Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24) | PAR 17 172

Opportunity Information: Apply for PAR 17 172

The Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24) opportunity (PAR-17-172) is a National Institutes of Health (NIH) cooperative agreement designed to fund a dedicated Data Coordinating Center (DCC) that will partner with, and directly support, an investigator-initiated multi-site clinical trial focused on natural products. The trial itself must be a Phase III (or later) multi-site clinical trial submitted under the companion clinical trial announcement (PAR-17-174), and the DCC application is not meant to stand alone. A key requirement is that the DCC application must be tailored to a specific collaborating Clinical Coordinating Center (CCC) application, with both applications submitted at the same time so the National Center for Complementary and Integrative Health (NCCIH) can review them together as a coordinated package.

At its core, the FOA is about building the operational and analytic backbone for a large, complex clinical study. The DCC is expected to propose a detailed, end-to-end plan for overall project coordination and day-to-day operational support across all participating clinical sites. This includes the administrative infrastructure needed to keep a multi-site trial running smoothly, such as trial governance support, coordination of communication among sites and committees, standardized procedures, training, documentation, scheduling, tracking milestones, and helping ensure consistent implementation of the protocol across locations. Because this is a cooperative agreement (U24), the relationship with NIH/NCCIH is collaborative, meaning the award typically involves substantial scientific or programmatic involvement from the funding institute compared to a standard research grant.

The DCC responsibilities emphasized in the announcement span three major functional areas: administration and coordination, data management, and biostatistics. From a data management perspective, the DCC is generally expected to develop and maintain systems and processes that support high-quality, reliable clinical trial data, including database design and maintenance, case report form development, data collection workflows, data validation and quality control, query management, data security and confidentiality protections, and preparation of clean, analysis-ready datasets. On the biostatistics side, the DCC is expected to provide the statistical leadership and analytic capacity needed for a Phase III+ multi-site trial, which often includes randomization support, statistical analysis planning, interim monitoring and reporting as appropriate, support for a Data and Safety Monitoring Board (if applicable), final analyses, and assistance with interpretation and dissemination of trial results. In practice, NCCIH is looking for a DCC that can demonstrate it has the people, systems, and experience to manage the full life cycle of a large multi-site trial, from study start-up through closeout and reporting.

This funding opportunity falls under the Health funding activity category and is associated with CFDA number 93.213. The listed agency is NIH, with NCCIH as the relevant institute for this program. The original closing date provided in the source information is February 7, 2018, and the FOA creation date is March 10, 2017. The source fields do not specify an award ceiling or expected number of awards in the excerpt provided, so applicants would typically need to consult the full FOA text and related NIH guidance for budget expectations, project period norms, and review considerations.

Eligibility is broad and includes many types of U.S.-based organizations and governments. Eligible applicants named in the source 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, public housing authorities/Indian housing authorities, and Native American tribal organizations (other than federally recognized tribal governments). The eligibility list also includes nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education in those categories), for-profit organizations other than small businesses, small businesses, and a catch-all “other” category. The FOA also explicitly highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal government agencies, and U.S. territories or possessions.

Foreign eligibility is restricted in a specific way. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, the FOA states that foreign components, as defined in the NIH Grants Policy Statement, are allowed. In practical terms, that usually means a U.S. applicant can include certain scientifically justified activities performed outside the U.S. as part of the project, so long as they meet NIH policy requirements and are appropriately justified and documented, but the main applicant organization must be domestic and structured according to the FOA’s rules.

Overall, this FOA is essentially a call for a specialized coordinating center team that can professionally run the data, statistical, and cross-site operational side of a large natural product clinical trial, in lockstep with a separate but linked clinical coordinating center application. The emphasis is on comprehensive planning, demonstrated capacity, and integrated collaboration between the DCC and CCC so the trial can be executed consistently across multiple sites and produce credible, high-quality evidence suitable for a Phase III or later-stage clinical trial.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213.
• This funding opportunity was created on 2017-03-10.
• Applicants must submit their applications by 2018-02-07. (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.

Apply for PAR 17 172

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: