How to Read a Form FDA 1572

A Form FDA 1572 gets handled, sometimes, like onboarding paperwork — collect the signature, file it, move on to the protocol. Under 21 CFR 312.53, it isn’t an intake form. It is the investigator’s own signed statement of what they are agreeing to do, and the sponsor’s documented proof that it checked before letting the study start at that site.

In brief

21 CFR 312.53(c) requires the sponsor to obtain a signed Statement of Investigator — Form FDA-1572 — before an investigator may begin participating in a study, along with the investigator’s current curriculum vitae and financial disclosure information.
The form records more than contact details: the protocol and amendment numbers the investigator agrees to conduct, the research facility and the IRB that will oversee the study, and the sub-investigators who will assist.
Signing it is a commitment, not a formality — to conduct the study according to the protocol, to personally conduct or supervise the investigation, to ensure informed consent and IRB requirements are met, to report adverse events, and to maintain records FDA can inspect.
Every co-investigator named on a study signs a separate 1572. The regulation treats each one as fully responsible for those commitments, not as a junior name covered by someone else’s signature.

What the signature actually commits to

The obligations attached to a signed 1572 go well beyond showing up. An investigator commits to conducting the study according to the protocol and not making changes to it without sponsor and IRB approval, except where immediately necessary to protect a subject’s safety. They commit to personally conducting or supervising the investigation, to ensuring that informed consent is obtained the way 21 CFR part 50 requires, and to ensuring the IRB reviews and continues to oversee the study under part 56. They commit to reporting adverse events and to maintaining the case histories and records FDA can request under 21 CFR 312.62. It is the same oversight loop that shows up from the other side of the relationship when you are reading an IRB approval letter — the 1572 is the investigator’s half of that loop, in writing, before the study begins.

Why the sponsor’s job doesn’t end once it’s signed

The sponsor’s obligation isn’t satisfied by collecting a signature. It starts with selecting only investigators qualified by training and experience to conduct the specific study, and it continues through monitoring the investigation while it runs. The 1572 itself isn’t a one-time artifact either — it gets updated and re-signed when something material changes: a new sub-investigator joins, the research facility changes, the IRB of record changes. A 1572 that no longer reflects who is actually running the study is itself a finding in an inspection, independent of how the study is otherwise conducted. All of this sits inside the broader IND application the study is conducted under, and it is the same file discipline that eventually produces the safety reports a sponsor has to submit once subjects are enrolled.

Where this goes wrong

Treating the 1572 as paperwork rather than a protocol commitment

Signing without having read the current protocol version doesn’t satisfy 312.53 — the commitment is to that specific protocol, not to the study in general.

Letting a sub-investigator start before they’re added

Someone working on the study who isn’t on the 1572 and delegation log, with documented training, is a protocol deviation waiting to be found.

Not re-signing the form when something material changes

A new facility, a new sub-investigator, a new IRB of record — each one makes the form on file inaccurate until it’s updated.

A Form FDA 1572 is one page. The commitments behind it — to the protocol, to the IRB, to the records FDA can ask for — are not small, and checking that they still match reality is ongoing regulatory affairs work, not a box checked once at study start.

Sources & further reading

eCFR — 21 CFR 312.53, Selecting investigators and monitors ecfr.gov
FDA — Form FDA 1572, Statement of Investigator fda.gov
Regulatory Academy — How to Read an IND Application regulatoryacademy.com
Regulatory Academy — How to Read an IND Safety Report regulatoryacademy.com

This essay is provided for general educational purposes and reflects the regulatory landscape as of its publication date. It is not legal, regulatory, or career advice.