NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional) | PAR 18 423

Opportunity Information: Apply for PAR 18 423

The NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreement (U34 Clinical Trial Optional), listed as PAR 18 423, is a National Institutes of Health (NIH) funding opportunity meant to help research teams get a large, investigator-initiated, multi-center clinical study ready to launch. In this program, "multi-center" specifically means three or more participating sites. The core idea is that NIDDK uses a two-part process for these complex studies: first, a structured planning phase supported by a U34 cooperative agreement, and then (if the planning work results in a strong, feasible study package) a later stage where the full clinical study can be proposed for implementation. The U34 itself is not the full trial award; it is the supported planning and readiness step that helps teams avoid common pitfalls that can derail large studies once they begin enrolling participants.

The U34 is designed around four practical goals that map closely to what reviewers and NIDDK program staff need to see before committing to a major multi-site clinical study. First, it enables early peer review of the scientific rationale, meaning the field can assess whether the underlying hypothesis and clinical importance justify moving forward at scale. Second, it supports an in-depth assessment of the study design and protocol, which is where key decisions are pressure-tested, such as eligibility criteria, endpoints, statistical power, recruitment assumptions, randomization plans (if applicable), feasibility of interventions, follow-up schedules, and the overall risk-benefit profile. Third, it provides direct support to develop the operational documents needed to actually run the study, especially a Manual of Operations (MOP). A MOP is typically the backbone of a multi-center project because it standardizes procedures across sites so that data collection, intervention delivery, outcome measurement, safety reporting, and quality control are consistent. Fourth, the U34 supports development of other essential elements required to conduct the clinical study, which commonly includes items like finalized case report forms, data management and quality assurance plans, site training plans, recruitment and retention strategies, safety monitoring approaches, and coordination structures needed to keep multiple centers aligned.

From a scientific scope standpoint, the proposed clinical study must be hypothesis-driven and must focus on diseases relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). In practical terms, this means the study should be built around a clear, testable question (not just descriptive data collection), and it should fit within NIDDK program areas such as diabetes, endocrinology and metabolic diseases, digestive diseases, nutrition-related conditions within NIDDKs remit, and kidney and urologic diseases. Because NIDDK uses this mechanism to manage risk and ensure readiness, consultation with NIDDK scientific staff before submitting a U34 application is strongly encouraged. That early interaction is often important for aligning the proposed study with NIDDK priorities, clarifying expectations for the planning deliverables, and confirming that the project is appropriate for the U34 cooperative agreement structure.

Administratively, this opportunity is categorized as a discretionary cooperative agreement. A cooperative agreement differs from a standard grant in that NIH staff typically have substantial programmatic involvement during the project, which fits a planning award where coordination, milestone tracking, and alignment on protocol development are central. The funding activity category is listed under Food and Nutrition, Health, and the CFDA number associated with the opportunity is 93.847. The stated award ceiling is $225,000. The listing also shows an original closing date of 2020-11-02 and a creation date of 2017-11-28, which is useful for historical reference; applicants would still need to verify the current status of the announcement and any active receipt dates if they are planning to apply now, since NIH announcements can be reissued, expired, or replaced.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, and 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 and Indian housing authorities; Native American tribal organizations that are not federally recognized tribal governments; nonprofits with and without 501(c)(3) status (outside of higher education); for-profit organizations other than small businesses; and small businesses. The opportunity also explicitly highlights additional eligible categories 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), eligible federal agencies, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. These inclusions signal that NIDDK is open to a wide range of institutional settings, including community-connected organizations that may strengthen recruitment, retention, or real-world relevance in multi-site clinical research.

There are also important limits related to non-U.S. participation. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply directly, and non-domestic components of U.S. organizations are not eligible to apply. At the same time, foreign components are allowed as defined by the NIH Grants Policy Statement. In NIH terms, a "foreign component" usually means a specific element of the project being conducted outside the U.S. under a U.S. applicant organization, subject to NIH rules and justification. This creates a narrow pathway for certain international activities or collaborations without allowing a non-U.S. institution to be the applicant organization.

Overall, the U34 mechanism here functions as a structured, funded planning phase for complex multi-center clinical studies, with NIDDK using it to ensure the study has a strong scientific premise, a workable and well-reviewed protocol, and the operational infrastructure needed to execute consistently across three or more sites. The emphasis on early peer review, protocol refinement, and production of a Manual of Operations reflects the realities of multi-center clinical research, where success depends as much on rigorous standardization and feasibility planning as it does on the underlying hypothesis.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2017-11-28.
• Applicants must submit their applications by 2020-11-02. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $225,000.00 in funding.
• 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 18 423

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