Glossary

Back-translation

Re-translating a translated document into the source language to verify meaning is preserved.

What it means

Back-translation is a quality step in which a translated document is translated back into the original source language by a separate linguist. The resulting text is compared with the original to identify discrepancies, ambiguous phrasing, or shifts in clinical meaning. It is commonly used for informed consent forms, patient questionnaires, and critical safety language.

Why it matters for LATAM submissions

Back-translation catches meaning shifts that a single forward translator might miss. For regulatory documents, it is a standard part of a defensible translation workflow.

Relevant regulators

ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA

Related terms

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