National Center for Complementary and Integrative Health (NCCIH)
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NCCIH Clinical FOAs Required Application Elements—Mind and Body

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Phased Innovation Award for Mechanistic Studies to Optimize Mind and Body Interventions in NCCIH High Priority Research Topics (R61/R33)

PAR-17-149

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: a limit of $300,000 per year in direct costs is recommended; R33 phase: a limit of $500,000 per year in direct costs is recommended

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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): No
  • Regulatory Communication Plan (up to 3 pages): No
  • Clinical Trial Experience (up to 3 pages): No
  • Timeline and Milestone Plan (up to 5 pages): No
  • Project Management Plan (up to 3 pages): No
  • Study Organization Plan (up to 6 pages): No
  • Draft Informed Consent Form: No

Research Plan

  • Statistical Analysis Plan: To be described in the Research Strategy Section
  • Milestone Plan: Part of Go/No-Go Criteria section
  • Go/No-Go Criteria: Yes

Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34)

PAR-14-182

Period of Award: Up to 3 years (includes the optional administrative period)

Budget: Up to $450,000 total (includes optional administrative period budget of up to $100,000; and limited to $225,000 in direct costs per 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): Draft protocol must be submitted as Appendix
  • Regulatory Communication Plan (up to 3 pages): No
  • Clinical Trial Experience (up to 3 pages): No
  • Timeline and Milestone Plan (up to 5 pages): No
  • Project Management Plan (up to 3 pages): No
  • Study Organization Plan (up to 6 pages): No
  • Draft Informed Consent Form: Yes (must be submitted as Appendix)

Research Plan

  • Statistical Analysis Plan: To be included as part of the Study design description
  • Milestone Plan: No
  • Go/No-Go Criteria: No

Innovation Award for Mechanistic Studies to Optimize Mind and Body Interventions in NCCIH High Priority Research Topics (R33)

PAR-17-162

Period of Award: Up to 3 years

Budget: A limit of $500,000 per year in direct costs is recommended

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): No
  • Regulatory Communication Plan (up to 3 pages): No
  • Clinical Trial Experience (up to 3 pages): No
  • Timeline and Milestone Plan (up to 5 pages): No
  • Project Management Plan (up to 3 pages): No
  • Study Organization Plan (up to 6 pages): No
  • Draft Informed Consent Form: No

Research Plan

  • Statistical Analysis Plan: To be described in the Research Strategy Section
  • Milestone Plan: Part of Approach section
  • Go/No-Go Criteria: No

NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01)

PAR-17-215

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
  • Draft Informed Consent Form: No

Research Plan

  • Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis”
  • Milestone Plan: Yes
  • Go/No-Go Criteria: No

Clinical Coordinating Center for NCCIH Multi-Site Investigator-Initiated Clinical Trials of Mind and Body Interventions (Collaborative UG3/UH3)

PAR-17-175

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
  • Draft Informed Consent Form: No

Research Plan

  • Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis”
  • Milestone Plan: To be included as “Other Attachments”
  • Go/No-Go Criteria: No

Mind and Body Intervention Multi-Site Clinical Trial Data Coordinating Center (U24)

PAR-17-173

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
  • Draft Informed Consent Form: No

Research Plan

  • Statistical Analysis Plan: Yes
  • Milestone Plan: to be included as “Other Attachments”
  • Go/No-Go Criteria: No

This page last modified September 24, 2017