Clinical Research Update: The New FDA Form 1572 is Available

The FDA recently refreshed Form 1572, extending its validity through September 30, 2026. While the form’s content and structure remain identical to the previous version, the update has sparked the usual round of questions regarding back-filing and compliance timelines. The transition is straightforward: there's no regulatory requirement to re-sign existing forms if your study staff, protocols, and site details remain unchanged. However, maintaining a "business as usual" approach requires a bit of nuance.

If your site signed the expired version during the brief transition window after March 2025, a simple Note to File is a proactive way to ensure clarity during future audits. Staying informed on these administrative shifts helps research teams avoid unnecessary paperwork loops. In this article, we review the full guidance to help ensure your site stays compliant through the transition.