Individual Case Safety Reports Flashcards
7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Individual Case Safety Reports flashcards as text
A company receives a case where the only reporter is a patient who cannot name the specific drug, only describing it as 'a white pill for blood pressure.' Is this a valid ICSR?
Answer: No, because the specific drug cannot be identified
A valid ICSR requires an identifiable suspect medicinal product; a vague description insufficient to identify the drug means the minimum dataset is not met.
Under EMA regulations, what is the reporting timeframe for a non-serious spontaneous adverse drug reaction for a marketed product?
Answer: 30 days
EMA regulations require non-serious spontaneous adverse drug reactions for marketed products to be submitted to EudraVigilance within 90 days.
Which coding dictionary is most commonly used to code adverse events in ICSRs?
Answer: MedDRA
MedDRA (Medical Dictionary for Regulatory Activities) is the international standard used to code adverse events, medical history, and indications in ICSRs.
An ICSR is received for a patient who died. The cause of death is listed as the suspect adverse event. What seriousness criterion applies?
Answer: Results in death
When a patient dies and the adverse event is the cause, the seriousness criterion 'results in death' is checked, which is one of the defined ICH E2A criteria.
What does the term 'de-duplication' refer to in ICSR processing?
Answer: Identifying and merging cases reported more than once about the same patient event
De-duplication is the process of identifying ICSRs that represent the same patient event reported through multiple sources and merging them to avoid double-counting.
Which MedDRA level is used as the primary basis for signal detection in pharmacovigilance databases?
Answer: Preferred Term (PT)
Preferred Terms (PTs) are the primary level for signal detection because they represent distinct medical concepts at a clinically meaningful level of specificity.
A marketed drug's ICSR contains a concomitant medication that is also suspect. How should both drugs be documented?
Answer: Each suspect drug is listed as a separate drug entry with its own causality assessment
E2B(R3) allows multiple drug entries, each with its own characterization (suspect, concomitant, interacting) and individual causality assessment.