QPPV.COM KNOWLEDGE ASSESSMENT

Knowledge Assessment: ICSR Data Quality, Follow-Up and Reconciliation

Test your understanding of the concepts covered by GVP Module VI: ICSR Data Quality, Follow-Up and Reconciliation.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which CAPA is most appropriately aligned with a recurring product-coding mapping error?

A general instruction reminding staff to be more careful. A system or mapping correction supported by testing and, where needed, targeted training and enhanced monitoring. Deletion of all cases using the affected product term. Removal of coding quality checks to reduce workload.

Question 2 of 10 An inspector can see that a case is currently classified as serious but cannot determine when or why the classification changed. Which control weakness does this most clearly indicate?

Insufficient product-quality reconciliation An incomplete audit trail and inadequate traceability of material case changes Excessive follow-up prioritisation A failure to use standardised terminology

Question 3 of 10 A reconciliation log states that all discrepancies were 'resolved' but contains no investigation, impact assessment or corrective-action rationale. Why is this inadequate?

Reconciliation records must always contain a medical narrative for every case. Resolution without documented investigation does not demonstrate that safety, compliance and systemic impacts were assessed. Discrepancies are never allowed to be closed. Only the QPPV may record the existence of a discrepancy.

Question 4 of 10 Monthly reconciliation repeatedly identifies missing cases after an interface transfer. Which response best addresses the underlying risk?

Correct each missing case and close every issue independently. Ask processors to pay closer attention without changing the process. Perform root-cause analysis of the interface and implement proportionate systemic CAPA. Stop reconciliation because the discrepancies are already known.

Question 5 of 10 What should an effective change-control assessment consider when a safety database is upgraded?

Only whether users can log in after the upgrade. Potential effects on existing cases, new processing, migration, coding, electronic reporting, reconciliation and historical traceability. Only whether the vendor's release notes mention pharmacovigilance. Only the number of new database features.

Question 6 of 10 Why is accurate coding of clinical events important beyond the appearance of standardised terminology in the database?

It eliminates the need for a clinically coherent narrative. It determines whether follow-up is legally required in every case. It affects retrieval, signal detection, aggregate analysis and regulatory reporting. It allows missing source information to be inferred from the coded term.

Question 7 of 10 Two systems show different case identifiers and date formats for what appears to be the same report. What should investigators do first?

Classify the difference automatically as a data-integrity failure. Ignore the difference because reconciliation requires identical field formats. Determine whether a genuine discrepancy exists before assessing cause and impact. Correct both systems to use the identifier from the older record without further review.

Question 8 of 10 What is the primary purpose of reconciliation between a safety database and a regulatory reporting system?

To ensure both systems use identical internal identifiers in every circumstance. To demonstrate that relevant safety information moved through the intended process without unexplained loss, duplication or alteration. To replace individual case quality control. To confirm that the safety database contains more cases than the reporting system.

Question 9 of 10 What is the principal value of a source-to-submission review?

It confirms that the database has a sufficient number of fields. It assesses whether important information was preserved, transformed correctly or lost from the original source through regulatory output. It replaces the need to monitor regulatory acknowledgements. It demonstrates only that the original report was received.

Question 10 of 10 A product-quality complaint contains information about an adverse event, but no corresponding pharmacovigilance case can be found. What is the most appropriate interpretation?

The issue is outside pharmacovigilance because it originated in the quality system. The systems should be reconciled or their interface reviewed to determine whether relevant safety information was transferred. The complaint should be closed because product-quality records are not source data. Only cases received directly by the safety department require assessment.

Knowledge Assessment: ICSR Data Quality, Follow-Up and Reconciliation

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