NCCIH Natural Product Phase I-IIa Clinical Trial Phased Innovation Award (R61/R33)
Period of Award: Up to 2 years for R61 phase; Up to 3 years for R33 phase (R61/R33 combined up to 5 years)
Budget: R61 phase: limited to $400,000 total in direct costs for up to 2 years R33 phase: limited to $750,000 total in direct costs for up to 3 years
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Page Limits
- Specific Aims: 1 page (for both R61 and R33 phase together)
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
Other Attachments
- Clinical Protocol Synopsis (up to 12 pages): Yes
- Regulatory Communication Plan (up to 3 pages): Yes
- Clinical Trial Experience (up to 3 pages): Yes
- Timeline and Milestone Plan (up to 5 pages): To be described as part of the Research Plan
- Project Management Plan (up to 3 pages): No
- Study Organization Plan (up to 6 pages): No
Research Plan
- Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis”
- Milestone Plan: Yes
NCCIH Natural Product Phase I-IIa Clinical Trial Award (R33)
PAR-17-318
Period of Award: Up to 3 years
Budget: Limited to $750,000 total in direct costs for up to 3 years
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Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
Other Attachments
- Clinical Protocol Synopsis (up to 12 pages): Yes
- Regulatory Communication Plan (up to 3 pages): Yes
- Clinical Trial Experience (up to 3 pages): Yes
- Timeline and Milestone Plan (up to 5 pages): To be described as part of the Research Plan
- Project Management Plan (up to 3 pages): No
- Study Organization Plan (up to 6 pages): No
Research Plan
- Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis”
- Milestone Plan: Yes
NCCIH Natural Product Phase II Clinical Trial Cooperative Agreement (U01)
Period of Award: Up to 5 years
Budget: Budget should reflect needs of the proposed project. For applications requesting more than $500,000 please see: NCCIH Policy: Applications for Large Budget Clinical Trials Over $500,000 in Direct Costs in Any Year
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Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
Other Attachments
- Clinical Protocol Synopsis (up to 12 pages): Yes
- Regulatory Communication Plan (up to 3 pages): Yes
- Clinical Trial Experience (up to 3 pages): Yes
- Timeline and Milestone Plan (up to 5 pages): To be described as part of the Research Plan
- Project Management Plan (up to 3 pages): No
- Study Organization Plan (up to 6 pages): No
Research Plan
- Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis”
- Milestone Plan: Yes
Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Natural Products (Collaborative UG3/UH3)
Period of Award: UG3 phase: 1 year planning UH3 phase: up to 4 years implementation (up to 6 years with strong justification)
Budget: Budget should reflect needs of the proposed project. For applications requesting more than $500,000 please see: NCCIH Policy: Applications for Large Budget Clinical Trials Over $500,000 in Direct Costs in Any Year
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Page Limits
- Specific Aims: 1 page (for both UG3 and UH3 phase together)
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Yes
Other Attachments
- Clinical Protocol Synopsis (up to 12 pages): Yes
- Regulatory Communication Plan (up to 3 pages): Yes
- Clinical Trial Experience (up to 3 pages): Yes
- Timeline and Milestone Plan (up to 5 pages): Yes
- Project Management Plan (up to 3 pages): Yes
- Study Organization Plan (up to 6 pages): Yes
Research Plan
- Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis”
- Milestone Plan: To be included as “Other Attachments”
Natural Product Multi-Site Clinical Trial Data Coordinating Center (Collaborative U24)
Period of Award: Up to 5 years (up to 7 years with strong justification)
Budget: Budget should reflect needs of the proposed project. For applications requesting more than $500,000 please see: NCCIH Policy: Applications for Large Budget Clinical Trials Over $500,000 in Direct Costs in Any Year
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Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Yes
Other Attachments
- Clinical Protocol Synopsis (up to 12 pages): No
- Regulatory Communication Plan (up to 3 pages): No
- Clinical Trial Experience (up to 3 pages): Yes
- Timeline and Milestone Plan (up to 5 pages): Yes
- Project Management Plan (up to 3 pages): Yes
- Study Organization Plan (up to 6 pages): No
Research Plan
- Statistical Analysis Plan: Yes
- Milestone Plan: to be included as “Other Attachments”