Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) — National Institutes of Health funding opportunity
National Institutes of Health · Federal agency

Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and...

60
match
Deadline Nov 2 Location Alabama Type grant Level Federal Open posted Mar 18, 2026
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Next deadline: November 2, 2028.
  • Issued by: National Institutes of Health.
How was this generated?

The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

AI-generated. Always verify with the official source.

Deadline
Nov 2
Nov 2, 2028

About this opportunity

This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform Bayesian designs are encouraged. These trials may include ones that test different and implementation science clinical trials and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website.This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, participant recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. The application should also describe its approaches to increase community engagement from conceptual design of the intervention through implementation and sustainability, close gaps in health outcomes within the US population, and increase health for all.

Funding agency

Tags

Want help applying?

Our specialists will check your eligibility, prepare the application, and walk you through every step — for free. Create a free account →

Who can apply

Eligibility details aren't on file yet — check the agency source link in the Documents tab for the latest rules.

Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

How to apply

We don't have application instructions on file yet — head straight to the official source.

Apply on agency site
Tip from our team:

Read the agency's eligibility checklist before you start — it's almost always shorter than the full NOFO and will tell you in 90 seconds whether to keep going.

Need help getting in touch with the right agency contact?

Create a free account and our specialists will guide you through the application end-to-end.

Source documents

View on agency site
Canonical NOFO, application packet, and forms
No supplemental documents yet.

Direct downloads (NOFO PDFs, application forms, FAQs) will appear here once our team attaches them. For now, the agency site has the canonical packet.

Citation details

Source systemgrants.gov
Source ID358850
PostedMar 18, 2026

Frequently asked questions

No FAQs yet.

Have a question about this fund? Sign in to open a ticket about this fund.