SMQ (Standardised MedDRA Queries)
What is it?
An SMQ is a curated grouping of MedDRA Preferred Terms that relate to one medically meaningful concept, like anaphylactic reaction or acute liver injury. Instead of guessing every specific PT that might represent that condition, a safety scientist runs the SMQ and pulls every case coded to any term inside it, in one pass.
SMQs are deliberately broad by design. A "narrow" scope inside an SMQ favors precision, a "broad" scope favors not missing anything, and most safety teams start broad, then narrow down once they've confirmed what they're actually looking at.
Common Misconceptions
"If a bunch of cases show up under an SMQ search, doesn't that confirm a safety signal?"
An SMQ is a retrieval tool, not a verdict. It's built to be sensitive, so it deliberately pulls in cases that turn out to be irrelevant on closer look. What it surfaces still has to go through proper analysis before anyone calls it a signal.
