Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 15, 2026
Can you apply?
This grant is for organizations and institutions interested in implementing rigorous clinical trials related to infectious diseases and immunological research under NIAID (National Institute of Allergy and Infectious Diseases) oversight. Eligible applicants typically include academic medical centers, research hospitals, clinical research organizations, public health agencies, and nonprofit research institutions with established clinical research infrastructure. The cooperative agreement mechanism provides substantial funding for multi-year projects that align with NIAID research priorities. Geographic scope is national; projects must demonstrate capacity to conduct compliant, high-quality clinical research. Supported activities include patient recruitment and retention, protocol development, clinical trial management, regulatory compliance, and dissemination of trial results.
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Key dates
- Jun 16, 2026 Applications open
- Dec 1, 2026 Award announced
- Dec 1, 2026 Project start
- Jul 5, 2029 Application deadline in 1085 days
Program description
The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance its mission by continuing support for the NIAID Clinical Trial Implementation Cooperative Agreements. This program encourages cooperative agreement applications for implementation of investigator-initiated, milestone driven, high-risk clinical trials including mechanistic studies associated with these clinical trials. Due to this focus, the program encompasses both basic and clinical research. This program includes support for the conduct, completion, and analysis of the clinical trial. Additional activities supported are related to the conduct of the clinical trial including training of study personnel; enrollment and recruitment of study subjects; data collection, clinical data management and quality control; investigational product costs; laboratory work and data analyses; study management and oversight; post-trial activities; and regulatory activities and site monitoring. Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) application form
- Project narrative and specific aims (typically 15 pages)
- Detailed budget and budget justification
- Biosketches for all key personnel (senior/key project personnel, clinical trial PI, data manager, biostatistician)
- Facilities and administrative resources description
- Letters of commitment/support from collaborating institutions and clinical sites
- Data management and safety monitoring plan
- Human subjects protection documentation (IRB approval or anticipated timeline)
- Vertebrate animal care documentation (if applicable)
- Bibliography and references cited
- Appendices (study protocol, recruitment materials, data collection forms, as appropriate)
Program contact
- 👤 Cynthia de la Fuente, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
- 📧 cynthia.delafuente@nih.gov
- 📞 240-699-2740
Funding track record
Recent awards under CFDA 93.855 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$246,626,852
-
$201,437,825
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$185,816,804
-
$180,737,624
-
$136,265,880
-
$116,817,868
-
$93,394,862
-
$89,845,851
-
$74,456,241
-
$72,987,380
Top States by Funding
- CA 8 awards $696.2M
- MA 6 awards $602.8M
- NY 6 awards $335.0M
- TX 3 awards $280.9M
- GA 5 awards $257.9M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.855). How funding has trended year over year.
| 2024 | $4,073,812,529 | |
| 2025 | $4,378,235,639 | |
| 2026 est. | $4,299,426,996 |
FAQ
Who is eligible to apply for this cooperative agreement?
Typically, U.S. institutions with strong clinical research capabilities are eligible, including academic medical centers, research hospitals, nonprofit organizations, and public health agencies. International collaborators may be included as subawardees but the lead applicant must be a U.S. entity.
What types of clinical trials does NIAID fund through this mechanism?
This program supports trials focused on infectious diseases, immunological disorders, and related conditions within NIAID's scientific scope. Trials must be well-designed, follow rigorous protocols, and address significant public health needs.
Is there a funding cap, and what is the typical project duration?
Cooperative agreements typically range from multi-year initial funding periods (often 3-5 years) with possible renewals. Check the specific funding announcement for current budget limits and project periods.
How competitive is this opportunity?
NIH cooperative agreements are highly competitive. Applicants must demonstrate strong preliminary data, experienced research teams, adequate infrastructure, and clear alignment with NIAID priorities.
What is the difference between a cooperative agreement and a standard research grant?
Cooperative agreements involve more NIH involvement and oversight throughout the project period. The NIH program officer works more actively with awardees on implementation and progress toward specific milestones.
💡 Tips for applicants
- Establish partnerships early: Clinical trials require multiple sites and collaborating institutions. Demonstrate robust, committed partnerships with letters of support from all key stakeholders.
- Align with NIAID priorities: Thoroughly review current NIAID strategic priorities and research focus areas. Clearly articulate how your trial addresses significant gaps or unmet needs in infectious disease research.
- Show infrastructure readiness: Provide detailed evidence of your clinical research capacity, including regulatory affairs staff, data management systems, and proven experience with complex clinical trial operations.
- Develop a realistic timeline and budget: Be conservative in enrollment projections and realistic about costs. NIH reviewers scrutinize budgets for clinical trials carefully, so justify all expenses with concrete justification.
- Include robust data management and safety plans: Describe your DSMB (Data Safety Monitoring Board), data security protocols, adverse event reporting procedures, and regulatory compliance mechanisms in detail.
⚠️ Common mistakes
Applicants frequently fail to sufficiently demonstrate their institution's clinical trial infrastructure and regulatory experience, leading reviewers to question feasibility. Many proposals lack detailed, realistic patient recruitment and retention strategies specific to their target population, which raises concerns about whether enrollment targets will be met. Weak alignment with current NIAID scientific priorities—or proposing clinical trials that fall outside NIAID's mission—is a common reason for rejection.
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