Plain Language Summary
A patient-facing summary written at a low reading grade level and required for many LATAM ethics submissions.
What it means
Plain language summaries condense protocol synopses, ICFs, and trial results into text at roughly a 6th-to-8th-grade reading level. LATAM ethics committees expect Spanish and Portuguese plain-language versions calibrated to local literacy norms, not literal translations of English source text.
Why it matters for LATAM submissions
Literal translations of English plain-language text almost always exceed target reading level in Spanish and Portuguese. Local rewriting, not translation, is the correct approach.
Relevant regulators
Related terms
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