Reply To: Study Level, Country Level, Site Level Structure

[Eldin Rammell]

Hi Alexa

This is a matter of personal choice; the model provides a recommended approach but nothing is mandatory. Many sponsors prefer to group country level documents in their own files as this facilitates easier management and compliance monitoring by staff in those countries. When using electronic systems, it is easier to manage access control to those documents when filed at country level (particularly important to comply with data processing laws).

Kind regards
Eldin.