SafetyGlossary Term
ICH E2A Section II.C
A serious adverse reaction to an investigational medicinal product that is both suspected to be related to the product and is unexpected based on the reference safety information.
A SUSAR represents a particularly significant safety finding in clinical trials, combining three critical elements: the event is serious according to regulatory definitions, there is a reasonable possibility that the investigational product caused the event, and the nature or severity of the event is not consistent with the applicable reference safety information. This convergence of seriousness, suspected causality, and unexpectedness triggers the most stringent regulatory reporting requirements in drug development.
The reference safety information, typically contained in the Investigator's Brochure for investigational products or the Summary of Product Characteristics for authorized products, defines the expected adverse reaction profile against which new events are assessed. An adverse reaction that has not been previously observed or documented, or that occurs with greater severity or frequency than expected, qualifies as unexpected. This expectedness determination is crucial because regulatory authorities prioritize learning about new safety signals that were not anticipated based on prior knowledge.
Expedited reporting of SUSARs to regulatory authorities is mandated by regulations worldwide, with timelines typically requiring notification within seven calendar days for fatal or life-threatening SUSARs and fifteen calendar days for other SUSARs. Sponsors must also notify all investigators conducting trials with the investigational product, enabling them to assess the implications for their own participants and to update informed consent processes if warranted. The aggregation and analysis of SUSARs across all trials of an investigational product forms a key component of the ongoing safety evaluation throughout development.
Expedited reporting
"When a participant in a cardiovascular drug trial experienced sudden hepatic failure that was not listed in the Investigator's Brochure, the investigator reported it as a SUSAR within seven days due to its life-threatening nature and suspected relationship to the study drug."
Safety signal identification
"Three cases of severe peripheral neuropathy across different trial sites prompted the sponsor to report these as SUSARs and convene the Data Safety Monitoring Board to evaluate whether a new safety signal was emerging."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.
ICH E2A Section II.C
A serious adverse reaction to an investigational medicinal product that is both suspected to be related to the product and is unexpected based on the reference safety information.
A SUSAR represents a particularly significant safety finding in clinical trials, combining three critical elements: the event is serious according to regulatory definitions, there is a reasonable possibility that the investigational product caused the event, and the nature or severity of the event is not consistent with the applicable reference safety information. This convergence of seriousness, suspected causality, and unexpectedness triggers the most stringent regulatory reporting requirements in drug development.
The reference safety information, typically contained in the Investigator's Brochure for investigational products or the Summary of Product Characteristics for authorized products, defines the expected adverse reaction profile against which new events are assessed. An adverse reaction that has not been previously observed or documented, or that occurs with greater severity or frequency than expected, qualifies as unexpected. This expectedness determination is crucial because regulatory authorities prioritize learning about new safety signals that were not anticipated based on prior knowledge.
Expedited reporting of SUSARs to regulatory authorities is mandated by regulations worldwide, with timelines typically requiring notification within seven calendar days for fatal or life-threatening SUSARs and fifteen calendar days for other SUSARs. Sponsors must also notify all investigators conducting trials with the investigational product, enabling them to assess the implications for their own participants and to update informed consent processes if warranted. The aggregation and analysis of SUSARs across all trials of an investigational product forms a key component of the ongoing safety evaluation throughout development.
Expedited reporting
"When a participant in a cardiovascular drug trial experienced sudden hepatic failure that was not listed in the Investigator's Brochure, the investigator reported it as a SUSAR within seven days due to its life-threatening nature and suspected relationship to the study drug."
Safety signal identification
"Three cases of severe peripheral neuropathy across different trial sites prompted the sponsor to report these as SUSARs and convene the Data Safety Monitoring Board to evaluate whether a new safety signal was emerging."
A response to a medicinal product that is noxious and unintended, where a causal relationship between the product and the adverse event is at least a reasonable possibility.
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product.
The strictest warning required by the FDA to appear on prescription drug labeling, alerting prescribers and patients to serious risks that may lead to death or severe injury.
The systematic evaluation of the likelihood that an adverse event was caused by the investigational product or another factor, using established criteria to determine the relationship between exposure and outcome.
A standardized one-page format developed by the Council for International Organizations of Medical Sciences for reporting suspected adverse drug reactions from clinical trials to regulatory authorities.