Adverse Events Flashcards
6 cards from real SOCRA CCRP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Adverse Events flashcards as text
How is a 'Serious Adverse Event' (SAE) defined under ICH GCP?
Answer: Any untoward medical occurrence that results in death, is life-threatening, requires hospitalization, or causes disability
An SAE is defined as any adverse event that results in death, is life-threatening, requires inpatient hospitalization, results in persistent disability, or is a congenital anomaly.
What is the difference between an 'adverse event' (AE) and an 'adverse drug reaction' (ADR)?
Answer: An AE is any untoward event; an ADR implies a causal relationship to the investigational product
An AE is any untoward occurrence regardless of causality, while an ADR implies at least a reasonable causal relationship to the investigational medicinal product.
Under FDA regulations, what is the timeframe for expedited reporting of an unexpected fatal or life-threatening SAE to the FDA?
Answer: 7 calendar days
Unexpected, fatal or life-threatening SUSARs must be reported to FDA within 7 calendar days per 21 CFR 312.32.
What does 'SUSAR' stand for in clinical research?
Answer: Suspected Unexpected Serious Adverse Reaction
SUSAR stands for Suspected Unexpected Serious Adverse Reaction — a serious adverse reaction that is unexpected and for which there is a reasonable causal relationship to the study drug.
Who is primarily responsible for assessing causality of an adverse event to the study drug?
Answer: The investigator
Under GCP, the investigator is responsible for assessing the causal relationship between an adverse event and the investigational product.
What does 'unexpected' mean when describing an adverse event in a clinical trial?
Answer: An event not listed or not consistent with the nature or severity described in the Investigator's Brochure
'Unexpected' refers to an adverse reaction whose nature, severity, or frequency is not consistent with the information in the Investigator's Brochure or IND.