TMF Level

[Christina Salinas]

Hello,
I’m interested in understanding how to use and implement the TMF Level (columns U-Z) into our TMF. Currently, our CTMS captures/track information specific to the TMF for each study. For each document, metadata listed below is captured. The PDF of the documents are stored in Box, therefore the URL link is present for each document. The following metadata fields are currently being captured for each document:

Metadata fields for each document: Study #, Site #, Zone Name, Section Name, Artifact Name, Document Relationship, Document Name, Corresponding FDA Submission Number, Investigator Document, Notes (i.e. changes to document), Date Monitored, Effective Date, Expiration Date, Superceded, QC Required, QC Status

My company is in the process of making some updates to our CTMS, including process for tracking TMF. Can anyone share if and how they use the TMF Level columns U-Z into their own TMF structure? Is this information captured as medadata? What kind of reports do you generate using this information? Any information regarding this would be extremely helpful.

Thanks for your time.
Christina

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