Module 1administrativendaind● High priority
1.2.4 — Form FDA 3674 (ClinicalTrials.gov)
FDA Form 3674 certification of compliance with ClinicalTrials.gov requirements
Requirements by Phase
Phase 1
required
Phase 2
required
Phase 3
required
NDA
required
FDA Form 3674 certification of compliance with ClinicalTrials.gov requirements
Requirements by Phase
IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required
Content Requirements
- Certification of compliance with ClinicalTrials.gov registration requirements
- For NDA/BLA: certification that applicable clinical trials have been registered
- For IND: certification of trial registration
- Compliance with FDAAA Section 801 requirements
Expected Deliverables
- Completed FDA Form 3674
ICH Guidelines: 42 USC 282(j), FDAAA Section 801
Source: 42 USC 282(j); FDAAA Section 801
References
Related Sections
Up to1.2 — Cover Letter1.2.1 — Application Form (FDA Form 356h)
FDA Form 356h application form for NDA/BLA submissions
1.2.2 — Form FDA 1571 (IND)
FDA Form 1571 IND application cover form
1.2.3 — Form FDA 1572 (Statement of Investigator)
FDA Form 1572 signed statement from each participating investigator
1.2.5 — Prescribing Information / Labeling
Prescribing information and approved labeling for NDA
1.2.6 — Patent Information
Patent information for Orange Book listing
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