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How do you prepare Form FDA 1572?
Reconcile the investigator’s identity and qualifications, protocol, research facilities, laboratories, IRB and subinvestigators with the actual study organization. Present the commitments for the investigator’s review and signature, then follow the form’s instruction to provide it to the sponsor. Preparation is not a substitute for the investigator’s execution.
Before you begin
Statement of Investigator for the applicable IND study context. Do not impose the form automatically on every foreign study conducted outside an IND; establish the actual regulatory framework first.
What you will prepare: An accurate investigator statement with supporting qualifications and a sponsor-controlled receipt record.
Collect the evidence before filling the form
Obtain the investigator’s identity, current qualifications, protocol identifiers and the actual study organization. Reconcile the research facilities, laboratories, responsible IRB and subinvestigators with the sponsor’s site records. The form asks for these different roles separately: the clinic, testing laboratory and ethics body are not interchangeable addresses. Provide the qualification evidence and protocol-related information appropriate to the study. Do not use an old site packet without checking who and which locations will perform the current investigation.
Review commitments with the investigator
Present the actual commitment text for the investigator’s review, along with the protocol and relevant investigator information. A coordinator may prepare factual fields but cannot substitute a signature or attest that an unread commitment was accepted. Resolve discrepancies before execution and preserve the signed version in the sponsor’s controlled record. The form directs the investigator to send it to the sponsor, not directly to FDA. Its appearance in an explorer of forms does not change that instruction.
Handle discrepancies and changes explicitly
Maintain a reconciliation log containing the field, proposed value, evidence owner and resolution. If a laboratory address changes during preparation, establish whether the operational location changed or only a mailing address did; ask the study owner for the correct record. Do not silently revise a signed form. Use the sponsor’s controlled update process to evaluate changes and preserve the previous executed artifact. This is an editorial document-control practice, not a universal re-signing interval.
Fictional example: two facilities with one address
A worksheet lists a central laboratory and the research clinic under the clinic’s postal address because both belong to the same institution. Compare the actual laboratory service record and facility list, then correct the role-specific information. If the trial is a foreign non-IND study, stop before requesting an automatic 1572 and establish the governing investigator-document requirements. A complete address cannot resolve an incorrect scope decision.
Map each organization to the role it actually performs
Use a site-role map to stop institutional familiarity from replacing factual reconciliation.
| Role | Confirm against | Error to catch |
|---|---|---|
| Investigator | Current identity and qualification record | Another clinician’s details survive a copied packet |
| Research facility | Actual location of study conduct | Mailing address is substituted for the relevant facility |
| Laboratory | Service and location records | Clinic information is repeated for a different testing site |
| IRB | Responsible review body | A familiar institutional name is assumed to be the responsible IRB |
| Subinvestigators | Actual study responsibilities | Previous personnel are retained without review |
Change exercise: a laboratory’s billing address changes while its testing location remains the same. Determine which record and field are affected before revising the form. Do not silently alter an executed document or assume every administrative change triggers the same update process.
The official 4/25 download inspected October 6 still prints an OMB expiration date of September 30, 2026. Record that fact and confirm the appropriate current edition before execution; do not edit the footer or claim a renewal based on continued download availability.
Use the form-selection guide to distinguish this investigator commitment from the sponsor’s 1571 transaction. The same protocol can involve both documents while their parties and commitments remain different.
Your preparation checklist
0/3 checkedUse this to track your review in this visit. Checks are not saved and do not establish regulatory compliance.
Frequently asked questions
Can a study coordinator sign the investigator’s commitments on the investigator’s behalf?
Preparing factual fields does not authorize a coordinator to substitute for the investigator’s execution. Give the investigator the actual commitments and supporting study information for review. Resolve discrepancies and obtain the proper signed record through the sponsor’s controlled process.
Are the clinic, laboratory and IRB interchangeable addresses on Form 1572?
No. The form asks about different functions in the study. Reconcile each with the actual organization and responsible body rather than repeating one institutional address everywhere. Shared ownership or a familiar institution name does not establish that each role uses the same location.
Does a listing under FDA forms mean every foreign study needs a 1572?
No automatic conclusion follows from the list. Establish whether the study operates under the relevant IND framework and what investigator documentation applies to its actual context. Do not request a signature solely because the study is international or the document appears in a forms catalog.
Sources and revisions
Requirements, source recommendations and editorial preparation advice have different roles. Review the scope and revision of the source you use.
Form instructions
Form FDA 1572: Statement of Investigator ↗4/25 form, two pages; printed OMB expiry September 30, 2026. Fields, commitments and sponsor-delivery instruction inspected September 22, 2026.
FDA resource
FDA: IND Forms and Instructions ↗Live FDA form navigation reopened September 22, 2026. Use each linked form and its instructions, not the navigation date, to establish revision.
Technical specification · placement only
FDA eCTD v4.0 comprehensive hierarchy ↗Version 2.2, February 2025. Section 1.1. A heading identifies placement, not mandatory applicability.