Reply To: TMF structuring Trial, Country and Site Levels

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#2754
Sonya Cato
Participant

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.