To assist sponsors, industry, researchers, and investigators in complying with the requirement, we created a certification form (Form FDA 3674) to be used to satisfy the certification...

The Form FDA 3674 is a document that must accompany the initial submission, and when submitting a new protocol to IND. It is a signed statement from the sponsor that they will …

Form FDA 3674 must accompany an application/submission, including certain amendments, supplements, and resubmissions, submitted under §§ 505, 515, 520(m), or 510(k) of the …

Jun 18, 2025 · Learn when FDA Form 3674 is required, how global trial registries differ, and how to stay compliant with evolving disclosure timelines in the U.S. and abroad.

Form 3674 must accompany an application/submission, including certain amendments, supplements, and resubmissions, submitted under §§ 505, 515, 520(m), or 510(k) of the …

For electronic form submissions, see Electronic Regulatory Submissions.

Filling out the HHS Form FDA 3674 online is an essential step for compliance with the requirements for the ClinicalTrials.gov Data Bank. This guide provides clear, step-by-step …

UNC Clinical Trials must be registered through the Office of Clinical Trials. Please contact them by sending an email to: [email protected] From there, you will get your …

The FDA form 3674 is a document that must accompany all FDA IND initial submissions and submission of new protocols to INDs. It is a signed statement from the sponsor-investigator …

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