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Statement of Investigator (Form FDA 1572)

The Statement of Investigator (Form FDA 1572) articulates the investigators responsibilities and obligations, it applies to drug and biological investigations (not applicable to medical device investigations). This form must be completed and signed by the investigator before they can begin the study. The form will go from the investigator to the sponsor and then the sponsor will submit to the FDA. This is considered a contract for the study oversight/conduct.

Please visit the Frequently Asked Questions for Form 1572 for more information.

To download the most recent Form 1572 please see attachment of this resource page on the right panel.

Creator Organization	University of Virginia
Categories	PROPOSE > REGULATORY REQUIREMENTS > Clinical Research LEARN > RESEARCH REGULATIONS > Human Subjects Research LEARN > RESEARCH REGULATIONS > Regulatory Bodies CONDUCT > REGULATORY MANAGEMENT > Human Subject Clinical Research
Website	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-statement-investigator-form-fda-1572

Attachments

Filename	Size	Date Modified
FDA-1572_R7_Sec_03-30-2022 (2).pdf	1.18 MB	May 16, 2026 4:35 AM UTC