Definition

The degree to which similar adverse events are coded using the same MedDRA terms across cases and processors, essential for accurate signal detection.

Example

Both 'heart racing' and 'rapid heartbeat' should consistently be coded to the same PT 'Palpitations' or 'Tachycardia' based on clinical meaning, not just literal translation.

Regulatory source

MedDRA Best Practices

Common mistakes

Allowing individual processor preferences to drive coding decisions, resulting in same events coded differently across the database.

Inspector question

How do you ensure MedDRA coding consistency? Do you have a coding dictionary or conventions document?

Related terms