FDA Form 1572 Explained: The Statement of Investigator
Before an investigator can enroll a single subject in a study conducted under an investigational new drug application, they must sign FDA Form 1572. Officially called the Statement of Investigator, it is a legally binding commitment that establishes the formal relationship between the investigator and the US Food and Drug Administration. It is submitted through the study sponsor, and without a signed, current 1572 on file, no subject may be enrolled.
The Clarity Clinical Solutions training module on Form 1572 walks through every section of the form and why accuracy is non-negotiable. The FDA's own materials describe the 1572 as the mechanism through which the agency ensures clinical investigators understand and accept their regulatory responsibilities (FDA FAQ on Form 1572). The FDA also publishes step-by-step instructions for completing the form correctly (FDA: How to Complete Form FDA 1571 and Form FDA 1572).
What the sections say
The first sections capture the investigator's identity and qualifications. Section 1 asks for name, business address, and contact information. Section 2 covers the clinical research fellowship or training that qualifies the investigator to conduct the study. Section 3 lists every sub-investigator who will assist with the trial. Each person named there must be appropriately qualified, and the investigator bears responsibility for their oversight.
Sections 4 through 9 contain the heart of the investigator's commitments. Section 4 pledges compliance with FDA regulations and the study protocol. Section 5 commits to obtaining IRB approval before starting. Section 6 promises to supervise the investigation properly. Section 7 ensures informed consent will be obtained from every subject. Section 8 commits to prompt reporting of adverse events. Section 9 requires the investigator to certify that they have read and understood the investigator's brochure, the document that summarizes all preclinical and clinical data about the investigational product. That certification matters because it confirms the investigator knows the potential risks and benefits before treating subjects.
Financial disclosure sits alongside the 1572. Investigators must provide financial disclosure information under 21 CFR Part 54, typically through the separate Form FDA 3455.
The regulatory basis for all of this is 21 CFR 312.53, which requires sponsors to obtain a signed and dated Statement of Investigator from each investigator before the study proceeds (21 CFR 312.53).
A living document, not a one-time signature
A 1572 is not static. It must be updated whenever significant changes occur during a study. New sub-investigators joining the team, changes to the investigator's contact information, and a new version of the investigator's brochure all trigger an update. The investigator signs and dates a new 1572 reflecting the changes, and the sponsor submits it to the FDA as part of the IND amendment process.
Failure to keep the 1572 current is a common FDA inspection finding. The good clinical practice guidelines from ICH reinforce the same discipline: investigator qualifications and the commitments they make to the sponsor and regulators are a core part of running a trial properly (ICH E6(R2) Good Clinical Practice).
Who signs, and who collects
The 1572 must be signed by the clinical investigator, typically the principal investigator at a site, usually a licensed physician who will personally conduct or supervise the investigation. The sponsor is responsible for collecting the signed form from each investigator listed on the IND and keeping it in the study regulatory file. The investigator keeps a copy as well. Both parties must make sure the document is complete, accurate, and on file before any study-related activities begin.
What inspectors find
During clinical investigator inspections, the FDA frequently cites 1572-related deficiencies. Common findings include outdated forms that do not list all current sub-investigators, unsigned or undated forms, investigators who failed to recertify after reading a revised investigator's brochure, and discrepancies between the 1572 and other study documents. These errors point to weak regulatory oversight and can lead to Form 483 observations, warning letters, or even a clinical hold on the study.
Effective 1572 management starts with a tracking system that monitors staff changes, brochure version updates, and signature dates. Designate a regulatory coordinator at each site to review the 1572 whenever anything changes. Maintain a master log linking each study's IND number to its current 1572 version. Train investigators and sub-investigators on what triggers an amendment. Proactive management prevents the chaos of last-minute submissions when a monitor requests an updated form.
One form per site
In multi-center trials, each investigator at each site signs their own separate 1572. The coordinating center or lead investigator does not sign on behalf of other sites. The sponsor collects and reviews all 1572s from every participating site before the study initiates. In large global trials that is a serious document management challenge, and electronic regulatory files with automated version tracking have become essential tools for keeping dozens of site forms current.
The cost of non-compliance
Non-compliance carries real consequences. The FDA can issue a Form 483 observation, send a warning letter, or in severe cases disqualify the investigator from receiving investigational products. The sponsor may put the site on hold or terminate the study entirely. Data collected under an invalid or missing 1572 may be deemed unusable for the NDA submission. Beyond regulatory action, non-compliance damages the investigator's professional reputation and the institution's research standing.
How it differs from other documents
The 1572 is often confused with other trial documents, but each serves a distinct purpose. The 1572 is the investigator's regulatory commitment to the FDA. Form FDA 3455 separately collects financial disclosure information. The investigator's brochure provides the scientific background on the investigational product. The protocol describes the study design and procedures. A 1572 error cannot be fixed by pointing to correct information on another document.
The bottom line
Form 1572 is the investigator's formal declaration of qualifications and commitment to regulatory compliance. It must be signed, dated, and kept current before any subject is enrolled. Updates are required for staff changes, address changes, and investigator's brochure revisions. Each site in a multi-center trial needs its own 1572. Common errors, like outdated staff lists and missing signatures, are frequent inspection findings. Treat the 1572 as a living document that needs ongoing attention, not a one-time administrative formality. It is the foundation of regulatory compliance for clinical investigators.
This article is based on the Clarity Clinical Solutions video "Understanding FDA Form 1572 in Clinical Trials." Watch it here: Understanding FDA Form 1572 in Clinical Trials
References
- Clarity Clinical Solutions — "Understanding FDA Form 1572 in Clinical Trials" (framework for this article). https://www.youtube.com/watch?v=5HtFhjdoViU
- FDA — Frequently Asked Questions: Statement of Investigator (Form FDA 1572); explains the form's purpose and requirements. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/frequently-asked-questions-statement-investigator-form-fda-1572
- FDA — How to Complete Form FDA 1571 and Form FDA 1572; official instructions. https://www.fda.gov/news-events/expanded-access/how-complete-form-fda-1571-and-form-fda-1572
- eCFR — 21 CFR 312.53; regulatory requirement for the signed Statement of Investigator. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-312/subpart-D/section-312.53
- ICH — E6(R2) Good Clinical Practice guideline; investigator qualifications and commitments. https://www.ich.org/page/e6r2