TMF Content required translation in local language

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    • #3869
      Fernanda Manhaes
      Participant

      Dear all,

      As per my knowledge, there is no list of translated documents mandatory to be included in a TMF expect from the ones which is handled to the patients (artifacts 02.02.01 to 02.02.07).

      Therefore would much appreciate your input on which other documents would you consider necessary to include translations in local language and/or backtranslations in the TMF.

      Thank you very much!

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