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  1. IND & IDE Support

FDA Forms

FDA Form Requirement Description

Form FDA 1571

Completed by the IND Sponsor and must be included on all submissions made to the IND application.

This form includes administrative information pertinent to the IND application and acts as a cover sheet.

Form FDA 1572

Completed by the Clinical Investigator (i.e., Principal Investigator).  Required for all:

  • Initial IND applications,

  • Protocol Amendment – New Protocol, and

  • Protocol Amendment – New Investigator

  • Optional for Annual Reports to report current sub-investigators

This form represents the Statement of the Investigator conducting clinical research under the IND application.

Form FDA 3674

Completed by the IND Sponsor.   Required for all:

  • Initial IND applications,

  • Protocol Amendment – New Protocol

This form (instructions included) represents certification of compliance with requirements of ClinicalTrials.gov Data Bank.

Form FDA 3500A

Completed by the IND Sponsor.   Required for all events listed in 21 CFR 312.32 and 812.150 (b)(1)

This form, also known as the MedWatch form, is mandatory reporting for use by IND and IDE Sponsors.

Current versions of FDA forms can be found at this link https://www.fda.gov/about-fda/reports-manuals-forms/forms.  It is strongly recommended to refer to the form instructions for details on how to complete each field.

For best results, search criteria should be limited to the form number only.  Depending on the browser you are using, you may need to download the form to enable field fillable functionality.  If you encounter an issue, download/save as the form to your computer and open in Adobe.