Individual Case Safety Reports Flashcards
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Read the first 7 Individual Case Safety Reports flashcards as text
What is the primary purpose of the 'worldwide case number' (or global case ID) in an ICSR?
Answer: To uniquely identify and track the case across all submissions and follow-ups
The worldwide case number is a unique identifier assigned by the company that allows tracking of the case, linking initial and follow-up reports, and preventing duplication across databases.
Which of the following best describes a 'solicited' adverse event report?
Answer: A report collected through organized data-collection systems such as clinical trials or patient support programs
Solicited reports are those collected through organized systems such as clinical trials, registries, or patient support programs, distinguishing them from unsolicited spontaneous reports.
Under FDA 21 CFR Part 314.81, which report type requires marketing authorization holders to submit all ICSRs received during the reporting period, including those previously expedited?
Answer: Periodic Adverse Drug Experience Report (PADER)
The PADER (now largely replaced by PBRER in some contexts) required submission of all adverse experience reports, including those already submitted as 15-day alert reports, during the reporting period.
A literature article describes adverse events in 10 patients taking a suspect drug. How many ICSRs should be generated?
Answer: One ICSR per identifiable patient in the article
Each identifiable patient in a literature article with a reportable adverse event should generate a separate ICSR, as each patient represents an individual case.
What does 'listedness' refer to when assessing an adverse event in an ICSR?
Answer: Whether the adverse event is described in the current approved Reference Safety Information for the product
Listedness (or expectedness) is determined by comparing the reported adverse event to the Reference Safety Information (e.g., the current Investigator's Brochure or SmPC) to see if it is already described.
Which causality assessment term indicates the highest level of certainty that a drug caused the adverse event, according to WHO-UMC criteria?
Answer: Certain
The WHO-UMC causality category 'Certain' requires a plausible time sequence, known reaction pattern, improvement on dechallenge, and confirmation by rechallenge or definitive testing.
An ICSR is received 20 days after the company becomes aware of the event. For a 15-day serious expedited report, what action is required?
Answer: Submit immediately as a late report and notify the regulatory authority of the delay
The company must submit the overdue report as soon as possible and notify the relevant regulatory authority of the late submission, as the obligation does not disappear after the deadline passes.