Form FDA 1572: The Investigator's Binding Commitment, Not a Form-Fill

At a glance

• The 1572, the Statement of Investigator, is a signed commitment the sponsor must obtain before an investigator starts an IND study. It is required for US IND trials, not for non-IND or, typically, ex-US trials.
• The signature binds the investigator to specific obligations: follow the current protocol, change it only after notifying the sponsor (except to protect subjects), meet informed-consent and IRB requirements, and ensure the team knows its duties.
• The compliance risk lives in three fields: Section 1 (the investigator), Section 3 (the sites), and the sub-investigator listing. Accuracy there is what an inspection checks.
• A new 1572 (or a protocol amendment) is triggered by a new investigator, and the form must stay accurate as sites and staff change.
• The investigator does not mail the 1572 to FDA. The sponsor obtains it and incorporates it into the IND.

What the 1572 is and when it is required

Form FDA 1572 is the mechanism by which a sponsor secures, in writing, an investigator’s qualification and commitment before that investigator touches an IND study. Under 21 CFR Part 312, before permitting an investigator to begin participation, the sponsor must obtain a signed investigator statement (Form FDA-1572) containing the name and address of the investigator, the protocol identifying the studies to be conducted, the address of the research facilities, the address of any clinical laboratory facilities, and the IRB responsible for review and approval of the study (21 CFR Part 312 §312.53(c)(1)). That list is Sections 1 through 5 of the form, and each line is a factual assertion an inspector can check against reality.

The scope is specific. The 1572 is an instrument of the IND framework. It is required for clinical investigations conducted under a US IND, and it is not the right instrument for device studies (which run under IDE rules) or, as a general matter, for trials conducted entirely outside the United States. When in doubt, the question is not “is this a clinical trial” but “is this study under an IND.”

The commitments the signature binds

The reason the 1572 is a contract and not a cover sheet is the block of commitments the investigator signs. Under 21 CFR §312.53(c)(1)(vi)(a), the investigator commits to conduct the study in accordance with the relevant, current protocol and to make changes in a protocol only after notifying the sponsor, except when necessary to protect the safety, the rights, or welfare of subjects. Three further commitments are easy to under-read and heavily inspected:

• The investigator commits to comply with all requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR Part 312 (21 CFR §312.53(c)(1)(vi)(b)).
• The investigator commits to ensure that the requirements for obtaining informed consent under 21 CFR part 50 and for IRB review and approval under 21 CFR part 56 are met (21 CFR §312.53(c)(1)(vi)(d)).
• The investigator commits to ensure that all associates, colleagues, and employees assisting in the conduct of the study are informed about their obligations in meeting these commitments (21 CFR §312.53(c)(1)(vi)(g)).

These are not aspirational. The general-responsibilities rule makes the same point in plain terms: the investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations, and for protecting the rights, safety, and welfare of subjects under the investigator’s care (21 CFR §312.60). When you sign the 1572 you are taking on §312.60, in writing, by name.

Section 1, Section 3, and the sub-investigators: where findings live

Most 1572 findings are not philosophical; they are field-level accuracy problems in three places.

Section 1, the investigator. The person who signs must be the responsible investigator, qualified for the role. ICH E6(R3) sets the qualification bar the 1572 attests to: the investigator should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial (ICH E6(R3) §2.1.1). The CV or statement of qualifications behind Section 2 is the evidence.

Section 3, the sites. This lists every location where the investigation is conducted and data are generated. If the trial runs at a location not on the form, the form is wrong.

The sub-investigators. Anyone directly involved in performing protocol procedures or collecting data should be listed. This is the field teams most often get wrong, by under-listing staff who in fact run study procedures. The form connects directly to the delegation log here: ICH E6(R3) requires the investigator to ensure a record is maintained of the persons and parties to whom trial-related activities are delegated (ICH E6(R3) §2.3.3). The 1572 and the delegation log should tell the same story; an inspector will read them against each other.

When you need a new 1572

The form is not a one-time artifact. It has to stay true as the study changes. A clear regulatory trigger is a new investigator: a sponsor must submit a protocol amendment when a new investigator is added to carry out a previously submitted protocol (21 CFR Part 312 §312.30(c)). Beyond that, the operating principle is that Sections 1, 3, and 6 must remain accurate, so adding a site, or changing who runs procedures, is the moment to refresh the form rather than let it drift. An outdated, unsigned, or expired-version 1572 is a finding precisely because the commitments it carries are continuous.

Who signs and who submits

The investigator signs, and that signature is the operative act. But the investigator does not send the form to FDA. Under §312.53(c) the sponsor is the party that obtains the signed statement before letting the investigator begin, and the sponsor incorporates it into the IND. The investigator’s job is to make the assertions true and keep them true; the sponsor’s job is to collect, hold, and submit.

The rest of the commitments, and why they bite

The three commitments covered above are the ones people quote, but the signature binds the investigator to more, and the less-quoted ones are where day-to-day conduct is judged. By signing, the investigator commits to personally conduct or supervise the described investigation (21 CFR §312.53(c)(1)(vi)(c)). That single clause is the regulatory root of the delegation log: if you are committing to supervise, you need a record of who acted under your supervision and for what. A trial where procedures were run by staff the investigator never demonstrably oversaw is a breach of the form they signed, not merely a documentation gap.

The signature also pulls in the safety machinery. The investigator commits to report to the sponsor adverse experiences that occur in the course of the investigation in accordance with 21 CFR §312.64 (21 CFR §312.53(c)(1)(vi)(e)). So the SAE you report to your sponsor is not a courtesy; it is a 1572 commitment with a regulation behind it. And the investigator commits to having read and understood the information in the investigator’s brochure, including the potential risks and side effects of the drug (21 CFR §312.53(c)(1)(vi)(f)). That is the basis on which “unexpected” is judged for safety reporting: you cannot assess whether a reaction is consistent with the reference safety information if you never absorbed it.

Taken together, the commitment block is a compact map of the investigator’s whole regulatory job: follow the protocol, change it only with notice or to protect subjects, comply with Part 312, meet consent and IRB requirements, supervise the team, report safety, know the product, and keep the people assisting informed of their obligations. The form is one page because each line is a pointer to a duty defined elsewhere. Reading it as a contract means reading those pointers, not just signing under them.

This is also why an investigator should never sign a 1572 they have not actually read against reality. Signing attests that Sections 1 through 5 are true and that the commitments will be met. If the sub-investigator list is incomplete, or a site is missing, or the investigator has not in fact read the current brochure, the signature is already inaccurate the moment it is made, and that inaccuracy is the kind of thing a bioresearch monitoring inspection is built to surface.

Where teams get it wrong

• Treating it as a form-fill. The signature binds the investigator to §312.60 and the §312.53 commitments. It is a contract.
• Under-listing sub-investigators. Staff running protocol procedures belong on the form and on the delegation log, which must agree.
• Letting the form go stale. New site, new investigator, or changed staff means refresh the form (and, for a new investigator, a protocol amendment under §312.30(c)).
• Using it where it does not apply. Device (IDE) studies and, generally, ex-US trials are not 1572 territory.

The 1572 is short, which is exactly why it gets treated casually. It is also the document where an investigator personally signs up to the regulatory obligations of the trial. Fill it as the binding commitment it is, and keep it as accurate as the study it describes.

Sources

• 21 CFR Part 312, Investigational New Drug Application (current as of 4/14/2026)
• ICH E6(R3) Good Clinical Practice, version R3