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NCCIH Clinical FOAs Required Application Elements – Natural Products

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NCCIH Natural Product Early Phase Clinical Trial Phased Innovation Award (R61/R33 Clinical Trial Required)

PAR-18-829

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)

PAR-18-828

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)

PAR-18-125

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)

PAR-18-696

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

  • 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)

PAR-18-697

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

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.

This page last modified October 01, 2018