Definition of SMQ(Standard MedDRA Queries)

Result of cooperative effort between CIOMS and ICH (MSSO).Groupings of terms from one or more MedDRA System Organ Classes (SOCs) related to defined medical condition or area of interest. Included terms may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc., related to medical condition or area of interest intended to aid in case identification.

 

SMQ – an additional analytical tool for MedDRA-coded data, it is used for:

• Case identification
• Signal detection 

Why do we need SMQs?

• Potential scenarios:Regulators to monitor a newly-marketed product with a certain potential safety issue from late Phase III 
• Safety monitors (pre- or post-marketing) could set up “surveillance” parameters in safety system to alert them to incoming cases whose events “belong” to an SMQ of interest 
• Co-development/marketing safety issues (or potential issues) can be shared and compared readily 
• PSURs (overdose, pregnancy exposure, drug abuse, etc.) 
• Identify cases based on PSUR findings 
• Volume 9A recommends using SMQs for signal detection and retrieving cases of interest 
• EMEA and PMDA (Japan) currently testing SMQs for signal detection
• FDA exploring the use of SMQs in new drug review process.

Standardised MedDRA Queries (SMQs) are created by grouping relevant MedDRA terms to represent a particular medical concept. This grouping assists in the formulation of a "case definition" and in data exploration and retrieval.
Other than data presentation by SOCs, data retrieval was initially also addressed with 13 Special Search Categories (SSCs). These are simple groupings of associated PTs which pertain to the same medical concept. To better address the need for standardization of data retrieval queries, Council for International Organizations of Medical Sciences (CIOMS) and MSSO have been working together on developing an extensive set of SMQs. These are retrieval groupings with a more complex and thus useful structure, a narrow and broad scope, some with an inherent hierarchy, and some with an algorithm. MedDRA version 13.1 contains 8 SMQs in development or testing and 82 in production.