Definition

The highest level in the MedDRA hierarchy, grouping Preferred Terms by body system, etiology, or purpose (e.g., Cardiac disorders, Infections and infestations).

Example

The PT 'Myocardial infarction' belongs to SOC 'Cardiac disorders,' while PT 'Pneumonia' belongs to SOC 'Infections and infestations.'

Regulatory source

MedDRA Hierarchy

Common mistakes

Forgetting that some PTs can have multiple SOC assignments (multiaxiality). Primary SOC assignment is used for display purposes.

Inspector question

How do you handle MedDRA terms that have multiple SOC assignments in your aggregate analyses?

Related terms