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 seven specific commitments under 21 CFR 312.53(c)(1)(vi), listed in full below, plus a separate IRB commitment under 312.53(c)(1)(vii).
• Those commitments run to the sponsor: follow the current protocol, comply with Part 312, personally conduct or supervise, meet consent and IRB requirements, report adverse experiences, know the investigator’s brochure, and keep the team informed of its obligations.
• 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 investigator’s commitments to the sponsor, in full

The reason the 1572 is a contract and not a cover sheet is the block of commitments the investigator signs. There are seven, set out at 21 CFR §312.53(c)(1)(vi), clauses (a) through (g). This is the complete list:

1. Conduct the study per the current protocol (clause a). The investigator commits to conduct the studies in accordance with the relevant, current protocols 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 (21 CFR §312.53(c)(1)(vi)(a)).
2. Comply with Part 312 (clause b). 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)).
3. Personally conduct or supervise (clause c). The investigator commits to personally conduct or supervise the described investigations (21 CFR §312.53(c)(1)(vi)(c)).
4. Inform subjects, and meet consent and IRB requirements (clause d). The investigator commits to inform any potential subjects that the drugs are being used for investigational purposes, and to ensure that the requirements relating to obtaining informed consent under 21 CFR part 50 and institutional review board review and approval under 21 CFR part 56 are met (21 CFR §312.53(c)(1)(vi)(d)).
5. Report adverse experiences (clause e). The investigator commits to report to the sponsor adverse experiences that occur in the course of the investigations in accordance with 21 CFR §312.64 (21 CFR §312.53(c)(1)(vi)(e)).
6. Know the investigator’s brochure (clause f). The investigator attests 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)).
7. Keep the team informed of its obligations (clause g). The investigator commits to ensure that all associates, colleagues, and employees assisting in the conduct of the studies are informed about their obligations in meeting the above commitments (21 CFR §312.53(c)(1)(vi)(g)).

Note the direction of each one. These are commitments the investigator makes to the sponsor, because the sponsor is the party required to obtain the statement before letting the investigator begin. That is what distinguishes them from the investigator’s general responsibilities under §312.60 or from obligations owed to the IRB.

The separate IRB commitment

The seven clauses above are not the whole signature. The 1572 carries a further, separately numbered commitment at clause (vii), and it is the one most often missed because it sits outside the (a) to (g) block.

For an investigation subject to an institutional review requirement under 21 CFR part 56, the investigator commits that an IRB complying with that part will be responsible for the initial and continuing review and approval of the clinical investigation, that the investigator will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects or others, and that the investigator will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to the human subjects (21 CFR §312.53(c)(1)(vii)).

Read clause (d) and clause (vii) together and the structure is clear. Clause (d) commits the investigator to seeing that consent and IRB review happen; clause (vii) commits the investigator to an ongoing relationship with the IRB once they have. Continuing review, prompt reporting, and the no-changes-without-approval rule all live here, on the same signed page.

Why these commitments bite

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.

Three of the clauses carry more operational weight than their one-line phrasing suggests.

Clause (c), the commitment to personally conduct or supervise, 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.

Clause (e) pulls in the safety machinery. The adverse experience you report to your sponsor is not a courtesy; it is a 1572 commitment with a regulation behind it.

Clause (f) 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, supervise the team, inform subjects and meet consent and IRB requirements, 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.

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.

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.
• Counting seven commitments and stopping. Clause (vii), the IRB commitment, is part of the same signature and is easy to miss because it sits outside the (a) to (g) block.
• 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