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Knowledge Assessment: GVP Module VI Medical Literature Monitoring and Literature ICSRs

Test your understanding of the concepts covered by GVP Module VI: Medical Literature Monitoring and Literature ICSRs.

Question 1 of 10Pass mark: 80%

Question 1 of 10 For a valid literature ICSR identified through an MAH's regular global reference-database search, which event generally establishes the regulatory reporting day zero under the article's operational explanation?

The date the publication was submitted to the journal The date the article was first indexed, regardless of when it was found The date the search was conducted when sufficient information for a valid ICSR was identified through that search The date the MAH completes its internal quality-control review

Question 2 of 10 Which set of records would provide the strongest evidence that an MAH's literature-monitoring system is inspection-ready?

Only the current search string and the number of cases generated. Search versions, validation evidence, execution logs, screening decisions, exclusion rationale, full-text records, duplicate assessments and change history. Only a vendor invoice and a statement that searches were performed. A list of relevant journals without search or screening records.

Question 3 of 10 For a relevant meeting abstract monitored by the MAH, when does day zero generally begin according to the article?

When the abstract is accepted by the conference committee When the MAH identifies sufficient information to establish the minimum criteria for a valid ICSR When the abstract is later expanded into a full article At the end of the calendar month in which the conference occurs

Question 4 of 10 A case report describes severe liver injury in a patient taking three medicines, but the authors identify a different medicine as the suspected cause. What should the reviewer do?

Automatically assign suspicion to the MAH's product because it was included in the search. Ignore the authors' attribution and code all medicines as suspected. Assess the full clinical information and attribution before deciding whether the monitored product is a suspected medicinal product. Exclude the publication solely because more than one medicine was taken.

Question 5 of 10 An MAH outsources literature searching and screening to a specialist vendor. Which statement is most accurate?

The vendor assumes the MAH's regulatory responsibility once the contract is signed. The MAH remains responsible for oversight, compliance and ensuring that the outsourced process is adequately controlled. Outsourcing is permitted only if the vendor uses EMA's exact search strategy. The MAH no longer needs vendor qualification or quality agreements.

Question 6 of 10 Which approach is most appropriate when an MAH develops a literature search strategy for a new active substance?

Copy the exact Boolean string used for an unrelated substance. Use only the brand name and the phrase 'adverse reaction'. Construct a database-specific, validated strategy covering relevant substance variants and appropriate safety concepts. Limit the search to articles published in English to improve precision.

Question 7 of 10 Which statement about conference abstracts and local medical journals is most consistent with the article?

They are outside mandatory literature-monitoring activities because they are not full journal articles. They should be considered where relevant, including before a full article becomes available and in applicable local literature. They can be ignored if the content is not in English. They are relevant only for signal detection and never for ICSR identification.

Question 8 of 10 A published case series describes five patients with separate histories, outcomes and clinical chronologies. How should the information generally be handled?

As one ICSR with five unrelated reactions. As multiple potential individual cases, subject to available information and duplicate rules. As aggregate data only, because case series can never support ICSRs. As one spontaneous report regardless of how the cases were collected.

Question 9 of 10 Why can a safety-term-only search be inadequate?

Authors always use a standard pharmacovigilance vocabulary, so safety terms are unnecessary. Clinical events may be described without the exact expressions used in the search, causing relevant publications to be missed. Safety terms retrieve only animal studies. Safety terms prevent the use of controlled vocabulary in all databases.

Question 10 of 10 A cohort study reports an increased incidence of renal injury in exposed patients compared with an unexposed group but provides no individual patient information. What is the most appropriate interpretation?

Automatically create one ICSR for every exposed participant. Automatically create one ICSR representing the entire cohort. Recognise it as potentially important aggregate safety evidence, but do not automatically convert it into individual ICSRs. Exclude it from all pharmacovigilance activities because it contains no individual cases.

Knowledge Assessment: GVP Module VI Medical Literature Monitoring and Literature ICSRs

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