The Linguistic Validation (“LV”) of a questionnaire is a process which ensures that the translated questionnaire is valid, both linguistically and culturally, for patients in the target population, speaking the target language e.g. French speaking patients in France or Canada.
The process includes -
- Forward and backward translations
- Clinician review (by a medical specialist in the relevant condition)
- Psychologist review
- Cognitive debriefing by patients in the target population who have that condition e.g. diabetes/HIV/kidney disease.
This process ensures that the questionnaire is understood in the same way across all languages and countries and allows data to be compared across populations. The process needs to be able to meet the standards required by the US Food and Drug Administration (FDA) and the EU equivalent, the European Medicine Agency (EMEA).
New translations or adaptations needed
If a new language or adaptation of an existing language is needed, the LV work can be done commercially, but if this is not possible for financial reasons, researchers may be permitted to produce translations for their own local use, if they have the resources to follow the process we require.
Languages which require reformatting of the questionnaires:
For languages which are written other than from left to right, LV teams must include a member who can reformat the questionnaires, in Word, to the required standard of HPR. Target language versions of the questionnaires are required from the FT stage until formatting of the final versions.
If you wish to translate or adapt a questionnaire using your own resources, in collaboration with HPR, the agreement you sign would grant you a licence to translate/adapt the questionnaire as well as use it.
We will provide support with the linguistic validation process where possible, but it is a lengthy process and will take up a considerable amount of your time and resources. Please see the attached LV process flow chart. View sample » (196.2 KB) If the correct LV procedure is not followed you might end up with a flawed questionnaire which yields incomplete or inaccurate data.
All translations are linguistically validated for a particular country and will need to be adapted for use in any other country where the language is spoken. This applies to English as well as other languages.
Examples include -
- French (for Switzerland, Canada)
- German (for Austria and Switzerland)
- Italian (for Switzerland)
- Portuguese (for Brazil)
- Spanish (for USA and various other countries)
The process needed for an adaptation is slightly shorter than the full LV process needed for a completely new language. Some versions, however, are better done with a full LV process, using other same-language versions just as reference translations. We will discuss with you which route would be best for the language concerned.