Reply To: Study level or Site level or both?

[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.