MedDRA Coding & Term Selection · Section 4.1
~4 min read · The Drug Safety Coach — Global PV Career Course
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You met MedDRA coding briefly already, as step 6 of the 11-step case processing workflow in Module 1, and as the raw material every Standardised MedDRA Query and signal-detection algorithm in Module 3 depends on. This module goes deep on the dictionary itself: how it’s structured and governed, what disciplined term selection actually looks like in practice, and how Standardised MedDRA Queries turn well-coded cases into a searchable safety signal.
The reason this deserves its own module, rather than a paragraph inside case processing, is simple: coding quality is invisible until it fails. A signal-detection run that misses a real safety issue because half the relevant cases were coded to slightly different LLTs doesn’t announce itself as a coding problem — it just looks like a quiet database that never generates an alert. Getting comfortable with MedDRA’s structure and MTS:PTC’s term-selection discipline is what stands between "the data exists" and "the data is findable."
Two lessons follow: MedDRA’s five-level hierarchy and governance, then coding conventions, term selection, and SMQs — each with worked examples pulled directly from ICH/MSSO’s own training material, plus an interactive 3D model of the hierarchy itself in the next lesson, and a full mock interview on this exact material in Interview Prep Studio once you’re done.
Quick check
Test yourself before moving on — no pressure, just click an answer.
1. Which step of the 11-step case processing workflow does MedDRA coding correspond to?