The TMF Viewer allows you to manage a TMF by browsing dynamically organized content and switching between multiple configured hierarchies. You can further filter on Study Country and Study Site for more specific results.
Vault structures the TMF Viewer in a hierarchical view, allowing you to view all documents for a single Study. You can see both active and inactive document types within the TMF Viewer. Note that documents in inactive lifecycle states are not visible in the TMF Viewer.
The TMF Viewer can display documents based on:
- Reference Model: The viewer displays documents based on the mapping of a given type, subtype, or classification to the artifacts of a given model.
- Document Type Hierarchy: The viewer displays documents based on the configuration of your Vault’s custom document type, subtype, and classification hierarchy.
Note: This feature is only available on Clinical Operations eTMF Vaults.
How to Use the TMF Viewer
- Navigate to the TMF Viewer tab.
- Select a Study from the selector.
- Optional: Select a Study Country and Site to apply additional filters.
- Select a View from the dropdown menu to define the structure for organizing document types in the viewer. The TMF Viewer will display a hierarchical structure of folders containing all the documents related to the study you selected, based on how your documents are mapped to the view you select. Note that Vault only displays sections on the TMF Viewer when those sections contain documents. If document types are not mapped to a section within a view or no documents exist for a given section, the section will not appear.
- Hover over a document name to view document details. You can click the pop-out icon () in the document hovercard to view that document in the mini-browser window while maintaining your current view in the TMF Viewer. Note that you’ll need to enable pop-ups in your browser to open the mini-browser viewer.
Your Study, Study Country, Site, and View selections will persist, even when you navigate away from the page.
View models define the hierarchy structure of the TMF Viewer. Depending on the configuration of your Vault, you may see up to four (4) views to choose from:
- Document Type Hierarchy: Vault displays documents based on the configuration of your Vault’s custom document type, subtype, and classification hierarchy. This view model does not include any classifications that an Admin has hidden from view.
- TMF RM 2.0: Vault displays documents in sections according to the values in either the Model or Artifact fields.
- TMF RM 3.0: Vault displays documents in sections according to the values in either the Model or Artifact fields.
- Vault Clinical Docs: Vault displays documents in sections according to the values in either the Model or Artifact fields.
Reference model views include any relevant TMF Documents received from a source Vault via TMF Transfer. These documents are displayed in the viewer according to the value in the document’s Source Artifact field.
Viewing Previous Versions
Use the caret (>) icons next to each document link to expand or collapse all previous versions of the document that you have View Document permission for. Vault displays the version of each document in its own column. After navigating to a document, you can use the breadcrumb links to return to the TMF Viewer.
Viewing Archived Documents
The TMF Viewer displays only active or archived documents at a time. When you select an active Study from the selector, you’ll see all active documents associated with that study, but no archived documents. When you select an archived Study from the selector, you’ll see all archived documents associated with that study, but no active documents.
If you have the appropriate permissions, you can select studies that have been archived via the one-click Study Archival feature.
Customizing the TMF Viewer
You can use column headings to sort documents on specific fields, just as you would in your Library. You can add or remove columns as long as the total number of columns is no more than nine (9).
Additionally, you can Expand All sections of the folder hierarchy, as long as the total number of document types represented within the study is 4000 or less. If the total number of document types present is above 4000, you will need to further filter results before you can expand all sections.
Use the column filters to filter on Classification, Status, Document Date, picklists, and object reference fields to narrow your document list. Click the filter () icon next to the column name, enter conditions, and click Apply. Filters will persist, even when you navigate away from the page.
The TMF Viewer does not support filtering on Text, Number, DateTime, Currency, or Formula fields.
Filter by Filing Level
You can filter the TMF Viewer to display only study-, study site-, or study country-level documents. To do this, add the Filing Level column to the TMF Viewer to see the document’s level. You can filter on that field to exclude child-level documents from your view.
You can only see documents in the TMF Viewer on which you have View Document permission. You also need the following permissions to utilize the TMF Viewer:
|Security Profile||Tabs: TMF Viewer (NEW): View||Ability to view and access the TMF Viewer tab|
|Security Profile||Objects: Artifact: Read||Ability to view Artifact details|
|Security Profile||Objects: Model: Read||Ability to view Model details|
|Security Profile||Objects: Document Type Details: Read||Ability to view document details for documents in the viewer|
|Security Profile||Application: Search: View Archive||Ability to view archived documents in archived studies
You must also have a role on the archived document to view the document