QPPV.COM KNOWLEDGE ASSESSMENT

Knowledge Assessment: Pharmacovigilance System Master File (PSMF)

Test your understanding of the concepts covered by What is a Pharmacovigilance System Master File (PSMF)?.

Question 1 of 10Pass mark: 80%

Question 1 of 10 What is the principal value of the PSMF as institutional memory?

It preserves a complete record of every individual case report It preserves organisational understanding of structures, responsibilities, systems and governance despite personnel or business changes It prevents all future organisational restructuring It replaces the need to train new QPPVs and contributors

Question 2 of 10 A company outsources case processing to a vendor. What should the PSMF primarily enable an inspector to understand?

Only the vendor's commercial pricing model The vendor's role, allocated responsibilities, oversight arrangements and connection to the wider pharmacovigilance system The personal performance ranking of individual vendor employees The vendor's internal procedures in place of the company's own oversight

Question 3 of 10 What is the most appropriate design principle for a digital PSMF?

Automation should eliminate all human review and validation The system should support current information, audit trails, controlled access and a human-readable inspection representation Only the document custodian should be able to view any PSMF information A digital PSMF need not retain historical versions

Question 4 of 10 A new safety database is implemented. What is the most appropriate immediate governance question regarding the PSMF?

Whether the PSMF can remain unchanged until its next scheduled annual review Whether the change affects relevant PSMF sections, annexes, inventories or QPPV oversight and therefore requires a controlled update Whether only the database vendor should decide if an update is needed Whether the PSMF should be deleted and recreated from scratch

Question 5 of 10 What is the main risk of an inaccurate PSMF during an inspection?

Inspectors will be unable to ask any questions about pharmacovigilance The PSMF may mislead inspectors about the system, causing them to identify inconsistencies and apply additional scrutiny The inspection will automatically be cancelled Only document formatting findings can be raised

Question 6 of 10 Which activity best tests practical inspection readiness rather than merely document existence?

Counting the number of PSMF headings Conducting a mock inspection that tests navigation, retrieval of supporting evidence and QPPV interview readiness Confirming that the PSMF has a cover page Comparing the PSMF font with the corporate template

Question 7 of 10 A vendor is listed in the PSMF, but the organisation cannot explain which activities the vendor performs or how performance is monitored. What is the most appropriate interpretation?

The PSMF is adequate because listing the vendor is sufficient The issue indicates a potential integration and vendor-governance deficiency requiring clarification and supporting evidence The vendor's presence is irrelevant because outsourced work is outside the MAH's system The issue can be resolved by removing the vendor from the PSMF

Question 8 of 10 Which change should normally trigger prompt assessment of PSMF impact rather than waiting for the next routine review?

A minor correction to an internal formatting style with no system impact A new vendor responsible for a critical pharmacovigilance activity A change to an unrelated corporate travel policy A routine employee social event

Question 9 of 10 Which statement best reflects the relationship between PSMF contribution and ownership?

Any function contributing information becomes the legal owner The QPPV personally owns every factual detail and must author every section The Marketing Authorisation Holder remains responsible, although operational maintenance may be delegated The Quality Assurance function automatically owns the PSMF

Question 10 of 10 Which set of PSMF elements most directly addresses the risks of unclear accountability, outsourcing failure and data integrity?

QPPV information, vendor oversight and computerised-system descriptions Product marketing plans, financial budgets and commercial forecasts Training attendance, office layouts and travel policies Publication plans, sales targets and medical conference schedules

Knowledge Assessment: Pharmacovigilance System Master File (PSMF)

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