SAE Report (07.02.02 ) – who files at trial and site level?

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      Sarah Wilmschen
      Participant

      Dear all,
      I have a question to artifact 07.02.02 (SAE Report):
      – This artifact is listed as sponsor and investigator document, which means it must be filed in the TMF and ISF. Is this correct?
      – If so, does filing need to be done by the same person/party or is this done by separate parties (i.e. CRO, who is responsible for safety in the study, files it in the TMF and the site, of the subject where the SAE occurred, files it also in the ISF)?
      Thanks a lot for your help!

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