QPPV.COM KNOWLEDGE ASSESSMENT

Listedness, Expectedness and Reference Safety Information

Test your understanding of the concepts covered by Listedness, Expectedness and Reference Safety Information.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A reviewer argues that a reaction must be expected because it is pharmacologically plausible and has appeared in several company cases. What is the most appropriate response?

Those facts may inform medical evaluation, but they do not replace comparison with the applicable local label A reaction becomes expected once it has appeared in two or more company cases Pharmacological plausibility makes a reaction expected if the case is serious The CCSI should be used to decide expectedness whenever prior cases exist

Question 2 of 10 A serious suspected reaction is unexpected against the trial RSI but is already present in the marketed-product CCSI. What is the most appropriate conclusion?

The trial assessment must be changed to expected because the CCSI is global The marketed CCSI and trial RSI serve different purposes, so the classifications can differ The event cannot be a SUSAR if it is listed in any company document The local marketed label determines the trial classification

Question 3 of 10 A company updates the clinical-trial RSI after recognising a new risk. How should the organisation handle cases assessed before and after that update?

Reclassify all historical cases as though the revised RSI had always applied Preserve the version chronology and apply controlled transition rules to assessments Continue using the superseded RSI until the next DSUR Use the current marketed label for cases received before the RSI update

Question 4 of 10 A product label mentions an adverse reaction associated with the pharmacological class but does not establish it as a reaction for the individual product. How should the assessor treat that information?

Automatically treat the reaction as expected for every product in the class Treat it as listed against the CCSI without further review Do not automatically treat it as expected for the individual product; assess the product-specific wording Ignore the class information for all pharmacovigilance purposes

Question 5 of 10 A procedure instructs staff only to “check the RSI” but does not identify whether it means the PBRER reference or the clinical-trial reference. What is the main governance weakness?

RSI is a universal document, so no further definition is needed The procedure fails to connect the regulatory decision to the correct reference type and version Only the QPPV may choose an RSI for any assessment The procedure should use the local SmPC for every process

Question 6 of 10 A QC review finds frequent manual changes from “expected” to “unexpected” because the system matches broad label terms without considering severity. What is the most appropriate quality response?

Treat the overrides as normal and stop trending them Investigate whether the matching rules or reference data fail to reflect clinical assessment requirements Change all broad label terms to “unexpected” in the database Remove medical review from the process to improve consistency

Question 7 of 10 A reaction is already included in the CCSI, but new cases suggest a higher frequency and more severe outcomes than previously recognised. What is the best interpretation?

The reaction cannot be a signal because it is listed Listedness closes the safety question unless the reaction is removed from the CCSI The new evidence may still warrant signal evaluation as a new aspect of a known risk Only local-label expectedness determines whether any further evaluation is needed

Question 8 of 10 A product has no CCDS or CCSI. What is an appropriate approach when preparing its PBRER reference information?

Use no reference information because listedness cannot be assessed Select and clearly identify another appropriate national or regional product-information source Use the clinical-trial RSI automatically, whether or not it applies to the marketed product Use whichever label contains the greatest number of warnings

Question 9 of 10 Which statement correctly distinguishes seriousness, expectedness and causality?

An unexpected reaction is necessarily serious and caused by the product A serious reaction is necessarily unexpected if causality is suspected They are separate assessment dimensions, so a case can be serious and expected while causality remains uncertain Expectedness is determined by whether the reporter considers the product causal

Question 10 of 10 A local label lists a mild, self-limited rash. A case describes a severe blistering mucocutaneous syndrome. What is the best approach to expectedness assessment?

Classify it as expected because the word “rash” appears in the label Assess whether the case's clinical nature and severity are adequately represented by the label Classify it as expected if the coded MedDRA term contains “rash” Use listedness against the CCSI instead of assessing the local label

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Listedness, Expectedness and Reference Safety Information

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