Home Forums Adopting the Reference Model TMF structuring Trial, Country and Site Levels

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    • #2749
      Maria Lopez

      We have different opinions within my company regarding how we must structure the folders for country and site level.
      Should we:
      1. Create 3 first levels (Trial, Country and Site)
      2. Inside Country (11 zones, 48 Sections and 249 artifacts). Then, inside each artifact we will place ALL countries’ specific documents together. e.g.(Country Level) 03.REGULATORY > 03.01.Trial Approval > 03.01.01 Regulatory Submission > inside this folder we will directly place ALL countries submissions together (all PDFs for all countries together with diferent names Protocol number_Contry1_RA approval // Protocol number_Contry2_RA approval // Protocol number_Contry3_RA approval).

      Or should we:
      Inside country > Country 1 + Country 2 + Country 3.
      And inside Country 1 the 11 zones + 48 sections and 249 artifacts to archive the Country 1 specific documents.
      But this way, we will have the TMF RM structure replicated for each country, which will be a lot of folders.

      I hope I’ve been clear enough. Sorry…

    • #2750
      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.


    • #2751
      Darwin Thukkan

      Hi Maria,

      It will be difficult to find documents if many countries participates in the study if you opt for 1st option. My suggestion to go for second option to avoid any confusions and it will be also easy for everyone to search a documents in respective country or site.


    • #2752
      Maria Ladd

      I am in agreement with Eldin and Erwin that option 2 is most common, and for me is the most logical for a TMF structure. If you think of the TMF as a story of the trial – it is a more accurate story when it is country by country because that is how activity unfolds. Option one is more reflective of a repository of documents versus a TMF.


    • #2753
      Maria Lopez

      Thanks for all your comments!
      They have brought us enlightment!!!

    • #2754
      Sonya Cato

      The formats you illustrate yield a large number of empty file folders, especially if you include all sections and zones under each level. There are many artifacts that are not applicable at the site level, for example. How do you account for empty folders at the end of a trial?
      IF you are using an electronic system and are able to filter your TMF by metadata, would it be efficient to have the information grouped zone – section – artifact – region – site ? The system would rely on the ability to use the metadata for filtering the information for a specific region or site.

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