Opportunity Information: Apply for RFA NS 16 015
Apply for RFA NS 16 015
- The HHS-NIH11 in the health sector is offering a public funding opportunity titled "Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) - Data Coordinating Center (DCC) (U24)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.837, 93.838, 93.839, 93.853.
- This funding opportunity was created on Mar 09, 2016 and posted on Mar 09, 2016.
- Applicants must submit their applications by Jun 01, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
This funding opportunity (RFA NS 16 015) is a National Institutes of Health cooperative agreement (U24) to support a single Data Coordinating Center (DCC) for the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). The overall goal of SIREN is to make it easier to run high-quality, multi-site emergency care clinical trials that can directly improve outcomes for patients experiencing time-critical events, including neurologic, cardiac, respiratory, hematologic, and trauma emergencies. The network is structured to operate at scale across real-world emergency department and pre-hospital environments, where rapid decision-making, variable workflows, and tight time windows often make traditional clinical trial approaches difficult.
SIREN is designed as a coordinated national infrastructure with three main components: one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC), and up to 10 clinical centers referred to as Hubs. Within that structure, the DCC is the central operational and scientific backbone for trial data and analytics. Its responsibilities include building and running the network-wide data management systems, ensuring data quality and integrity, conducting statistical analyses, supporting and coordinating Data Safety Monitoring Board(s) (DSMB) activities, and preparing the reporting required for regulatory and oversight bodies. In practice, this means the DCC is expected to create standardized processes and tools that allow multiple sites to collect comparable data, transmit it reliably, monitor it continuously, and analyze it in a way that produces credible, actionable results.
A key emphasis of the network is implementation of at least four large, simple, pragmatic clinical trials, each targeting around 1,000 patients. These studies are intended to be conducted in emergency department and pre-hospital settings, reflecting the real-world conditions where emergency interventions are delivered. The trials themselves are not funded under this particular announcement; instead, they will be peer-reviewed, stand-alone projects awarded through separate funding announcements. The DCC, however, must be prepared to support these trials end-to-end from a data and statistical perspective, including protocol-level data planning, database development, data capture and validation, interim monitoring and safety oversight support, and final analyses and reporting.
The award is offered as a cooperative agreement, which signals substantial scientific and programmatic involvement by NIH staff during the project. Rather than operating in isolation, the DCC is expected to work closely with NIH and with the CCC and Hubs to develop common standards, coordinate timelines, and ensure consistent execution across sites. This cooperative structure is particularly important for emergency care trials because they often require harmonized approaches to consent (when applicable), rapid enrollment, integration with EMS and hospital workflows, and careful monitoring of safety and protocol adherence in fast-moving clinical situations.
Eligibility for the opportunity is broad and includes a wide range of organizations that can credibly operate a national-level coordinating center. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; and other entities as described in the announcement’s additional eligibility information. The sponsoring agency is HHS/NIH, and the relevant CFDA program numbers listed are 93.837, 93.838, 93.839, and 93.853, reflecting NIH programs aligned with heart, lung, blood, neurologic, and related emergency care research areas.
Administratively, the opportunity was posted March 9, 2016, created the same date, and had a closing date of June 1, 2016. NIH anticipated making one award, consistent with the intent to fund a single DCC that serves as the centralized data and statistical core for the entire SIREN network. The award ceiling was not specified in the provided summary, but the scope implies support sufficient to build and maintain enterprise-grade coordinating infrastructure capable of handling multiple large pragmatic trials across numerous emergency care sites.
Frequently Asked Questions (FAQs)
What is this funding opportunity?
This opportunity (RFA NS 16 015) is a National Institutes of Health (NIH) cooperative agreement (U24) to support a single Data Coordinating Center (DCC) for the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN).
Who is the sponsoring agency?
The sponsoring agency is HHS/NIH (U.S. Department of Health and Human Services / National Institutes of Health).
What is SIREN and what is its overall goal?
SIREN is a national clinical trials infrastructure designed to make it easier to run high-quality, multi-site emergency care clinical trials that can directly improve outcomes for patients experiencing time-critical events, including neurologic, cardiac, respiratory, hematologic, and trauma emergencies.
Why is SIREN focused on emergency department and pre-hospital settings?
SIREN is designed to operate in real-world emergency department and pre-hospital environments where rapid decision-making, variable workflows, and tight time windows can make traditional clinical trial approaches difficult.
What type of award is this and what does that mean for NIH involvement?
This is a cooperative agreement (U24), which indicates substantial scientific and programmatic involvement by NIH staff during the project. The DCC is expected to work closely with NIH and with the other SIREN components to develop common standards, coordinate timelines, and ensure consistent execution across sites.
How is the SIREN network structured?
SIREN has three main components: one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC), and up to 10 clinical centers referred to as Hubs.
What is being funded under this announcement?
This announcement funds the Data Coordinating Center (DCC) as the centralized data and statistical core for the entire SIREN network.
How many awards did NIH anticipate making?
NIH anticipated making one award, consistent with funding a single DCC to serve the entire SIREN network.
Are the clinical trials themselves funded under this announcement?
No. The large pragmatic clinical trials to be conducted within SIREN are not funded under this announcement. Those trials are expected to be peer-reviewed, stand-alone projects awarded through separate funding announcements.
How many trials is SIREN expected to implement, and how large are they?
SIREN emphasizes implementation of at least four large, simple, pragmatic clinical trials, each targeting around 1,000 patients.
What kinds of emergencies are within scope for SIREN trials?
The network is intended to support trials that can improve outcomes for time-critical events including neurologic, cardiac, respiratory, hematologic, and trauma emergencies.
What is the role of the Data Coordinating Center (DCC) within SIREN?
The DCC serves as the central operational and scientific backbone for trial data and analytics across the network. It is responsible for network-wide data management systems, data quality and integrity, statistical analyses, DSMB support and coordination, and reporting for regulatory and oversight bodies.
What specific data system responsibilities are described for the DCC?
The DCC is expected to build and run network-wide data management systems and create standardized processes and tools that allow multiple sites to collect comparable data, transmit it reliably, monitor it continuously, and analyze it to produce credible and actionable results.
What does the DCC do related to data quality and integrity?
The DCC is responsible for ensuring data quality and integrity across the network, including continuous monitoring and validation so that data collected across multiple sites remain consistent and reliable for analysis.
What statistical responsibilities does the DCC have?
The DCC is expected to conduct statistical analyses for network trials and be prepared to support trials end-to-end from a data and statistical perspective, including interim monitoring and final analyses and reporting.
What is the DCC expected to do for DSMB activities?
The DCC is expected to support and coordinate Data Safety Monitoring Board(s) (DSMB) activities as part of safety oversight and interim monitoring.
What reporting is the DCC expected to prepare?
The DCC is expected to prepare reporting required for regulatory and oversight bodies, as described in the opportunity summary.
At what stages of a trial is the DCC expected to provide support?
The DCC is expected to support trials end-to-end from a data and statistical perspective, including protocol-level data planning, database development, data capture and validation, interim monitoring and safety oversight support, and final analyses and reporting.
How does the cooperative structure affect how the DCC works with other SIREN components?
The DCC is expected to work closely with NIH, the CCC, and the Hubs to develop common standards, coordinate timelines, and ensure consistent execution across multiple sites.
What operational challenges in emergency care trials does SIREN aim to address?
The network is designed to address challenges such as rapid enrollment, integration with EMS and hospital workflows, variable workflows across sites, tight time windows, and the need for careful monitoring of safety and protocol adherence in fast-moving clinical situations.
Who is eligible to apply?
Eligibility is broad and includes state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; and other entities as described in the announcement’s additional eligibility information.
What CFDA program numbers are associated with this opportunity?
The CFDA program numbers listed are 93.837, 93.838, 93.839, and 93.853.
When was the opportunity posted and when did it close?
The opportunity was posted March 9, 2016 (and created the same date). The closing date was June 1, 2016.
Is an award ceiling specified in the provided summary?
No. The award ceiling was not specified in the provided summary.
What does the scope imply about the DCC capacity needed?
Based on the summary, the scope implies support sufficient to build and maintain enterprise-grade coordinating infrastructure capable of handling multiple large pragmatic trials across numerous emergency care sites.
How many clinical sites (Hubs) can be part of SIREN?
The network can include up to 10 clinical centers referred to as Hubs.
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