Tip for FDA Form 1572

Signing Form 1572 is a serious commitment — the investigator is personally accountable to the FDA for study conduct

Tip for FDA Form 1572

All sub-investigators and key research staff must be listed — update the form when staff changes occur

Tip for FDA Form 1572

The investigator must ensure the study has current IRB approval at all times

Clinical TrialsmoderateDoctor signature required

Statement of Investigator

FDA Form 1572 · U.S. FDA

Statement of investigator qualifications and commitment to conduct the study per FDA regulations. Accompanies IND submissions.

Form Details

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Where to Submit This Form

📬

Submit as part of the IND application or amendment to the FDA

This form is included in the IND submission by the study sponsor.

🌐

Submit electronically as part of the eCTD submission through the FDA Electronic Submission Gateway

https://www.fda.gov/industry/electronic-submissions-gateway

Filing Deadline

Must be signed and submitted before the clinical investigator can begin enrolling patients. Required for each investigator site in the study.

Required Attachments

📎 Completed FDA Form 1572 signed by the clinical investigator
📎 Curriculum vitae (CV) of the investigator
📎 List of sub-investigators and research staff
📎 Name and address of the IRB that will review the study
📎 List of the clinical facilities where the study will be conducted

Processing Time

Processed as part of the IND submission. No separate review timeline — the 30-day IND review period covers all included forms.

What Happens Next

The investigator is committing to comply with all FDA regulations for conducting clinical trials, including informed consent, IRB oversight, adverse event reporting, and record retention. The investigator is personally responsible for the conduct of the study at their site.

Tips for This Form

✓ Signing Form 1572 is a serious commitment — the investigator is personally accountable to the FDA for study conduct
✓ All sub-investigators and key research staff must be listed — update the form when staff changes occur
✓ The investigator must ensure the study has current IRB approval at all times
✓ Investigators must retain study records for 2 years after drug approval or investigation discontinuation

More Clinical Trials Forms

Informed Consent Document (ICF)

Study-specific · Study sponsor / institution

Comprehensive document explaining the clinical trial: purpose, procedures, risks, benefits, alternatives, voluntariness, and right to withdraw. Must be approved by IRB.

HIPAA Authorization for Research

Institution-specific · Research institution

Separate authorization for use and disclosure of PHI for research purposes. May be broader than clinical HIPAA authorization.

Eligibility Screening / Inclusion-Exclusion Checklist

Study-specific · Study sponsor

Checklist confirming the participant meets all inclusion criteria and no exclusion criteria for the clinical trial.

Individual Patient Expanded Access IND Application

FDA Form 3926 · U.S. Food and Drug Administration

Simplified form for requesting compassionate use of investigational drugs for patients with serious or life-threatening conditions and no alternatives. FDA approves over 99% of requests. Requires manufacturer agreement to provide the drug.

Investigational New Drug Application (IND)

FDA Form 1571 · U.S. FDA

Traditional IND application form for expanded access submissions. Form 3926 is the simplified alternative for individual patients.

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