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IND Information

IND Templates
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):
  1. Go to the SNOMED CT website
  2. In the main screen under Local Extensions, select “Go browsing… United States edition”
  3. 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.
  4. If necessary (due to a large number of results returned), check the “Group by concept” box and select Filter Results by “disorder”
  5. 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.
  6. Select the Expression tab on the right-hand side of the page.
  7. Copy the entire text that appears under the heading “Pre-coordinated Expression” and past into Box 7B
    • EXAMPLE: 700423003 |Adenocarcinoma of pancreas (disorder)|