Home Forums TMF Management, Content & Processing Translations without CoT

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    • #3699
      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!

    • #3761
      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).

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