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NIH Research Project Cooperative Agreement (U01)

NIAID Clinical Trial Implementation Cooperative Agreement

Funds running an investigator-initiated, milestone-driven clinical trial that needs closer NIH oversight, including any mechanistic sub-studies.

A trial that needs more than routine monitoring, because of its complexity, risk, or an ambitious mechanistic component, needs a funding mechanism built for that. This is NIAID's version.

It funds implementation of investigator-initiated, milestone-driven clinical trials that call for enhanced oversight, and lets those trials include mechanistic sub-studies alongside the clinical question. Mechan

Implementation of investigator-initiated, milestone-driven clinical trials needing enhanced NIH oversight, optionally including mechanistic sub-studies, running up to five years or, where justified, six to seven years; only one trial per application. A clinical trial is required.

CycleiHow often this grant runs — e.g. annually, on a rolling basis, or a one-off call.Multiple per year
Next deadlineiThe next date applications are due. Rolling means you can apply any time.5 Jul 2029
Decision timeiTypical time from the deadline to the funder's decision.26 weeks
Project durationiHow long the funded work is expected to run.
Award typeiThe form of funding — grant, equity, loan, tax credit, etc.Cooperative agreement
Match fundingiThe share of project costs you must cover yourself. 0% = fully funded.
Funding pooliThe total budget available across all awards in this round.

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Last verified: 25 Aug 2026Funder reference: PAR-27-064Source: www.grants.gov