NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional) | PAR 25 090

Frequently Asked Questions (FAQs)

What is PAR-25-090 (NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements, U34 Clinical Trial Optional)?

PAR-25-090 is an NIH cooperative agreement funding opportunity that supports a structured planning phase for complex, higher-risk, multi-center clinical studies. The goal is to get ambitious multi-site clinical research fully prepared to launch by strengthening the scientific premise, finalizing an implementable protocol, and building realistic operational plans and core trial documents.

What is the main purpose of the U34 planning award?

The U34 is intended to fund the upfront work needed before moving into full-scale study conduct. It is designed to "de-risk" a future multi-center clinical study by supporting a milestone-oriented planning phase that results in peer-reviewed, execution-ready materials and decisions.

How does this opportunity fit into a two-part pathway?

This opportunity is described as part of a two-part pathway: the U34 planning award supports the preparatory work needed before a project proceeds to full-scale study conduct. The planning phase is meant to produce a strong, feasible package that can inform a future implementation award or a launch decision.

What kinds of studies is this U34 meant to support?

The proposed clinical study is expected to be hypothesis-driven and focused on diseases and conditions within the mission area of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The program is aimed at multi-center studies, meaning more than one clinical site or center is involved.

Does the proposed project have to be a clinical trial?

Not necessarily. The opportunity is labeled "Clinical Trial Optional," meaning the planning effort may or may not meet NIH's definition of a clinical trial depending on the project specifics. Applicants still need to align their application with NIH definitions and requirements.

What makes this a "cooperative agreement" rather than a standard grant?

This is a cooperative agreement, which generally implies substantial scientific or programmatic involvement by NIH staff compared to a standard research grant. In practice, NIDDK program staff may play an active role during the planning period to help keep milestones on track, ensure protocol and operational plans meet expectations, and position the project for the next stage.

Is it recommended to contact NIDDK before applying?

Yes. NIDDK strongly encourages applicants to consult with NIDDK scientific staff before submitting a U34 application. This can help determine fit, clarify expectations for planning deliverables, and reduce the risk of submitting an application that does not align with the program's intent.

What are the four main planning goals this U34 is designed to accomplish?

This U34 mechanism is specifically designed to support four planning goals:

1. Early peer review of the scientific rationale: review of whether the hypothesis and justification are strong before a large multi-center study is undertaken.
2. Rigorous assessment of study design and protocol: evaluation of whether the design can answer the clinical question across multiple centers.
3. Development of core trial documents: especially a Manual of Operations to standardize procedures across sites.
4. Development of essential elements required for study conduct: operational plans and start-up materials (for example, data management and monitoring plans, coordination procedures, regulatory/IRB strategies, and participant retention approaches).

What is the Manual of Operations, and why is it emphasized?

The Manual of Operations is a core document that typically standardizes how the study will be run across all sites. It commonly covers items such as recruitment and screening workflows, intervention delivery, outcome assessments, data collection schedules, safety reporting, staff training, and quality control procedures. The opportunity highlights it as a key deliverable needed to ensure consistent, realistic, multi-center execution.

What types of start-up or operational materials may be developed during the planning phase?

In addition to core trial documents like the Manual of Operations, the planning phase may include detailed plans for data management and monitoring, site coordination procedures, regulatory and IRB strategies, participant retention approaches, and other start-up materials that support an informed implementation decision and feasible future study conduct.

What does "multi-center" mean in this announcement?

In this context, "multi-center" explicitly means more than one clinical site or center is involved in the proposed study.

Who is eligible to apply (domestic organizations)?

Eligibility is broad and includes many domestic organization types, including:

• 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 tribal governments
• Tribal organizations other than federally recognized tribal governments
• Public housing authorities/Indian housing authorities
• Nonprofits with or without 501(c)(3) status (outside of higher education institutions)
• For-profit organizations (other than small businesses)
• Small businesses

Are specific institution types highlighted as eligible?

Yes. The announcement highlights additional eligible applicant categories, including 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 agencies, and U.S. territories or possessions.

Are foreign organizations eligible to apply?

No. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply.

Can a U.S. applicant include any foreign involvement?

Yes, in a limited way. Foreign components (as defined by the NIH Grants Policy Statement) are allowed. That means a U.S.-based applicant may be able to include certain foreign elements if they meet NIH policy definitions and are justified, even though the primary applicant organization must be domestic.

What is the maximum funding amount listed for this opportunity?

The award ceiling provided is $225,000.

What is the sponsoring agency and activity area?

The sponsoring agency is the National Institutes of Health (NIH). The opportunity is categorized under the Food and Nutrition, Health activity area.

What CFDA number is associated with this opportunity?

The opportunity is listed under CFDA 93.847.

What type of funding is this categorized as?

The opportunity is categorized as discretionary funding.

What is the closing date shown for this opportunity?

The original closing date listed is 2027-06-10.

What is the opportunity record creation date?

The opportunity record shows a creation date of 2025-01-10.

What is the expected outcome of the planning phase?

The planning phase is expected to produce peer-reviewed, implementable materials and decisions that enable the project to move into full study execution with fewer preventable design flaws, clearer standardization across sites, and stronger readiness for recruitment, data quality, and participant safety oversight.

Why is this opportunity described as supporting "higher-risk" studies?

It is framed as supporting complex, higher-risk multi-center clinical studies where careful protocol finalization and operational planning are critical. By funding a structured planning phase, the mechanism is intended to reduce preventable design and execution risks before a large, expensive, multi-site study begins.