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 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 2 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 3 of 10 An email containing potentially reportable safety information is received on Monday but is not visible in the safety system until Thursday. What is the most appropriate initial interpretation?

The delay automatically proves a reportable compliance failure The delay is irrelevant if the eventual submission was timely The delay creates a traceability question whose significance depends on the information, applicable timelines and process controls The delay proves that the email system is the authoritative pharmacovigilance system

Question 4 of 10 An archive contains historical safety files, but their system context, version information and relationships to decisions cannot be determined. What problem does this illustrate?

Retention without sufficient interpretability and traceability Excessive segregation of duties A failure caused solely by medical coding A requirement to retain every employee email indefinitely

Question 5 of 10 What is the central inspection objective when assessing pharmacovigilance data integrity and traceability?

To confirm that every pharmacovigilance record is error-free To determine whether the organisation can reconstruct what happened to safety information and why decisions were made To verify that all pharmacovigilance activities are fully automated To establish that the organisation uses a single system for all safety information

Question 6 of 10 Which approach best prepares an organisation for an inspection of data integrity?

Review only procedures and training records Collect as many documents as possible immediately before the inspection Perform end-to-end reconstruction of real, risk-based historical transactions using records normally available to the organisation Select only recent records that have no corrections or exceptions

Question 7 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 8 of 10 What is the most important question when assessing an interface between a safety database and a reporting gateway?

Whether the interface was developed by the same vendor as the safety database Whether the organisation understands what should cross the interface and can detect and manage transfer failures Whether all interface transfers are manually repeated by a second employee Whether the interface has the longest possible technical specification

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 When an inspection identifies an unexplained discrepancy in one serious case, what should the organisation generally do before limiting the response to that case?

Assume the issue is isolated because only one record was sampled Assess potential scope across records, users, systems, products, markets and historical periods in a proportionate, evidence-based manner Delete the discrepant record and recreate it Declare that no impact exists unless a patient harm event is proven

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

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