Trial Master File (TMF)
Metadata → Package → TMF
This process can quickly create a fully user controlled Trial Master File (TMF) package for any study at any point of time.
The Metadata tool can create archives, with all the components created for a study stored in a easy to navigate folder.
Access to the study directory
Any study components
Open Microsoft Excel.
Navigate to the Metadata ribbon.
Locate the Deliverables section of the ribbon.
Click the Packages drop down then the Create TMF Package button.
A prompt will appear.
Ensure the Sponsor is selected.
As well as the Internal Study Number and the Protocol Number.
Click OK to continue.
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.
When the Archive Type is set to either Draft or Final all study-level archives are loaded into the Archive drop down.
Select the appropriate Archive package and the process will perform some auto-mapping.
An example of a Draft TMF package.
An example of a Final TMF package.
Users can exclude any item by updating the Include column within the data grid.
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".
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.