Form FDA 1572, Statement of Investigator, is legally binding between the investigator and the:
Form FDA 1572 is legally binding between the clinical investigator and the FDA. By signing, the investigator personally commits to conduct the study in compliance with FDA regulations and the protocol. It does not bind the investigator to the sponsor, subjects, or IRB.
The answer
Form FDA 1572, the Statement of Investigator, is a legally binding agreement between the clinical investigator and the U.S. Food and Drug Administration (FDA). It is used in studies conducted under an Investigational New Drug (IND) application. When an investigator signs the 1572, they are making a direct, personal legal commitment to the FDA that they will conduct the investigation according to the protocol and applicable federal regulations.
The sponsor collects the signed 1572 and submits it to the FDA as part of the IND, but the binding relationship created by the form runs between the investigator and the government agency. The investigator is essentially telling the FDA: "I will follow the rules, and I am personally accountable if I do not." That accountability can include debarment or criminal liability for false statements.
What the investigator agrees to
By signing, the investigator commits to specific obligations, including that they will:
- Conduct the study in accordance with the current protocol and make changes only after notifying the sponsor (except to protect subject safety).
- Comply with all requirements regarding obligations of investigators and 21 CFR Part 50 (informed consent) and Part 56 (IRB review).
- Personally conduct or supervise the investigation and ensure all sub-investigators are aware of their obligations.
- Ensure informed consent is obtained and that IRB review and approval are maintained.
- Report adverse events to the sponsor and maintain accurate records.
Why the other options are wrong
The sponsor. The sponsor holds the IND and provides the 1572 to the investigator, and there is a separate contractual/agreement relationship between sponsor and investigator (through the clinical trial agreement). But the 1572 itself is not the sponsor–investigator contract; it is the investigator's sworn commitment to the FDA. Confusing the two is the most common trap.
The research subjects. Subjects are protected through the informed consent document, not the 1572. The 1572 references the investigator's duty to obtain consent, but no legal agreement is formed between investigator and subject via this form.
The IRB. The IRB independently reviews and approves the study and oversees subject protections. The investigator agrees on the 1572 to comply with IRB requirements, but the form does not create a binding agreement with the IRB.
The bigger picture
The 1572 is required for studies conducted under an IND, most notably domestic drug and biologic trials. It is generally not required for medical device studies (which use an Investigator Agreement under the IDE regulations) or for certain foreign studies not conducted under a U.S. IND. Understanding that the form is a regulatory instrument, not a business contract, clarifies why the answer is the FDA: it is the mechanism by which the federal government secures a direct promise of regulatory compliance from each person running an investigational drug study.
| FDA | Receives the investigator's sworn commitment to follow regulations | Yes — the binding party |
| Sponsor | Provides and submits the form; has a separate clinical trial agreement | No — bound via other contracts |
| Research subjects | Protected through informed consent, not this form | No |
| IRB | Independently reviews/approves; investigator agrees to comply | No |
Frequently asked
What is Form FDA 1572 used for?
It is the Statement of Investigator, used in FDA-regulated drug and biologic trials conducted under an IND. It documents the investigator's qualifications, the study site, sub-investigators, and IRB, and records the investigator's commitment to comply with FDA regulations and the protocol.
Who signs the FDA 1572?
The clinical investigator who is responsible for conducting the study at a given site signs the 1572. The sponsor does not sign it; the sponsor collects the signed form and submits it to the FDA as part of the IND.
Is the 1572 required for all clinical trials?
No. It is required for studies conducted under an IND (typically domestic drug and biologic trials). Medical device studies use a separate Investigator Agreement under the IDE regulations, and some foreign studies not run under a U.S. IND do not require a 1572.
What commitments does an investigator make on Form 1572?
The investigator agrees to follow the protocol, comply with informed consent (21 CFR 50) and IRB (21 CFR 56) requirements, personally conduct or supervise the study, report adverse events to the sponsor, and maintain accurate records.
What is the difference between the sponsor and the FDA on the 1572?
The FDA is the party the investigator is legally bound to through the form's commitments. The sponsor is the entity that gives the investigator the form and submits it to the FDA, and maintains a separate contractual relationship with the site through the clinical trial agreement.