Services | 26.09.2009

Back-translation is very important when translating clinical trials documentation

To ensure compliance with regulatory authorities, translation in clinical trials must be as accurate as possible, and retain exactly the original meaning of the source text. One way of achieving this is to carry out so-called ‘back-translations’. Indeed, some local regulatory authorities, such as medical ethical committees or institutional review boards, demand that these are carried out.

Back-translation is a quality assessment procedure where a second translator translates an already-translated text back into its original source language. The back-translator usually makes a very literal translation, as the purpose is to test the accuracy of the translation rather than the style. By comparing the two versions in the original source language, any errors or ambiguities can be easily identified. For obvious reasons, it is essential that the back-translation is carried out by a different translator than the person who worked on the original.

As well as discrepancies in meaning, back-translation can also reveal sentence or phrase constructions which could be open to different interpretations. It is also a very useful method of ensuring that the language used in the original and the translation is as clear, concise and reader-friendly as possible. Patient consent forms or questionnaires, as well as reports on the outcomes of different phases of the trials process, can all benefit from this method of translation. For additional peace of mind, you might even want to consider carrying out the whole process twice.

There are many practical examples of the complex nuances in different languages, and how back-translation can help. In one clinical trial, for instance, the English text contained the phrase ‘aches and pains’. This was originally translated into the Spanish word ‘rigidez’, as there are no two Spanish equivalents for the two original words. The back-translation highlighted the fact that only the word ‘aches’ appeared in the first Spanish version; once the issue has been identified, the writers were able to rectify it with different phrasing.

Another good example is the English word ‘to impair’, which you might come across in texts referring to drug effects. In a literal Spanish translation, this would become ‘afectar’. Back-translated, this becomes ‘to affect’, a neutral word in contrast to ‘to impair’. This would trigger the writers to clarify or re-write the phrase.

The Translation People offer initial and back translations of medical, legal and clinical trials documentation. Contact us now  for more information.

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