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!
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
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
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
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