TMF Package
What Does It Do?
The Metadata tool can create TMF-ready archives, with all the components created for a study stored in a easy to navigate folder.
What Do You Need?
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A study-level archive
Guide
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Open Microsoft Excel.
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Navigate to the Metadata ribbon.
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​Locate the Packages section of the ribbon.
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Click the TMF Package button in the Packages section.
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A prompt will appear.
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Ensure the Sponsor is selected.
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As well as the Internal Study Number and the Protocol Number.
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Click OK to continue.
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IMPORTANT: Firstly, the user must determine if the TMF package will be a Draft (interim) package or a Final package. This directly impacts where the files and folders are output in the TMF.
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When the Archive Type is set to either Draft or Final all study-level archives are loaded into the Archive drop down.
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Select the appropriate Archive package and the process will perform some auto-mapping.
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An example of a Draft TMF package.
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An example of a Final TMF package.
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Users can exclude any item by updating the Include column within the data grid.
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Additionally, items unable to be auto-mapped can be manually adjusted by double clicking a row, which will will bring up a window asking the user to select the correct folder, e.g., the row above labelled "01-study\vendor data\meds".
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After clicking OK the process will begin to convert the Archive Package into an TMF Package, some items will be zipped up and ready for filing. ​