Home Forums TMF Management, Content & Processing Naming File convention

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    • #3693
      Janna Gonzalez

      Hi All,

      I have a Informed Consent Checklist. When filing in TMF should we add the documents date and the version date?


    • #3694
      Todd Tullis

      Hi Janna,

      There is a column in the reference model (“Dating Convention”, column AA) that indicates the best practice date to be associated with any given artifact. Even further, there is a guidance document here that describes more detail about how to interpret that column. For ICF it looks like the model expects Version Date to be the key identifying date for the record.

      If using an eTMF, the TMF RM expects that you should at least be able to capture one date specific to each record filed. Of course some systems may allow more than one or may provide other means of associating an ICF checklist with a particular ICF version…but the TMF RM itself doesn’t yet take any position on such additional attributes.


    • #3731
      Janna Gonzalez

      Thank you Todd.

      I have another questions.

      Filing naming convention.

      I’m organizing the file structure for the company. We are having a issues filing the correspondence in the correct folder for the study.

      I always used The subject information.

      Study_IRB ICF Process_PI_31Jul2020
      This document will be filed in the
      IRB Relevant Communication

      Thank you,

    • #3733
      Todd Tullis

      Hi Janna – That filing is probably OK. Keep in mind though that correspondence records need not be limited to filing in the zone-specific “Relevant Communications” artifacts…in certain cases it may make sense to file such records in a more specific artifact.

      In case it is relevant to your situation, a subteam of the RM recently developed specific guidance for emails, which you can learn more about here: https://tmfrefmodel.com/announcing-guidance-for-managing-trial-related-emails

    • #3739

      I need to train my team on TMF NAMING CONVENTION. Do you have a guidelines to share? Thank you

    • #3759
      Richard Golden

      If you are using Veeva Vault, the document name that’s automatically generated by the system provides a solid guide to naming conventions. The naming conventions need to be succinct yet still descriptive. One rule of thumb is “a person who knows absolutely nothing about this study should be able to read the name and know what the document is without opening it”

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