Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs - Frequently Asked Questions – Statement of Investigator (Form FDA 1572)

• Date: June 06, 2010
• Source: www.fda.gov

This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biologics. This guidance applies to clinical investigations conducted under 21 CFR Part 312 (Investigational New Drug Applications or IND regulations). It describes how to complete the Statement of Investigator form (Form FDA 1572).

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