Editing a structure

  • Published by Viedoc System 2025-03-26
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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:

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

Activating maintenance mode

To edit an instantiated TMF structure, you need to operate in maintenance mode.

To activate maintenance mode:

1

In the left navigation menu, select to expand TMF Admin and select the TMF Structure page.
2

Select the Maintenance switch:

When maintenance mode is activated, all non-applied changes to the active structure are shown.

Editing the structure

The edits that you can make on the structure level are as described in the following sub-sections.

Editing the structure name

To edit the structure name:

1

In maintenance mode, select Edit on the structure level.
2

In the window that is displayed, edit the structure name and select Ready.

Editing the version of the TMF reference model

To edit the version of the TMF reference model:

1

In maintenance mode, select Edit on the structure level.
2

In the window that is displayed, select the applicable version of the TMF reference model from the dropdown menu and select Ready.

Editing zones and sections

To edit a zone or section:

1

When maintenance mode is activated, select the Edit button that appears when you hover over a zone or section in the TMF structure.
2

In the Edit window, make your changes to the zone or section name.
3 Select Save changes.

Editing artifacts

To edit an artifact:

1

When maintenance mode is activated, select the Edit button that appears when you hover over an artifact in the TMF structure.
2

Make your changes in the Edit artifact window.

For more information about the artifact properties, see Customizing a template, specifically the sections The V 3.2.1 sheet and Role sheets.
3 Select Save.

Adding artifacts

To add an artifact:

1

To add a new artifact to a specific zone or section, select the Add new artifact button that appears when you hover over a zone or section in the TMF structure.

Alternatively, select Add new artifact at the bottom of the structure.
2

Fill in the artifact information in the Add new artifact window.

If you select New in the Zone name or Section name dropdown menu, you can create a new zone or section where the artifact will be added.

Note! The required fields are marked with red.
3 Select Save.

Deleting zones, sections or artifacts

To delete zones, sections or artifacts:

1

Select the Delete button that appears when you hover over a zone, section, or artifact.
2

The zone or section and all its artifacts are then marked as red strike-through text in the TMF structure.
3

If you delete on zone or section level, all artifacts in the zone or section are deleted when you apply the changes to the structure.

If you delete on artifact level, only that specific artifact is deleted when you apply the changes to the structure.

If you delete the only artifact in a section, the section is also deleted.

Likewise, if you delete the only section or artifact in a zone, the zone is also deleted.

For information about how to apply or revert changes to the structure, see Applying or reverting changes to the structure.

Note! If you delete a zone, section, or artifact, its associated records will not be deleted. Instead, the end user view will display the zone, section, and artifact as deleted to indicate that the records in it should be moved.

Managing milestones

Milestones are a tool for filtering records. Milestones are defined at the artifact level, and all records within that artifact will have the same milestone. Milestones may be used to search for records, to categorize records within a study timeline, or to filter audit trail reports or EMS repositories.

To manage the milestones defined for the study, select Edit in the Milestones section on the TMF structure tab.

Changing the sequence of milestones

The sequence of milestones is how they will appear in the milestones filter in the Trial Master File view, as well as in the milestones dropdown menus in the View artifact properties and the Edit artifact windows in the TMF Admin view.

To change the sequence of milestones within the group, select the up arrow on a milestone level. The changed sequences will be highlighted in red until the changes are applied to the structure or reverted

Editing milestones

To edit the properties of a milestone, select Edit at that milestone level.

The following applies when editing the properties:

  • Group, ID, and Name are mandatory.
  • The description properties are optional.
  • ID and Name of the milestones must be unique.

Adding milestones

To add a new milestone to the list, select Add new in the Edit milestones window.

Deleting milestones

Milestones that are linked to active artifacts cannot be deleted. To delete a milestone, you must remove these links either by deleting the artifact linked to it or by linking the artifact to another milestone.

To delete a milestone, select Delete this milestone at the bottom of that milestone edit window.

Applying or reverting changes to the structure

The Viedoc TMF application automatically recognizes when changes have been made to the TMF structure and displays a message where you can choose to apply or revert all changes that were made during the current maintenance session.

The confirmation window lists the changes that have been made. Select Apply changes to apply or select the X in the top right to close the window without applying the changes.

Note! Any applied changes to the structure will be listed in the complete audit trail report.

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