Configuring the TMF Viewer (eTMF)

The TMF Viewer allows you to manage a TMF by browsing dynamically organized content and switching between multiple configured hierarchies.

Vault structures the TMF Viewer in a hierarchical view, allowing users to view all documents for a single Study.

Users can further filter on Study Country and Study Site for more specific results.

The TMF Viewer pulls data based on:

  • Reference Model: The TMF RM 3.0, TMF RM 2.0, and Vault Clinical Docs model object records. The hierarchy displays documents based on the mapping of a given type, subtype, or classification to the artifacts of a given model.
  • Document Type Hierarchy: The configured document type hierarchy as it appears in the expandable tree view at Admin > Configuration > Document Types.

Vault only displays sections on the TMF Viewer when those sections contain documents. If document types have not been mapped to a section within a view or no documents exist for a given section, the section will not appear.

Configuration Overview

  • Ensure relevant users have View permission for the TMF Viewer tab.
  • From Admin > Configuration > Tabs, select the TMF Viewer tab and change its status to Active.
  • Change the status of the old TMF Viewer tab to Inactive if you do not want both tabs to show on users’ navigation bars.
  • Determine which view models users can see in the TMF Viewer.
  • Map documents to a view model (TMF RM 3.0, TMF RM 2.0, Vault Clinical Docs) for them to appear when users select that view in the TMF Viewer. You can map a document type to a view model within the Type Defaults tab of a document type’s configuration.
  • Optional: Exclude specific classifications from appearing to users in the TMF Viewer when they select the Document Type Hierarchy view.

View Models

View models define the hierarchy structure of the TMF Viewer. There are four (4) views to choose from:

  • TMF RM 2.0
  • TMF RM 3.0
  • Vault Clinical Docs
  • Document Type Hierarchy

Enabling View Models

You can configure which view models are available for users to choose from in the TMF Viewer. To reveal a view model:

First, configure the user action on the Model object:

  1. Navigate to Admin > Configuration > Objects > Model > Actions > Create.
  2. Select the Toggle Display in TMF Viewer action.
  3. Click Continue to review the details of the action.
  4. Click Save.

To reveal a specific view model to users:

  1. Navigate to Admin > Business Admin > Models
  2. From the Actions menu for the applicable Model record, select Toggle Display in TMF Viewer.

Reference Model Views

Each view has its own unique structure for organizing the documents of a Study. In order to have your documents appear in the TMF Viewer, you must map their document types to a view. To do this:

  1. Navigate to Admin > Configuration > Document Types.
  2. Click the Actions menu on a document type and click Edit Details.
  3. From the Type Defaults tab, select an artifact for each Reference Model. This will be the view that defines the section hierarchy for documents of this type.

Note that documents will only be visible in the TMF Viewer if the Reference Model Versions (model__v) and Artifacts (hierarchy__v) object fields of a document are populated. These fields indicate in which section Vault should display a document for a given view.

Documents transferred from a source Vault via TMF Transfer are classified as TMF Documents. Vault displays these based on the value in the Source Artifact (source_artifact__v) field rather than the values in the Reference Model Versions (model__v) and Artifacts (hierarchy__v) fields.

Document Type Hierarchy View

You can exclude specific classifications from being displayed to users when they select the Document Type Hierarchy view in the TMF Viewer. To do this, set the Display in TMF Viewer field to No on the corresponding Clinical Document Type Detail record or on any parent Clinical Document Type Detail record.

Users must have the Read permission on the Clinical Document Type Detail object in order to utilize the Document Type Hierarchy view.

Enabling Artifact Number

You can include the hierarchy item number in addition to the names on the hierarchical folder structure in the TMF Viewer. To enable this feature, navigate to Admin > Settings > Application Settings and set the Enable Artifact Number on TMF Viewer Index checkbox in the eTMF Features section.