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IND/IDE Support Path

1. Investigator Request
  • PI completes IND/IDE support request
  • Requests for IND/IDE support included in YCCI services request intake form
2. Triage
  • YCCI Reviews project details for IND/IDE needs and possible exemption
  • PI is contacted to discuss review or if more information is needed
3. Application Readiness
  • YCCI meets with PI to discuss application preparation needs
  • YCCI provides appropriate templates and guidance
  • Ancillary committees review
  • PI completes relevant IND/IDE trainings (Provided by YCCI)
4. Prepare Application
  • Documents collected by YCCI
  • YCCI provides guidance on content suitability
  • Application finalized with PI and submitted by YCCI
5. FDA Review
  • PI responds to any deficiencies communicated by FDA
  • FDA Communicates approval or clinical hold
  • PI notifies IRB of any comments and outcomes
6. Maintain Application
YCCI assists with:
  • Information amendments as needed
  • Safety Reporting
  • Annual Reports
  • Final Report at study conclusion