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Knowledge Assessment: GVP Module VI — Literature Cases and ICSR Management

Test your understanding of the concepts covered by GVP Module VI: Literature Cases and ICSR Management.

Question 1 of 10Pass mark: 80%

Question 1 of 10 What is the principal risk of treating every adverse event in a published clinical study as an individual spontaneous ICSR?

It may ignore the study design and the applicable reporting framework It prevents the company from conducting any signal assessment It makes the publication impossible to cite in the safety database It guarantees that all events will be assessed as expected

Question 2 of 10 What is the most appropriate description of literature monitoring within a pharmacovigilance system?

A periodic search performed only to locate published case reports for expedited reporting A controlled pharmacovigilance process that supports case identification, safety review, signal detection and risk assessment A scientific information service used primarily to support medical writing A replacement for spontaneous reporting because published evidence is more reliable

Question 3 of 10 A case series reports six patients receiving the same product and provides separate patient characteristics and outcomes. What should the reviewer primarily consider?

Creating one ICSR because the information appears in one publication Creating no cases because case series are never reportable Whether the patient-level information supports separate ICSR processing Reporting only the patient with the most serious outcome

Question 4 of 10 A systematic review reports an association between a product and an adverse event but provides no new patient-level information. What is the most appropriate action?

Create one new ICSR for each study mentioned in the review Discard the review because secondary literature has no pharmacovigilance value Use the review for signal or evidence assessment and evaluate underlying primary sources where appropriate Record the review as proof that the product caused the adverse event

Question 5 of 10 Which approach best addresses a missed relevant publication discovered during quality review?

Treat it solely as an individual reviewer error and close the issue Ignore it if no report was ultimately submitted Investigate underlying controls such as search terms, database coverage, schedule adherence and automated screening, and manage corrective actions as appropriate Delete the search record to prevent an apparent discrepancy

Question 6 of 10 What is the most appropriate response when direct follow-up with the patient described in a publication is not feasible?

Assume that follow-up is unnecessary for all literature cases Assess whether additional information can reasonably be obtained through authors or other available sources and document the decision Create a duplicate case to compensate for missing information Withhold all processing until the patient is contacted

Question 7 of 10 Which screening sequence best reflects a defensible literature-case process?

Publication type, author reputation, journal impact factor, then reporting decision Product relevance, human safety information, potential individual case, then potential reportability Seriousness, expectedness, causality, then confirmation that the product was studied Causality assessment, duplicate search, database entry, then review of the publication

Question 8 of 10 Which statement correctly distinguishes expectedness from publication status?

An event is expected whenever it has been published previously An event is unexpected whenever it originates from literature Expectedness, where relevant, must be assessed against applicable reference information and regulatory requirements Publication of an event makes expectedness irrelevant

Question 9 of 10 Which action best demonstrates that literature surveillance is functioning as a pharmacovigilance control rather than merely as a search exercise?

Maintaining a list of journal titles without recording screening decisions Performing searches but reviewing only articles that appear highly cited Maintaining traceable records from strategy and search through screening, extraction, duplicate assessment, reporting or documented disposition Delegating all decisions to an automated classifier without performance monitoring

Question 10 of 10 Which record set best supports reconstruction of a literature-monitoring decision during an inspection?

Only the final submitted ICSR and the publication title Search date, database, strategy version, result volume, screening outcome, reviewer and disposition Only the vendor invoice and the journal subscription record The publication abstract without documentation of the search or screening process

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Knowledge Assessment: GVP Module VI — Literature Cases and ICSR Management

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