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