QPPV.COM KNOWLEDGE ASSESSMENT

EU Pharmacovigilance Inspection Findings: Data Integrity, Traceability and the Evidence Chain

Test your understanding of the concepts covered by EU Pharmacovigilance Inspection Findings: Data Integrity, Traceability and the Evidence Chain.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A corrected serious case contains the right final information, but the original values were overwritten and no history remains. What is the principal concern?

The correction is automatically invalid The lack of preserved history prevents reliable reconstruction of what changed and why Serious cases may never be corrected after initial entry The issue is limited to document formatting

Question 2 of 10 Which factor is least appropriate as the sole basis for classifying a discrepancy as a data-integrity finding?

Whether the discrepancy is material Whether there is contemporaneous evidence explaining it Whether it affected reporting, assessment or reconstruction The mere fact that two records are not identical

Question 3 of 10 Why does the existence of an electronic audit trail not, by itself, establish data integrity?

Audit trails are never useful during inspections An audit trail may fail to capture relevant events, may be bypassed or may not be adequately governed, retained or reviewed Audit trails are relevant only to financial systems An audit trail proves the scientific validity of every decision

Question 4 of 10 What is the main traceability challenge created by system migration?

The new database must use the same software version as the old database The organisation must demonstrate that historical records remain complete, accurate, reliable and interpretable after transfer All historical audit trails must always be migrated in exactly the original technical format Migration eliminates the need for continued retention controls

Question 5 of 10 A final signal conclusion is scientifically plausible, but the underlying data set, assumptions and analytical steps cannot be reconstructed. What is the primary inspection weakness?

The conclusion is automatically scientifically invalid The organisation lacks sufficient evidence to demonstrate the basis of the decision The signal should necessarily have been submitted as an individual case The organisation must retain every informal working note created during the analysis

Question 6 of 10 Which example best illustrates a process-control failure that may not initially be a data-integrity failure?

A user overwrites historical values without preserving the original record A reconciliation is performed incorrectly even though the underlying databases remain unchanged A privileged user deletes records without attribution A system audit trail does not record material changes

Question 7 of 10 Which sequence best represents the practical evidence-chain framework described in the article?

Training, procedure approval, audit, inspection response, closure Source, capture, transformation, decision, action, retention Database, spreadsheet, vendor, QPPV, regulator, archive Error, correction, deletion, replacement, approval, filing

Question 8 of 10 How should data-integrity metrics such as reconciliation exceptions and data corrections be interpreted?

A low number always demonstrates a healthy system A high number always demonstrates poor control They should be considered alongside detection capability, investigation quality, recurrence and evidence that controls are effective They should be excluded from governance because metrics cannot support oversight

Question 9 of 10 Which self-inspection sample would most directly test the ability to reconstruct material changes to a case?

A recently modified case A case that has never been updated A blank case template A current organisational chart

Question 10 of 10 Why can a large volume of documents still represent a weak inspection evidence chain?

Inspectors generally disregard written records Documents are useful only if they establish relevant relationships between source, activities, decisions and actions A strong evidence chain requires no documentation Only documents created by regulators can support an inspection

EU Pharmacovigilance Inspection Findings: Data Integrity, Traceability and the Evidence Chain

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