The client then approves the recruited patients and sends the translated files ready for testing...
Usually, for clinical trial translations, a detailed and thorough linguistic validation process is needed to ensure that the text has been correctly translated and rendered into the target language to achieve an impeccable quality of the translated text, especially when it comes to patient health.
Linguistic validation is a multi-stage translation process of clinical questionnaires to assess a translation for clarity, intelligibility, appropriateness and cultural relevance.
In order to create the most accurate translation of the clinical questionnaire possible, two independent translators prepared two translated versions of the source text. After completing the translations, the main linguistic validation consultant (the main translator) chooses the best version of the two translations by creating a third (conciliatory) version of the translation.
The next step involves back translating the third version, which is done by a third translator to verify the accuracy of the translation. The main linguistic validation consultant reviews the back translation and again improves the quality of the third version.
The third version is edited by another translator. The main linguistic validation consultant reviews the proposed changes and accepts or rejects them, giving his arguments in both directions. If the text is entirely medically oriented and is intended for use by physicians, a physician (at the client’s request) may also be included in the review of the translation.
Finally, the main linguistic validation consultant performs a final check of the translation and its format to make sure that it meets all linguistic norms and requirements of the client.
Harmonization is an additional tool that may be used to provide consistency and uniformity if the project includes a number of different language translations. This ensures that the vocabulary and structure across all translations is consistent.
The questionnaire may need to be culturally adapted and then the translation must be linguistically validated.
Finally, the clinical trial questionnaire goes through cognitive debriefing to complete the linguistic validation process.
In short, the linguistic validation steps are as follows:
- Two straight translations
- Conciliation version
- Back translation
- Consultant with a doctor (at client’s request)
- Harmonization (at client’s request)
- Final review
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