Definition

Structured summary of the case including patient, drugs, events, chronology, and outcome; required for ICSR and must reflect source.

Example

Clear narrative: 45yo F, Drug X from Jan–Mar, hepatitis Feb, recovered.

Regulatory source

ICH E2B(R3), GVP Module VI

Common mistakes

Narrative inconsistent with coded terms or source.

Inspector question

Who writes the case narrative and how is it quality-checked?

Related terms