Guide

Form 1572 due diligence

Form FDA 1572 — the Statement of Investigator — is the document a clinical investigator signs before participating in a drug or biologic trial under an IND. By signing, the investigator commits personally to FDA: to conduct the study per the protocol, to supervise everyone to whom tasks are delegated, to ensure IRB review, to maintain records, to report adverse events. The signature is a commitment — the due diligence is everything the sponsor checks before asking for it.

Department of Health and Human Services, Food and Drug Administration: Statement of Investigator (Title 21, Code of Federal Regulations (CFR) Part 312). Form approved, OMB No. 0910-0014. The form’s note reads: “No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator, Form FDA 1572 (21 CFR 312.53(c)).” — The heading of Form FDA 1572, the Statement of Investigator. Its note reads: “No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator, Form FDA 1572 (21 CFR 312.53(c)).”

The qualification part of the file

The familiar part, driven by 21 CFR 312.53’s requirement that sponsors select clinical investigators qualified by training and experience:

Credentials and licensure — a current CV, an active and unrestricted medical license, and board status appropriate to the indication.

Relevant experience — prior trials in this phase and therapeutic area, access to the study population, and realistic enrollment capacity alongside competing studies.

Site and staff — adequate facilities for the protocol, a delegation plan, GCP and protocol training for the team the 1572 will list.

Financial disclosure — the 21 CFR part 54 disclosures the applicant will need when the marketing application is filed.

The record part of the file

The part a warning-letter check alone does not cover — and the part Clinical Precedent was purpose-built to address:

Inspection history and findings. Whether FDA has inspected the clinical investigator before, how each inspection was classified, and what was actually cited — informed consent, conducting the study, case histories, control of the investigational drug, supervision, data integrity. (What BIMO inspections cover.)

Debarment check. Applicants certify to FDA that no debarred person provided services in connection with the application. Screening the people on the 1572 against FDA’s debarment list before engagement — and re-screening periodically — is how that certification stays true. (Debarment vs. disqualification.)

Disqualification check. A disqualified clinical investigator is ineligible to receive investigational products; an investigator with open proceedings — a NIDPOE letter — is a risk decision the sponsor should make knowingly, not discover later.

Warning letters. Whether any inspection escalated to a warning letter, and whether its subject matter touches this protocol’s risks.

Document the check — including one that finds no record. The value of vetting is the file: what was checked, when, and what it showed. “Reviewed the FDA record on this date; no inspections on record, no findings, no status-list name matches” is exactly the sentence a quality file needs.

This is the working definition of clinical investigator vetting — the record part of 1572 due diligence, done systematically instead of by scattered manual lookups.

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About this guide. It is educational, and it is not regulatory or legal advice. The authorities are the Code of Federal Regulations, FDA’s guidance and ICH E6; where this guide and those sources differ, the sources govern.