Cutting Through the Confusion Around Repeated Form FDA 1572 Updates
Do you find yourself asking this question every time you’re asked to resubmit a Form FDA 1572? Is it being clearly explained as to why it was requested – and what happens if you push back on the request?
It’s not uncommon that the reason isn’t clear and push back can sometimes feel like climbing a wall without any gear; If you’re frustrated, you’re not alone. Clinical research sites often face repetitive and unnecessary 1572 update requests—even when changes don’t warrant a new submission.
Let’s clarify when an updated Form FDA 1572 is truly necessary—and when it’s not.
When an Updated 1572 IS Required:
According to Section 7 of the FDA’s May 2010 Frequently Asked Questions – Statement of Investigator (Form FDA 1572), there are specific cases requiring a new signed 1572:
- Adding a New Investigator:
Anytime a new Principal Investigator or Sub-Investigator joins the study, a new 1572 must be completed for them. - Transition to a New PI at the Same Site:
A PI change (due to departure or role change) must be documented with a new signed 1572 reflecting the new investigator’s information and responsibilities. Additionally, all the other required PI documentation must be completed for the new PI, the DoA must be appropriately updated; check the contract and responsility language, as well, to be sure nothing is left unchecked. - Adding a New Protocol to the IND:
A new protocol means a new 1572, even if the investigator has already signed a 1572 for another protocol under the same IND.
When an Updated 1572 Is NOT Required:
Despite clear FDA guidance, many sponsors and CROs continue to request 1572 revisions unnecessarily. There are as many reasons as there are people, it seems, but here are some frequent examples of when it’s not required by regulation:
Examples of Unfounded 1572 Requests for New or Revised Versions:
- “Please revise and re-sign the 1572 because it was electronically signed.”
A CRO may ask the site to reprint the form, wet-sign it, scan, and re-upload—despite the use of the FDA’s official fillable PDF template, which the PI signed electronically using a validated system. - “Update the 1572 due to change in the IRB’s mailing address.”
A central IRB updated its office location. The sponsor requested revised 1572s for all sites—yet FDA guidance explicitly states that this kind of change can be documented locally and does not require a new 1572. - “Submit a new 1572 every time a sub-investigator is removed from the study.”
A sub-I left the site. Rather than document the change in the delegation log and notify the sponsor, the CRO insisted on a revised 1572, even though FDA does not require a new one for sub-I removal—only addition. - “Submit a new 1572 because the version with the updated expiration date has been released by FDA.”
You do NOT need to update or resubmit a Form FDA 1572 just to use a newer version if the previously signed version was valid at the time.
FDA Guidance on Using Older Versions of Form 1572
While the form carries an OMB expiration date, that date refers to the administrative approval of the form’s format—not the validity of the commitments made when signed. Here’s what the FDA has stated (summarized from multiple official sources, including the FDA’s FAQ on expired forms):
“If the form was valid and current at the time it was completed and signed, it does not become invalid simply because the form’s OMB expiration date has passed or a newer version exists.”
If your PI signed a valid Form 1572 before a new version was released:
- It remains valid as long as the information is accurate at the time of signing.
- No regulatory requirement compels you to redo the form just because a newer version has been published.
- You only use the newer version when a 1572 update is otherwise required (e.g., new PI, new protocol, etc.).
Only switch to the new version when a legitimate update event occurs (e.g., new protocol, new investigator), and even then, carry over the existing information unless there’s a substantive change.
Critical Perspective as we Forge Ahead:
The newly required use of ICH E6(R3) reinforces a risk-based mindset when it comes to unnecessary document requests:
“The extent and nature of documentation should be proportionate to the risks to participants and to the importance of the information.”
Excessive revisions driven by formatting preferences or internal SOPs—rather than regulatory need—run counter to this principle.
At Ridge Research Solutions, We’re Changing the Game:
We help sites, sponsors, and networks rethink the system by:
Auditing and updating SOPs to align with FDA and ICH guidance
Training staff to document appropriately without over-compliance
Let’s stop the paperwork treadmill and focus on what matters—trial progress and patient care.
Want to streamline your regulatory process without cutting corners? Let’s talk.
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