Applicants should follow instructions in the application package and use the PHS Human Subjects and Clinical Trial Information form to provide details about their clinical trial (see Annotated FORMS-E). NIH policy has eliminate most Appendix materials related to clinical trials (NOT-OD-18-126); however, investigators should follow instructions within the FOA and outlined below to provide additional attachments when required by the FOA. Please be sure to check the “Related Notices” section of the FOA for any changes to the required elements.
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
See More
Page Limits
- Specific Aims: 1 page (for both R61 and R33 phases together)
- Research Strategy: 12 pages (for both R61 and R33 phases together)
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
PHS Human Subjects and Clinical Trials Information
- Complete all required elements
- Additional instructions for sections 2.4, 2.5, 3.3, 4.6, and 4.7 provided in the FOA
Required 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
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
See More
Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
PHS Human Subjects and Clinical Trials Information
- Complete all required elements
- Additional instructions for sections 2.4, 2.5, 3.3., 4.6, and 4.7 provided in the FOA
Required Other Clinical Trial-related Attachments
- Clinical Trial Experience (up to 3 pages): Yes
Research Plan
- Milestone Plan: Brief summary to be included in the Research Plan
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
See More
Page Limits
- Specific Aims: 1 page
- Research Strategy: 12 pages
- Introduction (for Resubmission applications): 1 page
Cover letter: Encouraged
PHS Human Subjects and Clinical Trials Information
- Complete all required elements
- Additional instructions for section 2.5, 2.7, 3.3, 4.4, and 4.7 provided in the FOA
Required Other Clinical Trial-related Attachments
- Regulatory Communication Plan (up to 3 pages): Yes
- Clinical Trial Experience (up to 3 pages): Yes
Research Plan
- Milestone Plan: Brief summary to be included in the Research Plan
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
See More
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
- Complete all required elements
- Additional instructions for sections 2.4, 2.5, 3.3, 3.5, 4.6, and 4.7 provided in the FOA.
Required Other Clinical Trial-related Attachments
- Clinical Trial Experience (up to 3 pages): Yes
- Milestone Plan (up to 5 pages): Yes
Other Attachments
- Project Management Plan (up to 3 pages): Yes
Research Plan
- Milestone Plan: Brief summary to be included in the Research Plan
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
See More
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
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 (additional instructions provided in FOA)
- 4.4 Statistical Design and Power (additional instructions provided in FOA)
- 4.7 Dissemination Plan (additional instructions provided in FOA)
- 5.1 Other Clinical Trial-related Attachments
Required Other Clinical Trial-related Attachments
- Clinical Trial Experience (up to 3 pages): Yes
- Milestone Plan (up to 5 pages): Yes
Other Attachments
- Project Management Plan (up to 3 pages): Yes
Research Plan
- Milestone Plan: Brief summary to be included in the Research Plan