QPPV.COM KNOWLEDGE ASSESSMENT

QPPV Metrics Knowledge Assessment

Test your understanding of the concepts covered by QPPV Metrics.

Question 1 of 10Pass mark: 80%

Question 1 of 10 The denominator for expedited reporting timeliness should generally represent which population?

All cases received, including duplicates and non-reportable cases All cases closed during the period, regardless of reporting obligation All reportable ICSRs requiring expedited reporting during the measurement period, after defined exclusions Only cases that were submitted late

Question 2 of 10 Which combination is most appropriate for making a metric inspection-ready?

A dashboard screenshot and an informal explanation from the metric owner A metric name, purpose, defined numerator and denominator, frequency, owner, threshold and escalation action A monthly percentage without source data because the result is self-explanatory A vendor report that does not identify the underlying calculation method

Question 3 of 10 Which approach is most appropriate when a coding error-rate metric exceeds its red threshold?

Reduce the sample size immediately to lower the reported rate Increase or otherwise adjust sampling according to the plan, investigate root causes, and implement targeted remediation Exclude errors found during quality review because they were detected internally Wait until the annual QA review before taking action

Question 4 of 10 Which action best demonstrates risk-based use of metrics by a QPPV?

Reviewing every metric with identical frequency and escalation criteria Focusing more frequent review and automated monitoring on expedited reporting timeliness and backlog Ignoring metrics that are below threshold because they do not require oversight Using only historical annual averages to determine current priorities

Question 5 of 10 Which evidence would most convincingly demonstrate that the QPPV used a red expedited-reporting result in oversight?

A current dashboard with no historical results A spreadsheet showing the percentage but no decision record Meeting minutes or sign-off documenting review, escalation, root-cause analysis and mitigation or CAPA A general statement in an SOP that the QPPV is responsible for pharmacovigilance

Question 6 of 10 What is the main purpose of maintaining a version-controlled metrics glossary linked to the PSMF?

To allow metric definitions to change without approval To provide a controlled, traceable record of definitions, thresholds, changes, ownership and evidence links To replace SOPs and vendor contracts To store only final dashboard screenshots

Question 7 of 10 What is the appropriate relationship between a metric breach and CAPA?

Every breach automatically requires a permanent CAPA A breach should trigger appropriate investigation and may require CAPA, with effectiveness later verified where CAPA is implemented CAPA is relevant only to audit findings, not operational metrics CAPA completion alone proves that the underlying problem was resolved

Question 8 of 10 Why should metric dashboards be annotated with relevant events such as campaigns, regulatory actions or system changes?

To justify changing unfavorable results after calculation To provide context that helps distinguish expected variation from unexplained changes and supports informed investigation To replace the need for source-data reconciliation To ensure all metrics appear within green limits

Question 9 of 10 Which statement best describes the role of QA in the metrics framework?

QA owns every metric and performs all first-line operational actions QA independently reviews metric integrity, sampling methods and use in oversight, especially annually and after major system changes QA reviews metrics only when an inspector requests evidence QA determines all regulatory reporting deadlines

Question 10 of 10 Which documentation package would be most complete for an inspection involving a vendor SLA metric?

The vendor's invoice and a verbal confirmation of performance The KPI definition, contract clause, raw vendor evidence, reconciliation records, review minutes and documented remediation where applicable Only the aggregate green or amber status A current vendor presentation without historical results

QPPV Metrics Knowledge Assessment

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