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Linguistic Validation: Everything You Need To Know


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Linguistic validation is a complex, yet necessary process for many clinical trial translation projects. Not sure what it entails? We've outlined it all for you right here!

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Linguistic Validation: Everything You Need To Know

  1. 1. Everything you need to know about: Linguistic Validation
  2. 2. Topics: • What is Linguistic Validation? • When Is Linguistic Validation Needed? • What is the Linguistic Validation Process? • The 7 Steps of Linguistic Validation: – 1. Translation and Localization – 2. Reconciliation – 3. Back Translation – 4. Editing – 5. Cognitive Debriefing – 6. Review – 7. Final Preparation • Why Perform Linguistic Validation? • Language Connections
  3. 3. What is Linguistic Validation?
  4. 4. Linguistic Validation: the process of ensuring content validity and of translated clinical outcome materials. It is:  Highly technical  A multi-step procedure  Necessary to satisfy content validity regulations
  5. 5. When Is Linguistic Validation Needed?
  6. 6. Linguistic validation is required for trials involving multiple language groups. What’s Validated?  Patient Reported Outcomes (PRO)  Clinician Reported Outcomes (ClinRO)  Observer Reported Outcomes (ObsRO)  Quality of Life Questionnaires (QoL)
  7. 7. What is the Linguistic Validation Process?
  8. 8. 1. Translation & Localization Source documents are translated and localized into the target language This Involves:  Two teams of translators  Native speaking linguists  Translators with clinical document experience
  9. 9. 2. Reconciliation Translations developed by the different teams are reconciled into one document Why is this done? Two independent teams ensure production of the most accurate translation possible
  10. 10. 3. Back Translation Reconciled translations undergo back translation to ensure original meanings are not lost Note:  This step must be performed by a different set of translators to prevent bias
  11. 11. 4. Editing Translations are edited and reviewed before being approved for field testing For electronic PROs:  Software undergoes testing to ensure correct formatting in the electronic data collection system
  12. 12. 5. Cognitive Debriefing Translations undergo cognitive debriefing interviews to ensure accurate comparisons of data across language groups This involves:  Testing of translations by patients from the target demographic  Reports on comprehension levels of the translations
  13. 13. 6. Review Documents are reviewed, and adjustments are made based on the results of cognitive debriefing At times further translation and back translation may be necessary
  14. 14. 7. Final Preparation The final document is prepared based on the adjustments made after cognitive debriefing and further translation
  15. 15. Why Perform Linguistic Validation?
  16. 16. To satisfy FDA regulations
  17. 17. To ensure accurate comparison of qualitative data
  18. 18. To allow for more precise conclusions for trials performed across diverse linguistic & cultural groups
  19. 19. To decrease patient confusion, increase patient-physician communication, and create better treatment options in the long-run
  20. 20. Why Perform Cognitive Debriefing?
  21. 21. The testing portion of linguistic validation confirms: conceptual and construct value equivalence across all target language groups.
  22. 22. Language Connections Our linguistic validation services ensure:  Adherence to the best quality control processes  Use of native speaking linguists and editors  Use of linguists with subject matter experience  A dedicated project manager
  23. 23. Need More Information For Your Linguistic Validation Project? Visit