FDA Form 1572 (Statement of Investigator)

FDA Form 1572, titled Statement of Investigator, is the signed document through which an individual formally becomes an “investigator” of record on an FDA-regulated drug or biologic clinical trial conducted under an Investigational New Drug (IND) application, binding them by signature to comply with FDA’s clinical-trial regulations at 21 CFR Part 312.

Signing Form 1572 is a legal commitment, not a formality: the investigator’s signature affirms they are qualified to conduct the study. A sponsor may not permit an investigator to begin participating in an IND-regulated study until this form, along with the investigator’s curriculum vitae and financial-disclosure information, is completed and on file.

What Form 1572 is for

Under 21 CFR 312.53, a sponsor may select only investigators “qualified by training and experience as appropriate experts to investigate the drug,” and before an investigator may participate, the sponsor must obtain a signed Statement of Investigator on Form FDA-1572. The form itself collects:

• The investigator’s name, address, and the protocol(s) they will conduct under that IND
• The name and address of the research facility(ies) where the study will be conducted, and of any clinical laboratory facilities used
• The name and address of the Institutional Review Board (IRB) responsible for reviewing and approving the study
• The names of subinvestigators (e.g., research fellows, residents, or co-investigators) who will assist in conducting the investigation
• The investigator’s signature and the date

The completed 1572, together with the investigator’s CV or equivalent statement of qualifications, an outline of the clinical protocol appropriate to the study phase, and financial disclosure information under 21 CFR Part 54, is submitted to the sponsor — never directly to FDA. The sponsor incorporates it into the IND submission and retains it as part of the trial’s regulatory documentation.

What the investigator is committing to

Form 1572 includes a “Commitments” section that the investigator’s signature affirms. Consistent with 21 CFR 312.53(c) and FDA’s own instructions for completing the form, the investigator commits to:

1. Conduct the study(ies) in accordance with the current, sponsor-approved protocol, and make no changes to it without prior sponsor and IRB agreement — except where immediately necessary to protect the safety, rights, or welfare of subjects
2. Personally conduct or supervise the described investigation(s)
3. Ensure that informed consent is obtained from subjects in accordance with 21 CFR Part 50, and that IRB review and approval requirements under 21 CFR Part 56 are met, both initially and on a continuing basis
4. Report adverse experiences to the sponsor in accordance with the adverse-event reporting obligations at 21 CFR 312.64
5. Have read, and ensure that all subinvestigators assisting in the study have read, the current investigator’s brochure (or equivalent product information for a marketed drug)
6. Ensure that all associates, colleagues, and employees assisting in the study are informed of their obligations regarding these commitments
7. Maintain adequate and accurate records in accordance with 21 CFR 312.62, and make those records available for inspection
8. Ensure the IRB is promptly notified of all changes in research activity and of all unanticipated problems involving risk to subjects or others

This is a written, personal commitment — not a description of the sponsor’s obligations, and not identical to what the trial’s protocol or informed consent document independently requires. An investigator who signs Form 1572 without having actually read the protocol and investigator’s brochure is signing something they cannot substantiate, which is itself a documented inspection finding pattern.

Who is required to sign

“Investigator” is a specifically defined regulatory role, not every member of a study team. Under 21 CFR 312.3, an investigator is “an individual who actually conducts a clinical investigation” — the person under whose immediate direction the investigational drug is administered or dispensed to a subject. When a trial is conducted by a team at a site, the investigator is the responsible leader of that team, commonly called the principal investigator (PI). Every other team member who participates in conducting the study — research fellows, residents, co-investigators, sub-Is — is a subinvestigator under 21 CFR 312.3.

Only the investigator identified in Field 1 signs a given Form 1572. Subinvestigators are listed by name on the form but do not sign a separate Statement of Investigator of their own; the PI’s signature covers the commitments for the site’s conduct of the study as a whole. A multi-site trial requires a separately signed Form 1572 for each site’s principal investigator, and a new or amended Form 1572 is generally required when a new protocol is added under the same IND or when a new principal investigator joins the study — not for routine changes such as adding a subinvestigator or updating a laboratory, which are documented in the study record and communicated to the sponsor instead.

Form 1572 vs. other clinical-trial regulatory documents

Form 1572 is frequently confused with other FDA-related documents that serve entirely different purposes in the trial lifecycle:

• Timing: Form 1572 is executed before an IND-regulated trial begins at a site — it is a pre-trial eligibility and commitment document. An FDA Form 483, by contrast, is issued after an FDA inspection has already taken place, listing the investigator’s on-site observations of possible noncompliance. The two forms are unrelated in function even though both carry the “Form” naming pattern: 1572 is a commitment made going in, 483 is a finding written up on the way out.
• Relationship to inspection outcomes: because Form 1572’s commitments (protocol adherence, IRB oversight, adverse-event reporting, recordkeeping) are exactly the areas an FDA Bioresearch Monitoring (BIMO) inspection evaluates, deficiencies against those same commitments are a common category of Form 483 observation at investigator sites. Maintaining a state of continuous inspection readiness — essential documents organized and current, protocol deviations logged, delegation-of-authority records matching what is actually on file — is largely the practice of being able to demonstrate, at any time, that the site is doing what its Form 1572 says it will do.
• Scope: Form 1572 applies specifically to drug and biologic trials conducted under an IND per 21 CFR Part 312. It has no equivalent requirement for device trials under an Investigational Device Exemption (IDE, 21 CFR Part 812), which instead uses an Investigator Agreement, or for many trials conducted entirely outside U.S. FDA jurisdiction, which instead rely on the investigator undertakings built into ICH E6 Good Clinical Practice documentation.

Example

A principal investigator at an academic medical center is added to an industry sponsor’s multi-site Phase 2 trial of an investigational biologic. Before enrolling any subjects, the PI completes Form 1572, listing the IRB of record, two subinvestigators (a research fellow and a study coordinator physician), and the protocol number; attaches a current CV; signs the commitments section; and returns the packet to the sponsor, who incorporates it into the IND. Only after the sponsor confirms the signed 1572, CV, and financial disclosure are on file does the site receive authorization to begin screening subjects.

Counter-example

A postdoctoral research fellow who screens subjects and collects study data under a PI’s direct supervision, but is not the individual under whose immediate direction the investigational drug is administered and who does not bear overall responsibility for the site’s conduct of the trial, is listed on the PI’s Form 1572 as a subinvestigator — they are not themselves required to sign a Statement of Investigator, because they do not meet the 21 CFR 312.3 definition of “investigator.”

Related terms

• FDA Form 483
• Inspection Readiness
• ICH E6(R3) (Good Clinical Practice Guideline Revision)
• Investigational Medicinal Product Dossier (IMPD)
• Clinical Trial Phases: FDA Definitions, Milestones, and Trial Administration