Standardized MedDRA Queries (SMQs)

Definition

Groupings of MedDRA terms from one or more System Organ Classes (SOCs) that relate to a defined medical condition or area of interest. 

 

Purpose

To support the retrieval of potentially relevant safety reports that includes a broad selection of terms that may relate to signs, symptoms, diagnoses, syndromes, physical findings, laboratory and other physiologic test data, etc., that are associated with a given medical condition or area of interest

Benefits

• Uniformity of search strategies and results across organizations
  
• Reproducibility of  search strategies and results from regulatory perspective
  
• Convenience of pre-defined grouping based on a medical condition of interest
  
• Maintenance by MSSO and standard frame of reference
  

Example

SMQs combine narrow and broad search strategies allowing as much safety related information as relevant to be tagged to the query. 

Acute Renal Failure definition : Acute renal failure is a syndrome characterized by a relatively rapid decline in renal function that leads to the accumulation of water, crystalloid solutes, and nitrogenous metabolites in the body.

Acute Renal Failure Narrow SMQ: Acute prerenal failure, Anuria, Azotemia, Dialysis, Hemodialysis, Neonatal anuria, Nephropathy toxic, Oliguria, Peritoneal dialysis, Renal failure acute, Renal failure neonatal, Renal impairment neonatal, and Renal impairment, and Renal insufficiency.

Acute Renal Failure Broad SMQ: Albuminuria, Blood creatinine abnormal, Blood creatinine increased, Blood urea abnormal, Blood urea increased, Blood urea nitrogen/creatinine ratio increased, Creatinine renal clearance decreased, Edema due renal disease,  Hepatorenal failure, Nephritis, Nephritis interstitial, Proteinuria, Renal clearance decreased, Renal function tests abnormal,  Renal transplant, Renal tubular disorder, Renal tubular necrosis, Tubulointerstitial nephritis.

Development of SMQs

SMQs are developed by consortium of swiss based Council For International Organization Of Medical Sciences (CIOMS) and MSSO. They are tested on one instance of federal safety database and one industrial partner database.