For those who don’t work in localization of life science materials or clinical research, the answer is yes!

It’s an all-singing all-dancing, bells and whistles-type fancy translation. To give you an extremely simplified version, linguistic validation is the following process:

Dual translation > harmonization > review > proofreading > translating back into English > analyzing > refining > testing on end users > analyzing > retesting (if necessary) > final proofread  



It’s mainly to do with what is being translated and why. Linguistic validation is usually carried out on patient-reported outcome (PRO) measures. Generally, these are questionnaires or symptom diaries that are filled in by patients for clinical research.

Arguably the most important part of the process is when the translated text is tested with participants in the target country. These will typically be people who speak the target language and have the condition that is the subject of the PRO measure.  For example, a PRO measure about eczema for a study in Japan will be tested via interviews with Japanese native speakers with eczema.

The main goal of these interviews is to ensure that the translated version of the PRO measure is fully understood and appropriate for use within the target country. This is done to avoid ‘literal translations’ and to localize to the country’s culture, avoiding differences that may confuse the participants who are filling in the questionnaire.


It might seem like an incredibly convoluted way to get a translated PRO measure, but it’s all about being culturally equivalent in all the concepts shared in the translation. If the translation isn’t checked thoroughly, it’s impossible to know if the questions are conveying the same meaning as the original. This in turn would mean that any data taken from the research using that translation could not be relied on.

To sum up, linguistic validation is an elaborate translation process. It involves a large team of experts. Whether they be linguists, project managers, clinicians or patients, everyone plays a significant role towards improving clinical research outcomes.

By Anna Richards

Coralie Rassinoux