Dear Pia,
Based on long experience and being tri lingual myself I recommend the following procedure:
- make a translation by a qualified medical professional familiar with the procedure / field beeing a native speaker of the target language
- make a review by a sworn in translation office of the original text / translation to obtain a "certification" for the accuracy
- solve any issues of discrepancy between the first native speaker translation and eventual comments received by the translation office (in case)
Giving it directly to a translation office may result in funny, useless and even dangerous translations - based on my experience.
Kindest Regards
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Michael Maier
Senior Partner - Medidee Services AG
Switzerland
michael.maier@medidee.com------------------------------
Original Message:
Sent: 29-Jul-2021 04:21
From: Pia Windelov
Subject: Audit findings on translations
Hi there
I am very interested in which the most frequent audit findings are when it comes to translating essential clinical documents for clinical investigations as well as for new drug filings. I am also keen to hear opinions from regulatory professionals and industry on back translations. When do you apply back translations, i.e., for which types of content and purposes is this a standard procedure for you?
Appreciate any thoughts on the topic.
Thanks and have a great day
Pia
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Pia Windelov
Director, Regulated Solutions, Life Sciences
Denmark
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