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    • February 22, 2023 at 11:28 am #4932
      Anna SzczepkowsaAnna Szczepkowsa
      Participant

      Dear All,
      I would like to discuss where do you file Certificate of translation in your eTMF. Basically we are using 3 different scenarios and I would like to verify how other companies are doing that.

      Possible Scenarios:
      1 Upload CoT as attachment to translated document (no standalone document, no metadata for CoT)
      2 Upload CoT as standalone doc under Company specific Artifact (for example we have – 02.04.97 Certificate of Translation) and link to translated document (full metadata available)
      3 Upload CoT as standalone doc in the same artifact as the translated document and link to original doc (full metadata available)

      Best regards,
      Anna

    • March 16, 2023 at 9:50 pm #4967
      Noreen BouchardNoreen Bouchard
      Participant

      We require that they upload the CoT as an attachment to the document. This ensures that it was in fact translated and we don’t have to search for the CoT when we’re reviewing documents. Much cleaner that way. In the past they were separate and we couldn’t always connect the two documents together.

    • October 9, 2023 at 11:50 am #5119
      Chelo RamirezChelo Ramirez
      Participant

      We merge in one file the original and translated document and add the COT at the end.
      Hope this helps.

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