Reply To: Study level or Site level or both?

[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.