FDA Form 1572 should be updated in only two specific situations under federal regulations: when a principal investigator joins a new protocol added to an existing IND, or when a new principal investigator is added to a study. Despite what many sponsors and CROs request, FDA guidance explicitly states that other changes—like adding sub-investigators, changing IRBs, or updating laboratories—do not require a new signed form.
This distinction matters enormously because 21 CFR 312.53(c) creates binding legal obligations for investigators who sign the form, and violating commitments made on Form 1572 is the most common reason for FDA warning letters to clinical investigators. In FY2023, FDA conducted 681 clinical investigator inspections, with “failure to comply with Form FDA 1572 requirements” ranking among the top inspection findings.
In this article, you will learn:
📋 The exact regulatory triggers that require a new Form 1572 versus documentation-only changes
⚠️ How to avoid the most common mistakes that lead to FDA warning letters and disqualification proceedings
🔬 Step-by-step guidance on completing each section of the form correctly with real-world scenarios
📅 Timeline requirements for submitting updates to sponsors and the IND
✅ Best practices for sponsors, investigators, and site staff to maintain ongoing compliance
What Is FDA Form 1572 and Why Does It Matter?
FDA Form 1572, known officially as the “Statement of Investigator,” functions as a legally binding contract between clinical investigators and the federal government. By signing this form, investigators commit to conducting research according to 21 CFR Part 312 and affirm their qualifications to investigate drugs or biologics under an Investigational New Drug (IND) application.
The form serves two critical purposes under FDA regulations. First, it provides sponsors with documentation about investigator qualifications and site capabilities. Second, it secures the investigator’s written commitment to follow all applicable regulations, including informed consent requirements under 21 CFR Part 50 and IRB oversight requirements under 21 CFR Part 56.
Making a willfully false statement on Form 1572 constitutes a criminal offense under 18 U.S.C. 1001. Investigators who sign this form should understand that FDA can use submission of deliberately false information as grounds for disqualification proceedings under 21 CFR 312.70.
The Two Situations Requiring a New Form 1572
Situation 1: New Protocol Added to an Existing IND
When an investigator agrees to participate in a new protocol that has been added to an existing IND, a new Form 1572 must be completed and signed. This applies even if the same investigator has already signed a 1572 for a different protocol under the same IND.
| Scenario | New 1572 Required? | Reason |
|---|---|---|
| Same investigator joins Protocol B under existing IND (already participating in Protocol A) | Yes | Each protocol requires separate investigator commitment |
| Protocol amendment changes study procedures | No | Amendment to existing protocol, not new protocol |
| Protocol title changes due to amendment | No | Document change in records; update IND through sponsor |
Example: Dr. Martinez signed Form 1572 for a Phase 2 oncology trial under Sponsor ABC’s IND. Six months later, ABC adds a Phase 3 trial to the same IND. Dr. Martinez must sign a new Form 1572 specifically for the Phase 3 protocol before participating, even though she already has an active 1572 on file.
Situation 2: New Principal Investigator Added to a Study
21 CFR 312.53(c) requires sponsors to obtain a completed Form 1572 from any new investigator before permitting participation in a clinical investigation. This includes situations where an investigator replaces another at an existing site.
The sponsor must submit the new Form 1572 to FDA within 30 days of adding the investigator. Once the 1572 is submitted, the investigational drug can be shipped to the new investigator.
| Scenario | New 1572 Required? | Timeline |
|---|---|---|
| New PI added to ongoing study | Yes | Submit to FDA within 30 days of addition |
| New site added with new PI | Yes | Before first patient enrolled at new site |
| PI replaced at existing site | Yes | Before departing PI completes transition |
| Co-investigator added (both fully responsible) | Yes | Each co-investigator signs separate 1572 |
Example: Dr. Chen relocates to another institution, leaving her clinical trial site without a principal investigator. Dr. Patel agrees to take over. Before Dr. Patel can begin supervising the study or receiving investigational product shipments, the sponsor must obtain a new signed Form 1572 from him.
Changes That Do NOT Require a New Form 1572
The FDA’s May 2010 Guidance Document explicitly states that many common changes do not require investigators to sign a new form. Instead, investigators should document changes in clinical study records and inform the sponsor so the IND can be updated through an information amendment or protocol amendment.
Sub-Investigator Changes
Adding or removing sub-investigators does not require a new Form 1572. This is one of the most misunderstood requirements in clinical research, with many sponsors and CROs incorrectly demanding new forms for sub-investigator changes.
| Action | Document Requirement |
|---|---|
| Adding new sub-investigator | Update study records; notify sponsor; list on Delegation of Authority log |
| Removing sub-investigator | Document end date in records; notify sponsor |
| Sub-investigator name change | Document in records; note to file acceptable |
Why This Matters: The FDA has confirmed in direct correspondence with sites that “the information in the FDA 1572 form guidance still applies” and sub-investigator changes do not require form revision. However, sponsors are required to submit updated information to the IND, which they typically accomplish through information amendments.
IRB Changes
When the IRB responsible for study oversight changes—whether through institutional transitions, switching to a central IRB, or address updates—no new Form 1572 is required. Document the change in study records and notify the sponsor.
Laboratory and Facility Changes
Adding or removing clinical laboratories, changing research facilities, or modifying locations where study procedures occur requires documentation and sponsor notification, but not a new Form 1572.
| Change Type | New 1572? | Required Action |
|---|---|---|
| IRB address change | No | Document in records; notify sponsor |
| Switch to central IRB | No | Document in records; notify sponsor |
| Add new clinical laboratory | No | Document in records; notify sponsor |
| Add satellite research facility | No | Document in records; notify sponsor |
| Investigator name change (marriage) | No | Document in records; sponsor discretion |
Section-by-Section Breakdown: How to Complete Form 1572
Understanding each section of Form 1572 helps prevent errors that can delay study startup or create compliance issues during inspections.
Section 1: Investigator Name and Address
Enter the investigator’s full legal name as it appears on official documents (birth certificate or marriage certificate). Titles and degrees may follow the name. The address should be where the investigator can be reached by mail or in person—typically a business address.
Critical Rule: Only one investigator should appear in Section 1. The term “co-investigator” means each person is fully responsible under 21 CFR 312.60, so each must sign a separate Form 1572.
Section 2: Education and Qualifications
Attach a curriculum vitae (CV) or statement of qualifications demonstrating expertise relevant to the investigation. FDA regulations do not require CVs to be updated during a study or signed and dated—the investigator’s signature on the 1572 attests to accuracy.
Section 3: Research Facilities
List the name and address of every location where study activities will occur and clinical data will be generated. This includes:
- Healthcare facilities where investigational products are administered
- Locations where physical examinations occur
- Research laboratories where test articles are prepared
- Special storage facilities for investigational products
- Locations where tissue specimens are collected
Home Administration Exception: If the protocol permits administration at subjects’ homes (e.g., nurse-administered injections), home addresses do not need listing.
Section 4: Clinical Laboratories
Identify laboratories performing testing that directly contributes to study data—diagnostic labs, imaging centers, pharmacokinetic analysis facilities, and efficacy testing labs.
If a primary laboratory sends samples to satellite or contract labs, only the primary laboratory needs listing, provided it can trace samples to each testing location.
Section 5: IRB Information
Provide the name and address of the IRB responsible for initial and continuing review. The IRB does not need to be physically located where research is conducted. Central IRBs and cooperative review arrangements are permitted under 21 CFR 56.114.
Section 6: Sub-Investigators
List individuals who will assist the investigator and make “direct and significant” contributions to the data. This typically includes:
| Should Be Listed | Generally Not Listed |
|---|---|
| Research coordinators who recruit subjects, collect data, maintain records | Pharmacists with limited dispensing roles |
| Physicians performing protocol-specified procedures | Nurses providing only intermittent ancillary care |
| Staff performing protocol-required assessments | On-call physicians handling temporary adverse events |
| Anyone directly generating clinical data | Rotating residents (document separately) |
Financial Disclosure Requirement: All individuals listed in Section 6 must submit financial disclosure information under 21 CFR Part 54.
Section 7: Protocol Information
List the names and code numbers of all protocols under the IND that the investigator will conduct. For Phase 4 post-marketing studies, indicate “Phase 4” in this section.
Typographical Error Rule: Errors in protocol number, compound number, or IND number make the form unacceptable and require revision.
Section 8: Phase of Investigation
Select only one box indicating the study phase. For combined Phase 1/2 investigations, check the second box.
Section 9: Commitments
This section contains the investigator’s binding agreements to:
- Conduct research according to current protocol
- Comply with all 21 CFR Part 312 requirements
- Personally conduct or supervise the investigation
- Ensure informed consent compliance (21 CFR Part 50)
- Ensure IRB requirements are met (21 CFR Part 56)
- Report adverse events to sponsors
- Maintain adequate records
- Ensure study staff understand their obligations
The investigator should sign only after reviewing the protocol, investigator’s brochure (if required), and understanding all Section 9 commitments.
Sections 10-11: Date and Signature
The date must reflect when the investigator actually signed. The signature must match the name in Section 1 and can be handwritten or electronic if compliant with 21 CFR Part 11.
Three Common Real-World Scenarios
Scenario 1: Multi-Site Study With PI Turnover
Situation: A sponsor is conducting a 24-site Phase 3 trial. At Site 14, Dr. Williams announces retirement in three months. The sponsor identifies Dr. Thompson as the replacement.
| Action | Responsibility | Timing |
|---|---|---|
| Dr. Thompson completes new Form 1572 | Investigator | Before assuming PI responsibilities |
| Sponsor verifies qualifications | Sponsor | Before accepting 1572 |
| Sponsor submits 1572 to FDA | Sponsor | Within 30 days of adding investigator |
| Dr. Williams signs delegation log end dates | Outgoing PI | Before departure |
| Dr. Thompson reviews and accepts delegations | Incoming PI | At transition |
Consequence of Non-Compliance: If Dr. Thompson begins supervising subjects before the 1572 is submitted, the sponsor violates 21 CFR 312.53(c), potentially resulting in Form 483 observations or warning letters.
Scenario 2: Adding a Sub-Investigator Mid-Study
Situation: Site 7 experiences rapid enrollment. The PI wants to add Dr. Garcia, a qualified physician, to assist with patient assessments.
| Action | Required? | Documentation |
|---|---|---|
| New Form 1572 | No | Not required for sub-investigator |
| Update Delegation of Authority log | Yes | PI signs to confirm delegation |
| Verify Dr. Garcia’s CV and license | Yes | Maintain in regulatory binder |
| Notify sponsor of personnel change | Yes | Sponsor updates IND via information amendment |
| Submit financial disclosure | Yes | Required for all sub-investigators |
| Train Dr. Garcia on protocol | Yes | Document in training log |
Consequence of Non-Compliance: While FDA does not require a new 1572, failure to document the addition and notify the sponsor violates 21 CFR 312.62 (adequate record-keeping) and prevents proper IND maintenance.
Scenario 3: IRB Transition to Central Review
Situation: An institution transitions from a local IRB to WCG-IRB for all industry-sponsored research. Twenty active studies must transfer IRB oversight.
| Action | Required? | Documentation |
|---|---|---|
| New Form 1572 for each study | No | IRB change doesn’t trigger new form |
| Document IRB change in study records | Yes | Note date and reason for transition |
| Notify each sponsor | Yes | Provide new IRB contact information |
| Update Form 1572 on file? | Optional | May update at sponsor’s discretion |
| Obtain continuing review from new IRB | Yes | Required under 21 CFR 56 |
Mistakes to Avoid
Mistake 1: Updating the Form for Every Change
The Error: Many sites submit new Form 1572s for every sub-investigator addition, lab change, or administrative update because sponsors or CROs request it.
The Consequence: Excessive paperwork burdens. Sites report receiving “tremendous pushback” when they follow FDA guidance and decline unnecessary updates, creating adversarial relationships.
The Solution: Cite FDA’s May 2010 guidance directly when sponsors request unnecessary updates. Offer to document changes in study records and notify sponsors for IND amendments instead.
Mistake 2: Listing Everyone on the Delegation Log
The Error: Sites routinely list everyone in their department on Form 1572 rather than identifying who actually works on a specific study.
The Consequence: Audit findings, confusion about actual responsibilities, and potential violations if unlisted personnel perform study duties or listed personnel never contribute.
The Solution: List only individuals making “direct and significant” contributions to the specific study’s data. Match Section 6 with an accurate Delegation of Authority log.
Mistake 3: Failing to Document Delegations Concurrently
The Error: PIs sign delegation logs retroactively, sometimes with dates after staff already began protocol procedures.
The Consequence: Audit findings document altered dates and staff performing duties before authorization. FDA warning letters cite this as evidence of inadequate supervision and inaccurate record-keeping.
The Solution: Update delegation logs immediately when adding staff. PI initials and dates must reflect real-time authorization.
Mistake 4: Inadequate PI Oversight
The Error: Investigators sign Form 1572, then delegate study oversight entirely to coordinators without maintaining personal involvement.
The Consequence: This is the single most common reason for FDA warning letters to clinical investigators—representing a 24% increase over a three-year period. By signing Section 9, investigators commit to “personally conduct or supervise” the investigation.
The Solution: Establish regular oversight activities—weekly check-ins, source document review, adverse event assessment, and delegation log maintenance. Document all oversight activities.
Mistake 5: Missing the 30-Day Submission Window
The Error: Sponsors fail to submit Form 1572 to FDA within 30 days of adding a new investigator.
The Consequence: Violation of 21 CFR 312.30(c), potential clinical hold, and inspection findings. Sponsors may be cited for “failure to obtain signed Investigator agreement” during BIMO inspections.
The Solution: Build Form 1572 collection into site activation timelines. Track submission dates systematically.
Do’s and Don’ts for Form 1572 Compliance
Do’s
| Do | Why |
|---|---|
| Do sign only after reviewing the protocol and investigator’s brochure | Section 9 commitments are legally binding |
| Do verify all information before signing | False statements are criminal offenses under 18 U.S.C. 1001 |
| Do maintain documentation when changes occur | Creates audit trail without requiring new form |
| Do review the form annually during IRB renewal | Identifies needed documentation updates |
| Do ensure sub-investigators complete financial disclosures | Required by 21 CFR Part 54 for everyone listed in Section 6 |
| Do use the current version of the form | FDA periodically updates the form; current version approved through September 2026 |
Don’ts
| Don’t | Why |
|---|---|
| Don’t list co-investigators in Section 1 | Each co-investigator must sign a separate form |
| Don’t submit a new 1572 for sub-investigator changes | FDA guidance explicitly states this is unnecessary |
| Don’t have someone else sign your name | Warning letters cite this as a serious violation |
| Don’t assume typographical errors are acceptable | Errors in protocol/IND numbers require revision |
| Don’t delegate oversight to study coordinators | Supervision responsibility cannot be delegated |
Sponsor Responsibilities and Monitoring Oversight
Sponsors carry significant regulatory obligations related to Form 1572 under 21 CFR 312.53. These responsibilities extend throughout the study lifecycle.
Required Sponsor Actions
| Requirement | Regulation | Action Required |
|---|---|---|
| Obtain signed 1572 before investigator participation | 21 CFR 312.53(c) | Collect before any study activities begin |
| Verify investigator qualifications | 21 CFR 312.53(a) | Review CV and documentation |
| Submit 1572 to FDA | 21 CFR 312.23(a)(6)(iii)(b) | Include investigator information with IND |
| Monitor investigator compliance | 21 CFR 312.56 | Ongoing verification throughout study |
| Secure compliance or terminate | 21 CFR 312.56(b) | Act promptly when violations discovered |
Monitoring for 1572 Compliance
CRAs (Clinical Research Associates) should verify during monitoring visits:
- Form 1572 is complete, accurate, and signed
- All sub-investigators listed are actually contributing to the study
- Personnel performing study duties are documented appropriately
- Delegation logs match 1572 Section 6 entries
- Any changes since the last visit are properly documented
When monitors discover an investigator is not complying with the signed 1572, sponsors must “promptly either secure compliance or discontinue shipments of the investigational new drug to the investigator and end the investigator’s participation in the investigation.”
Consequences of Non-Compliance
FDA Inspection Findings
Over the past five years, FDA has reported a 36% failure rate in clinical trial site inspections. “Failure to follow investigational plan and Form FDA 1572 requirements” ranks among the top inspection observations for clinical investigators.
Warning Letter Consequences
When FDA issues a warning letter, investigators must:
- Respond in writing within 15 working days
- Address each violation with specific corrective actions
- Implement preventive measures
- Provide documentation of compliance
Warning letters are publicly posted on FDA’s website, identifying investigators and violations.
Disqualification Proceedings
Under 21 CFR 312.70, FDA may disqualify investigators who “repeatedly or deliberately” fail to comply with regulations or submit false information. Consequences include:
- Ineligibility to receive investigational products
- Ineligibility to conduct any clinical investigation supporting FDA marketing applications
- Notification to all sponsors with whom the investigator participates
- Review of all previously submitted data for reliability
- Potential criminal prosecution
Close-Out Considerations
At study close-out, sites should ensure Form 1572 documentation is complete and filed appropriately. The final regulatory binder should include:
- Original signed Form 1572 (and any amended versions)
- Final delegation log with PI signature
- Financial disclosure forms for all Section 6 personnel
- Documentation of any changes made during the study
The 1572 should reflect all information current as of study completion. While a new form isn’t required for study closure, sites may choose to update the form to capture any personnel who joined during the study.
FAQs
Does a new Form 1572 need to be signed when the OMB expiration date passes?
No. There is no requirement to prepare a new 1572 when the OMB expiration date is reached. The expiration reflects Paperwork Reduction Act clearance, not form validity.
Is Form 1572 required for medical device studies?
No. Form 1572 applies only to studies of investigational drugs and biologics under an IND. Device studies require an investigator agreement under 21 CFR 812.43(c), which contains similar information.
Must foreign investigators sign Form 1572?
Yes, if the foreign study is conducted under a U.S. IND. If local laws prohibit signing, sponsors may request a waiver under 21 CFR 312.10 before study initiation.
Does the sponsor submit Form 1572 to FDA?
Not required, but many sponsors voluntarily submit the 1572 because it collects investigator information required under 21 CFR 312.23(a)(6)(iii)(b) in one document.
Should CVs be updated during the study?
No. FDA regulations do not require CVs to be updated during a clinical study, nor must they be signed and dated.
Can an investigator sign Form 1572 electronically?
Yes, if the electronic signature complies with 21 CFR Part 11 requirements or applicable predicate rules. The completed form must still be retained with the investigator’s signature.
What if a typographical error appears on a submitted Form 1572?
It depends on the error. Errors in protocol number, compound number, or IND number make the form unacceptable and require revision. Minor errors in addresses or facility names may be corrected on future submissions.
Does removing a sub-investigator require updating Form 1572?
No. Removal does not require an updated Form 1572. Document the end date in study records and notify the sponsor.
How long must Form 1572 be retained after study completion?
Records must be retained for 2 years after a marketing application is approved for the indication, or 2 years after the investigation is discontinued and FDA is notified.
Can sponsors require more frequent 1572 updates than FDA mandates?
Yes. While FDA guidance is clear about when updates are required, sponsors may include additional update requirements in clinical trial agreements. Sites should negotiate these terms and cite FDA guidance when appropriate.