National Center for Complementary and Integrative Health (NCCIH)
NIH…Turning Discovery Into Health

Información en Español

Health Topics A-Z

NCCIH Clinical FOAs Required Application Elements—Mind and Body

Share:
email
Twitter
Facebook
AddThis

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

PAR-18-114

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

See More

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 Trial Information

  • Statistical Analysis Plan: To be described in the Research Strategy section

Other Attachments

  • None

Research Plan

  • Milestone Plan: Part of Go/No-Go Criteria section
  • Go/No-Go Criteria: Yes

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

PAR-18-115

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

PHS Human Subjects and Clinical Trial Information

  • Statistical Analysis Plan: To be described in the Research Strategy section

Other Attachments

  • None

Research Plan

  • Go/No-Go Criteria: No

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

PAR-18-417

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)

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 Trial Information

  • Statistical Analysis Plan: To be included as part of the Study Design description
  • Milestone Plan: No

Other Attachments

  • Clinical Trial Experience (up to 3 pages): Yes

Research Plan

  • Go/No-Go Criteria: No

NCCIH Mind and Body Clinical Trial Cooperative Agreement (U01)

PAR-18-118

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

PHS Human Subjects and Clinical Trials Information

  • Clinical Protocol Synopsis (up to 12 pages): Yes
  • Statistical Analysis Plan: To be included as part of the “Clinical Protocol Synopsis” 

Cover letter: Encouraged

Other Clinical Trial-related Attachments

  • Regulatory Communication Plan (up to 3 pages): Yes
  • Clinical Trial Experience (up to 3 pages): Yes

Other Attachments

  • Project Management Plan (up to 3 pages): No
  • Study Organization Plan (up to 6 pages): No
  • Draft Informed Consent Form: No

Research Plan

  • Milestone Plan: Yes
  • Go/No-Go Criteria: No

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

PAR-18-662

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 phases 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
  • Study Organization Plan (up to 6 pages): Yes, under Protection and Monitoring Plans
  • 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
  • Timeline and Milestone Plan (up to 5 pages): Yes

Other Attachments

  • Regulatory Communication Plan (up to 3 pages): Now part of the protocol synopsis.
  • Project Management Plan (up to 3 pages): Yes
  • Draft Informed Consent Form: No

Research Plan

  • Go/No-Go Criteria: No

Mind and Body Intervention Multisite Clinical Trial Data Coordinating Center (U24)

PAR-18-663

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. The combined budgets of the Clinical Coordinating Center and Data Coordinating Center will be used to determine whether the policy regarding direct costs of $500,000 or more in any year will be applied.

See More

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 (up to 3 pages): Yes
  • Timeline and Milestone Plan (up to 5 pages): Yes

PHS Human Subjects and Clinical Trials Information

  • Statistical Analysis Plan: Yes 

Other Attachments

  • Project Management Plan (up to 3 pages): Yes

Research Plan

  • Statistical Analysis Plan: Yes 
  • Go/No-Go Criteria: No

 

This page last modified October 01, 2018