Managing Binder Templates

Binder templates allow quick creation of new binders from a configured template. When users create the new binder, Vault copies the binder template structure and uses that copy as the starting structure for the new binder. If the template includes planned documents, Vault also creates new documents within the binder. This process allows for more consistent creation of complex binder structures. Binder templates are associated with a specific document type, like binders themselves.

Accessing Template Management

You can manage binder templates in Business Admin > Templates > Documents & Binders.

How to Create Templates

To create a binder template:

  1. From the Document & Binder Templates page, navigate to the appropriate level in the document type hierarchy for the new template.
  2. In the templates pane, click Create > Binder Template.
  3. Enter the Label. When users create a binder from a template, they will see this value in the list of available templates.
  4. Optional: Modify the Name. This value does not appear to end users, but is used through the API.
  5. Set the Status field. If disabled, users cannot see the template when creating binders.
  6. eTMF Only: If you’re creating a binder template within a standard binder document type, set the Filing Model.
  7. eTMF Only: Select the Enable Dynamic View checkbox to make the template available in the legacy TMF Viewer tab.
  8. Click Save to create the template with an empty structure.
  9. In the Binder Structure section, click Edit to begin modifying the binder structure.
  10. Add, move, or delete sections as needed at any level in the binder hierarchy. This process is the same as editing a binder.
  11. eTMF Only: If you’re creating a binder template within a standard binder document type, use the Hierarchy Mapping field on the binder section to associate each section with a specific Artifact linked to the model selected in Filing Model. Learn more.
  12. Optional: Add planned documents.
  13. When finished, click Done Editing to exit edit mode.

Templates for Auto-Filing Binders

Vault files documents into binders configured for auto-filing based on filing rules that you define for each section of the binder. You can create templates for binders that are configured for auto-filing:

  1. Ensure that the Enable Dynamic Filing checkbox is set from Admin > Settings > Application Settings.
  2. Create a binder template and select which sections should auto-file using the Set Filing Rules action from the Actions menu.
  3. Set the Allow automatic document filing into this section checkbox. This permits Vault to auto-file documents to this section.
  4. Select Any document type or Selected document type to control what document types Vault will file to this section. If you choose Selected document type, you must also specify the document type to be auto-filed.
  5. Select fields that define the filing rules for the documents. When users create binders using this template, they will provide values for these fields when defining the filing rules. For example, if you select the Product field, a user will be able to select a Product value, “Cholecap” for instance, to match documents on.
  6. Optional: Select Propagate fields and values to subsections to apply provided field values to subsections. For example, if a user selects “Cholecap” for the Product field when defining filing rules for a section, Vault applies “Cholecap” to the filing rules of all subsections.

How to Edit Templates

To edit a template:

  1. Change the status of a template directly from the template list by selecting Set to Active or Set to Disabled in the Actions menu.
  2. Click on a template name from the list.
  3. Click Edit in either the template details section or the binder structure section.
  4. Make any necessary changes. You can update the template label, name, status, or binder structure. You can also add planned documents.
  5. Click Save. The updated template is immediately available to users, but the changes do not affect documents created before the update.

How to Move Templates

Moving a binder means selecting a new document type for it and removing its association with the current document type. To move a binder template:

  1. Select the Move option from the template list Actions menu.
  2. In the dialog, select a new document type for the binder template.
  3. Click OK to move the template to the new document type.

How to Copy Templates

Copying binder templates creates a duplicate which you can associate with a different document type. Once copied, the templates are entirely separate. Changes you make to one template do not affect the other. To copy a binder template:

  1. Select the Save As option from the template list Actions menu.
  2. In the dialog, select the document type for the copied template.
  3. Click OK to create a new instance of the template.

How to Disable and Delete Templates

Deleting a template permanently removes it from the Vault and deletes the binder structure. Disabling makes the template temporarily unavailable to users creating new binders. Setting the disabled template back to Active makes it available again. Neither action affects binders created from the template.

To delete a template:

  • From the template list panel, select Delete from the Actions menu.
  • From the template details page, click Delete.

To disable a template:

  • From the template list panel, select Set to Disabled from the Actions menu.
  • From the template detail page, click Edit, change the status and click Save.

Audit Trail

The audit trail for a binder created from a binder template includes an event that lists the binder template used: ‘Binder created from template “<template name>”.’ For example, ‘Binder created from template “WonderDrug Binder Template”.’

Configuring Templates for the TMF Viewer

The TMF Viewer allows users to manage a TMF by browsing dynamically organized content and switching between multiple configured hierarchies, represented by binder templates.

eTMF Vaults include specialized binder templates with the default document types Study Level File, Study Country Level File, or Study Site Level File. Note that these document types may have been renamed in your Vault. To make one of these binder templates available in the TMF Viewer, it must meet the following criteria:

  • Status must be “Active.”
  • Filing Model must be selected.
  • Filing Model cannot be “Binder Section to Document Type” or “Vault Clinical Docs.”
  • Enable Dynamic View setting must be checked.

To make a general binder template (not one of the specialized templates described above) available in the TMF Viewer, it must meet the following criteria:

  • Status must be “Active.”
  • Enable Dynamic View setting must be checked.

Note that the Platform Dynamic Filing feature must be enabled by Veeva Support for the eTMF Vault in order for the Enable Dynamic View setting to be available on the general (non-specialized) binder templates. The TMF Viewer will show documents in the binder nodes based on the specified filing criteria for those nodes.