Definition

The patient's relevant pre-existing conditions, prior medications, allergies, and risk factors that may influence adverse event assessment and causality.

Example

A patient with pre-existing cirrhosis develops elevated liver enzymes on a new drug. The medical history is critical context for assessing whether the event is drug-related or disease progression.

Regulatory source

ICH E2B(R3)

Common mistakes

Recording only conditions explicitly stated as relevant, missing potentially important background (e.g., smoking, alcohol use, family history).

Inspector question

How do you determine what medical history is relevant to capture? What is your approach when detailed history is unavailable?

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