Readability / User Testing
Structured user testing of patient-facing leaflets to confirm comprehension of key safety information.
What it means
Readability testing evaluates whether a patient-facing document (ICF, package insert) is understood by its target audience. LATAM ethics committees increasingly expect evidence of patient input on ICF plain language before approval, especially for pediatric and low-literacy populations.
Why it matters for LATAM submissions
A translation that passes linguistic QC but fails user testing must be redone. Testing early in the source language avoids parallel rework across every target language.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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