Opportunity Information: Apply for RFA NS 22 013
This NIH funding opportunity (RFA-NS-22-013) is a limited competition cooperative agreement (U24; clinical trial not allowed) to support the Data Coordinating Center (DCC) for the Strategies to Innovate EmeRgENcy Care Clinical Trials Network, known as SIREN. The overall goal of SIREN is to make it feasible to run high-quality, multi-site, real-world clinical trials in emergency care environments, specifically targeting urgent neurologic, cardiac, respiratory, hematologic, and trauma events. In practical terms, the network is designed to improve patient outcomes in situations where care is time-sensitive and difficult to study, such as in the emergency department and pre-hospital settings like EMS.
SIREN is structured as a coordinated national network with three main components: one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC), and up to 10 clinical centers referred to as Hubs. The DCC being solicited under this announcement functions as the central backbone for the network's data and analytics operations. Its core responsibilities include building and maintaining the systems and processes for study data capture and management, ensuring data quality and integrity across participating sites, conducting statistical planning and analyses, and supporting safety oversight through Data Safety Monitoring Board (DSMB) operations. The DCC is also expected to handle reporting obligations to regulatory and oversight bodies, meaning it serves as a key interface for compliance-focused documentation and standardized reporting across the network.
A central expectation of the SIREN program is the execution of at least four large, simple, pragmatic clinical trials, each enrolling roughly 1,000 patients, conducted in emergency department and pre-hospital environments. These trials are intended to be practical and scalable, emphasizing streamlined protocols and real-world implementation rather than highly specialized or narrowly controlled studies. Importantly, the individual clinical trial projects themselves are not funded under this specific DCC announcement; instead, they are described as meritorious, peer-reviewed studies that will be competed and awarded under separate funding announcements. The DCC awardee must therefore be prepared to support multiple trials over time that may vary in clinical focus but share the operational constraints and fast-paced decision-making typical of emergency care research.
From an administrative standpoint, this opportunity is a cooperative agreement, which generally means NIH anticipates substantial scientific and programmatic involvement in the conduct of the award compared to a standard grant. The activity category is health, and the opportunity references multiple CFDA numbers (93.233, 93.837, 93.838, 93.839, 93.840, 93.853), reflecting its alignment with NIH institutes and programs involved in emergency and acute care research domains. The listed eligible applicant type includes public and state-controlled institutions of higher education, and the announcement explicitly restricts foreign involvement: non-U.S. institutions may not apply, non-U.S. components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.
Key dates and funding parameters provided in the source data include an original closing date of January 18, 2022, and an award ceiling of $290,000 (as presented in the extracted listing). The opportunity was created on November 19, 2021. Applicants considering this FOA would need to focus their proposal on demonstrating the capacity to serve as a high-functioning coordinating center for a complex, multi-site emergency care trials network, with strong infrastructure for data systems, statistical leadership, DSMB and safety monitoring support, and reliable regulatory reporting, all tailored to the operational realities of emergency and pre-hospital research.Apply for RFA NS 22 013
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Data Coordinating Center (DCC) (U24 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840, 93.853.
- This funding opportunity was created on 2021-11-19.
- Applicants must submit their applications by 2022-01-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $290,000.00 in funding.
- Eligible applicants include: Public and State controlled institutions of higher education.
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Frequently Asked Questions (FAQs)
What is the funding opportunity number and what is being offered?
This NIH funding opportunity is RFA-NS-22-013. It supports a limited competition cooperative agreement (U24; clinical trial not allowed) to establish and operate the Data Coordinating Center (DCC) for the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN).
What is SIREN, and what is its overall purpose?
SIREN is a coordinated national network designed to make it feasible to run high-quality, multi-site, real-world clinical trials in emergency care settings. Its purpose is to improve patient outcomes for time-sensitive and difficult-to-study urgent events, including neurologic, cardiac, respiratory, hematologic, and trauma emergencies, across emergency departments and pre-hospital environments such as EMS.
What component of SIREN is funded under this announcement?
This announcement funds the Data Coordinating Center (DCC), which serves as the central backbone for SIREN's data and analytics operations.
How is the SIREN network structured?
SIREN is structured with three main components: one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC), and up to 10 clinical centers referred to as Hubs.
What are the core responsibilities of the DCC?
The DCC is expected to: build and maintain systems and processes for study data capture and management; ensure data quality and integrity across participating sites; conduct statistical planning and analyses; support safety oversight through Data Safety Monitoring Board (DSMB) operations; and handle reporting obligations to regulatory and oversight bodies, serving as an interface for compliance-focused documentation and standardized reporting across the network.
Is this opportunity intended to fund clinical trials directly?
No. The DCC award under this specific announcement does not fund the individual clinical trial projects themselves. The trials are described as meritorious, peer-reviewed studies that will be competed and awarded under separate funding announcements. The DCC must be prepared to support multiple trials over time once those separate awards are made.
What kinds of trials is SIREN expected to execute?
A central expectation of the SIREN program is the execution of at least four large, simple, pragmatic clinical trials. Each trial is expected to enroll roughly 1,000 patients and be conducted in emergency department and pre-hospital environments.
What does "large, simple, pragmatic" imply for these trials?
Based on the description provided, the trials are intended to be practical and scalable, emphasizing streamlined protocols and real-world implementation rather than highly specialized or narrowly controlled studies, while still being high-quality and multi-site.
What clinical areas does SIREN focus on?
SIREN specifically targets urgent neurologic, cardiac, respiratory, hematologic, and trauma events in time-sensitive emergency care contexts.
What settings are emphasized for SIREN research?
SIREN is built to support research in emergency departments and pre-hospital settings such as EMS, where care is time-sensitive and research can be operationally challenging.
What does it mean that this is a cooperative agreement (U24)?
This is a cooperative agreement, meaning NIH anticipates substantial scientific and programmatic involvement in how the award is conducted compared to a standard grant mechanism.
Are clinical trials allowed under this DCC award?
No. The mechanism is described as U24; clinical trial not allowed, indicating the award is for coordinating center functions rather than conducting a clinical trial as the funded activity under this award.
Who is eligible to apply based on the information provided?
The eligible applicant type listed includes public and state-controlled institutions of higher education.
Are foreign institutions or foreign components allowed?
No. The announcement explicitly restricts foreign involvement: non-U.S. institutions may not apply; non-U.S. components of U.S. organizations are not eligible; and foreign components (as defined by NIH policy) are not allowed.
What is meant by "limited competition" in this context?
The opportunity is described as a limited competition. Based on the information provided only, this indicates the competition is restricted rather than fully open, though the specific restriction criteria are not detailed in the provided description.
What is the activity category for this opportunity?
The activity category is health.
Which CFDA numbers are associated with this opportunity?
The opportunity references multiple CFDA numbers: 93.233, 93.837, 93.838, 93.839, 93.840, and 93.853.
What is the award ceiling listed for this opportunity?
The extracted listing presents an award ceiling of $290,000.
What are the key dates mentioned?
The opportunity was created on November 19, 2021, and the original closing date is listed as January 18, 2022.
What should applicants emphasize in a proposal for the DCC?
Applicants should focus on demonstrating capacity to serve as a high-functioning coordinating center for a complex, multi-site emergency care trials network, including strong infrastructure for data systems, statistical leadership, DSMB and safety monitoring support, and reliable regulatory/oversight reporting tailored to emergency and pre-hospital research realities.
Why is the DCC considered central to the network?
The DCC is described as the central backbone for data and analytics operations and is responsible for core cross-network functions like data capture/management, quality and integrity, statistical planning/analysis, safety oversight support, and standardized reporting to oversight bodies.
Will the DCC need to support multiple trials over time?
Yes. The DCC awardee must be prepared to support multiple trials over time that may vary in clinical focus but share common operational constraints typical of emergency care research.
What types of reporting and oversight support are expected from the DCC?
The DCC is expected to support DSMB operations for safety oversight and handle reporting obligations to regulatory and oversight bodies, serving as a key interface for compliance documentation and standardized reporting across the network.
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