QPPV.COM KNOWLEDGE ASSESSMENT

PASS and Risk Management Plans

Test your understanding of the concepts covered by PASS and Risk Management Plans.

Question 1 of 10Pass mark: 80%

Question 1 of 10 What is the fundamental justification for including a PASS in an RMP?

To replace routine pharmacovigilance for all safety concerns To answer a defined safety question that routine pharmacovigilance cannot adequately resolve To demonstrate that the medicinal product has no safety risks To generate clinical efficacy data after authorisation

Question 2 of 10 Why might routine spontaneous reporting be insufficient for estimating the incidence of an adverse event?

It generally provides complete data on the population exposed It is unaffected by under-reporting It often lacks a reliable denominator and may be affected by under-reporting It routinely includes validated comparator data

Question 3 of 10 Which item is especially important when a PASS is imposed by a regulatory authority?

The study may be managed without documented milestones Regulatory commitments and submission dates should be formally tracked with evidence of completion or delay management The sponsor may change the primary objective without documenting the change Public registration is prohibited

Question 4 of 10 Which statement best reflects the role of public registration and publication in PASS transparency?

Registration is unnecessary for imposed studies Registration and transparent reporting help make study methods and results visible and support regulatory accountability Only favourable findings should be publicly disclosed Registration replaces the need for a complete protocol

Question 5 of 10 Why may an active-comparator new-user design improve a comparative safety study?

It guarantees the absence of all confounding It can reduce biases related to differences between prevalent users and non-users and improve comparability at treatment initiation It eliminates the need to define exposure duration It allows outcomes to be left unvalidated

Question 6 of 10 Why is outcome validation important in a PASS using claims or electronic health record data?

Administrative or electronic codes always perfectly identify clinical outcomes Validation helps determine whether the operational definition accurately captures the clinical event of interest Validation is needed only for efficacy studies Validation removes the need for sensitivity analyses

Question 7 of 10 A PASS uses repeated interim analyses in electronic health records to identify a possible emerging risk. Which additional methodological issue requires particular attention?

Control of multiple testing and predefined decision thresholds Avoidance of all interim reporting Removal of the statistical analysis plan Use of only spontaneous reports as the comparator

Question 8 of 10 A study detects a serious adverse drug reaction during PASS conduct. How should the study team approach this finding?

Assume that the PASS database removes all reporting obligations Follow predefined processes and timelines for evaluating and reporting serious ADRs consistently with applicable spontaneous reporting obligations Report it only if the final PASS analysis is statistically significant Wait until the study has been published

Question 9 of 10 Which design is particularly suited to estimating incidence in new users while preserving a clear temporal relationship between exposure and outcome?

Prospective non-interventional cohort Case series based only on spontaneous reports Case-control study without a defined source population Self-controlled case series for a non-recurrent outcome with long latency

Question 10 of 10 Which action best demonstrates inspection-ready handling of a protocol deviation?

Correcting the deviation informally without a record Maintaining an issues log with the deviation, corrective action, impact assessment and relevant communications Excluding all affected participants without documenting why Waiting for an inspection to determine whether the deviation mattered

PASS and Risk Management Plans

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