Instructions For Filling Out Form Fda 1572 - Statement Of Investigator (Page 3 of 3) in pdf

Field 11: SIGNATURE OF INVESTIGATOR

The investigator identified in Field 1 must sign the form.

The investigator’s signature on this form constitutes the investigator’s affirmation that he or she is qualified

to conduct the clinical investigation and constitutes the investigator’s written commitment to abide by FDA

regulations in the conduct of the clinical investigations.

FORWARD THE COMPLETED FORM AND OTHER DOCUMENTS BEING PROVIDED TO THE SPONSOR.

The sponsor will incorporate this information along with other technical data into an Investigational New Drug

Application (IND). INVESTIGATORS SHOULD NOT SEND THIS FORM DIRECTLY TO THE FOOD AND

DRUG ADMINISTRATION.

Frequently Asked Questions – Statement of Investigator (Form FDA 1572)

FDA has published an Information Sheet for Guidance for Sponsors, Clinical Investigators, and IRBs

Frequently Asked Questions – Statement of Investigator (Form FDA 1572) May 2010 that is intended to

assist sponsors, clinical investigators, and institutional review boards involved in clinical investigations of

investigational drugs and biologics conducted under 21 CFR Part 312 (Investigational New Drug Applications

or IND regulations). Please refer to this guidance for further information on how to complete the Statement

of Investigator Form FDA 1572 and to review FDA’s responses to the most frequently asked questions about

Form FDA 1572.

FORM FDA 1572 SUPPLEMENT (7/13) – FORM INSTRUCTIONS

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Instructions For Filling Out Form Fda 1572 - Statement Of Investigator Page 3