Is it acceptable to utilize only a study level & site level in an eTMF when multiple countries are involved in the study? It seems that many “country level” documents can easily be filed at the study level and the naming convention for the document can specify what country it is for.
There does not seem to be a real need for the country level.
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).