Economic Report

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    • March 6, 2020 at 11:44 am #2909
      Maria Lopez
      Participant

      Dear all,
      I’d like to know your opinion on where to file the Economic Report, detailing the payments the sponsor will do for each pacient, for the hospital, for the investigators etc.
      I guess the best place would be under Artifact 05.02.12 Clinical Trial Agreement since it is an annex to the Trial Agreement but I’d like to hear your opinion.
      Thanks

    • March 6, 2020 at 11:51 am #2910
      Eldin Rammell
      Participant

      Hi Maria,

      If included as an annex or supplement to the Trial Agreement, then I agree that 05.02.12 would be the most appropriate classification. You might also consider artifact 05.04.07 Financial Documentation. I’ve seen sponsors use this for trial budgets and payment summaries/reports. Remember that the filing level is for guidance only; if the Reference Model just has an “X” in the site column but an artifact covers the whole trial or just a specific country, there’s no problem filing at the trial level or country level, as appropriate.

      Eldin.

    • March 6, 2020 at 1:29 pm #2911
      Maria Lopez
      Participant

      Thanks Eldin for your support.

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