Patient-Reported Outcome (PRO)
A measurement of a health outcome reported directly by the patient without interpretation by a clinician.
What it means
PROs capture symptoms, function, and quality of life directly from patients. When used as trial endpoints, PRO instruments must be linguistically validated per country and, for ePRO, screen-tested on the actual device before use.
Why it matters for LATAM submissions
A PRO instrument used without country-specific validation can invalidate endpoint data at the analysis stage, months after enrollment.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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