FDA form 1572

The 1572 is a federal form and is the statement of the investigator that he will abide by the federal guidelines set forth in the Code of Federal Regulations for the use of drugs in an investigational setting.
An investigator that is involved in drug or biologic research under Investigative New Drug (IND) regulations is obligated to sign a FDA form 1572. The PI signs a contract with the FDA which documents his or her agreement to follow the protocol and study obligations in conducting the trial. The investigator makes this contractual commitment when the FDA form 1572 (drug/biologic studies) or Investigator’s Agreement (device studies) is signed; the PI serves as the communication link between the sponsor and the FDA.
A new FDA 1572 Form must be submitted to the Program Management Board (PMB) whenever a change in any of the required information, such as the name or address of the PI or a change in the site IRB, occurs within the current year.
Regulation/Reference: 21 CFR 312
Purpose:
1. Document that the Investigator of Record (IoR) (i.e., Principal Investigator or PI)
agrees to conduct the trial according to the obligations stated in the form.
2. Update as study personnel and/or other data on the form changes.
3. The original version and any updated form must be retained as per regulatory
requirements.
4. The Investigator in box 1 of Form FDA 1572 is the individual who must sign and
date the signature box
5. Only laboratories specified in the protocol need to be listed in Section 4 to address
the following:
• Research /academic labs do not need to be listed on Form FDA 1572
• Research /academic labs should be listed in the protocol
• Central lab should be listed in the protocol for multi-center study protocol
• List individual clinical labs as in the protocol, unless it is a large multi-center
study and it would be impractical to list labs for every site.
1572 itself declares that, “No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator, Form FDA 1572.” And FDA regulations at 21 CFR 312.53(c)(1) add that, “Before permitting an investigator to begin participation in an investigation, the sponsor shall obtain the following: (1) A signed investigator statement (Form FDA-1572)….” Therefore, the Form 1572 is a document that an investigator must submit to the study sponsor.
Through the 1572 Form and the attachments typically sent with it, an investigator provides a sponsor with, among other things, information on his or her education, training, and experience (CV or other statement of qualifications) that qualifies him or her to undertake the clinical investigation, information on the relevant facility, IRB, and sub investigators, protocol information, and the investigator’s commitment to conduct the study in accordance with the protocol and FDA regulations.

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