https://www.fda.gov/media/134964/downloadTips for Form Completion |
Links to Forms and Instructions |
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Form FDA 1571: Coversheet for all IND submissions. |
Form FDA 1571 Instructions for |
Form FDA 1572: Statement of Investigator. |
Form FDA 1572 Instructions for completing 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 Instructions for completing |
Form FDA 3926: A single-patient IND expanded access request that allows for IRB chairperson concurrence rather than full board review. |
Form FDA 3926 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 |