SUSAR Explained: Where Safety Meets Speed

Pharmacy
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In clinical research, not all adverse events are equal ,some would require urgent regulatory actions!
:magnifying_glass_tilted_left: What is SUSAR?
SUSAR stands for Suspected Unexpected Serious Adverse Reaction.
It refers to an adverse reaction that is:

  • Suspected to be related to the investigational drug
  • Unexpected - not consistent with the Investigator’s Brochure or product information/ there is not previous report of the drug causing this ADR
  • Serious - results in any one of these: life-threatening, fatal, requires hospitalization, causes disability, or congenital anomaly

Reporting timeline

Timely reporting is critical in pharmacovigilance and clinical trials:

  • Fatal or life-threatening SUSAR → report within 7 days
  • Other SUSAR → report within 15 days

Why is SUSAR reporting so important?

  • Protects safety of trial participants
  • Triggers safety signal detection and protocol modifications
  • Ensures regulatory compliance
  • Promote public fealth safety
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MBH/PS

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SUSAR reporting helps in drug safety and really needed to understand drugs better.

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I am hearing about SUSAR for the first time. It is very informative and helpful for my studies. Thank you.

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