FDA Forms

Tips for Form Completion

Links to Forms and Instructions

Form FDA 1571: Coversheet for all IND submissions. 
The 1571 must be signed by the Sponsor of the IND.

 

Form FDA 1571
Investigational New Drug Application

Instructions for
completing Form FDA 1571

Form FDA 1572: Statement of Investigator. 
The 1572 must be signed by the Principal Investigator of the clinical trial.

Form FDA 1572
Statement of Investigator

Instructions for completing Form FDA 1572

FAQs Form FDA 1572

Form FDA 3674: Certification of the Requirement to post the trial on clinicaltrials.gov

A 3674 should be completed for every trial conducted under an IND. The 3674 must be signed by the sponsor of IND. This form is not required for IDE applications. Internet Explorer is best for accessing the form.

Form FDA 3674
Certification of Compliance

Instructions for completing
Form FDA 3674

Form FDA 3926: A single-patient IND expanded access request that allows for IRB chairperson concurrence rather than full board review. 

**Note: Download and save form to your local computer, close, and re-open from your local computer to enable form functionality. 

Form FDA 3926
Individual Patient Expanded Access Investigational New Drug Application 

Instructions for completing Form FDA 3926

Form FDA 3500A: Required for reporting Serious Adverse Events that are determined to be unexpected (including unexpected in severity or frequency) and is at least possibly related to the investigational product. 

Form FDA 3500A 
MedWatch: The FDA Safety Information and Adverse Event Reporting Program - Mandatory

Instructions for completing Form FDA 3500A