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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 Why should duplicate assessment continue throughout the ICSR lifecycle?

Because every case must be reclassified as a duplicate at each processing step Because later literature, follow-up, EudraVigilance or partner information may reveal a previously unrecognised relationship Because initial case creation is not permitted until all external sources are searched Because duplicate status is determined only during audit

Question 2 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 3 of 10 A published case appears to describe a patient already reported spontaneously to the MAH and contains additional laboratory results. What is generally the most appropriate approach?

Create an unrelated case and omit the publication from source history Update the existing case with relevant information while retaining literature traceability Ignore the publication because spontaneous reports take precedence Replace the spontaneous report entirely with the publication

Question 4 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 5 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 6 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

Question 7 of 10 Two reports contain the same product and adverse reaction, but the available clinical histories indicate different patients. What is the most appropriate conclusion?

They should be merged because the product and reaction match They should remain separate because similarity does not establish duplication One report should be deleted to prevent double counting They should be treated as duplicates unless the reporters are different

Question 8 of 10 What is the appropriate role of an automated duplicate-detection algorithm?

To make final duplicate decisions without review in all circumstances To identify and prioritise potential matches for appropriate assessment To merge every record sharing a product and event term To replace reconciliation with affiliates and regulators

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 What distinguishes a potential duplicate from a confirmed duplicate?

A potential duplicate has been identified for assessment; a confirmed duplicate is supported by evidence as the same underlying case A potential duplicate is always generated by automation; a confirmed duplicate is always generated manually A potential duplicate has a different reporter; a confirmed duplicate has the same reporter A potential duplicate must be merged immediately; a confirmed duplicate must remain separate

GVP Module VI: Duplicate ICSR Identification and Management

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