How to Fill Out FDA Form 1572 (w/Examples) + FAQs

FDA Form 1572, called the Statement of Investigator, is a legal contract between clinical investigators and the U.S. Food and Drug Administration. This form must be completed and signed before any investigator can participate in a clinical trial conducted under an Investigational New Drug (IND) application. The form serves two key purposes: it proves to the sponsor that you are qualified to run the trial, and it binds you to follow all FDA regulations while conducting the study.

Under 21 CFR 312.53(c), sponsors cannot allow investigators to begin work until they have a completed, signed Form 1572. Making a willfully false statement on this form is a federal crime under 18 U.S.C. 1001. The immediate consequence of submitting false information includes potential disqualification from conducting future FDA-regulated studies and criminal prosecution.

According to FDA Bioresearch Monitoring (BIMO) data, failure to comply with Form FDA 1572 requirements remains among the top inspection observations every year. Between 2022 and 2024, Form 1572 violations ranked as the #1 most common inspection finding for clinical investigators.

Here’s what you will learn in this guide:

📋 Every section of FDA Form 1572 explained line-by-line with real examples and proper formatting rules

⚠️ The top mistakes that trigger FDA warning letters and how to avoid them during inspections

👥 Who must be listed as sub-investigators and who can be left off the form legally

📝 When you must update or sign a new 1572—and when updates are not required

💼 How the 1572 connects to financial disclosure forms, IRB requirements, and sponsor obligations

What Is FDA Form 1572?

The Statement of Investigator form creates a binding agreement between a clinical investigator and the FDA. When you sign this document, you commit to following all regulations in 21 CFR Part 312 governing clinical investigations.

The form collects critical information about who is running the trial, where it will happen, what labs will process samples, which IRB will provide oversight, and who will assist with the study. Sponsors use this information to verify that you and your site can properly conduct the investigation.

Understanding each section helps you complete the form correctly the first time. Errors cause delays, trigger sponsor concerns, and can lead to inspection findings.

Section-by-Section Breakdown

Section 1: Name and Address of Investigator

This section requires your full legal name as it appears on official documents like your birth certificate or medical license. You may add professional titles, degrees, and qualifications after your name, but this is optional.

Address requirements: Enter the address where you can be reached by mail or in person. This is typically your work or business address—not your home. The FDA guidance document specifies that P.O. Box numbers alone are not acceptable. You must provide a full street address.

Co-investigator rules: Only one investigator name goes in Section 1. The term “co-investigator” means each person is fully responsible for all investigator obligations under 21 CFR 312.60. Each co-investigator must sign a separate Form 1572. You cannot list two names in the same Section 1 box.

Example scenario: Dr. Sarah Chen and Dr. Michael Torres both want equal responsibility for a multi-center oncology trial at their academic hospital. Each must complete and sign their own Form 1572. They cannot share one form.

Section 2: Education, Training, and Experience

This section requires you to attach documentation proving you are qualified to investigate the drug for its intended use. You have two options:

Important clarifications from FDA:

• Your CV does not need to be signed and dated. Your signature on the 1572 attests to its accuracy.
• Your CV does not need to be updated during the study. FDA regulations explicitly state no update is required.
• Industry best practice suggests keeping CVs current within two years, but this is not a regulatory requirement.

Real-world tip: Many sponsors request signed and dated CVs as company policy. While FDA does not require this, sponsors may have internal quality standards. Check with your sponsor about their specific requirements before pushing back.

Section 3: Research Facilities

List every location where study activities will happen. This includes places where:

• Subjects will be seen and examined
• Study procedures will be performed
• Test articles will be administered
• Test articles will be stored
• Tissue specimens will be collected
• Physical examinations will occur

If you conduct study visits at multiple clinic locations, you must list each address. However, if your protocol allows home administration of the investigational product (such as daily injections given by a nurse), you do not need to list patient home addresses.

Drug shipment address: If the investigational product will be shipped to a different address than your office, clearly indicate the shipping location in this section. This helps sponsors and monitors track drug accountability.

Example: Dr. Rodriguez sees patients at University Hospital Main Campus and at the downtown specialty clinic. Both addresses must appear in Section 3, with continuation pages if needed.

Section 4: Clinical Laboratory Facilities

List every laboratory that will directly contribute to or support your clinical trial. According to UCLA’s 1572 Standard Operating Procedure, this includes:

• Diagnostic laboratories performing blood work
• Imaging centers conducting protocol-required scans
• Cardiology labs running ECGs or echocardiograms
• Pharmacokinetic analysis laboratories
• Laboratories providing efficacy data

Contract lab rules: If your primary laboratory sends samples to satellite or contract labs for additional testing, you only need to list the primary lab. The primary lab must be able to trace samples to each satellite location where tests were performed.

What to exclude: Laboratories used only once for an emergent clinical need (not related to protocol requirements) do not need listing. Only include facilities used for protocol-driven testing.

Section 5: Institutional Review Board (IRB)

Provide the name and complete address of the IRB responsible for reviewing and approving your study. The IRB does not need to be located at your research site. FDA regulations at 21 CFR 56.114 explicitly permit:

• Independent IRBs located off-site
• Central IRBs reviewing multiple sites
• Cooperative IRB review processes

When you sign the 1572, you commit to ensuring an IRB compliant with 21 CFR Part 56 will provide initial and continuing review. You also agree to:

• Report all changes in research activity promptly to the IRB
• Report all unanticipated problems involving risks to subjects
• Never make changes to research without IRB approval (except to eliminate immediate hazards)

Foreign studies: If conducting a foreign clinical study under an IND, the investigator may use an Independent Ethics Committee (IEC) instead of a U.S. IRB. However, the sponsor must request a waiver from FDA under 21 CFR 56.105 before proceeding.

Section 6: Sub-investigators

List the names of all individuals who will assist you and make a “direct and significant contribution” to the clinical data. FDA regulation 21 CFR 312.3(b) defines a sub-investigator as any member of the investigative team.

Who must be listed:

Who does NOT need listing:

Critical warning: Being listed in Section 6 does not make someone qualified to perform investigator tasks. FDA has clarified that listing someone as a sub-investigator does not automatically mean they can perform duties normally reserved for investigators. You must still verify each person is qualified for their delegated tasks.

Financial disclosure: Everyone listed in Section 6 must provide financial disclosure information to the sponsor using Form FDA 3454 or 3455. This includes disclosures for spouses and dependent children of each sub-investigator.

Section 7: Protocol Name and Code Number

List the name and sponsor-assigned code number for every protocol under the IND that you will conduct. If conducting multiple protocols under the same IND, list each one separately.

Example: Protocol ABC-2025-001: “Phase 2 Study of Drug X in Advanced Solid Tumors”

For Phase 4 (post-marketing) studies, simply enter the protocol information here. You do not need to complete Section 8 checkboxes for Phase 4 studies.

Section 8: Clinical Protocol Information

Check only one box based on your study phase:

For Phase 1 studies: Attach a general outline including:

• Estimated study duration
• Maximum number of subjects involved

For Phase 2 or 3 studies: Attach a protocol outline including:

• Number of subjects to receive the drug
• Number of control subjects (if applicable)
• Clinical uses under investigation
• Subject characteristics (age, sex, condition)
• Clinical observations and laboratory tests planned
• Estimated duration
• Case report form descriptions or copies

You may submit the full study protocol instead of an outline if preferred.

Section 9: Commitments (The Legal Heart of the Form)

When you sign below Section 9, you make eight binding commitments:

1. Protocol compliance: Conduct studies per current protocol; only make changes after notifying sponsor (except for immediate safety needs)
2. Personal oversight: Personally conduct or supervise the investigation
3. Informed consent: Tell patients drugs are investigational; ensure informed consent (21 CFR Part 50) and IRB approval (21 CFR Part 56) requirements are met
4. Adverse event reporting: Report adverse experiences to the sponsor per 21 CFR 312.64
5. Brochure understanding: Read and understand the investigator’s brochure, including potential risks and side effects
6. Staff training: Ensure all associates and employees understand their obligations
7. Recordkeeping: Maintain adequate, accurate records per 21 CFR 312.62 and make them available for FDA inspection per 21 CFR 312.68
8. Full regulatory compliance: Comply with all other requirements in 21 CFR Part 312

Sections 10-11: Date and Signature

Sign and date the form only after you have:

• Received and read the study protocol
• Reviewed the investigator’s brochure (if applicable)
• Understood all commitments in Section 9
• Confirmed you can comply with FDA regulations

Electronic signatures: FDA accepts electronic signatures compliant with 21 CFR Part 11. Acceptable methods include:

• Scanned images of handwritten signatures
• Digital signatures applied electronically
• Flattened digital signatures (must include printed name, date/time, and reason for signature)

Double-sided printing: Both double-sided printing and two-page single-sided documents are acceptable. FDA recommends stapling two-page documents so there is no question about what form was signed.

When to Update or Sign a New 1572

This is one of the most misunderstood aspects of the form. FDA guidance is explicit: a new 1572 is required in only two situations:

For changes that do not require a new 1572, document the changes in your study records and inform the sponsor. The sponsor will update the IND appropriately. Many sponsors still request updated 1572s for these changes as company policy, but FDA regulations do not require it.

30-day timeline: When a new investigator is added, the sponsor must notify FDA within 30 days of the addition per 21 CFR 312.30(c).

Three Common Scenarios with Examples

Scenario 1: First-Time Investigator Starting an Oncology Trial

Dr. Amanda Wright is a newly board-certified oncologist joining her first industry-sponsored Phase 2 trial.

Key lesson: Amanda cannot begin screening patients until the signed 1572 is in the sponsor’s hands.

Scenario 2: Adding a New Sub-Investigator Mid-Study

Dr. Thomas Chen has been running a diabetes trial for 8 months. A new endocrinology fellow, Dr. Patel, joins the team.

Key lesson: Despite sponsor requests, FDA does not require a new 1572 for sub-investigator changes.

Scenario 3: Multi-Site Trial with Decentralized Elements

Dr. Lisa Novak runs a decentralized clinical trial where some visits occur via telemedicine and local nurses administer the investigational product at patient homes.

Key lesson: Decentralized trials still require comprehensive 1572 documentation of all facilities contributing to the study.

Mistakes to Avoid

FDA warning letters reveal the most common errors that lead to enforcement action:

1. Failing to personally supervise the investigation

When you sign the 1572, you commit to personally conducting or supervising the study. You cannot delegate general oversight responsibilities. FDA warning letters have cited investigators who allowed research nurses to function independently without adequate supervision.

Consequence: Warning letter, potential disqualification proceeding, study data rejection.

2. Not updating records when changes occur

Even though a new 1572 isn’t required for sub-investigator changes, you must document changes in study records and inform the sponsor. Failing to maintain current documentation creates inspection findings.

Consequence: FDA Form 483 observation, potential regulatory action.

3. Enrolling ineligible subjects

Recent warning letters cite investigators for enrolling subjects who failed to meet eligibility criteria. Your 1572 commitment to follow the protocol means strictly adhering to inclusion/exclusion criteria.

Consequence: Subject safety risks, data integrity issues, regulatory action.

4. Using correction fluid on the form

TransCelerate guidance explicitly prohibits using “White Out” or correction tape. Hand corrections require a single line through the error, plus the investigator’s initials and date.

Consequence: Form rejection, delays in study initiation.

5. Leaving sections blank

Never leave any section blank. Write “N/A” or “None” where applicable (except Section 8 for Phase 4 studies).

Consequence: Incomplete form, sponsor rejection, delays.

Do’s and Don’ts

Do’s

✅ Do read the entire protocol and investigator’s brochure before signing—your signature confirms you understand the study and its risks

✅ Do list all facilities where protocol procedures occur—missing locations create inspection vulnerabilities

✅ Do maintain a current Delegation of Authority Log—this document tracks who performs which study tasks and supports your 1572

✅ Do inform the sponsor of any changes promptly—they need accurate information for IND updates

✅ Do keep copies of signed 1572s in your regulatory binder—inspectors will review these documents

Don’ts

❌ Don’t sign until you can commit to all Section 9 obligations—your signature is legally binding

❌ Don’t list staff who only provide intermittent care as sub-investigators—this overcrowds Section 6 and creates unnecessary financial disclosure burdens

❌ Don’t assume sponsors’ additional requirements are FDA requirements—know the difference between regulatory mandates and company policy

❌ Don’t backdate forms—this constitutes falsification and is a federal crime

❌ Don’t let anyone else sign your name—warning letters have cited investigators for allowing staff to forge signatures

FDA Inspection Focus Areas

During BIMO inspections, FDA investigators compare your 1572 to actual study conduct. They verify:

Discrepancies between your 1572 and actual practice lead to FDA Form 483 observations or warning letters.

Relationship to Other Documents

The 1572 does not exist in isolation. It connects to several other regulatory documents:

Form FDA 1571: The IND application cover sheet. Sponsors submit 1571 with each IND communication. The 1572 provides investigator information referenced in the 1571.

Form FDA 3454 (Certification): Certifies that clinical investigators have no disclosable financial interests. Required for all investigators and sub-investigators listed on the 1572.

Form FDA 3455 (Disclosure): Required when financial interests do exist. Must describe the nature of interests and steps taken to minimize bias.

Investigator’s Brochure: The document you commit to reading and understanding when you sign the 1572. Contains all clinical and nonclinical information about the investigational product.

Delegation of Authority Log: Internal site document that tracks which individuals perform specific study tasks. Supports the sub-investigator list in Section 6.

State Considerations

While FDA Form 1572 is a federal document, state medical licensing boards impose additional requirements:

• Some states require investigators to hold an active, unrestricted medical license in the state where research is conducted
• State medical practice acts may define who can delegate certain clinical tasks
• Individual institutions may have additional credentialing requirements beyond the 1572

Always verify your state’s specific requirements for conducting clinical research.

Disqualification and Consequences

FDA maintains a public database of investigators subject to disqualification proceedings. Disqualification means you cannot:

• Receive investigational drugs, biologics, or devices
• Conduct any clinical investigation supporting an FDA marketing application
• Participate in FDA-regulated research in any capacity

21 CFR 312.70 outlines the disqualification process. FDA initiates proceedings when investigators repeatedly or deliberately:

• Violate FDA regulations
• Submit false information to sponsors or FDA
• Fail to protect subject safety

Reinstatement is possible but rare. The database shows investigators’ current status and any conditions for reinstatement.

FAQs

Can a non-physician sign the 1572?

Yes, but with limitations. FDA regulations do not require the investigator to be a physician. However, a qualified physician (or dentist when appropriate) should be listed as a sub-investigator to handle all medical decisions.

Must the 1572 be submitted directly to FDA?

No. Send completed forms to your sponsor, not FDA. Sponsors incorporate 1572 information into the IND. Many sponsors voluntarily submit 1572s to FDA, but regulations do not require this.

Does the CV attached to the 1572 need to be signed?

No. FDA regulations do not require signed or dated CVs. Your dated signature on the 1572 attests to the CV’s accuracy. Sponsors may request signed CVs as company policy.

Must foreign investigators sign a 1572?

Yes, if the foreign study is conducted under an IND. If the study is not under an IND, foreign investigators do not need to sign. The sponsor may need to request an IRB waiver for foreign sites.

Is a new 1572 needed when sub-investigators change?

No. FDA guidance explicitly states that sub-investigator changes do not require a new form. Document changes in study records and inform the sponsor so they can update the IND.

Can electronic signatures be used on the 1572?

Yes. FDA accepts electronic signatures compliant with 21 CFR Part 11, including scanned handwritten signatures, digital signatures, and flattened digital signatures with required elements.

What happens if I cannot meet all Section 9 commitments?

Do not sign. Your signature is a legal commitment. If circumstances prevent compliance (such as foreign IRB requirements), work with the sponsor to request an FDA waiver before signing.

Must I update the 1572 when the OMB expiration date passes?

No. The OMB expiration date refers to the federal paperwork burden estimate, not the validity of your form. Continue using your signed 1572 regardless of the OMB date.

How long should I keep copies of signed 1572 forms?

Keep them for at least 2 years after the investigation is completed or discontinued, per 21 CFR 312.62. Your institution may require longer retention periods.

Can one 1572 cover multiple protocols under the same IND?

No. You need a new 1572 for each protocol added to the IND. List only the specific protocol(s) you will conduct in Section 7 of each form.