Mind and Body Intervention Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 - Clinical Trial Required) | PAR 18 663

Opportunity Information: Apply for PAR 18 663

The Mind and Body Intervention Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 - Clinical Trial Required) opportunity (PAR-18-663) is a National Institutes of Health (NIH) cooperative agreement designed to fund a dedicated Data Coordinating Center (DCC) that will partner with an investigator-initiated Clinical Coordinating Center (CCC) to run a large, multi-site clinical trial focused on mind and body interventions. The key idea is that NIH, through the National Center for Complementary and Integrative Health (NCCIH), is looking for a well-qualified coordinating hub that can handle the operational backbone of a Phase III (and beyond) multi-site trial, especially the data and statistical infrastructure that keeps the study consistent, reliable, and compliant across all participating sites.

This FOA is explicitly collaborative and dependent on a paired submission structure. A DCC application under this U24 mechanism must be submitted at the same time as a corresponding CCC application submitted under PAR-18-117, and the DCC proposal must be tailored to that specific companion trial application. In other words, applicants cannot submit a generic coordinating-center proposal; the DCC plan has to be built around the particular trial design, endpoints, recruitment plan, sites, intervention, and operational workflow proposed by the CCC. NCCIH will consider the DCC and CCC together as a coordinated package, because the purpose is to ensure the trial has both clinical leadership (CCC) and a strong centralized engine for data, quality control, and statistical rigor (DCC).

The DCCs role is to provide a comprehensive plan for overall project coordination and day-to-day execution support that spans administration, data management, and biostatistics. Practically, that typically means building and maintaining the trials data systems; setting up standardized data collection and management procedures across all sites; developing or implementing case report forms and databases; overseeing data quality assurance, validation, and monitoring; managing randomization (when applicable) and other central trial operations; and delivering the statistical leadership needed for interim and final analyses. Because this is a cooperative agreement, the expectation is usually that NCCIH staff will have substantial programmatic involvement compared with a standard research grant, so the DCC must be prepared to work closely with NIH/NCCIH on governance, reporting, and trial oversight structures.

The clinical trials supported under this announcement must fit NCCIHs mission and be considered a high priority for the Center. NCCIH is the NIH component that supports research on complementary and integrative health approaches, so the trial topic needs to align with NCCIHs strategic vision and research priorities. The FOA encourages prospective applicants to review NCCIH materials and also to contact the relevant NIH scientific/research staff before applying, which is a strong signal that early alignment on fit, priority, and expectations can materially affect competitiveness and whether the project is appropriate for this specific mechanism.

Eligibility is broad and includes many domestic organization types that can credibly function as a coordinating center. Eligible applicants include state, county, and local 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; tribal organizations (including those other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other qualified entities. The announcement also highlights inclusion of organizations such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. Foreign institutions are not eligible to apply as applicants, and non-U.S. components of U.S. organizations are not eligible to apply; however, foreign components (as NIH defines them in the NIH Grants Policy Statement) may be allowed, which generally means a primarily U.S.-based award could include certain carefully justified foreign elements under NIH rules.

Administratively, this is a discretionary health funding opportunity under a cooperative agreement (U24) and is associated with CFDA number 93.213. The opportunity was created on 2018-02-14, and the listed original closing date is 2020-06-29. The synopsis does not specify an award ceiling or expected number of awards in the excerpt provided, so applicants would typically rely on the full FOA text and NIH/NCCIH communications to understand budget expectations and award levels. Overall, the core purpose of the announcement is to ensure that complex, multi-site mind and body intervention trials have a centralized, expert team responsible for consistent trial coordination, robust data handling, and high-quality statistical execution, tightly integrated with the trials clinical leadership team through the companion CCC application.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Mind and Body Intervention Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24 - Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.213.
• This funding opportunity was created on 2018-02-14.
• Applicants must submit their applications by 2020-06-29. (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 18 663

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