Linguistic validation

Linguistic validation is the process of investigating the reliability, conceptual equivalence, and content validity^[1] of translations of patient-reported outcome (PRO)^[1] measures.

^ ^a ^b U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH) "Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" December 2009

[FDA-1] U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH) "Guidance for Industry - Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims" December 2009

[1]