NIDDK Multi Center Clinical Study Implementation Planning Grants (U34) | Apply Online

FAQs: NIDDK Multi-Center Clinical Study Implementation Planning Grants (U34) - PAR-10-197

What is the NIDDK Multi-Center Clinical Study Implementation Planning Grant (U34)?

The U34 is an NIH/NIDDK planning grant intended to help research teams prepare a multi-center clinical study for a full-scale launch. It supports the planning and start-up work needed to make a proposed study scientifically justified, operationally realistic, and ready to run smoothly across multiple clinical sites.

What is the Funding Opportunity Number for this program?

The Funding Opportunity Number is PAR 10-197.

Does the U34 fund the actual conduct of a clinical trial or clinical study?

No. The U34 is specifically for planning and preparation. It does not pay for executing the full clinical trial or study. The implementation phase would be supported through a separate, second-step mechanism.

Why does NIDDK use a two-step pathway for certain multi-center studies?

NIDDK requires investigator-initiated clinical studies that involve three or more clinical sites to follow a structured two-step pathway. The first step is the U34 planning stage, and the second step is an implementation-stage application under a cooperative agreement mechanism intended to support the actual conduct of the study.

How many clinical sites trigger the requirement to use the U34 pathway?

The described requirement applies to investigator-initiated clinical studies involving three or more clinical sites.

What are the main goals of the U34 planning grant?

The core purpose of the U34 is fourfold: (1) enable early peer review of the scientific rationale; (2) support detailed assessment and refinement of the study design and protocol; (3) fund development of essential documentation such as a Manual of Operations; and (4) support development of other critical elements needed for implementation readiness (for example, data management plans and start-up materials).

What does "early peer review of the scientific rationale" mean in this context?

It means the U34 allows reviewers to evaluate whether the proposed multi-center clinical study addresses an important question and is built on a strong evidence base before major resources are committed to running the study.

What types of design and protocol issues can be refined during the U34?

The U34 supports refinement of key methodological choices that can affect success in a multi-site study, including eligibility criteria, outcomes, statistical plans, recruitment projections, and site coordination strategies.

What is a Manual of Operations and why is it emphasized?

A Manual of Operations is a core planning product that typically standardizes procedures across clinical sites so activities such as recruitment, interventions, assessments, data collection, safety reporting, and quality control are performed consistently across all locations.

Besides a Manual of Operations, what other planning products may be developed with U34 support?

Other critical elements can include data management plans, case report forms, training plans, governance structures, monitoring approaches, and other start-up materials needed to ensure the study is ready for implementation.

Is completing the U34 planning stage optional if a team wants NIDDK support for implementation?

No. Completing the required U34 planning products is described as not optional for teams that intend to seek NIDDK support to conduct the multi-center clinical study.

What is the next step after the U34 if the team wants to conduct the study with NIDDK support?

The next step is submitting a second-step application for the multi-center clinical study cooperative agreement (U01), which is the mechanism intended to fund and support the actual conduct of the study.

Is the U34 a prerequisite for applying to the NIDDK U01 implementation award?

Yes. The U34 functions as a formal planning and readiness stage that must be successfully completed before moving to the implementation stage under a U01.

Do applicants need to contact NIDDK before submitting a U34 application?

Yes. Applicants must obtain pre-approval from NIDDK before submitting a U34 application, indicating investigators are expected to engage NIDDK early to confirm program fit and readiness for the planning award process.

What does it mean that the U34 is a cooperative agreement?

It means the award uses a cooperative agreement mechanism and generally involves substantial NIH scientific or programmatic involvement compared with a standard research grant.

Are award size, number of awards, or project duration fixed for this opportunity?

No. The announcement indicates budgets, award sizes, and project duration may vary because study concepts and planning needs differ. It also states total funds and the number of awards are not fixed and depend on factors such as the number of applications received, overall quality, proposed duration, and requested costs.

Is cost sharing or matching required?

No. The announcement states there is no cost-sharing or matching requirement.

Who is eligible to apply for this U34 opportunity?

Eligibility is broad and includes many organization types across government, academic, nonprofit, and private sectors. Examples listed include public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); small businesses; and multiple levels of government (state, county, city/township, special district governments, independent school districts, and public housing authorities/Indian housing authorities).

Does the eligibility list include specialized or community-focused entities?

Yes. The eligibility list explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities, tribal governments (federally recognized and other than federally recognized), faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

Are foreign (non-U.S.) organizations eligible?

Yes. The eligibility list includes non-U.S. entities (foreign organizations).

What NIH/NIDDK mission area is associated with this opportunity?

The listing references CFDA 93.847 (Diabetes, Digestive, and Kidney Diseases Extramural Research), aligning with NIDDK mission areas.

Is this funding opportunity currently open?

No. The administrative dates provided indicate it is a historical listing: it was posted/created May 18, 2010, had a closing date of June 28, 2013, and an archive date of July 29, 2013.

Where were additional details for this opportunity provided?

Additional details were provided through the NIH grants guide link included in the announcement, and NIH Office of Extramural Research webmaster contacts were listed for access or technical issues.