Definition

Assignment of MedDRA terms (LLT/PT/SOC) to verbatim AE and indication; must be consistent and version-controlled.

Example

Verbatim 'heart attack' coded to PT Myocardial infarction, SOC Cardiac.

Regulatory source

GVP Module VI, MedDRA

Common mistakes

Over-coding to serious PT when verbatim is not serious.

Inspector question

How do you ensure consistent and correct MedDRA coding?

Related terms