Clinical Outcome Assessment (COA)
Any measure of how a patient feels, functions, or survives, used as an endpoint in a clinical trial.
What it means
COA is the umbrella category that includes patient-reported, clinician-reported, observer-reported, and performance outcomes. Each subtype has its own linguistic validation expectations across LATAM countries.
Why it matters for LATAM submissions
Endpoint credibility depends on COA translation quality. Regulators can discount country data if the COA was not properly validated in that language.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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