Linguistic Validation Process
Our linguistic validation process is modeled on the U.S. Food and Drug Administration PRO guidance document as well as on the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Good Practice recommendations.
The process involves the following key steps:
• ePRO Translation Consultation
• Face Validation
• Harmonization
• Back Translation
• Cognitive Debriefing
• Validation Reports and Certifications
• Survey Research Expert Review
