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 A case contains values in all required fields, but the narrative states that the reaction began after treatment stopped, while the structured dates indicate onset during treatment. Which quality principle is most directly involved?

Timeliness Internal consistency Vendor oversight Submission acknowledgement monitoring

Question 2 of 10 A literature publication is identified during monitoring, but no case appears in the safety database. Which disposition would be acceptable if properly documented and traceable?

The publication may be ignored if it does not appear to describe a serious reaction. The organisation may document that it resulted in a new case, an update, a duplicate determination or a justified decision not to create an ICSR. The publication must always be entered as a new ICSR. The publication should be transferred to product quality without further assessment.

Question 3 of 10 Which information is particularly important in regulatory submission reconciliation?

Only the total number of cases submitted each month. The names of all individuals who entered case data. Submission dates, acknowledgements, rejected messages, corrected submissions and unresolved discrepancies. Only the date on which the internal case was created.

Question 4 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 5 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 6 of 10 A source report does not provide the patient's age. What is the most appropriate processing approach?

Estimate the age from the patient's treatment indication. Enter an approximate age so the record appears complete. Leave the information unavailable and document or pursue follow-up where appropriate. Use the age of the reporter if the reporter is a healthcare professional.

Question 7 of 10 What is the most useful interpretation of a rising rejected-submission rate?

It proves that all rejected cases were clinically invalid. It is a quality signal requiring contextual investigation of causes, impact and trends. It shows that internal quality control is unnecessary. It can be evaluated solely by comparing it with the number of database users.

Question 8 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 9 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 10 of 10 Which outcome best represents a mature ICSR data-quality system?

A database with no recorded errors, regardless of how errors are detected. A system that detects important errors, corrects them, investigates causes and prevents recurrence where necessary. A process focused exclusively on meeting initial submission timelines. A system in which all missing information is replaced with professional assumptions.

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

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