Form FDA 1572 and What Signing It Commits

Part of Regulatory Affairs and the Jurisdiction Map: The United States under 21 CFR.

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Why this matters

Form FDA 1572, the Statement of Investigator, is the most consequential single page an investigator signs, and it is routinely treated as an administrative formality by everyone except the people who later have to defend it.

It is a signed commitment to the agency. The investigator personally undertakes to conduct the study according to the protocol, to supervise the administration of the investigational product, to ensure informed consent and review board requirements are met, to report adverse experiences, and to maintain adequate and accurate records.

The commitments are specific, they are personal to the signer, and they are enforceable.

What the form records

Beyond the commitments, the form records facts, and the facts are where problems originate.

The investigator's name, address and qualifications, supported by a curriculum vitae.

The name and address of each facility where the study will be conducted. Each one. This is the single most common source of error, because facilities are added during a study without anyone updating the form.

The name and address of each clinical laboratory used for the study.

The name and address of the institutional review board responsible for review.

The names of subinvestigators who will assist in conducting the study.

The protocol identification.

Every one of those is a fact that can change during a trial, and the form is a snapshot of them at the moment of signing.

The word "regional equivalents" and what it hides

Outside the United States there is usually no Form 1572. Some sponsors ask non-US investigators to sign one anyway, which creates a genuine difficulty: the form contains a commitment to comply with 21 CFR Part 312, and an investigator in another country may not be in a position to make that commitment meaningfully.

The common alternative is an investigator agreement carrying equivalent commitments expressed against the applicable local framework. That is usually the better instrument, because a commitment an investigator cannot actually honor is worse than no commitment.

The regulatory question to settle for any given study is which instrument each investigator signs and why, and to settle it deliberately rather than by inheriting whatever the last study did.

Keeping it current

Because the form records facts that change, it goes stale in predictable ways:

A subinvestigator joins and is not added. The person is performing trial duties while not listed on the form that names who is assisting.

A facility is added, often a satellite location for a specific procedure, and the form still names only the original site.

The laboratory changes, frequently mid-study when a central laboratory contract changes.

The review board changes, which happens when an institution moves to a central board.

Each requires the form to be updated and re-signed. Sponsors track this with varying diligence, and a regulatory professional who audits the 1572s against the current state of the study will reliably find at least one discrepancy per twenty sites.

In practice

A regulatory associate reviews the 1572s for a study with eighteen US sites, comparing each against the delegation log and the current site information.

Fourteen match. Four do not, and the four failures are instructive:

One site added an imaging facility six months ago for a substudy; the 1572 names only the main clinic. One site's principal investigator left and the form was updated, but two subinvestigators listed under the previous investigator were never removed, so the form names people who are no longer at the site. One site changed its central laboratory when the sponsor's vendor contract changed, and the form names the old one. One site's review board transitioned to a central board, and the form names the institution's own former board.

None of these is misconduct. All four are the form failing to keep pace with the study, which is what the form does unless someone makes it keep pace.

The associate's deliverable is not a complaint. It is four updated forms and a recurring quarterly reconciliation, because a check performed once finds four errors and a check performed quarterly finds them when they happen.

What this looks like when it goes wrong

An inspector at a US site asks to see the 1572 and compares it against who actually performed trial procedures.

A person who performed study assessments for eight months is not named on the form and is not on the delegation log either. The site's answer is that the person was trained and supervised, which is probably true and is not the point.

The finding is that the sponsor and the investigator cannot evidence that this person was permitted to perform the task. The form the investigator signed states who would assist in conducting the study, and the statement was not accurate for eight months.

That is a finding against the investigator personally, on a commitment they signed, and it is difficult to argue because the signature is on the document.

Key takeaways