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. In June 2012, the Drug Information Association (DIA) established a guideline called TMF Reference Model Version 2.0. 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 another model or create a completely new one.

 

 

Copying TMF Reference Model to Modify

Although you cannot edit the DIA's TMF Reference Model model, you can add a new model by clicking the 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

Upon install, this feature is turned off. To enable, 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 True. Click Save.

 

 

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 button.

 

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

 

Columns can be sorted  in ascending or descending order by clicking the column heading.

 

Click Common Buttons for a description of the buttons found throughout the system and their uses.

 

 

 

Field

Description

Search Fields

 

Records

The user can filter the records based on whether they are active or inactive, or simply select all records.

Search

The user can enter any word or string to see if it exists in the database.

Column Headings

 

Name*

This column displays the names of the document reference models.

Comment*

This column displays information about the reference model.

# of Levels*

This column displays how many levels (either 1,2, or 3) this module contains.

Level 1 Caption*

This column displays the name given to the first level.

Level 2 Caption*

This column displays the name given to the second level.

Level 3 Caption*

This column displays the name given to the third level.

Project

A check in this column indicates that project documents can be mapped under this model.

Country

A check in this column indicates that country documents can be mapped under this model.

Site

A check in this column indicates that site documents can be mapped under this model.