Document TMF Templates

The Document TMF Templates page allows the administrator with the ability to map Project, Country, and/or Site Documents to a specific structure. To help in setting a structure, the Drug Information Association (DIA) established a guideline called the TMF Reference Model. This Model is not a regulation, but it has become widely accepted as the method to categorize and collect essential documents. ClinPlus CTMS includes this model for you to categorize your documents. You can create a new model by basing it on this model or create a completely new one. The model can have 1, 2, or 3 levels. Each level can be uniquely named.

Copying TMF Reference Model to Modify

Although you cannot edit the DIA's TMF Reference Model, you can add a new model by clicking the Add New button, which will open the TMF Template module. You can then select the TMF Reference Model, or another model that is available, as a starting point and modify it to fit your needs or create a new model. Click to edit a model that has already been created, which also opens the TMF Template module.

Turn Feature On/Off

Upon install, this feature is turned on. To disable, click the Administration tab and select either System, Domain, or Project Configuration. Click  next to Enable Document Trial Master Files, then click the Override field and select False. Click Save.

Another configuration variable, Enable Selection of Unmapped TMF Document Types, is available. When set to False, this variable will prevent users from selecting any Document Type that has not been mapped to the current TMF Template.  This applies only to Project, Country, and Site Documents.  Other documents, such as Attachments, will not be affected. This is most valuable when you want only mapped documents to be available for a Project.

Users can filter by Active or Inactive records as well as search for a word or string in the record. To remove all search options, click the Reset Filters button.

Click Document Trial Master File for more information on the process.