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NCCIH Clinical FOAs Required Application Elements – Natural Products

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NCCIH Natural Product Phase I-IIa Clinical Trial Phased Innovation Award (R61/R33)

PAR-17-319

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)

PAR-17-216

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

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)

PAR-17-174

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

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)

PAR-17-172

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
  • 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”

This page last modified September 24, 2017