NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)
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 $500,000 total in direct costs for up to 2 years; R33 phase: limited to $1,050,000 total in direct costs for up to 3 years
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Page Limits
- Specific Aims: 1 page (for both R61 and R33 phases together)
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
PHS Human Subjects and Clinical Trials Information
- Clinical Protocol Synopsis (up to 12 pages): Yes
- Regulatory Communication Plan (up to 3 pages): Yes
- Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis”
Other Clinical Trial-related Attachments
- Clinical Trial Experience (up to 3 pages): Yes
Other Attachments
- Milestones and Go/No-Go Criteria Plan (up to 3 pages): Yes
- Project Management Plan (up to 3 pages): No
- Study Organization Plan (up to 6 pages): No
Research Plan
- Milestone Plan: Brief summary to be included in the Research Plan
NCCIH Natural Product Early Phase Clinical Trial Award (R33 Clinical Trial Required)
Period of Award: Up to 3 years
Budget: Limited to $1,050,000 total in direct costs for up to 3 years
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PHS Human Subjects and Clinical Trials Information
- Clinical Protocol Synopsis (up to 12 pages): Yes
- Regulatory Communication Plan (up to 3 pages): Yes
- Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis”
Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
Other Clinical Trial-related Attachments
- Clinical Trial Experience (up to 3 pages): Yes
Other Attachments
- 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
- 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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PHS Human Subjects and Clinical Trials Information
- Timeline and Milestone Plan (up to 5 pages): To be described as part of the Research Plan
- Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis”
Other Attachments
- Clinical Trial Experience (up to 3 pages): Yes
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
- Project Management Plan (up to 3 pages): No
- Study Organization Plan (up to 6 pages): No
Research Plan
- Milestone Plan: Yes, to be included in the Approach section.
Clinical Coordinating Center for NCCIH Multisite 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
PHS Human Subjects and Clinical Trials Information
- Clinical Protocol Synopsis (up to 12 pages): Yes
- Regulatory Communication Plan: Yes, as part of Section 4, Protocol Synopsis
- Clinical Trial Experience (up to 3 pages): Yes, in Section 5: Other Clinical Trial-related Attachments
- Timeline and Milestone Plan (up to 5 pages): Yes, in Section 5: Other Clinical Trial-related Attachments
- Study Organization Plan: Yes, in Section 3: Protection and Monitoring Plans/ 3.5 Overall Structure of the Study Team
- Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis”
Other Attachments
- Project Management Plan (up to 3 pages): Yes
Research Plan
- Milestone Plan: To be included as “Other Attachments.” The research plan should include a description of the milestone plan as well as clinical trial experience.
Natural Product Multisite 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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PHS Human Subjects and Clinical Trials Information
Only the following fields/attachments below may be submitted. Other fields/attachments may not be submitted:
- 1.1 Study Title
- 1.2 Is this Study Exempt from Federal Regulations?
- 1.4 Clinical Trial Questionnaire
- 2.1 Conditions or Focus of Study
- 2.4 Inclusion of Women, Minorities, and Children
- 3.1 Protection of Human Subjects
- 3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?
- 3.3 Data and Safety Monitoring Plan
- 4.4 Statistical Design and Power
- 4.7 Dissemination Plan
- 5.1 Other Clinical Trial-related Attachments
Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Yes
Other Clinical Trial-Related Attachments
- Clinical Trial Experience
- Milestone Plan
Other Attachments
- Project Management Plan (up to 3 pages): Yes
- Study Organization Plan (up to 6 pages): No
Research Plan
- Milestone Plan: to be included as “Other Attachments.” The research plan should include a description of the milestone plan.