Definition

The final status of an adverse event at the time of the last observation, categorized as recovered, recovering, not recovered, recovered with sequelae, fatal, or unknown.

Example

A patient's drug-induced rash completely resolved 2 weeks after stopping the medication. The outcome is 'Recovered/Resolved' with no sequelae.

Regulatory source

ICH E2B(R3)

Common mistakes

Recording outcome at the time of event occurrence rather than at last follow-up. Outcomes should reflect the most recent available information.

Inspector question

How do you update outcomes when follow-up information is received? What triggers a follow-up submission?

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