Form FDA 1572 and Regional Equivalents

Part of Principal Investigator (PI) Training: Signatures and What They Attest.

About 4 minutes. Free, in your language, no account needed.

Why this matters

ICH E6(R3) requires your agreement to the protocol to be documented. It does not prescribe a form. The forms come from regional law, and the best known is the United States' Form FDA 1572 — a document many physicians sign without reading, and which is a binding statement of commitment to a regulator.

Knowing which of your obligations are ICH and which are national is not pedantry. It determines what applies to you, and it prevents the common error of teaching a US rule to a site in another country as though it were universal.

What the 1572 is

Under 21 CFR 312.53(c), a sponsor conducting a study under a US Investigational New Drug application obtains a signed Statement of Investigator — Form FDA 1572 — from each investigator before that investigator participates. It is a commitment made to the US Food and Drug Administration, not to the sponsor, even though the sponsor collects it.

The form gathers your name and address, your qualifications, the site or sites, the clinical laboratory facilities, the IRB responsible for review, the sub-investigators who will assist, and the protocol identification. Then it asks you to commit.

The commitments, in plain terms

The commitments section is short, and each line has consequences worth understanding before you sign.

Two practical points follow. First, sub-investigators listed in section 6 must be kept current — adding a fellow to your delegation log without updating the 1572 is a common and avoidable discrepancy. Second, a new 1572 is required when the information on it changes materially, not merely at the next amendment.

What the 1572 is not

It is not a contract with the sponsor; the clinical trial agreement is that. It is not evidence of training. It is not required outside the scope of a US IND — a purely European study under Regulation (EU) 536/2014 does not use one, and asking a site in a country with no IND involvement to sign one is a frequent start-up error.

Where a study runs under a US IND at sites outside the United States, the sponsor may collect either a 1572 or, under the alternative permitted for non-IND foreign studies, documentation that the study complies with GCP. Which route applies is the sponsor's regulatory decision, and it is reasonable to ask them to explain it rather than signing a form whose applicability is unclear.

Elsewhere in the world

There is no single global analogue. In the European Union the equivalent commitments are distributed across the clinical trial application under Regulation (EU) 536/2014, the protocol signature and the contract with the sponsor. Other jurisdictions use their own investigator undertaking or declaration.

The reliable habit is to ask one question at start-up: what am I signing, to whom, and under which law? If the sponsor cannot answer it crisply, that is useful information about the study.

Key takeaways