Editing a structure

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:

Introduction

Edits can be made to an instantiated TMF structure by activating maintenance mode in TMF Admin (see section below). Edits can be made to the structure name, TMF reference model version number, zone and section names, artifact details and access, and milestones used in the TMF.

Activating 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, sections and artifacts

Changes that can be made to zones, sections and artifacts are described in this section.

Important! Making changes to any fields (in zones, sections, or artifacts) that are part of the metadata of a record may cause some changes to the record statuses. For examples of the impact of these changes, please see the Impact of changes to zones, sections and artifacts section below.

Editing zones and sections

Only the name can be edited for zones and sections in Maintenance mode.

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 section or Edit zone 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. Select Edit and the Edit artifact window will display:
2	Make your changes in the Edit artifact window.
	The fields available in the Edit artifact window are: Classification Zone, Section, and Artifact numbers and names Definition Unique ID Sub-artifacts TMF side Trial, Country, and Site level settings Record requirements Roles and accesses Milestones Details File name extension details Blinded data Privacy data Dating convention Record sharing Enable sharing for Viedoc Clinic and/or Viedoc Me users
	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.

Impact of changes to zones, sections and artifacts

When there are uploaded records in a structure, it is important to understand the impact of editing the structure, specifically fields in zones, sections and artifacts that are part of a record's metadata. Everything that you see in the record properties window when you open a record is the metadata, except for the file itself.

To show the impact of such changes, please review the example scenario below:

1	An artifact contains multiple uploaded files with the following statuses: Flagged by QC Awaiting review Finalized and locked Finalized Unpublished
2	A TMF Admin user switches on Maintenance mode and makes the following changes: Changes the zone name Changes the dating convention in the artifact from "new dating convention" to "last entry date". The changes are then applied. Note! These changes were made to fields that are part of the metadata for the records.
3	The following changes can now be observed: In the Structure page, the zone is displayed with the new name. The record that was Flagged by QC: Maintains the same status. Has a comment added to the record by the system with a description of the changes made. In the history section, it states that the record was Flagged by QC by the system (versus by a user taking an action). The record that was Awaiting review: Has the status changed to Flagged by QC because the changes affected the metadata of this record, therefore a reviewer will need to take action on it. Once a reviewer edits the record, the new zone name and dating convention are shown in the metadata fields. The changes are saved and the record goes back to an Awaiting review status. The history states the modifications that were made. The record that was Finalized and locked: Nothing has changed. The zone name and dating convention still display the original data. There is nothing noted in the history. To reflect the changes in this record, the user will need to create a new version of the record (copy file from current version) and then the changed zone name and dating convention are shown in the metadata fields of the new version. If a new version is not created, the original metadata will remain in the record. There is no large impact, however in the eTMF-EMS repository there will be "duplicate" zones, one for the old name (with this record in it) and one for the new name (with any records that got the new zone name linked to them. The record that was Finalized: Is the same as the Finalized and locked record above. The record that was Unpublished: Maintains the same status. The changes are reflected in the metadata fields of the record. The changes are also reflected in the record history.
	Note! The status changes described above occur because the changes made to fields that are included in the record's metadata. If changes are made to other fields (for example Unique ID, adding a new sub artifact, or selecting Blinded data or privacy data not accepted) then all the statuses for uploaded records will remain the same.

Adding artifacts

To add an artifact:

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.

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.

Select Save.

Deleting zones, sections or artifacts

To delete zones, sections or artifacts:

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

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

Notes on deletion:

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.