In clinical trial translations, both back translation and reconciliation are an essential part of the linguistic validation process before materials are sent for cognitive debriefing.
The reconciliation comes as a second method of improving translation quality of clinical trial texts. The reconciled text is one of the preferred versions of the two previously translated forward versions or a combination of both to clearly indicate a third version that best reflects the source meaning of text and unifies both versions in one. After reconciliation comes to the back translation process that aims at catching missing parts, deviation of meaning, wrong terminology and ambiguous understanding of words and phrases in clinical trial questionnaires.
BT mainly checks translation for accuracy, which is an important step in the linguistic validation process. The back translation should be performed by a third translator different from the ones who did the initial forward translations. The translator who was not previously involved in the translation of the original version translates the text in the opposite direction. He translates the text in a more literal way to make sure he catches the meaning as close as possible.
No doubt the BT is not fully equivalent to the source text but the linguistic validation consultant and project manager will pay special attention to nuances of meaning of the words and if they are applicable in the given context. In this way, any ambiguities or missing parts will be easily caught if they have become elusive in the first part of the translation process, i.e. the initial forward translations. This is extremely important when we strive to take into account the tiny details especially when it comes to text in the clinical trial industry where each error may cost somebody’s life. Also, clients want to be 100% sure there are no translation errors in the clinical trial text when this concerns patients’ health and wellbeing.
When choosing a translation company clients need to ask if BT and reconciliation will be covered by the linguistic validation process just to make sure in advance that any misunderstandings or ambiguities in text will be caught in time to avoid any serious consequences afterwards. Very often when even only one word is mistranslated throughout the whole text, this can ruin huge projects which inevitably lead to the loss of great time and money. By using both reconciliation and back translation client will be on the safe side and will feel secure that the translation quality is high enough to cover all safety standards in terms of the linguistic part of the project.
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