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).
The Food and Drug Administration (FDA or agency) has received a number of questions about Form FDA 1572. The most frequently asked questions are answered in the document. If you do not see your question answered there, you may submit it to gcp.questions@fda.hhs.gov or druginfo@fda.hhs.gov
To access the guidance please click here: Frequently Asked Questions – Statement of Investigator (Form FDA 1572)
