Definition

Assigning standardized medical terminology to adverse event verbatim text using the MedDRA dictionary to support analysis and reporting.

Example

Verbatim 'stomach upset' may be coded to an appropriate preferred term depending on context.

Regulatory source

Industry standard dictionary usage.

Common mistakes

Overuse of overly broad terms (e.g., NOS) when the verbatim supports a more specific concept.

Inspector question

How do you ensure consistent coding decisions across coders and over time?

Related terms