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Why Back Translation for Clinical Trial Documentation is important?  


Back translations are recommended for clinical trial documents and informed consent forms to ensure that translations have been done correctly and with no loss of meaning.  


This is especially recommended for trials that may involve high risks or are very complex in nature. Essentially, they should always be done if it is necessary to be really confident that accurate translation has been done. 


So what is a back translation? Basically, a translated document is translated back into its original language by a second translator without having seen the original version. In other words, the second translator performs a blinded translation. He has no idea of the content of the original source text and will simply translate the text he has been given into the source language as he sees it. 


This translation is then checked by the project manager against the original, un-translated document to see if any of the meaning has been lost during translation. 


There are few situations in which it is more important to perform such added checks than in clinical trials. Even an experienced, highly skilled translator can on the odd occasion miss a slight variation in meaning, be it through human error, a simple misjudgment or the subjectivity of a particular language. Adding back translations is another step to assure quality of translations. 


Essentially, the steps involved start with the source text being translated into the so-called target language. This may, for instance, involve translating an informed consent form from English into Hindi. This process is the forward translation.  


Occasionally, a dual, or double forward translation, where two translators translate the same text into the same language and then one or maybe both of them compare the two versions and decide on the better version, or combine the best of both. This is required by some committees and it is best to enquire of the relevant local committee if this is so before commencing work. 


This forward translation is then translated back by an independent second (or third) translator, who should be a native speaker of the language used in the source text, in this example English, as well as being fluent in the target language, in our example Hindi. 


The individual reviewing the back translation in comparison should be a native speaker of the source language again and, although not required to speak the target language, should have good linguistic skills. 


If there are any discrepancies, they will then be discussed; a revised version will be produced and back translated again. The whole process should be documented, showing what needed to be changed, how it was changed, etc, ultimately creating an audit trail of the process. 


Once all reviews and necessary revisions have been completed, the final version is proofread, this time concentrating on minor typing errors, etc.  


This process may seem very elaborate, but it is of great importance to ensure that these forms can be readily understood by participants in clinical trials. Failure to ensure this could lead to serious repercussions.


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