Linguistic Validation
The multi-step process to produce a conceptually equivalent translation of a clinical outcome assessment.
What it means
Linguistic validation is the ISPOR-endorsed process for translating patient-reported outcomes and clinical outcome assessments: forward translation, reconciliation, back-translation, harmonization, cognitive debriefing, and finalization. Each LATAM country typically requires its own validated version rather than a single 'universal Spanish'.
Why it matters for LATAM submissions
Regulators and instrument owners reject shortcuts. An unvalidated COA translation can invalidate the primary endpoint of a trial in that country.
Relevant regulators
Related terms
Translating this concept for a submission?
Send one document to Amavita and we'll return it with the correct terminology, certification, and formatting for the regulator you're targeting. No charge, no commitment.
Start your LATAM pilot