Definition

A standardized international medical terminology used to classify and code adverse events, medical history, and indications in regulatory submissions and safety databases.

Example

A patient reports 'my heart was racing and skipping beats.' The safety processor codes this using MedDRA Preferred Terms 'Tachycardia' and 'Palpitations' for standardized analysis.

Regulatory source

ICH, MedDRA MSSO

Common mistakes

Coding to the lowest level term (LLT) that matches verbatim text without considering if a more appropriate Preferred Term exists.

Inspector question

How do you ensure consistency in MedDRA coding across processors? What training and quality processes are in place?

Related terms