This blog covers the following:
- Explanation of SUSAR.
- Distinctions between SUSAR and other severe cases.
- Timelines associated with SUSAR incidents.
SUSAR stands for “Suspected Unexpected Serious Adverse Reaction“.
It is a term used in the context of clinical trials. It refers to any serious and unexpected side effect. It must have suspected and related to investigational product.
Table of Contents:
- What are SUSAR cases?
- Key Takeaways
- How SUSAR are differ from other serious cases?
- Timelines for SUSAR cases
- Conclusion
What are SUSAR cases?
SUSAR cases are a serious adverse drug reaction that observed during clinical trials. They are distinct from other adverse events that may occur during a trial.
SUSAR cases are adverse reactions:
- Unexpected
- Suspected.
Unexpected: An overview
These Serious Adverse Reactions (SAR) state a certain probability that are:
- Harmful
- Undesired reaction
to the investigational medicinal product, irrespective of the administered dose. Thus, unexpected SARs are referred to as SUSARs.
In this context, “unexpected” that does not rely with the the reference safety information (RSI). That its nature and severity of the adverse reaction.
Collection of SUSAR cases
SUSAR cases evaluated based on data gathered from the clinical trial cases. The evaluation is to ensure the safety of the study participants and to identify the potential risks and benefits.
“Within the intricate web of clinical research, SUSAR cases are the vital threads that weave safety and vigilance into the fabric of medical advancement.”
Effectively oversee your SUSAR cases with vigilant care using Drugvigil.
Regulatory requirement for SUSAR cases
These reports expedited in reporting requirements and are closely monitored by regulatory authorities. Importance of proper evaluation and reporting of SUSAR cases are to maintain the integrity of the clinical trial process.
SUSARs have to be reported to the reviewing MREC from the moment the dossier submitted.
The reporting of SUSAR cases is mandatory in clinical trials.
📢 To read more in precise, check out “DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL“.
Unforeseen tip: SUSARs are extracted from recorded reactions in clinical trial cases but are not classified as events. In serious cases from the study, they are further categorized as expected and unexpected. Both expected and unexpected cases, mostly related to causality, the one unexpected are considered SUSAR cases. You might wonder why SUSARs are not considered events, but reactions. This is because they are recorded from clinical trial cases.
How SUSAR are differ from other serious cases?
SUSAR’s evaluation is more closely than other SAEs. Because they are unexpected and may show potential safety issues with the investigational product.
Regulatory authorities need that SUSARs be reported within a shorter timeline than other SAEs. To ensure that appropriate actions can be taken to protect patient safety.
Proper evaluation and reporting of SUSARs are important to maintaining the integrity of clinical trials. And ensure the safety of study participants.
✍️ Note: In terms of labeling, Investigator Brochure (IB) labeling is required for every Suspected Unexpected Serious Adverse Reaction (SUSAR) case.
Timeline for SUSAR cases
If a SUSAR meets the criteria :
- 7 calendar days for life-threatening and/or resulting in death.
- 15 calendar days for other than life-threatening or does not result in death.
It does necessary to be submitted to regulatory authorities.
Key Takeaways
SUSARs explicitly denote serious cases.
SUSARs do not encompass all serious reactions.
SUSARs always require prioritization over other serious cases.
SUSARs are strictly regarded as adverse (reactions but not events) because they are recorded during clinical trial investigations.
In serious cases from the study, they further categorized as expected and unexpected.
Both expected and unexpected cases, mostly related to causality, the one unexpected are considered SUSAR cases.
You might wonder why SUSARs not considered events, but reactions. This is because they recorded from clinical trial cases.
SUSAR are expedited in reporting. (Click here to explore in detail about what is expedited safety reporting)
SUSARs generated from pre-marketing sources. (Click here to explore more about sources if adverse event reports)
IB labeling is necessary for every SUSAR cases. (IB: Investigational brochure)
Conclusion
This blog gives you a clarity of the difference of SUSAR and other serious cases. It is matter of addressing any prior confusion about reactions versus events.
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Abbreviations:
- SAR: Serious Adverse Reactions
- SAE: Serious Adverse Event
- MREC: Multi-center Ethics Committee or Multi-center Research Ethics Committee
- SUSAR: Suspected Unexpected Serious Adverse Reactions
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