1.2.3 — Form FDA 1572 (Statement of Investigator)

FDA Form 1572 signed statement from each participating investigator

Requirements by Phase

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

Content Requirements

• Investigator name, address, and qualifications
• Education, training, and experience (curriculum vitae)
• Medical license number and state
• Names of sub-investigators and research assistants
• Name and address of IRB responsible for review
• Names of research facilities and laboratories
• Protocol title(s) and number(s) for studies to be conducted
• Commitments: conduct study per protocol, supervise administration, informed consent per 21 CFR 50, report adverse experiences per 21 CFR 312.32, IRB review per 21 CFR 56, maintain adequate records, ensure drug disposition per protocol, restrict drug distribution
• Investigator signature and date

Expected Deliverables

• Completed signed FDA Form 1572 (one per investigator)

ICH Guidelines: 21 CFR 312.23(a)(6)(iii)(b)

Regulatory Requirements (ICH M3R2)

• Informed consent for WOCBP should be based on known reproduction toxicity information; if none, potential for unidentified risks should be communicated.
• If phototoxicity assessment indicates potential photocarcinogenic risk, risk should be managed by protective measures including warning statements in informed consent and product information.

Note: One per investigator

Source: 21 CFR 312.23(a)(6)(iii)(b)