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!

1. Everything you need to
know about:
Linguistic Validation

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. What is
Linguistic
Validation?

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. When Is
Linguistic
Validation
Needed?

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. What is the
Linguistic
Validation
Process?

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. 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. 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. 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. 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. 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. 7. Final Preparation
The final document is prepared
based on the adjustments made
after cognitive debriefing and
further translation

15. Why
Perform
Linguistic
Validation?

16. To satisfy FDA regulations

17. To ensure accurate comparison
of qualitative data

18. To allow for more
precise conclusions
for trials performed
across diverse
linguistic & cultural
groups

19. To decrease patient confusion, increase
patient-physician communication, and create
better treatment options in the long-run

20. Why
Perform
Cognitive
Debriefing?

21. The testing portion of linguistic
validation confirms:
conceptual and construct value
equivalence across all target language
groups.

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. Need More Information For
Your Linguistic Validation Project?
Visit LanguageConnections.com