The Active Dossier structure in Vault helps sponsors maintain a list of current documents for a given product and market. Vault automatically populates and updates the Active Dossier structure for a given submission or a regulatory objective and its related submissions based on source content in your Vault.
You can use the Active Dossier Viewer to see the content that is currently approved as well as a document’s status across multiple markets. The Active Dossier Editor allows you to update the Active Dossier and add new documents directly into the structure.
Note: This feature is only available on RIM Vaults. An Admin must configure your Vault to support Active Dossiers.
About the Active Dossier
Vault includes four objects that make up the Active Dossier: Active Dossier Template, Active Dossier Structure, Active Dossier Item, and Active Dossier Item Detail. Vault automatically populates and updates the Active Dossier structure for a given submission or a regulatory objective and its related submissions based on source content in your Vault. In countries where submissions must be provided to the Health Authority in the local language, Vault also includes the translation source files in the Active Dossier structure. See About Active Dossiers for more information about the supporting objects and how Vault creates, populates, and updates Active Dossiers.
Active Dossier Actions
The View Active Dossier and Edit Active Dossier actions in a supported record’s Actions menu open the Active Dossier Viewer and Active Dossier Editor, respectively. Vault pre-filters the available Active Dossier records within the viewer and editor based on the record from which you opened the dossier.
Opening the Active Dossier from an Event
You can view and edit an Active Dossier from an Event record.
Vault opens the Active Dossier Viewer or the Active Dossier Editor with filters automatically applied:
- If the View or Edit Active Dossier from Transaction - Default filter by Transaction setting is selected, Vault filters the records directly on the Submission.
- If the View or Edit Active Dossier from Transaction - Default filter by Transaction setting is de-selected, Vault filters the records on the Submission relationships:
- The Product, Product Variant, Manufacturer, Active Substance, and Inactive Ingredient fields within the Submission Product, Submission Active Substance, and Submission Inactive Ingredient relationship records
- The Product Family Application records from the Submission’s Application
The Country columns you see in the Active Dossier Viewer are based on a combination of the activity’s related Submission Country records (as determined by the Activity record’s Related Submission field) and the countries populated in the Activity record’s Impacted Market field. Vault does not display Country columns if these components do not exist or are blank.
While Vault does not automatically include a Country column in the Active Dossier Editor, the records you see are filtered according to the Active Dossier Item Detail records for the relevant countries.
Opening the Active Dossier from a Submission
You can view and edit an Active Dossier from a Submission record.
Vault opens the Active Dossier Viewer or the Active Dossier Editor with filters automatically applied:
- If the View or Edit Active Dossier from Transaction - Default filter by Transaction setting is selected, Vault filters the records directly on the Submission.
- If the View or Edit Active Dossier from Transaction - Default filter by Transaction setting is de-selected, Vault filters the records on the Submission relationships:
- The Product, Product Variant, Manufacturer, Active Substance, and Inactive Ingredient fields within the Submission Product, Submission Active Substance, and Submission Inactive Ingredient relationship records
- The Product Family Application records from the Submission’s Application
The Country columns you see in the Active Dossier Viewer are based on the Submission Country join records. If no Submission Country join records exist, Vault displays Country columns based on the Region of the Submission’s Application.
While Vault does not automatically include a Country column in the Active Dossier Editor, the records you see are filtered according to the Active Dossier Item Detail records for the relevant countries.
Opening the Active Dossier from a Regulatory Objective
You can view and edit an Active Dossier from a Regulatory Objective record.
When the setting is deselected, Vault opens the Active Dossier Viewer or the Active Dossier Editor with filters automatically applied:
- If the View or Edit Active Dossier from Transaction - Default filter by Transaction setting is selected, Vault filters by the record directly.
- If the View or Edit Active Dossier from Transaction - Default filter by Transaction setting is de-selected, Vault filters by the Event relationships:
- The Product, Product Variant, Manufacturer, Active Substance, and Inactive Ingredient fields within the Event Product, Event Active Substance, and Event Inactive Ingredient relationship records
- The Related Application’s Product Family records
The Country columns you see in the viewer are based on the Regulatory Objective’s Country Decision Detail records. If there are no related Country Decision Detail records, Vault displays Country columns based on the Region of the Regulatory Objective’s Application.
While Vault does not automatically include a Country column in the Active Dossier Editor, the records you see are filtered according to the Active Dossier Item Detail records for the relevant countries.
Viewing the Active Dossier
You can open the Active Dossier Viewer from the Active Dossier tab, or from a Submission, Regulatory Objective, or Event record. Where you open the viewer determines the Active Dossier structure you see and the documents included.
This section explains how to use the Active Dossier Viewer. In addition to the options in this section, some options are available in both the Active Dossier Viewer and the Active Dossier Editor, such as filters, saved view, and more. See details about using the Active Dossier Viewer and Editor below.
Opening the Active Dossier Tab
To open the Active Dossier Viewer directly, click the Active Dossier tab. The location of this tab depends on your Vault’s configuration. When you open the Active Dossier Viewer from the Active Dossier tab:
- Select the filter object from the the picklist:
- Non-transactional filters include Active Substance, Product, Product Family, Product Variant, _and _Manufacturer.
- Transactional filters include _Application, Event, Registration, Regulatory Objective, _and _Submission. _
- When a transactional filter is displayed, the country columns displayed are determined by the selected countries or regions. When a non-transactional filter is applied, you can select between Region **or **Country.
Vault displays the Active Dossier based on the values you select in these filters.
Viewing Country Status
Icons in each row of the grid tell you whether the country that you’re viewing is Current (
), Dispatched (), Submitted (
), Superseded (
), or Deprecated (
). When you hover over a country’s status, Vault displays a hovercard with fields from the corresponding Active Dossier Item Detail record. The hovercard includes links to source documents tracked in Active Dossier, submitted documents in Submissions Archive, as well as the following objects:
- Application
- Regulatory Objective
- Submission
- Event
- Activity
When the Translation Document field is populated on the Active Dossier Item Detail record, the document appears in the hovercard with the Translated Document icon. When a source document is not in English, Vault expects the source English document to be set using the Translation Document relationship on the non-English document.
Viewing Only Current Documents
You can toggle to adjust the content you see in the Active Dossier Viewer. The toggle appears above the grid, next to the Actions menu on the far right of the screen.
- Clicking Show All displays all Active Dossier Structure and Active Dossier Item records that are relevant based on applied filters.
- Clicking Show Only Current displays only Active Dossier Item records for which the country’s Active Dossier Item Detail record has the Current status is the Active Dossier Status field. Vault also includes the parent Active Dossier Template and Active Dossier Structure records for the current Active Dossier Item records.
When the Show Only Current view is applied in the Active Dossier Viewer, Vault includes only the Active Dossier Item for which the country’s Active Dossier Item Detail record has the Current status is the Active Dossier Status field in an Excel Tree with All Descendants export.
Viewing Only Pending Documents
You can toggle to adjust the content you see in the Active Dossier Editor. The toggle appears above the grid, next to the Actions menu on the far right of the screen.
- Clicking Show All displays all Active Dossier Structure and Active Dossier Item records that are relevant based on applied filters.
- Clicking Show Only Pending displays only Active Dossier Item Detail records with a Pending-type status in the Active Dossier Status field, for example, Pending Current or Pending Superseded. Vault also includes the parent Active Dossier Template and Active Dossier Structure records for the pending Active Dossier Item records.
When the Show Only Pending toggle is applied in the Active Dossier Editor, Vault includes only the Active Dossier Item Detail records with a Pending-type status in an Excel Tree with All Descendants export.
Editing the Active Dossier
In the Active Dossier Editor, you can see and edit the pending Active Dossier Item Detail records included in the current Active Dossier structure. Vault orders all Active Dossier Item Detail records within a section based on the country, submission, and document name. Vault always displays the Active Dossier Status field in the Active Dossier Editor grid, but the rest of the columns you see depend on your Vault’s configuration.
This section explains how to use the Active Dossier Editor. In addition to the options in this section, some options are available in both the Active Dossier Viewer and the Active Dossier Editor, such as filters, saved view, and more. See details about using the Active Dossier Viewer and Editor below.
Opening the Active Dossier Editor
You can open the Active Dossier Editor from a Submission, Regulatory Objective, or Event record. Vault displays the Active Dossier structure and documents differently depending on how you access the editor.
Inline Editing
You can inline edit object record fields in the grid.
Performing Bulk Actions
In the Active Dossier Editor, you can perform bulk actions on object records in the grid. There are two ways to perform bulk actions:
- When you select Perform Bulk Action from the Actions menu above the grid pane, Vault includes all records within the current filtered view in the scope of the action.
- When you select Perform Bulk Action from a record’s Actions menu within the grid, Vault includes all of the filtered section’s descendant Active Dossier Item Detail records in the scope of the action.
Adding a Single Document to the Active Dossier
When a document is unaccounted for in an imported submission or a local country requires an extra document, you can drag documents from your Vault Library and drop them into the Active Dossier structure. To add a document to the Active Dossier:
- Open the Active Dossier Editor in one browser window and the Library in another browser window. You must use the same browser for both windows.
- Click the document’s name in the Library and drag it into the Active Dossier structure in the grid. Vault shows an orange dotted border around the target record.
- Drop the document into the desired location.
- In the Add to Active Dossier dialog, Vault populates the section name based on the section where you dropped the document. Alternatively, you can select a different template section to, for example, correct any drag and drop errors, or to set the document within a section that is not displayed in the editor. Select a Country, populate additional document fields, and click Save.
- Vault creates the Active Dossier Structure, Active Dossier Item, and Active Dossier Item Detail records automatically based on the fields you populated in the dialog and adds them inline in the Active Dossier Editor. If an error occurs, Vault displays a banner to inform you about the reason for the failure.
When you drag and drop a document into a section, Vault uses that section’s parent section as the parent Active Dossier Structure record for the new Active Dossier Item record by default. You can also select a different active template section from the Section picklist in the dialog.
If the document you add has the Submissions Archive document type, Vault retrieves the source document and translation document.
Limitations
- You cannot drag and drop a binder into the Active Dossier structure.
- You cannot drag and drop a document from another Vault.
- You cannot drag and drop a Submissions Archive-type document that does not have a Source Reference relationship.
Updating Country Status
After you’ve reviewed the pending Active Dossier Item Detail records and made any changes, you can update the country’s status on the parent Active Dossier Item record in one of two ways:
- Choose Set Active Dossier Item Country Status from an Active Dossier Item Detail record’s Actions menu in the grid.
- Apply filters in the Active Dossier Editor to narrow your view, and then perform a bulk action.
When the action runs, Vault updates the corresponding country’s field on the Active Dossier Item record based on the Active Dossier Status and Country fields on the Active Dossier Item Detail record. For example, if an Active Dossier Item Detail record for Canada is Current or Pending Current, Vault sets the Canada (CA) field on the Active Dossier Item record to Current.
Vault cannot update the Active Dossier Item record if a country’s field is inactive or missing, or if there is no matching lifecycle state in the Active Dossier Status field.
Using the Active Dossier Viewer & Editor
These options are available when working in either the Active Dossier Viewer or the Active Dossier Editor. Note that Vault only loads the first 2,000 records in both the viewer and the editor.
Customizing the Grids
Both Active Dossier views offer options for customizing the grid appearance:
Resizing Columns
Resize the width of each column by dragging the edges of the column heading. An orange dotted line appears while you drag.
Rearranging Columns
Change the order of columns for each object by clicking and dragging the column header to a new location in that object’s column group. A blue dotted line appears to highlight the new location while you drag. You cannot move the Name column.
Adding or Removing Columns
To add or remove columns, select Edit Columns from the Actions menu above the grid. Vault opens a dialog of fields sorted by object. From the dialog box, you can move fields between the Available Columns box and the Selected Columns box. In the Selected Columns box, rearrange the column order using the Up and Down arrow buttons. To reset all settings to default, click Restore.
You cannot remove or rearrange the Name column. To improve performance, we recommend adding no more than 16 columns, including the Name column.
Customizing Column Text Appearance
Sometimes text is too long to fit properly inside its column. In the main Actions menu, the Truncate Cell Text and Wrap Cell Text options let you toggle between truncating and wrapping cell text.
Opening Sections
Vault opens both the Active Dossier Viewer and the Active Dossier Editor with all sections collapsed. To expand or collapse an individual section, click the caret icons. To expand an entire section and its descendant records, open a record’s Actions menu in the grid and click Expand.
Breadcrumbs
When you click a record’s name in the grid, Vault shows that record as the root and updates the breadcrumb trail to reflect your selection. Clicking a link to a content plan section or content plan item in the breadcrumb trail refreshes the grid to display that section.
Filtering
Some columns in the grid include a Filter icon. When this icon is available, you can apply a filter on that field. Vault applies your filters to the entire Active Dossier structure. To apply a filter, click the Filter icon, select or enter a filter value, and click Apply.
Applied filters appear under the Filters section above the grid. You can click the caret icon next to Filters to hide or view your applied filters. All filtered results appear in the grid until you refresh the page, even if you update values so that they no longer meet filter criteria or so that additional items meet filter criteria. To remove filters, click the X button to clear an individual filter or Clear All Filters at once.
Using Global Filters
Viewing or editing Active Dossier from a RIM transactional record (Submission, Regulatory Objective, Event) displays the filtered Active Dossier with the global filter header set appropriately.
When the View or Edit Active Dossier from Transaction – Default filter by Transaction setting is de-selected, Vault displays records based on the selected transactional record’s relationships.
When the View or Edit Active Dossier from Transaction – Default filter by Transaction setting is selected, Vault displays records based on the selected transactional record.
Using Saved Views
Saved views allow you to save or “bookmark” your current columns, filters, and grid settings and return to this view with a single click. Using Saved Views in RIM describes using saved views in the Active Dossier Viewer and Active Dossier Editor, although much of the functionality is similar to custom views in the Library.
When you navigate to the Active Dossier Viewer or Active Dossier Editor from a Submission or Regulatory Objective record and create a saved view, Vault saves the source record as part of the view. Saved views are specific to the Active Dossier Viewer and Active Dossier Editor. A view you create in the Active Dossier Viewer will not be available in the Active Dossier Editor and vice versa.
Using the Mini-Browser
You can click the pop-out icon next to the Active Dossier Item Detail records in the grid pane to view the associated document in a mini-browser window while maintaining your current view in the grid. When you open another document from the Active Dossier Viewer or Active Dossier Editor, Vault refreshes the current mini-browser window with the new details. Note that you’ll need to enable pop-ups in your browser to open the mini-browser viewer.
Exporting the Active Dossier
To export the filtered Active Dossier view to Microsoft Excel, open the main Actions menu above the grid and select Excel Tree with All Descendants. Vault exports the tree asynchronously and sends you an email and a Vault notification when complete.
When you export the Excel tree, Vault downloads the current grid view, including the current columns in the grid and the Active Dossier Status field, in XLSX format. Values in the Name column and document columns link back to the object record detail page or the document viewer.
Related Permissions
Generally, to view or create records and fields within the Active Dossier Viewer or Editor, you must have the respective Read or Edit permissions for the Active Dossier Item and Active Dossier Item Detail objects and fields. You must also have the appropriate permissions to view the documents in the Active Dossier.
See Active Dossier Configuration for further details.