Get a license

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

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 an eTMF Manager

This step is performed by the Study Manager.

See Managing users.

Enable eTMF

This step is performed by the eTMF Manager.

1	In the study details page, click the tools symbol in the eTMF area:
2	Toggle the Enable switch to ON in the eTMF settings dialog:

Map study roles to eTMF roles and permissions

This step is performed by the eTMF Manager.

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

Launch eTMF in admin mode

This step is performed by the eTMF Manager.

1	On the study details page, select the tools symbol in the eTMF area:
2	Select Launch study eTMF:

Customize the template

This step is performed by the eTMF Manager.

Baseline template

The first time you set up your eTMF application, you begin with a baseline template provided by Viedoc. This template is not intended to be used as it is, but to be adapted to the needs of your organization. See Viedoc-provided templates to download the template.

Once customized, import the template to eTMF, see Import the template.

Existing templates

Imported templates can be customized to fit your study needs.

To export a template for customization:

1	In Viedoc eTMF, select the TMF Admin view:
2	Select the Templates tab:
3	Select Export for the template you want to customize. The template is downloaded in Excel format.

There are two types of templates:

• Organization template - available for all studies within your organization
• Study template - available only for the specific study

It is recommended that you adapt the eTMF template to your specific documentation landscape. For example, you can customize, add, or delete zones, sections, and artifacts.

See also Customizing a template.

Import the template

This step is performed by the eTMF Manager.

1	Select Import in Organization templates or Study templates, depending on what type of template you're importing.
2	Once imported, select your template to make it available in the TMF structure.

Instantiate the template

This step is performed by the eTMF Manager.

On the TMF structure tab, select the Instantiate button for the template.

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

Launch eTMF in production mode

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

Select the eTMF icon on the Viedoc landing page:

The eTMF application opens.

• Previous
• Next