Study level or site level?

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    • #3671
      Manali Shah
      Participant

      Artifact 10.04.03 Validation documents are marked in TMF as site level (Column O – Investigator document is checked). Any thoughts on why the site needs to have this documentation filed?
      Any examples on kinds of documents filed in this section by other sponsors/CRO will be helpful

      • This topic was modified 2 weeks, 3 days ago by Manali Shah.
      • This topic was modified 1 week, 6 days ago by Eldin Rammell.
    • #3677
      Elvin Thalund
      Participant

      Source data are site responsibility and needs SOPs for source data capture, so if ePRO or other sourcing tools are being used, each site needs to validate the systems used and file that in their iSF.

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