FDA Form 1572, Box by Box | CASRAI

Form FDA 1572, the Statement of Investigator, is the document a clinical investigator signs to formally agree to the obligations of running a study under an Investigational New Drug (IND) application. It has 11 numbered fields. This page walks through each one, using FDA’s own field-by-field instructions for the form as the source, plus the errors that most commonly get a 1572 sent back for correction.

Last verified: August 16, 2026, against FDA’s Instructions for Filling Out Form FDA 1572 (fda.gov/media/79326/download) and 21 CFR 312.53/312.3.

Quick-reference table: what goes in each box

Field	What it asks for	Who/what goes in it
1	Name and address of investigator	One investigator only, full legal name, work/business address
2	Education, training, and experience	Not filled in directly — a CV or “Other Statement of Qualifications” is attached
3	Facility(ies) where the investigation will be conducted	Every site where subjects are seen, procedures performed, or the test article administered
4	Clinical laboratory facilities used in the study	Labs directly contributing to or supporting the trial (diagnostic, imaging, PK analysis, etc.)
5	IRB responsible for the study	Name and address of the reviewing IRB
6	Subinvestigators	Team members making a direct, significant contribution to the data — not ancillary staff
7	Protocol name(s) and code number(s)	Every protocol under the IND that this investigator will conduct
8	Clinical protocol phase	One box only; combined Phase 1/2 checks the Phase 2 box; Phase 4 also checks the Phase 2 box, with “Phase 4” noted in Field 7
9	Commitments	Pre-printed regulatory commitments — the investigator’s signature affirms these, nothing is typed in
10	Date	Date the investigator signs
11	Signature of investigator	Must be the person named in Field 1 — no one else can sign on their behalf

Field-by-field walkthrough

Field 1: Name and address of investigator

Enter the clinical investigator’s full legal name (the name on their birth certificate or marriage certificate is FDA’s own example of the standard). Degrees and professional titles may follow the name but aren’t required. The address should be one where the investigator can actually be reached — typically their work or business address, not a personal address.

Field 1 lists exactly one investigator. FDA regulations don’t define the term “co-investigator,” but as commonly used it means each co-investigator is fully responsible for the obligations of an investigator under 21 CFR 312.60. Because of that, under 21 CFR 312.3(b) each co-investigator is legally an investigator in their own right — and each must sign a separate Form FDA 1572, not share one.

Field 2: Education, training, and experience

This field isn’t completed as text on the form itself. Instead, the investigator attaches either a current CV or an “Other Statement of Qualifications” document showing the education, training, and experience that qualify them as an expert in the clinical investigation of that specific drug or biologic for the use under investigation. A generic CV that doesn’t speak to relevant experience is a common point of sponsor pushback.

Field 3: Facility where the investigation will be conducted

List the address(es) of every location where the investigation will actually be conducted and where clinical data will be generated or collected — this includes sites where subjects are seen, where procedures or physical exams are performed, where the test article is administered, where it’s prepared, or where specimens are collected. If the investigator sees subjects at more than one site, list each one. One specific carve-out: if the protocol allows the test article to be administered in a subject’s home (for example, a nurse administering daily injections), individual subject home addresses do not need to be listed — study records should simply document that home administration occurred per protocol. Use the form’s continuation page if Field 3 runs out of room.

Field 4: Clinical laboratory facilities

Identify clinical laboratories or testing facilities that directly contribute to or support the study — diagnostic labs doing blood work, imaging centers, cardiology labs, pharmacokinetic analysis labs, and labs supplying efficacy data under the IND all belong here. If a lab sends samples on to satellite or contract labs for further testing, only the primary lab needs to be listed, provided it can trace every sample to wherever it was actually tested.

Field 5: Institutional Review Board (IRB)

Name and address of the IRB responsible for reviewing and approving the study. Use the continuation page if more than one IRB is involved and space runs short.

Field 6: Subinvestigators

Under 21 CFR 312.3(b), when a team conducts an investigation, the investigator is the responsible leader of that team, and “subinvestigator” covers every other individual team member. 21 CFR 312.53(c)(1)(viii) requires a list of subinvestigators — for example, research fellows or residents — who will assist in conducting the investigation.

The test FDA’s own instructions use is level of responsibility: if someone is directly involved in performing protocol-required procedures and collecting data, they belong in Field 6. FDA’s example: if the protocol requires a specific internist to perform a qualifying physical exam on every subject, that internist is listed. By contrast, hospital staff, nurses, residents, fellows, or office staff providing ancillary or intermittent care — without making a direct, significant contribution to the clinical data — do not need to be listed individually. This distinction is one of the more common sources of over- or under-listing on real 1572s.

Field 7: Protocol name and code number

List the name and code number (if the sponsor has assigned one) of every protocol under the IND that this specific investigator will conduct. If a Phase 4 study is being conducted (see Field 8 below), note that fact here in Field 7 as well.

Field 8: Clinical protocol phase

Only one box may be checked. Two edge cases FDA’s instructions call out explicitly: a combined Phase 1/2 investigation checks only the second (Phase 2) box, and a Phase 4 postmarketing study also checks only the second box — with the Phase 4 status stated in Field 7, not indicated by a dedicated Phase 4 checkbox.

Field 9: Commitments

Field 9 is pre-printed with the regulatory commitments the investigator agrees to by signing — nothing is typed into this field. By signing, the investigator affirms they will, among other things: conduct the study per the current protocol, deviating only when necessary to protect subject safety, without other changes absent IRB and sponsor approval; personally conduct or supervise the investigation; ensure informed consent is obtained per 21 CFR Part 50; ensure the study has initial and continuing IRB review and approval per 21 CFR Part 56; comply with all applicable IND regulations; report adverse experiences to the sponsor per 21 CFR 312.64; ensure they and every subinvestigator have read and understood the current Investigator’s Brochure (where one is required); and ensure all associates, colleagues, and employees assisting in the study are informed of these obligations. FDA is explicit that the investigator should only sign after having received enough information — typically meaning they’ve received, read, and understood the protocol and Investigator’s Brochure, and are familiar with the regulations governing clinical studies. The commitments also carry through to recordkeeping under 21 CFR 312.62 and prompt IRB notification of protocol changes or unanticipated problems.

Field 10: Date

The date the investigator actually signs the form — not the date the protocol was finalized or the date the site was activated.

Field 11: Signature of investigator

Only the investigator named in Field 1 signs. FDA’s instructions describe the signature as constituting two things at once: an affirmation that the investigator is qualified to conduct the study, and a written commitment to abide by FDA’s regulations governing the conduct of the investigation. A common process mistake is having a coordinator or delegate sign on the investigator’s behalf — the form is only valid with the named investigator’s own signature.

Where the completed form goes

FDA’s instructions are explicit on this point: the completed Form FDA 1572, together with the attached CV/qualifications statement, is forwarded to the sponsor, not to FDA directly. The sponsor incorporates it, along with other technical and manufacturing data, into the IND application it submits to FDA. An investigator should never send a completed 1572 straight to the agency.

Common mistakes that get a 1572 sent back

Listing more than one investigator in Field 1. Each co-investigator needs a separate, individually signed form.
Missing continuation pages. Fields 3, 4, 5, and 6 all explicitly allow a continuation page when space runs out — cramming multi-site or multi-lab information into the printed box instead of using it is a frequent cause of illegible or incomplete submissions.
Checking the wrong phase box. Combined Phase 1/2 and Phase 4 studies both check the Phase 2 box; there’s no dedicated box for either.
Over- or under-listing subinvestigators. The test is direct, significant contribution to protocol-required procedures and data collection — not simply being on staff at the site.
Someone other than the named investigator signing. Delegation of clinical duties does not extend to signing Field 11.
Sending the form to FDA instead of the sponsor. The 1572 flows to the sponsor, who files it as part of the IND.
Not updating the form when circumstances change. A new protocol added to the same IND, or a new principal investigator joining the study, generally calls for a new or amended 1572. Routine changes — adding a subinvestigator, or updating a lab or IRB address — are typically handled through study-record documentation and sponsor notification rather than a wholesale refiling; confirm the specific threshold with the sponsor’s regulatory affairs team, since this determination sits partly in institutional practice rather than a single bright-line FDA rule.

Frequently asked questions

Who is required to sign Form FDA 1572?

The clinical investigator named in Field 1 — defined under 21 CFR 312.3 as the individual who actually conducts the investigation, or, where a team is involved, the responsible leader of that team (the principal investigator). Subinvestigators are listed by name in Field 6 but do not sign their own 1572.

Does a sponsor-investigator need to complete a 1572 for their own study?

Sources are not fully consistent on this point. FDA’s IND content regulation, 21 CFR 312.23(a)(6)(iii)(b), requires the same qualifications/commitments information the 1572 captures to be part of the IND regardless of who holds it; some institutional sponsor-investigator policies treat completing an actual Form 1572 as required practice even when the same person holds both roles, while other guidance suggests it isn’t strictly mandated for a sponsor’s own study. If you’re a sponsor-investigator, confirm your institution’s specific policy rather than assuming either way.

What has to be attached to Form FDA 1572?

Under 21 CFR 312.53(c), a sponsor must obtain, before allowing an investigator to participate: the signed Form FDA 1572 itself, a CV or equivalent statement of qualifications (Field 2), an outline of the clinical protocol appropriate to the study phase, and financial disclosure information under 21 CFR Part 54.

Is Form FDA 1572 the same as Form FDA 1571?

No. Form FDA 1571 is the cover sheet filed with FDA for every submission under an IND. Form FDA 1572 is a separate, per-investigator document that never goes to FDA directly — it’s collected by the sponsor and incorporated into the IND file.

Is Form FDA 1572 the same as an FDA Form 483?

No, despite the similar-sounding names. The 1572 is executed before a trial begins, as part of investigator selection. An FDA Form 483 is issued after an FDA inspection and lists inspectional observations — the two documents serve entirely different purposes at different points in a study’s lifecycle.

Form FDA 1572, Box by Box: How to Complete the Statement of Investigator

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