[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.

So:
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.

Eldin.

[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.

[Eldin Rammell]

Hi Manali,

In the published Reference Model, this artifact is identified as a site level document only.

Kind regards,
Eldin.

[Eldin Rammell]

I agree with Karen. You can’t beat talking to people who have already made the journey.

One of the primary drivers for using an eTMF that I mention when talking to people is to just think about how we do our work in the 21st century. We create documents using computer software, creating electronic documents. Even when our TMF is allegedly paper, we still collaborate with each other electronically. When we need to see a document, we go to SharePoint, our email, or a network drive to get the information we need. We send around documents electronically by email. And most critically, we rarely work just in one geographic location so we need the ability to access documents from wherever we are located.

So given this working scenario, why would we print everything and retain it using a medium that limits sharing and limits access? A printout is a secondary copy and contains almost none of the metadata generated during the life of the original; best to keep the original e-record in an eTMF!

I’m sure others can provide some additional insights.

Eldin.

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