A Standardised MedDRA Query is an ICH-recognised, maintained grouping of MedDRA terms for a defined medical condition or safety interest. It is typically compiled at the Preferred Term level to identify potentially relevant individual case safety reports in a targeted manner. The English designation Standardised MedDRA Query is abbreviated as SMQ.
Structure of an SMQ
An SMQ contains terms that may belong to a medical condition or a defined area of interest. Depending on the topic, these include symptoms, diagnoses, syndromes, physical findings, and laboratory or other physiological measurements. The query thus creates a professionally curated bridge between different clinical descriptions and the coded data in a safety database.
As a rule, an SMQ works with Preferred Terms. Lowest Level Terms are included only insofar as they are linked to a Preferred Term used in the SMQ. This construction prevents the query from becoming an uncontrolled collection of similar words and enables traceable assignment to the respective MedDRA version.
SMQs do not cover every conceivable medical condition or safety issue. Their content may change across successive MedDRA versions because terms are reviewed and developed. When evaluating, it is therefore necessary to record which version was used and whether a query includes special features such as hierarchies or algorithms.
Narrow and broad search
Many SMQs offer a narrow and a broad search. The narrow search is intended to identify cases that represent the medical condition in question with high probability; it thus prioritises specificity. The broad search is intended to capture all potential cases and deliberately accepts that, after individual case review, some hits may prove less relevant; it prioritises sensitivity.
A broad search contains the narrow terms plus additional, usually less specific terms. The results are therefore not independent of one another: for an SMQ with both scope variants, every case found via the narrow search also belongs to the broad result. If an SMQ has only narrow terms, both search scopes yield the same result.
The choice of search scope is a methodological decision that must fit the purpose of the evaluation. For an initial signal review, the broad search may be appropriate if medical review follows. For precise case characterisation, a narrow search may be more suitable. The number of hits alone does not indicate whether a signal is confirmed or whether all cases are causally explained by the medicinal product.
Distinction: original SMQ or modified MedDRA query
A Standardised MedDRA Query remains an SMQ only if its maintained content and structure are used unchanged. If a user modifies terms, adds local expressions, or removes elements, the result may no longer be called an SMQ according to the SMQ Guide. The correct designation is then “modified MedDRA query based on an SMQ”.
A query newly compiled exclusively for the needs of an organisation may also not bear the name SMQ if it could be confused with an ICH-recognised SMQ. This naming rule protects the transparency of the method: other professionals must be able to recognise whether they are evaluating the standardised and maintained query or a project-specific modified variant.
The existing entry meddra designates the medical terminology itself. An SMQ is not a synonym for MedDRA and is not a single coding of an adverse event. It is a search construct within the terminology by which many coded cases are brought together according to a medical concept.
Relevance for clinical trials
For clinical trials, an SMQ may be used to search coded safety data across sites, countries, and study arms according to a defined medical concept. The decision on narrow or broad search scope, MedDRA version, and any case review belongs in a traceable analysis plan. If terms are modified locally, this must be clearly documented in the safety review as a modified query so that results are not incorrectly equated with an unchanged SMQ.
Full-service CROs such as Mediconomics support SMQ evaluations by defining reproducible search specifications, verifying the MedDRA version used, programming data listings, and medically reviewing hits. For signal evaluations, biostatistics, pharmacovigilance, and medical writing can jointly document which search scope was employed, which cases remained relevant after review, and how the results are explained in the safety report.
Frequently Asked Questions (FAQ)
Is a broad SMQ search always better than a narrow search?
No. The broad search increases sensitivity and captures additional, less specific hits. The narrow search is focused on cases with higher specificity; which variant is appropriate depends on the specific evaluation question.
May an organisation call its own term grouping an SMQ?
No, if it does not use the standardised and maintained SMQ unchanged. A custom-adapted compilation must be designated as a modified MedDRA query based on an SMQ or with another unambiguous designation.
Does a hit in an SMQ confirm a drug effect?
No. The query identifies potentially relevant case reports based on coded terms. Medical case review, causality assessment, and analysis of further data remain necessary.
Regulatory References
- MedDRA MSSO, Introductory Guide for Standardised MedDRA Queries – defines structure, search scopes, and naming rules.
- ICH, Medical Dictionary for Regulatory Activities – recognises SMQs as standardised queries within MedDRA.
- GVP Module VII, Periodic Safety Update Report – names SMQs as a possible method for signal evaluation.
- ICH E2B(R3), Individual Case Safety Report – supports the structured use of coded safety data.