1.3.2 — Financial Disclosure

Financial disclosure forms (Form 3454/3455) for clinical investigators

Requirements by Phase

IND Phase 1: required IND Phase 2: required IND Phase 3: required NDA: required

Content Requirements

• Financial disclosure forms (FDA Form 3454 or 3455) for each clinical investigator
• Disclosure of compensation arrangements affected by study outcome
• Disclosure of equity interest in sponsor exceeding $50,000
• Disclosure of proprietary interest in the product (patent, trademark, copyright, licensing agreement)
• Disclosure of significant payments of other sorts exceeding $25,000
• Coverage period: one year prior to study participation through completion
• Steps taken to minimize potential bias (if financial interest identified)

Expected Deliverables

• Financial disclosure forms (Form 3454/3455) for each investigator

ICH Guidelines: 21 CFR 54

Source: 21 CFR 54