Study level or Site level or both?

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    • #2732
      Manali Shah
      Participant

      Hello All,

      For the 05.04.08 Final Trial Close Out Monitoring Report, the tmf reference model states this section as a study level only. However, the description of this section mentions documenting trial activites that are completed for sites closure prior to trial completion and may include confirmation letters/emails.

      Hence, I feel 05.04.08 should be both study level (sponsor document) and site level (Investigator document). Can someone please clarify why this section is labelled as a study level document only?

    • #2733
      Eldin Rammell
      Participant

      Hi Manali,

      In the published Reference Model, this artifact is identified as a site level document only.

      Kind regards,
      Eldin.

    • #2734
      Manali Shah
      Participant

      Hi Eldin,

      Thank you for your response. Yes, I do see that under the published Reference Model – Column “Y” – TMF Level – Site Level does mention 05.04.08 as a site level document. However, under Column “O” – TMF Artifacts (non-device) – Investigator document it mentions 05.04.08 as a NO.

      Hence, I am interested to know as to which column is the best reference for identifying site level/study level documents within the reference model.

    • #2735
      Eldin Rammell
      Participant

      Hi Manali,

      Column O defines whether or not the artifact is expected in the investigator TMF i.e an investigator document rather than a sponsor document (column N). So for artifact 05.04.08, column O is identified with “No” to signify that this is not a document that is usually expected to be filed in the investigator TMF (ISF).

      I hope this helps.

      Kind regards,
      Eldin.

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