementand monitor the ERN trials; 2) help respond to issues/protocol changes that
emerge during trial implementation and initiate timely necessary changes to assure trial success; 3) provide
collection and analysis of data; and 4) assist with timely publication of study results.
 Our application has three Speciﬁc Aims: 1. Work with ERN investigators and other HEAL ERN Resource
Centers to provide collaborative clinical trial expertise and assistance in study and protocol design, single IRB,
study implementation and management, accrual of subjects, interim study reporting, ﬁnal study analyses, and
assistance with timely publication and dissemination of study results. 2. Provide comprehensive data manage-
ment for current and new ERN trials, including database and data collection systems, data management plans,
data risk assessment and quality control, implementation of randomization, assistance with Data Safety Monitor-
ing Board (DSMB) reports, and training for using the data collection systems. 3. Facilitate sharing of data from
HEAL/ERN trials by incorporating HEAL Common Data Elements(CDEs) into protocols, continuing to support
NIH program staff in development of HEAL CDEs, continued participation in the HEAL Collective Board, and
preparation of ﬁnal data sets suitable for deposit in NIH-designated repositories for incorporation into the HEAL
Data Ecosystem.
 Our collaboration with ERN investigators and integration with the other Resource Centers will maximize the
likelihood of successful and timely completion of the HEAL ERN clinical trials, leading to translation of research
ﬁndings to the effective management of acute and chronic pain, while minimizing addictive opioid dosing regi-
mens.

## Key facts

- **NIH application ID:** 10909920
- **Project number:** 5U24TR004315-03
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** Jamie P. Dwyer
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $3,350,650
- **Award type:** 5
- **Project period:** 2022-09-23 → 2027-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10909920

## Citation

> US National Institutes of Health, RePORTER application 10909920, HEAL ERN: Data Coordinating Resource Center (5U24TR004315-03). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10909920. Licensed CC0.

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