Adverse Event Safety Reporting Flashcards
7 cards from real SOCRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Adverse Event Safety Reporting flashcards as text
In causality assessment, 'dechallenge' refers to:
Answer: The improvement or resolution of an adverse event after the investigational drug is withdrawn
Dechallenge is the observation that an AE improves or resolves after stopping the investigational product, which supports a causal relationship.
A subject in a Phase II trial develops severe liver injury that is unexpected and has a reasonable causal relationship to the investigational drug. This event is best classified as:
Answer: A suspected unexpected serious adverse reaction (SUSAR)
An event that is serious, unexpected (not in the IB), and possibly caused by the investigational drug meets the definition of a SUSAR requiring expedited reporting.
Which factor is LEAST relevant when assessing causality between an adverse event and an investigational drug?
Answer: The subject's health insurance plan and coverage type
A subject's insurance status has no bearing on the clinical or pharmacological assessment of whether a drug caused an adverse event.
Which regulatory body requires safety data for clinical trials conducted in the European Union to be submitted via the EudraVigilance database?
Answer: European Medicines Agency (EMA)
The European Medicines Agency (EMA) requires sponsors and marketing authorization holders to submit individual case safety reports (ICSRs) through the EudraVigilance electronic reporting system.
When assessing causality, a 'positive rechallenge' refers to:
Answer: The AE recurring or worsening when the investigational drug is reintroduced after a dechallenge
A positive rechallenge — where the AE reappears upon reintroduction of the drug — substantially strengthens evidence of a causal relationship.
According to ICH E6, who is primarily responsible for determining causality of an adverse event to the investigational product at the site level?
Answer: The investigator
ICH E6 assigns the investigator the primary responsibility for assessing and documenting the causal relationship between the investigational product and any adverse event at their site.
Which of the following adverse events would be classified as 'medically significant' and therefore serious, even without death or hospitalization?
Answer: Development of drug dependence or a potentially carcinogenic finding
Events that may jeopardize the subject or require intervention to prevent one of the other SAE outcomes — such as drug dependence, malignancy signals, or anaphylaxis — qualify as 'medically significant' SAEs.