Translation for Clinical Trial Documentation is important?
are recommended for clinical trial documents and informed consent forms to ensure that translations have been
done correctly and with no loss of meaning.
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
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.
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.
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
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.
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.
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.
Contact email@example.com for forward and back
translation into Indian languages