Study level or Site level or both?

[Manali Shah]

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?

[Eldin Rammell]

Hi Manali,

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

Kind regards,
Eldin.

[Manali Shah]

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.

[Eldin Rammell]

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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