SAE
Serious Adverse Event, a safety event that must be reported to regulators and ethics committees.
What it means
SAE stands for Serious Adverse Event. In clinical trials, an SAE is an adverse event that results in death, is life-threatening, requires hospitalization, causes disability, or is otherwise medically significant. SAE narratives must be translated into the local language for regulator and ethics committee reporting.
Why it matters for LATAM submissions
SAE narratives contain high-stakes clinical and legal language. A mistranslated causality or severity term can trigger a regulator query or affect patient safety assessment.
Relevant regulators
Related terms
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