Safety Results Section
ICH E3 gives safety evaluation its own clinical study report structure, including extent of exposure, adverse events, deaths/serious events, laboratory data, vital signs, and other safety observations as applicable. This page is about presenting study safety results in a CSR, not the separate operational duty to submit expedited or regulatory safety reports during trial conduct.
A Safety Results section organizes the study’s safety evidence so exposure, adverse events, serious outcomes, laboratory findings, and other relevant safety observations can be reviewed together.
Key details
Important caveats
Scope Boundary
This page is about presenting study safety results in a CSR, not the separate operational duty to submit expedited or regulatory safety reports during trial conduct.
Further guidance
Content
Report the safety population and relevant exposure first, then present adverse-event and other safety findings with the tables/listings/narratives required by the applicable CSR framework.
Purpose
A Safety Results section organizes the study’s safety evidence so exposure, adverse events, serious outcomes, laboratory findings, and other relevant safety observations can be reviewed together.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E3 Structure and Content of Clinical Study Reports (opens in a new tab)U.S. Food and Drug Administration · FDA-hosted ICH E3 guidance defining the structure and content of a core clinical study report