Opportunity Information: Apply for RFA AI 19 002
The HIV/AIDS Clinical Trials Networks Statistical and Data Management Centers (SDMC) opportunity (RFA-AI-19-002) is a National Institutes of Health (NIH) funding announcement that supports the creation or continuation of specialized centers responsible for the statistical and data management backbone of NIAID-supported HIV/AIDS clinical trials networks. The core aim is to fund SDMCs that can provide leadership, coordination, and operational support for the design, conduct, monitoring, and analysis of complex, multi-site HIV/AIDS clinical trials. In practical terms, these centers serve as the hub for trial data: they help shape statistical approaches, ensure data are collected and stored correctly, maintain high data quality, and produce reliable analyses that networks can use to make scientifically and clinically meaningful conclusions.
This award is offered as a cooperative agreement (UM1), which typically means the NIH expects substantial programmatic involvement with the awardee rather than a hands-off grant relationship. The "Clinical Trial Required" designation signals that the work supported under the award is directly tied to ongoing or planned clinical trials activity within the HIV/AIDS clinical trials networks. The SDMC role is not limited to routine database work; it is positioned as a leadership function that is "critical" to network success, implying responsibility for developing and harmonizing standards across studies, supporting protocol development with statistical input, coordinating data flow from clinical sites, and ensuring that the network can meet regulatory, ethical, and scientific expectations for human subjects research.
The applicant pool is broad and includes many types of U.S.-based organizations and governments. Eligible applicants listed include state, county, city or township governments, special district governments, and independent school districts, as well as public and state-controlled institutions of higher education and private institutions of higher education. The FOA also allows federally recognized Native American tribal governments and other Native American tribal organizations, public housing authorities/Indian housing authorities, and a range of nonprofit organizations (both 501(c)(3) and non-501(c)(3)). For-profit organizations (other than small businesses) and small businesses are also eligible, along with other entities that fit NIH eligibility rules. The announcement explicitly highlights additional eligible categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also notes that faith-based or community-based organizations and eligible federal government agencies may apply, and it includes regional organizations and U.S. territories or possessions as eligible applicants.
Foreign eligibility is restrictive in a way that is common for NIH network infrastructure awards. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the primary applicant, and non-domestic components of U.S. organizations are also not eligible to apply. However, the FOA allows foreign components as defined under the NIH Grants Policy Statement, meaning a U.S. awardee may include certain foreign collaboration elements when they meet NIH definitions and requirements, even though the main applicant organization must be domestic.
Administratively, the opportunity falls under the discretionary category and is tied to multiple CFDA numbers (93.121, 93.242, 93.279, 93.853, 93.855, 93.865), reflecting that HIV/AIDS clinical trials networks can touch several NIH/NIAID program areas and funding lines. The posting indicates an original closing date of August 1, 2019, and a creation date of January 24, 2019. The award ceiling and expected number of awards are not specified in the provided listing, which typically means applicants would need to consult the full FOA or NIH documentation for budget expectations, project period details, and the anticipated scale of funded activities.
Overall, this FOA is aimed at building and sustaining the statistical and data management infrastructure that makes large HIV/AIDS clinical trials networks function effectively. It emphasizes coordinated leadership in statistics and data systems rather than isolated study-by-study support, aligning with the needs of networked research where consistent standards, centralized oversight, and rigorous analytics are essential for credible results and efficient trial operations.Apply for RFA AI 19 002
- The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "HIV/AIDS Clinical Trials Networks Statistical and Data Management Centers (SDMC) (UM1 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.242, 93.279, 93.853, 93.855, 93.865.
- This funding opportunity was created on 2019-01-24.
- Applicants must submit their applications by 2019-08-01. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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.
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Frequently Asked Questions (FAQs)
What is the HIV/AIDS Clinical Trials Networks Statistical and Data Management Centers (SDMC) opportunity (RFA-AI-19-002)?
RFA-AI-19-002 is a National Institutes of Health (NIH) funding announcement that supports the creation or continuation of specialized Statistical and Data Management Centers (SDMCs) for NIAID-supported HIV/AIDS clinical trials networks. These centers provide the statistical and data management backbone needed to run complex, multi-site clinical trials.
What is the main purpose of funding an SDMC under this opportunity?
The main purpose is to support SDMCs that can provide leadership, coordination, and operational support for the design, conduct, monitoring, and analysis of HIV/AIDS clinical trials conducted across multiple sites. In practice, the SDMC serves as a central hub for trial data and statistical leadership to help ensure trials produce reliable, meaningful scientific and clinical conclusions.
What types of activities would an SDMC be responsible for?
Based on the description provided, an SDMC is expected to play a central role in network operations by supporting statistical approaches and trial analytics, helping ensure trial data are collected and stored correctly, maintaining high data quality, producing reliable analyses, coordinating data flow from clinical sites, supporting protocol development with statistical input, and helping develop and harmonize standards across studies within the network.
Is this opportunity focused on a single study or on network-wide infrastructure?
This opportunity is aimed at network-wide infrastructure. It emphasizes coordinated leadership in statistics and data systems across multiple studies rather than isolated, study-by-study support. The SDMC role is described as critical to network success, reflecting the need for consistent standards, centralized oversight, and rigorous analytics in networked clinical research.
What funding mechanism is used for this award?
The award is offered as a cooperative agreement (UM1). This typically means NIH expects substantial programmatic involvement with the awardee, rather than a largely hands-off relationship.
What does it mean that this is a cooperative agreement (UM1)?
A cooperative agreement (UM1) generally indicates that NIH will have substantial involvement in the programmatic aspects of the project. In other words, the relationship is more collaborative than a standard grant mechanism, with NIH likely engaged in key elements of the effort.
Does this opportunity require clinical trials?
Yes. The opportunity includes a "Clinical Trial Required" designation, meaning the funded work is directly tied to ongoing or planned clinical trials activity within the HIV/AIDS clinical trials networks.
Is the SDMC role limited to routine database management?
No. The SDMC is positioned as a leadership function that is described as critical to the success of the clinical trials networks. The scope goes beyond routine data handling to include harmonizing standards across studies, providing statistical leadership, coordinating multi-site data flow, and supporting the network in meeting regulatory, ethical, and scientific expectations for human subjects research.
Which NIH institute or program area is this opportunity associated with?
The description ties the SDMCs to NIAID-supported HIV/AIDS clinical trials networks (NIAID is part of NIH). The listing also references multiple CFDA numbers, reflecting that HIV/AIDS clinical trials networks can span several NIH/NIAID program areas and funding lines.
Who is eligible to apply?
The eligible applicant pool is broad and includes many U.S.-based organizations and governments. Eligible applicants listed include 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 Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); small businesses; eligible federal government agencies; regional organizations; and U.S. territories or possessions, consistent with NIH eligibility rules.
Are minority-serving institutions specifically included as eligible applicants?
Yes. The announcement explicitly highlights additional eligible categories including Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
Can faith-based or community-based organizations apply?
Yes. The eligibility list notes that faith-based or community-based organizations may apply, as long as they meet applicable NIH eligibility rules.
Are foreign organizations eligible to apply as the primary applicant?
No. Non-domestic (non-U.S.) entities (foreign organizations and foreign institutions) are not eligible to apply as the primary applicant under this opportunity.
Can a U.S. organization with a non-U.S. component apply?
The information provided states that non-domestic components of U.S. organizations are not eligible to apply. However, the FOA allows foreign components as defined under the NIH Grants Policy Statement, meaning a U.S. awardee may include certain foreign collaboration elements when they meet NIH definitions and requirements, even though the main applicant organization must be domestic.
What are the CFDA numbers associated with this funding opportunity?
The listing references multiple CFDA numbers: 93.121, 93.242, 93.279, 93.853, 93.855, and 93.865.
When was this funding opportunity created, and what was the original closing date?
The listing indicates a creation date of January 24, 2019, and an original closing date of August 1, 2019.
Is the award ceiling provided in the listing?
No. The award ceiling is not specified in the provided listing.
Is the expected number of awards provided in the listing?
No. The expected number of awards is not specified in the provided listing.
Where would an applicant typically look for budget expectations or project period details?
The listing notes that because the award ceiling and expected number of awards are not specified, applicants would typically need to consult the full FOA or NIH documentation for budget expectations, project period details, and the anticipated scale of funded activities.
What does the opportunity mean by SDMCs being the "hub" for trial data?
In practical terms, the SDMC acts as the central point for trial data across the network. This includes helping define statistical approaches, ensuring data are collected and stored correctly, maintaining high data quality, and producing analyses that support scientifically and clinically meaningful conclusions across complex, multi-site trials.
Why is harmonizing standards across studies emphasized?
Because the opportunity is designed to support networked research, consistent standards and centralized oversight help ensure data quality, comparability across studies, efficient trial operations, and credible results across multiple sites and protocols.
What makes this opportunity different from funding a single clinical trial?
This opportunity focuses on the statistical and data management infrastructure that enables many trials within HIV/AIDS clinical trials networks to function effectively. It prioritizes coordinated leadership, shared standards, and centralized data oversight rather than support limited to one protocol or one site.
What category of funding is this opportunity listed under?
The opportunity is identified as being under the discretionary category.
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