CATO Associate Safety Reporting & Adverse Events Flashcards
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What is the definition of a Serious Adverse Event (SAE) in clinical trials?
Answer: An adverse event that results in death, is life-threatening, requires hospitalization, causes persistent disability, or is a congenital anomaly
An SAE is defined by regulatory criteria including death, life-threatening events, hospitalization, persistent disability, congenital anomaly, or other medically significant events.
Within what timeframe must a fatal or life-threatening unexpected SUSAR (Suspected Unexpected Serious Adverse Reaction) be reported to regulatory authorities in the US under IND regulations?
Answer: 7 calendar days
Fatal or life-threatening unexpected SUSARs must be reported to the FDA within 7 calendar days under IND regulations (21 CFR 312.32).
What is the difference between 'causality assessment' and 'expectedness' in adverse event reporting?
Answer: Causality assesses the relationship of the event to the investigational product; expectedness compares the event to what is described in the reference safety document
Causality determines if the adverse event is related to the IP, while expectedness compares the event to descriptions in the Investigator Brochure or labeling.
Who at an investigative site is responsible for assessing causality of adverse events to the investigational product?
Answer: The Principal Investigator or qualified sub-investigator
The Principal Investigator or a qualified sub-investigator is responsible for assessing the causal relationship between the IP and the observed adverse event.
What action must the investigator take upon learning of a fatal SAE occurring in a study subject?
Answer: Report it to the sponsor immediately and to the IRB/IEC within required timeframes
Fatal SAEs must be reported to the sponsor immediately (often within 24 hours) and to the IRB/IEC within required timeframes per protocol and regulations.
What is an 'Adverse Event of Special Interest' (AESI) in clinical trials?
Answer: A scientifically or medically important event that may require special monitoring or reporting, as defined in the protocol
An AESI is a pre-specified event of scientific or medical importance that requires special surveillance or expedited reporting as defined in the protocol.