Paper TMF Labeling

[Jenn Leaning]

I have a new start up that would like a paper-based TMF maintained while utilizing the DIA’s reference model structure. Can anyone give me suggestions/ideas on how we can label the TMF file folders so it’s organized and easy to identify? We used to have a color labeling system, but we are finding it challenging to update the programming to incorporate the reference model format / information…

Any recommendations on the layout of the labels, or if there is a suggested software/program that creates folder labels and easily incorporates the RM would be greatly appreciated.

Thank you!

[Lynn Petrillo]

For our TMFs, we put a leading “1” for trial level; a leading “2” for country level and a leading “3” site. When we used to file paper we would have a set of folders at the Trial level and we would label, ex. 101.01.01 – TMF Plan. If country level applies to your study I would suggest doing a set of folders for each country participating. ex. 201.01.08 Monitoring Plan; and a set of folders for each site ex. 301.01.11 Debarment Statement.

Trial: 101.01.01
Country: 201.01.01
Site: 301.01.01

You can certainly color code individual countries, or give them a country code. 01-US; 02-CAN; 03-UK; 04-EU, etc.

Hope this helps. This is how our eTMF is structured using the TMF RM.

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