QPPV.COM KNOWLEDGE ASSESSMENT

Pharmacovigilance Reconciliation: Professional Knowledge Assessment

Test your understanding of the concepts covered by Pharmacovigilance Reconciliation: What Should Be Reconciled, With Whom and How Often?.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A process has had no recorded discrepancies for several months, but its reconciliation checks only items preselected by staff. What is the most defensible conclusion?

The process is proven effective because the discrepancy count is zero The absence of discrepancies may not demonstrate screening completeness; the control's population and limitations should be assessed The reconciliation frequency should automatically be reduced The source process no longer needs monitoring

Question 2 of 10 Which record is most useful for making a reconciliation extraction reproducible and auditable?

The final match percentage alone System and version, query or filter, extraction date, period, row count, preparer and transformations A screenshot of the reconciliation dashboard without the underlying population A summary stating that the data were reviewed by an experienced employee

Question 3 of 10 A company is designing a reconciliation for a registry that collects a broad range of adverse events, while the PV system records individual cases meeting applicable reporting criteria. Which approach is best?

Require every registry event to have an individual PV case number Compare only total event counts and accept any difference as expected Define the reportable or otherwise relevant population and reconcile its transfer or documented disposition Exclude the registry from PV oversight because it is a research database

Question 4 of 10 A team proposes closing every discrepancy once it has been removed from the worklist. What is the key weakness in this approach?

Worklists cannot be used in a PV quality system Closure should be supported by a reasoned disposition, evidence and appropriate approval Only discrepancies involving valid ICSRs may be closed Every discrepancy must remain open until an audit is completed

Question 5 of 10 A monthly reconciliation identifies an unmatched source item that may describe a serious suspected adverse reaction. What should the reviewer do first?

Wait until the source and destination extracts have been fully re-run Route the potentially safety-relevant information to PV immediately while investigating the mismatch Close the item as a data-extraction issue until the next scheduled review Ask the source team to remove the item from the reconciliation population

Question 6 of 10 A team proposes reconciling only monthly totals because the sending and receiving systems do not share record identifiers. Which interpretation is most appropriate?

Equal totals prove that every expected record was received Aggregate totals can conceal a missing record offset by a duplicate or other difference Totals are sufficient whenever both systems are validated A record-level comparison is unnecessary if the monthly transfer completed successfully

Question 7 of 10 A process has a high match rate, but its report does not state exclusions or explain whether one source record can map to multiple PV records. What is the main interpretive limitation?

The match rate cannot be interpreted without its denominator, population definition and relationship rules A high match rate proves that source recognition is complete The report is sufficient if it is approved by a manager The number of PV cases should always equal the number of source records

Question 8 of 10 A literature reference has been reviewed and documented as a duplicate of an existing case. How should this ordinarily be handled in a reconciliation?

Remove it from the source population because it did not create a new case Record a traceable duplicate or linked-update disposition Count it as an unmatched item because no new case number was created Create a new case solely to make source and PV totals agree

Question 9 of 10 A reviewer finds a mismatch caused by one system using local time and the other using a different time zone near a period boundary. What is the best corrective approach?

Delete boundary records from both populations Define and apply consistent time-zone and cut-off conventions, then re-evaluate the affected population Move all boundary records into the following period without documentation Close the mismatch as harmless because the counts are close

Question 10 of 10 Which statement best reflects the article's regulatory interpretation of reconciliation frequency?

EU rules require monthly reconciliation for every PV interface GVP sets one universal calendar frequency for all contracted transfers Frequency should be risk-based unless a specific applicable obligation or agreement fixes an interval Reconciliation frequency is entirely optional whenever a quality system exists

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Pharmacovigilance Reconciliation: Professional Knowledge Assessment

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