The FDA’s 2025 updated safety reporting guidance offers clearer expectations for how investigators and IRBs should evaluate adverse events (AEs) and unanticipated problems (UPs). Rather than changing core principles, it aligns safety reporting with FDA inspections in clinical trials, emphasizing consistency, accountability, and action.
But what does that mean for your study? Safety reporting should clearly communicate what changed and what needs to happen next.
This article, featured in Clinical Leader, digs deeper, explaining:
- What has changed in FDA safety reporting guidance, including how IND safety reports should be treated as unanticipated problems
- Why the focus is shifting from classification debates to understanding impact on participant safety and study conduct
- What sponsors, CROs, investigators, and IRBs should do to support inspection readiness and clinical research compliance
