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Eldin Rammell

Hi Maria,

The 2nd option is the one I see most often. This ensures that all TMF for a single country is all located together in a set of folders (or virtual folders in many eTMF systems). It makes it easier to navigate between zones within a country. Similarly, as the site level, you would have all of your zones, sections and artifacts organized within each site folder to allow you to see the full content for the site within a single set of folders.

Study XXX Trial-Level
— Zone 1
— Zone 2 etc
Study XXX Country-Level
— Argentine
— Brazil
—–Zone 1
—–Zone 2 etc
Study XXX Site–Level
—-Brazil Site 001
——Zone 1
——Zone 2 etc

Some systems group all of the countries together and then group all of the sites together. Other systems have the site folders positioned within the respective country folders.

I rarely see the country and site folders underneath the individual artifact folders….I think I’ve only seen this once, where all of the monitoring visit reports, for example, are all filed together, structured first by country and then by site. And then in a different folder the IRB approvals, filed by country and then by site etc.

Hope this helps.