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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: Clinical Trials and Human Subject Protection

Clinical Trial Forms

This page provides links to commonly used clinical trial forms relevant to clinical trials.

FDA 1571 (PDF - 2MB)
Investigational New Drug Application
Instructions for completing Form FDA 1571
FDA 1572 (PDF - 1.4MB)
Statement of Investigator
Instructions for completing Form FDA 1572

FDA 3454 (PDF - 673KB)
Certification: Financial Interest and Arrangements of Clinical Investigator
FDA 3455 (PDF - 673KB)
Disclosure: Financial Interest and Arrangements of Clinical Investigators
FDA 3674 (PDF 2.6MB)
Certification of Compliance Under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (includes instructions)

For other FDA forms, visit the FDA Forms page.

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