Click through for IND information. For questions or submission assistance please contact the YCCI IND/IDE Office.
IND FDA Forms
- Please contact the YCCI IND/IDE Office for submission assistance. Templates available include:
- Initial IND
- IND Annual Report
- FDA Meeting Request
- FDA Meeting Background Package
- Protocol Amendment
- Safety Report
- Withdrawal of an IND
- Response to FDA Comment or Request for Information
- Request for IND Exemption
- Transfer of IND
- Letter of Authorization to Cross-Reference IND
IND Additional Helpful Links
- To find the SNOMED CT term for your IND indication (Box 7B of 1571 form):
- Go to the SNOMED CT website
- In the main screen under Local Extensions, select “Go browsing… United States edition”
- In the search box begin typing the name of the disease/condition to be treated, prevented, diagnosed, cured, or mitigated in the trial.
- TIP: For an early safety trial in healthy volunteers, use the disease that you are eventually aiming to target – what the drug is being developed for.
- If necessary (due to a large number of results returned), check the “Group by concept” box and select Filter Results by “disorder”
- A number of choices will be presented under the search box; select the most appropriate term.
- TIP: Only a single term may be selected for a given indication. For multiple indications each will be entered separately into a pair Box 7A and Box 7B.
- Select the Expression tab on the right-hand side of the page.
- Copy the entire text that appears under the heading “Pre-coordinated Expression” and past into Box 7B
- EXAMPLE: 700423003 |Adenocarcinoma of pancreas (disorder)|
YCCI IND/IDE Office Contact
Amy C. Hummel, MS
Associate Director for IND/IDE Management
Yale Center for Clinical Investigation
2 Church Street South, Suite 112
New Haven, CT 06519