IND Application Reporting: Overview

Sponsors of IND applications are responsible for sending periodic updates and reports related to their applications to FDA. All submissions with IND application amendments or reports should include Form 1571 (PDF - 830KB) sent along with the respective amendment or report.

Form 3674 (PDF - 3MB) should be submitted for all new clinical trials.

Form 1572 (PDF - 718KB) should be included if the amendment concerns change in application sponsor or addition of a new investigator.

For any given IND application, FDA may receive the following categories of amendments and reports:

• • Protocol Amendments

  • Information Amendments

  • IND Safety Reports

  • IND Annual Reports  

 

Related Information

• Investigator-Initiated IND Applications