# Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Data Coordinating Center (DCC)

> **NIH NIH U24** · MEDICAL UNIVERSITY OF SOUTH CAROLINA · 2020 · $343,467

## Abstract

Emergency care often determines the patient outcome as it is critical to make accurate and timely
diagnoses and interventions during the early stages of the injury or disease. The Strategies to Innovate
EmeRgENcy Care Clinical Trials Network (SIREN) was created by the NIH to enable the investigation of
different emergency care treatments spanning across organ systems and diseases without duplication of effort,
thereby minimizing start-up costs and promoting economies of scale. The purpose of the Data Coordinating
Center (DCC) for SIREN is to provide a comprehensive data management and statistical infrastructure to
support the network's goal of conducting high quality clinical trials that will improve outcomes for patients with
neurologic (not including stroke), cardiac, respiratory, hematologic and trauma emergency events.
 The DCC's role is to establish a collaborative relationship with all parties involved in the Network and
provide efficient and standardized central data management that yields high quality data, provide statistical
support in the planning and execution of the clinical trials, prepare and disseminate trial reports for the various
stakeholders and facilitate data sharing by participating in manuscript and presentation preparation as well as
the timely submission of public use datasets. To this end, the Data Coordination Unit (DCU) at the Medical
University of South Carolina has developed a web-based comprehensive integrated data and project
management system, WebDCU™, that enables distributed data entry from the participating clinical sites with
extensive data quality control. It also provides the necessary tools to efficiently manage operational activities
across multiple trials, while ensuring compliance with FDA regulations and guidelines. Using the WebDCU
system, we will develop, implement and maintain a central database that streamlines and maximizes efficiency
in the management of data collection, processing, and monitoring of clinical data. In addition, the WebDCU™
will incorporate trial management information that will provide full support for all study operational activities in
SIREN. In collaboration with the individual study Principal Investigator and our partners of SIREN (CCC, Hubs,
Governance Committees), the DCU will: contribute to the innovative and efficient protocol development
(including study design and case report form development); oversee data quality; generate reports for the
DSMB, regulatory parties and the study teams; conduct interim and final analysis and dissemination of study
results via presentations and publications; and create public use datasets for data sharing.

## Key facts

- **NIH application ID:** 9976602
- **Project number:** 5U24NS100655-04
- **Recipient organization:** MEDICAL UNIVERSITY OF SOUTH CAROLINA
- **Principal Investigator:** VALERIE L DURKALSKI
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $343,467
- **Award type:** 5
- **Project period:** 2017-07-15 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9976602

## Citation

> US National Institutes of Health, RePORTER application 9976602, Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Data Coordinating Center (DCC) (5U24NS100655-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9976602. Licensed CC0.

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