Mind and Body Intervention Multi-Site Clinical Trial Data Coordinating Center (U24) | PAR 17 173

Opportunity Information: Apply for PAR 17 173

The Mind and Body Intervention Multi-Site Clinical Trial Data Coordinating Center (U24) opportunity (PAR-17-173) is a National Institutes of Health cooperative agreement announcement from the National Center for Complementary and Integrative Health (NCCIH) that funds the Data Coordinating Center (DCC) for an investigator-initiated, multi-site Phase III (and beyond) clinical trial focused on mind and body interventions. The core idea is that NCCIH is not looking for a stand-alone data center project; it is looking for a DCC that is purpose-built to support a specific, companion multi-site clinical trial application. In practice, this means the DCC application must be tightly linked to, and submitted at the same time as, a corresponding Clinical Coordinating Center (CCC) application for the actual trial (the companion trial FOA is PAR-17-175). NCCIH reviews the pair together, so a DCC application that is not clearly matched to a CCC/trial application would not meet the intent of the announcement.

The purpose of the DCC is to serve as the operational and analytic backbone of the clinical trial. Applicants are expected to propose a comprehensive, trial-wide plan for overall project coordination and administration, robust data management, and biostatistical support across all participating sites. This typically includes setting up and maintaining the systems and processes that allow a large, multi-site study to run consistently and produce high-quality, credible results. While the FOA summary highlights administration, data management, and biostatistics, the broader expectation for a DCC in a Phase III+ setting generally implies responsibility for cross-site harmonization, standard operating procedures, centralized tracking and reporting, database and case report form development, data quality control, and support for prespecified statistical analyses that match the protocol and the trial's primary and secondary endpoints. Because the award mechanism is a cooperative agreement (U24), the relationship with NIH is collaborative, with substantial NIH involvement compared to a standard research grant; applicants should anticipate active coordination with NCCIH program staff and alignment with NIH expectations for rigor, oversight, and data stewardship.

Eligibility is broad and includes many types of domestic organizations that can carry out complex clinical trial coordination work. The announcement lists eligible applicants such as 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; other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education where applicable); for-profit organizations (other than small businesses); and small businesses. It also explicitly calls out additional eligible categories often emphasized in NIH programs, including Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, Historically Black Colleges and Universities, Tribally Controlled Colleges and Universities, faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply; however, foreign components as defined by the NIH Grants Policy Statement are allowed, meaning the project can include certain types of foreign involvement under NIH rules even though the applicant organization itself must be domestic.

From the administrative details provided, the opportunity falls under the NIH health activity category, CFDA 93.213, with an original closing date of February 14, 2018, and a creation date of March 10, 2017. The award ceiling and expected number of awards are not specified in the source summary. The key takeaway for prospective applicants is that NCCIH is funding the centralized infrastructure needed to coordinate and analyze a definitive, late-phase, multi-site clinical trial of mind and body interventions, and it requires a synchronized, paired submission: one application for the clinical trial leadership and operations (CCC under PAR-17-175) and one for the coordinating data and statistical hub (DCC under PAR-17-173).

• 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 (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 2018-02-14. (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 17 173

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