What MedDRA Coding Actually Does

Part of Pharmacovigilance and Drug Safety (PV) Training: Coding and the Narrative.

About 2 minutes. Free, in your language, no account needed.

Turning words into something countable

Reporters describe events in their own words. "Terrible stomach pain", "belly ache", "abdominal cramping" and "epigastric discomfort" may all be the same clinical event. Left as free text, they are four things and none of them can be counted.

MedDRA is the standard dictionary that assigns each verbatim description a defined term, so that the same event described four ways becomes one countable entry.

The levels

MedDRA is hierarchical. The two levels that matter most in daily work:

Preferred Term (PT). The level at which a single medical concept is represented, and the level at which individual events are normally coded and counted.

System Organ Class (SOC). The top level, grouping terms by body system. Used for presenting data in aggregate.

Between them sit High Level Terms and High Level Group Terms, used for grouping in analysis. Below the Preferred Term sits the Lowest Level Term, which is what you actually select: the term closest to the reporter's own words, which then maps upward to its Preferred Term.

Code the words, not the interpretation

Select the Lowest Level Term that most closely matches what the reporter said. If they said "heart attack", that is what you code, and it maps to its Preferred Term.

What you do not do is decide what they must have meant and code that instead.

Keep the verbatim

The reporter's original wording is retained in the case alongside the coded term, always. It is the only thing that lets anyone later check whether the coding was right, and recoding a whole database is possible only because the verbatim text survived.