QPPV.COM KNOWLEDGE ASSESSMENT

Standardised MedDRA Queries (SMQs): Practical Knowledge Assessment

Test your understanding of the concepts covered by Standardised MedDRA Queries (SMQs): How and When to Use Them.

Question 1 of 10Pass mark: 80%

Question 1 of 10 A safety team finds that cases relevant to a syndrome are coded across several Preferred Terms and System Organ Classes. What is the principal reason to consider an SMQ?

An SMQ can group coded concepts around a medical topic that may cross MedDRA hierarchy boundaries. An SMQ replaces the need to code individual cases to MedDRA terms. An SMQ confirms that each retrieved case meets a clinical diagnostic definition. An SMQ restricts retrieval to terms within a single System Organ Class.

Question 2 of 10 A periodic safety analysis is repeated every six months. Which information is most important to preserve so that the SMQ retrieval can be reproduced and interpreted?

Only the SMQ name, because its content is fixed over time. The MedDRA/SMQ version, scope, hierarchy or algorithm choices, modifications, data cut-off, unit of analysis, and review method. Only the final medically confirmed case count. The name of the analyst, but not the query settings or database details.

Question 3 of 10 A high-volume database is being configured to generate rapid alerts for a well-defined, established risk. Review capacity is limited. Which approach is most defensible as a starting point?

Use narrow scope or a relevant specific sub-SMQ, then evaluate alerts clinically. Use broad scope because every alert should maximise sensitivity regardless of workload. Treat any matching narrow term as a confirmed case to avoid review delays. Use the entire highest-level hierarchical SMQ to ensure no topic branch is omitted.

Question 4 of 10 A potential signal has been identified, and the team wants to assess whether related cases were coded under several different terms. Which use of an SMQ is most appropriate?

Use a suitable SMQ to assemble a candidate case series, then assess clinical relevance and causality separately. Use the SMQ result as a substitute for signal evaluation. Use the SMQ only if every case already has the definitive diagnostic PT. Use the SMQ to calculate incidence without defining a population or exposure denominator.

Question 5 of 10 A team is screening an emerging risk and believes cases may be coded only as symptoms or investigation abnormalities. Which initial search choice is generally most aligned with prioritising case finding?

Use broad scope, recognising that it will increase sensitivity and the review workload. Use narrow scope because it retrieves more incomplete and nonspecific presentations. Use only the diagnostic PT because an SMQ cannot retrieve supporting findings. Use broad terms only and omit the narrow terms to avoid duplicate retrieval.

Question 6 of 10 A team has selected the correct SMQ and scope, but relevant events were omitted or miscoded in the source data. What is the likely implication?

The SMQ will reconstruct the missing source information from related terms. The retrieval may be incomplete or inaccurate because SMQs operate on the coded data they are given. The SMQ will correct the original MedDRA coding automatically during retrieval. The query remains reliable because standardisation removes coding-quality effects.

Question 7 of 10 Which statement best explains why an analyst should read the current SMQ Introductory Guide section before using an unfamiliar query?

The SMQ name alone specifies every inclusion rule, exclusion, hierarchy, and algorithm. The guide describes the query's medical scope and may explain its term logic, hierarchy, algorithm, weighting, and implementation limitations. The guide provides a substitute for documenting the version used. The guide confirms that all SMQs use the same narrow/broad structure.

Question 8 of 10 A regulator requests a cumulative review of a medical safety topic. The company uses a standard SMQ but adds several PTs requested for the product-specific analysis. What should the response do?

State only the standard SMQ name because additions do not affect query identity. Describe the SMQ scope and version, identify the added PTs, and make clear that the query was modified. Describe the result as a confirmed case count without explaining the search. Omit the query details if medical review was performed.

Question 9 of 10 Which statement best describes the relationship between an SMQ and medical review?

Medical review is needed only for broad scope; narrow results are definitive. An SMQ standardises retrieval, while medical review determines whether retrieved cases fit the analytical case definition. An SMQ replaces case definitions when the query is maintained by MedDRA. Medical review should occur before retrieval because the SMQ diagnoses cases.

Question 10 of 10 A safety question concerns thrombocytopenia, while the related superordinate SMQ also includes other types of cytopenia. What is the best next step?

Automatically use the superordinate SMQ because the highest level is always the most specific. Check the SMQ documentation and consider the thrombocytopenia sub-SMQ if it is suitable for standalone use. Remove all terms from other cytopenias without documenting the change, then call the result the standard SMQ. Use the entire hierarchy and assume medical review will make the initial scope choice irrelevant.

Standardised MedDRA Queries (SMQs): Practical Knowledge Assessment

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