Note! This page contains information and instructions for the new TMF user interface. If you are using the old interface, please go to the relevant user guides:

• Viedoc eTMF User Guide (old interface)
• Viedoc User Guide for eTMF Managers (old interface)

Want to browse more information for the new interface? Please go to the new TMF user guides:

• Viedoc TMF User Guide
• Viedoc TMF Admin User Guide

TMF setup overview

Get a license

Make sure you have a valid license for using Viedoc TMF.

Publish a design

This step is performed by the Designer.

Note! To publish the CRF design, you only need to have the roles configured and enabled, and a form added to the start event in your workflow (the form can be without any items at this stage). The actual CRF design can be added in subsequent versions.

See Publishing a study design.

Assign the design to production sites

This step is performed by the Study Manager.

See Assigning a study design.

Invite a TMF Manager

This step is performed by the Study Manager.

See Managing users.

Enable the TMF

This step is performed by the TMF Manager.

1	In Viedoc Admin, select Show studies, then open the study details page:
2	In the study details page, select the tools symbol in the eTMF area:
3	Toggle the Enable switch to ON in the TMF settings window:

Map study roles to TMF roles and permissions

This step is performed by the TMF Manager.

1	In the eTMF roles mapping area, select the TMF roles and permissions that you want to map to the Viedoc study roles:
2	Select Save changes.

Launch TMF in admin mode

This step is performed by the TMF Manager.

1	On the study details page, select the tools symbol in the TMF area:
2	Select Launch study eTMF:
3	When you launch Viedoc TMF for the first time, this message is displayed:

Customize and import the template

All the steps in this section are performed by the TMF Manager.

Download the baseline template

The first time you set up your Viedoc TMF, you begin with a baseline template provided by Viedoc. It is recommended that the TMF template is customized to your specific documentation needs.

See Viedoc-provided templates to download the template.

Customize the template

The template can be customized for your study or organization's specific needs. For example, you can edit, add, or delete zones, sections, and artifacts. See Customizing a template for more information.

Exporting and customizing an existing template

If there is a template that was previously imported, it can be exported in order to customize it, then imported again.

See Exporting a template for more information.

Import the template

Once customized, import the template to TMF. See Importing a template for more information.

Instantiate the structure

This step is performed by the TMF Manager.

See Instantiating a structure for more information.

The template is now applied to the trial and the TMF structure is available for end users to work with.

Note! Once a structure is instantiated, it can not be uninstantiated.

Launch TMF in production mode

This step is performed by a Clinic user with a mapped TMF role.

Select the eTMF icon on the Viedoc landing page:

The TMF application opens.

Back to top of page

• Previous
• Next