FDA Form 1572, the Statement of Investigator, is the signed agreement in which a clinical investigator commits to the FDA and the study sponsor that an Investigational New Drug (IND) trial will be conducted in accordance with the approved protocol and 21 CFR Part 312. It documents who you are, where the study will run, who is helping, and the specific regulatory obligations you personally accept. Once signed, it travels with the IND application and governs your conduct for the life of the study.
The form has eight sections that identify the investigator, the sites, and the study, and a ninth section that contains the binding commitments. Section 9 is where the legal weight sits, and it is worth understanding before you sign.
What You Are Agreeing To in Section 9
By signing, you agree to personally conduct or supervise the investigation at your site.1FOOD AND DRUG ADMINISTRATION. Form FDA 1572 – Statement of Investigator That responsibility cannot be delegated. You may assign tasks to sub-investigators and coordinators named on the form, but accountability for the trial remains with you.2eCFR. 21 CFR 312.60 – General Responsibilities of Investigators
Following the Protocol
You commit to conducting the study according to the current, IRB-approved protocol and to making changes only after notifying the sponsor. The single exception is when a participant faces an apparent immediate safety risk, in which case you may deviate right away.1FOOD AND DRUG ADMINISTRATION. Form FDA 1572 – Statement of Investigator Outside that narrow window, unilateral protocol changes can trigger enforcement action, and this is one of the more common findings during FDA inspections.
Informed Consent
You agree to follow the informed consent requirements in 21 CFR Part 50. Every participant must give legally effective consent, on an IRB-approved written form, before enrollment.3eCFR. 21 CFR Part 50 – Protection of Human Subjects The consent document must make participation voluntary and allow withdrawal at any time. It cannot contain language that waives or appears to waive a participant’s legal rights, or that releases you, the sponsor, or the institution from liability for negligence.
IRB Review
You commit to ensuring that an IRB meeting 21 CFR Part 56 provides initial and continuing review of the study, and to promptly reporting protocol changes and unanticipated risks to that IRB.4eCFR. 21 CFR 312.66 – Assurance of IRB Review No changes to the research may be made without IRB approval, except to eliminate immediate hazards. A lapse in IRB approval, even a short one, creates a serious problem for any subjects enrolled during the gap.
Adverse Event Reporting
Serious adverse events must be reported to the sponsor immediately, whether or not you believe the drug caused them, along with your assessment of whether a causal relationship is reasonably possible.5eCFR. 21 CFR 312.64 – Investigator Reports Non-serious adverse events follow the reporting cadence set in the protocol. Study endpoints that happen to be serious adverse events, such as all-cause mortality in some trials, follow the protocol’s schedule unless there is evidence the drug caused the event, in which case immediate reporting applies.
Records and FDA Access
You agree to keep adequate and accurate records throughout the investigation.1FOOD AND DRUG ADMINISTRATION. Form FDA 1572 – Statement of Investigator When an FDA inspector arrives, you must allow access to all records and reports at reasonable times and permit copies to be made. You are not required to disclose participant names unless the FDA needs more detailed case review or has reason to believe the records do not reflect actual results.6eCFR. 21 CFR 312.68 – Inspection of Investigator’s Records and Reports
Drug Accountability
You are personally responsible for controlling the investigational drug at your site.2eCFR. 21 CFR 312.60 – General Responsibilities of Investigators The drug may only be administered to enrolled subjects under your supervision or that of a sub-investigator listed on the 1572, and it cannot be supplied to anyone not authorized under the regulations.7eCFR. 21 CFR Part 312 – Investigational New Drug Application Records must track every unit received and used by each subject, and unused supplies must go back to the sponsor or be disposed of on the sponsor’s instructions when the study ends.8eCFR. 21 CFR 312.62 – Investigator Recordkeeping and Record Retention Controlled substances require a securely locked cabinet or enclosure with limited access.
Information the Form Asks For
Sections 1 through 8 collect the factual information the sponsor will file with the IND. Filling these out accurately matters, because the FDA relies on this information when evaluating the application.
You and Your Qualifications
Section 1 requests your full legal name and business address. Degrees and professional titles can follow the name, but the name itself must match your legal documents. Section 2 requires an attached curriculum vitae or equivalent statement showing that your education, training, and experience qualify you to investigate the drug for its intended use.9U.S. Food and Drug Administration. Form FDA 1572 – Instructions
Facilities and Laboratories
Section 3 lists each medical school, hospital, or research facility where the study will be conducted. Section 4 identifies the clinical labs and testing facilities supporting the study, including diagnostic labs, imaging centers, and analytical labs providing pharmacokinetic or efficacy data.10Food and Drug Administration. Frequently Asked Questions – Statement of Investigator (Form FDA 1572) If a primary lab sends samples to satellite or contract labs, you list the primary lab, which must be able to trace samples to wherever the work was actually done.
IRB, Sub-Investigators, and Protocol
Section 5 names the IRB responsible for reviewing and approving the study.1FOOD AND DRUG ADMINISTRATION. Form FDA 1572 – Statement of Investigator Section 6 lists sub-investigators who will assist you and make a direct, significant contribution to the study data. The regulation cites research fellows and residents as examples, but the test is functional: anyone supervising drug administration or otherwise contributing meaningfully to the conduct of the investigation belongs on the list.9U.S. Food and Drug Administration. Form FDA 1572 – Instructions Staff performing only administrative or logistical support generally do not need to be listed. Section 7 identifies the protocol by name and code number, and Section 8 covers additional clinical protocol information.
Financial Disclosure That Goes With the Form
Alongside the 1572, you must provide the sponsor with financial information required under 21 CFR Part 54. The sponsor uses it to file either a certification (Form FDA 3454) confirming no problematic financial interests exist, or a disclosure statement (Form FDA 3455) describing them.11eCFR. 21 CFR Part 54 – Financial Disclosure by Clinical Investigators You must keep the information current throughout the study and for one year after it ends.
Interests that trigger disclosure include compensation arrangements where pay could increase with a favorable study outcome (including royalty interests tied to product sales); proprietary interests such as patents, trademarks, copyrights, or licensing agreements related to the product; any equity stake in a non-publicly traded sponsor, or equity in a publicly traded sponsor exceeding $50,000 during the study and for one year afterward; and sponsor payments to you or your institution above $25,000 beyond the direct costs of conducting the study, covering things like other research grants, equipment, consulting retainers, and honoraria.12eCFR. 21 CFR 54.2 – Definitions These thresholds have not changed since the regulation took effect in 1998 and are not indexed to inflation.
Submitting the Form and Keeping It Current
The signed 1572 goes to the study sponsor, not directly to the FDA. The sponsor incorporates it and your attached qualifications into the IND.9U.S. Food and Drug Administration. Form FDA 1572 – Instructions No investigator may participate in an investigation until a completed, signed 1572 is in the sponsor’s hands.1FOOD AND DRUG ADMINISTRATION. Form FDA 1572 – Statement of Investigator It is a hard prerequisite, not paperwork to backfill after enrollment starts.
Most later changes do not require a new form. Adding a sub-investigator, changing the IRB, or switching a clinical laboratory can be handled by documenting the change in your study records and informing the sponsor so the IND can be updated. The regulation does not set a hard deadline for those notifications, but prompt communication is expected. A new 1572 is required in only two situations: when a new principal investigator joins the study, or when the existing investigator begins work on a new protocol added to the same IND.10Food and Drug Administration. Frequently Asked Questions – Statement of Investigator (Form FDA 1572)
You must retain the signed 1572 and supporting study records for two years after a marketing application is approved for the drug in the indication you studied. If no application is filed or the application is not approved, the period runs until two years after the investigation is discontinued and the FDA has been notified.8eCFR. 21 CFR 312.62 – Investigator Recordkeeping and Record Retention Because some studies take years to reach a marketing decision, actual retention can run well beyond two years.
When Form 1572 Is Not Required
The 1572 applies only to clinical investigations conducted under an IND. Several common research scenarios sit outside that scope.
Medical device studies are governed by 21 CFR Part 812 and run under an Investigational Device Exemption. Device investigators sign a different agreement covering the investigational plan, supervision of testing, and informed consent, not the 1572.13eCFR. 21 CFR Part 812 – Investigational Device Exemptions
Research that studies an already-approved drug used within its approved labeling generally does not require an IND, and therefore does not require a 1572. Good Clinical Practice standards still apply.
Foreign investigators are not required by their local regulators to sign a 1572, though a sponsor may request one if the data will support an FDA marketing application. When a foreign investigator cannot or will not sign, the sponsor can request a waiver from the FDA under 21 CFR 312.10 by submitting an IND amendment, and must have the waiver granted in writing before enrolling subjects at that site.14Food and Drug Administration. Frequently Asked Questions – Statement of Investigator (Form FDA 1572) – Revision 1 (Draft Guidance)
Consequences of Non-Compliance
If the FDA finds that you have repeatedly or deliberately failed to comply with 21 CFR Parts 312, 50, or 56, or that you have submitted false information to the sponsor or the agency, it can begin disqualification proceedings.15eCFR. 21 CFR 312.70 – Disqualification of a Clinical Investigator The process opens with a written notice describing the alleged violations and giving you the chance to respond, in writing or at an informal conference. If the response satisfies the reviewing Center, the matter ends there. If not, you receive a formal opportunity for a regulatory hearing.
After the hearing, the FDA Commissioner can declare you ineligible to receive investigational drugs, biologics, or devices. A disqualified investigator cannot conduct any clinical investigation supporting an application for any FDA-regulated product, and that bar reaches beyond pharmaceuticals to devices, foods with health claims, dietary supplements, and tobacco products.16U.S. Food and Drug Administration. Clinical Investigators – Disqualification Proceedings In less severe cases, the FDA may offer a restricted agreement instead, allowing continued work under specific conditions. Data generated during a period of non-compliance can be examined separately for reliability, and if the FDA concludes the data is unreliable and essential to an ongoing investigation or marketing application, that application faces serious consequences.