Manali Shah

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  • in reply to: Study level or Site level or both? #2734
    Manali Shah
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    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.

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