HIV/AIDS Clinical Trials Networks Statistical and Data Management Centers (SDMC) (UM1 Clinical Trial Required) | RFA AI 19 002

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.

• 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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