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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Heard about SUSAR for first time. I was aware of PSUR,PBRER,PADER.I think SUSAR is necessary and is a link between patients and immediate health care.This urgent reporting can save many patiemts from adverse drug reactions

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SUSAR need to be discussed and well-aware in terms of investigational product.

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Great explanation of SUSAR! Timely reporting truly plays a crucial role in ensuring patient safety and maintaining the integrity of clinical trials.

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Short and concised explanation, but covers the core of the topic. Informative. Can you please explain other adverse reaction reporting systems in the same format? It would be really helpful.

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Timely reporting is important to protect the participants.

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Life threatening or lethal SUSAR needs to be reported In 7 days. This is like emergency in clinical trials. Investigator gets notification of a event happening in some part of world. He contacts the Clinical site, and collects available information. Decides if the event is serious, unexpected and causality relation to investigational drug. If all three criterias are positive it is a SUSAR case. It needs to be entered in database so cro is notified . All these steps need to be completed within 7 days. IB needs to include the event. All site conducting trial are notified within 7 days. Last step is ‘signal detection’.