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Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Data Coordinating Center

Award Number: U24NS100655
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Emergency care often determines the patient outcome as it is critical to make accurate, 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, cardiac, respiratory, hematologic and trauma emergency events. This renewal application, in response to RFA-NS-22-013, describes the features, functions and coordination we will continue to provide as the DCC for the SIREN Network. 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. 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. The DCU 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 have developed, implemented and maintained a central database that streamlines and maximizes efficiency in the management of data collection, processing, and monitoring of clinical data. In addition, the WebDCU™ incorporates trial management information that provides 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 continue to: 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. SIREN initiated 5 large, simple multicenter trials over the previous 5 year grant period and will initiate at least 4 more in the next grant period. The network aims to transform the emergency research enterprise, by exploring innovations in clinical trial designs, by better and earlier engagement of patient stakeholders in trial planning, and by creative improvements in implementing and performing trials.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	7	11/1/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $419,635 )
2024	2024	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	004	7	4/10/2024	NON-COMPETING CONTINUATION	$30,284
2024	2024	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	7	1/31/2024	NON-COMPETING CONTINUATION	$389,351
2024	2023	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	6	12/22/2023	COMPETING CONTINUATION	$0
2024	2023	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	6	1/23/2024	COMPETING CONTINUATION	$181,829
2024	2021	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	5	1/23/2024	NON-COMPETING CONTINUATION	-$181,829
														Subtotal = $419,635

Issue Date FY: 2023 ( Subtotal = $433,820 )
2023	2023	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	6	1/27/2023	COMPETING CONTINUATION	$433,820
2023	2021	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	1/26/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $433,820

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	5	5/18/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $343,467 )
2021	2021	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	003	5	5/25/2021	NON-COMPETING CONTINUATION	$343,467
2021	2020	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	4	10/30/2020	NON-COMPETING CONTINUATION	$0
2021	2020	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	002	4	4/16/2021	NON-COMPETING CONTINUATION	$0
2021	2019	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	3	4/13/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $343,467

Issue Date FY: 2020 ( Subtotal = $343,467 )
2020	2020	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	4	5/22/2020	NON-COMPETING CONTINUATION	$343,467
2020	2019	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	12/11/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $343,467

Issue Date FY: 2019 ( Subtotal = $694,228 )
2019	2019	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	7/11/2019	NON-COMPETING CONTINUATION	$694,228
														Subtotal = $694,228

Issue Date FY: 2018 ( Subtotal = $718,401 )
2018	2018	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	5/31/2018	NON-COMPETING CONTINUATION	$368,401
2018	2018	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	2	9/20/2018	SUPPLEMENT FOR EXPANSION	$350,000
														Subtotal = $718,401

Issue Date FY: 2017 ( Subtotal = $642,850 )
2017	2017	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	7/19/2017	NEW	$0
2017	2017	MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	7/6/2017	NEW	$642,850
														Subtotal = $642,850

Grand Total All Awards = $3,595,868

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Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Data Coordinating Center

Award Number: U24NS100655

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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