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IND#: XXXXXX
Sponsor-Investigator:
Annual Report: mm/yyyy
IND Annual Report Template
A Sponsor or Sponsor-Investigator is required to submit a report on the progress of the investigation
within 60 days of the anniversary date that the IND went into effect.
The following template provides guidance for preparing this annual report. FDA requires a response to
every question outlined at 21 CFR 312.33, which are outlined below. For more information, these
regulations can be reviewed at:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.33
Note:

The regulations do not specify a format for these responses, and you may modify or delete the
tables below as necessary.

This form may be used to report on multiple studies investigating one IND, but each question
Section A will need to be answered individually for each study.

Do not skip any questions. If a question is not applicable for any reason, describe why it is not
applicable.

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IND#