Translations without CoT

[Sarah Wilmschen]

Dear all,
I have a question concerning translated documents.
In case of translations not performed by a translation company but by the Sponsor/CRO directly (hence no certificate of translation available), is a declaration of competence (e.g. mother tongue) of the person who translated the document sufficient for filing?
Thank you for your help!

[Richard Golden]

The translation process could be explained in a Note to File, signed by the Country Study Manager (or similar person in charge of the study for that country).

[Author]

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