SUSAR
Suspected Unexpected Serious Adverse Reaction, a safety report requiring expedited regulatory submission.
What it means
SUSAR stands for Suspected Unexpected Serious Adverse Reaction. It is a suspected serious adverse reaction that is both unexpected in nature and severity relative to the reference safety information. SUSARs must be reported to regulators and ethics committees on an expedited basis, and translations must be accurate and submitted within tight deadlines.
Why it matters for LATAM submissions
SUSAR translations have short turnaround times and high clinical precision requirements. A delayed or inaccurate SUSAR translation can violate reporting timelines and create regulatory exposure.
Relevant regulators
Related terms
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