The Statement of Investigator, Form FDA 1572, is a legally binding document that the clinical investigator signs to confirm their commitment to the sponsor. By signing, the investigator agrees to conduct the study in accordance with the protocol and applicable U.S. Food and Drug Administration (FDA) regulations. Key commitments include personally conducting or supervising the investigation, ensuring informed consent is obtained from all subjects, reporting adverse events, and maintaining adequate and accurate records. The form serves as a formal agreement to comply with the regulatory requirements for conducting clinical trials under an Investigational New Drug (IND) application.

A. A statement disclosing investigator financial interests is required by 21 CFR Part 54 but is collected on a separate form (e.g., Form FDA 3455), not the Form 1572.

B. A statement responding to FDA inspection observations (Form FDA 483) is a separate communication that occurs after an inspection and is not part of the initial investigator agreement.

C. A statement describing preclinical and human safety data is provided to the investigator by the sponsor in the Investigator's Brochure (IB), not included in the Form 1572.

1. U.S. Food and Drug Administration (FDA). Form FDA 1572, Statement of Investigator. The form itself lists nine specific commitments the investigator makes, all of which relate to complying with regulations. Section 9 explicitly states the investigator agrees to "comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR part 312." Available at: https://www.fda.gov/media/75835/download

2. U.S. Food and Drug Administration (FDA). Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions – Statement of Investigator (Form FDA 1572). (May 2010). Section III, Question 9, clarifies, "The 1572 is a document that an investigator must sign to assure the sponsor that he/she will abide by the FDA regulations."

3. Code of Federal Regulations, Title 21, Part 312, Subpart D — Responsibilities of Sponsors and Investigators. § 312.53 Selecting investigators and monitors. This regulation requires sponsors to obtain a signed Form 1572 from the investigator, which serves as the investigator's signed commitment.

4. Johns Hopkins University, Institute for Clinical and Translational Research. Regulatory Binder: Essential Documents. The courseware describes the Form 1572 as the document where "the investigator agrees to follow the FDA’s code of conduct for the ethical performance of clinical research." (Accessed via materials on clinical research conduct).