Linguistic Validation

Patient Reported Outcomes and Quality of Life Measures
Linguistic Validation
Patient Reported Outcomes and Quality of Life Measures
Linguistic validation methodology
in accordance with FDA guidelines
Only local translators (specifically
for linguistic validation tasks)
Access to local medical experts
and patient populations
> 25 years of experience
> 3,000 validated questionnaires
Translations Quality Management System meets the ISO standard
Linguistic Validation Workflow
Translatability Assessment
Preference linguistic expert develops translation guidelines for all local teams in collaboration with the author of the instrument.
Forward Translation
Back Translation
Clinical Review
Cognitive Debriefing
Proofreading
Simultaneous translation from source language into target language by two translators. Final translation developed by the linguistic validation expert.
The translated version is reviewed (edited) by a clinician (medical doctor) specialized in treating patients the questionnaire is intended for.
The first target version is translated back into the original language. The resulting back-translation and the original are compared by the linguistic validation expert.
A sample of patients/subjects from the target population are interviewed. Each participant is asked to explain the meaning of each item in his/her own words. Patients' answers are recorded and translated into English, analyzed, and summarized in a report by the local linguistic validation expert.
The final version is proofread by the local linguistic validation expert and by an independent proofreader. It is the responsibility of the local linguistic validation expert to finalize the target version.
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