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GVP Module VI: Duplicate ICSR Identification and Management

Test your understanding of the concepts covered by GVP Module VI: Duplicate ICSR Identification and Management.

Question 1 of 10Pass mark: 80%

Question 1 of 10 Which inspection finding most strongly suggests a systemic governance weakness?

One potential duplicate requires clinical review Different affiliates and vendors consistently apply different decisions to comparable cases A case contains information from two sources An algorithm produces a potential-match alert

Question 2 of 10 An EudraVigilance case appears to correspond to an MAH case already held internally. What should the MAH do first?

Create a new internal case because the EudraVigilance identifier differs Delete the internal case and retain only the EudraVigilance record Compare patient, product, event and chronology information and document the assessment Assume that all NCA-originated cases are duplicates of MAH cases

Question 3 of 10 Why is clinical chronology particularly valuable in duplicate assessment?

It replaces the need to review patient characteristics It can reveal that differently worded reports describe the same sequence of events It proves duplication whenever the onset dates are identical It is used only for literature cases

Question 4 of 10 Which combination provides the most robust basis for assessing a potential duplicate?

Product name alone and the order in which reports were received Reporter identity alone and identical reaction terminology Patient characteristics, clinical chronology, product and event information, dates, setting and narrative details Automated similarity score alone

Question 5 of 10 A patient reports an event to an MAH and the patient's physician later submits a report describing the same treatment course. How should the different reporter types be interpreted initially?

They prove that two patients are involved They prove that the physician report is a follow-up and not a new source They are compatible with one event and require comparison of the available information They require both reports to be discarded until the patient confirms the identity

Question 6 of 10 An audit identifies two internal cases that appear to describe the same patient. What is the most complete response?

Merge the records and close the audit finding immediately Correct the records through the controlled process, assess possible wider impact and investigate systemic root causes Delete the older record without further assessment Wait until the next routine reconciliation cycle

Question 7 of 10 Once two reports are confirmed as duplicates, what is the key objective of selecting a master or surviving case?

To retain only the report received first and discard all later information To preserve clinically relevant information and source history while avoiding duplicate counting To ensure that only MAH-originated information remains in the database To eliminate the need for an audit trail

Question 8 of 10 Two apparently similar reports contain different onset dates. What is the most appropriate professional response?

Exclude duplication automatically because onset dates must always match Confirm duplication automatically because date differences are immaterial Investigate whether the dates represent different stages, an error or separate episodes Delete the report with the less precise date

Question 9 of 10 A duplicate assessment reveals a serious laboratory result present only in one source. What should happen to that information?

It should be discarded because duplicate sources cannot add information It should be assessed for incorporation into the surviving case and for any required regulatory follow-up It should be retained only in the deleted record It should be treated as evidence that the reports must be separate

Question 10 of 10 Why should duplicate metrics such as confirmed duplicate rate or false-positive rate be interpreted in context?

Because metrics have no relevance to pharmacovigilance quality Because a high or low value may reflect differences in reporting channels, search practices, case mix or process performance Because only financial metrics are suitable for vendor oversight Because confirmed duplicate rates are legally fixed for all organisations

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GVP Module VI: Duplicate ICSR Identification and Management

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