QPPV.COM KNOWLEDGE ASSESSMENT

GVP Module I: Pharmacovigilance Systems and Quality Systems Knowledge Assessment

Test your understanding of the concepts covered by GVP Module I Explained: Pharmacovigilance Systems and Quality Systems.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which statement best describes the primary focus of GVP Module I?

The detailed medical assessment requirements for individual adverse-event cases The architecture, governance and quality controls of the pharmacovigilance system as a whole The scientific methodology for detecting new safety signals The structure and content of periodic safety update reports

Question 2 of 10 A case-processing backlog persists for several months. Which response best reflects Module I thinking?

Treat the backlog solely as an individual productivity issue Focus only on reducing the numerical backlog as quickly as possible Investigate contributing factors such as staffing, triage, vendor capacity, system limitations and management controls Remove the backlog metric from governance reporting

Question 3 of 10 Repeated similar processing errors are observed across several employees. What should the investigation consider first?

Whether the employees should all receive the same generic training module Whether the pattern indicates unclear procedures, workload, system design or ineffective controls Whether the errors can be excluded because each event involved a different person Whether the SOP should be archived to avoid further confusion

Question 4 of 10 What is the most appropriate way to maintain the PSMF in a mature pharmacovigilance system?

Treat it as a static annual document independent of operational changes Update it only after an inspection finding Maintain it as a current, structured description that reflects actual organisational, vendor, system and process arrangements Use it as a replacement for procedures and operational records

Question 5 of 10 What is the principal objective of business-continuity planning for pharmacovigilance?

To ensure that every possible disruption is eliminated To ensure that critical safety activities can continue or recover within appropriate timeframes during credible disruptions To transfer all operational responsibilities permanently to a backup vendor To avoid documenting system outages until normal operations resume

Question 6 of 10 Which set of information is most important for reconstructing a significant historical pharmacovigilance decision?

Only the final approved document The identity of the current process owner and the current SOP What was done, when and by whom, what information was used, what review occurred and what decision resulted A general statement that the activity was performed according to GVP

Question 7 of 10 Which control is primarily preventive rather than detective?

A retrospective sample review of processed cases A monthly reconciliation of two safety databases A mandatory system field that prevents submission of an incomplete record An audit of the vendor's previous performance

Question 8 of 10 Which change most appropriately requires assessment of potential impact on the pharmacovigilance system?

A change in vendor, system interface or intended use of a computerised system A routine filing of a completed record with no process change A scheduled team meeting using the existing agenda A replacement of office stationery

Question 9 of 10 An MAH outsources case processing to a vendor. Which statement best reflects the MAH's responsibility?

The vendor assumes all regulatory responsibility once the contract is signed The MAH remains responsible for ensuring that outsourced activities are appropriately controlled and overseen The QPPV is responsible only if the vendor is located outside the EU Oversight is unnecessary if the vendor has a pharmacovigilance certificate

Question 10 of 10 What is the main purpose of CAPA in a mature pharmacovigilance quality system?

To document that an individual event was closed as quickly as possible To assign blame to the person associated with a deviation To address causes of deficiencies and improve the reliability of the underlying process To replace the need for management oversight

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GVP Module I: Pharmacovigilance Systems and Quality Systems Knowledge Assessment

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