Guided Notes

Medical Coding with MedDRA & WHODrug

Why trial terms are coded, the MedDRA hierarchy (LLT→PT→HLT→HLGT→SOC), WHODrug and ATC classes, autocoding and manual coding, coding conventions, versions and medical review.

Why code medical terms

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Sites describe events in their own words: 'headache', 'head ache', 'HA', 'cephalgia', 'migraine-like pain'. To count and analyze safety, these verbatim terms must be mapped to a standard dictionary. • Adverse events and medical history → MedDRA. • Concomitant and prior medications → WHODrug. Coded data supports safety tables, regulatory reporting and signal detection.

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