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    • May 7, 2024 at 4:22 am #5149
      Anke Fronius
      Participant

      Hello,
      I want to file an IRB stamped patient reported outcome questionnaire. This is a multicentric trial and the IRB stamp is specific to a site. I wanted to file it on site level under 02.02.02 but turns out there is no such artifact on site level in the TMF reference model. Any recommendations where else to file this?
      The version is of course the same as trial level, but the document I want to file has the IRB’s approval stamp on it. Would you file this as an IRB decision (04.01.02)? Or as Other documentation given to subjects (02.02.07)? Any other suggestions?

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