Active Dossier Configuration (RIM)

RIM Submissions and RIM Submissions Archive Vaults include the Active Dossier structure to help sponsors maintain a list of current documents for a given product and market. Users can view the Active Dossier in a designated tab to see a document’s status across multiple markets.

When configured, Vault can automatically populate the Active Dossier based on changes to Submission and Regulatory Objective records:

When a Submission record moves to the Health Authority Received state, Vault can automatically create and update Active Dossier Item and Active Dossier Item Detail records. Active Dossier Structure records may be created for newly-added Active Dossier Items.
When a Regulatory Objective record moves to the Health Authority Approved state, Vault can automatically update Active Dossier Item and Active Dossier Item Detail records for all related submissions.

You can also configure Vault to generate Active Dossier records from a Global Content Plan dispatch.

Note: This feature is only available in Vaults licensed for both RIM Submissions and RIM Submissions Archive. Active Dossier generation from Global Content Plan Dispatch requires a license for RIM Registrations.

Active Dossier Objects & Components

The following objects support the Active Dossier and capture the structure, product-related metadata, and the status of a specific document within a given market or country:

Active Dossier Template contains the template outline of the Active Dossier. Active Dossier Template records are provisioned and maintained by Veeva. Users can only edit the Status, Document Type, and Reference Model fields on these records. The Active Dossier Template is limited to Quality documents.
Active Dossier Structure contains the outline of the Active Dossier built based on metadata and the Active Dossier Template. Vault creates these records automatically based on the tokens specified in the Active Dossier Template records and unique combinations related object reference fields. For example, Vault creates a “3.2.S Drug Substance - Wondersubstance” Active Dossier Structure record for Active Dossier Item records with “Wondersubstance” as the Active Substance.
Active Dossier Item captures each individual source document and version and the current state of the document per country, as well as the product information metadata. Users cannot edit the product information metadata or any fields related to the document.
Active Dossier Item Detail is a child object of Active Dossier Item that captures the in-progress state and additional context of the document in a specific country. This includes the regulatory transaction related references such as the Application, Regulatory Objective, Submission, Event, and Activity. It also captures additional documents related to the instance of the document for the country, such as the Submissions Archive Document and Translation Document. Users cannot edit the Country, product information fields, or any fields related to the document.
Active Dossier Loader is a raw object available for creating Active Dossier records for migration purposes. To expedite the initial migration in your Vault, you can use Vault Loader to load records of this object to quickly create Active Dossier Item, Active Dossier Item Detail, and Active Dossier Structure records in bulk. See Loading Active Dossier Records.

Configuration Overview

Activate the Active Dossier tab and reorder it to be a sub-tab of the Product tab.
Activate and configure the Edit Active Dossier and View Active Dossier actions. See details about configuring these actions below.
Create an object workflow that allows Vault to generate Active Dossier records when submission creation completes. See details about object workflow configuration for submissions below.
Review your Vault’s Submission object lifecycle configuration. Add a Start Workflow entry action for the Generate AD records from Submissions workflow on the Health Authority Received state, and for any lifecycle states where records should be generated, for example, the Archived state.
Review your Vault’s Regulatory Objective object lifecycle configuration. Add an Update Active Dossier entry action on the Health Authority Approved state, and any lifecycle states where the status and optionally the Approval Type of related Active Dossier records should be updated, for example Rejected, Withdrawn, or On Hold.
Update the Regulatory Objective object page layout to add a related object section for the Active Dossier Item Details object.
Update Active Dossier Template records to populate the Document Type field or the Reference Model field. See details about updating the Active Dossier Template below.
Enable the Active Dossier Consolidation Application Setting to allow Vault to consolidate Active Dossier sections by Product or Active Substance. See details about consolidating Active Dossier sections below.
Review your Vault’s security configuration to ensure users can view and create Active Dossier records, as well as execute actions.
Optional: Load active dossier records using Vault Loader. This step is recommended if your organization plans to migrate dossier information from an existing custom solution or an external system for tracking current documents in Vault. See Loading Active Dossier Records.
Optional: Configure your Vault to generate Active Dossier records from a Global Content Plan dispatch.

Configuring Active Dossier Actions

The Edit Active Dossier and View Active Dossier actions are available on the Submission, Regulatory Objective, and Event objects. When a user selects either action from these records, Vault filters the Active Dossier based on the record’s join relationships.

Complete these steps on the Submission, Regulatory Objective, and Event objects:

Navigate to Admin > Configuration > Objects > {Object} > Actions.
Edit the Edit Active Dossier and View Active Dossier actions and set the Status to Active for both.
Navigate to Admin > Configuration > Objects > {Object} > Object Types and click Actions.
From the Actions menu, select Edit Object Type Actions.
Add the Edit Active Dossier and View Active Dossier actions to all object types.
Click Save.

Configuring Active Dossier Workflows

Configuring an Active Dossier Workflow for Submissions

Vault includes a system action that generates Active Dossier records automatically after submission creation is complete. Configure a new object workflow that includes this system action as follows:

Navigate to Admin > Configuration > Workflows and click Create.
Select the Object Workflow type in the Create Workflow dialog and click Continue.
Enter a Label. We recommend Generate AD records from Submissions.
In the Lifecycle field, select Submission Lifecycle.
Set the Allow auto-start from entry action and event action checkbox.
Click Save to save the workflow and begin adding steps.
Create a Generate AD Records step and select the System Action type.
In the System Action field, select Populate the Active Dossier.
Click Save.
Activate the workflow.

Configuring Regulatory Objective Lifecycle Update Active Dossier Entry Actions

The Update Active Dossier entry action automates the status change of Active Dossier records to Pending Current/Superseded/Deprecated, Rejected, Withdrawn, or No Decision. The entry action can also be configured to set the Approval Type when updating records to Pending Current. To configure this entry action:

Navigate to Admin > Configuration > Object Lifecycles > Regulatory Objective.
Configure an Update Active Dossier entry action on a Regulatory Objective lifecycle state and select the corresponding Decision/Status.
If No Decision, Rejected, or Withdrawn is selected, then all valid Active Dossier Item Detail records related to the Regulatory Objective are moved into that configured status. If Current is selected, then the pending Current/Superseded/Deprecated calculation is run. For example, Vault moves valid Active Dossier records related to the Regulatory Objective to Pending Current, and previous superseded Active Dossier Item Details to Pending Superseded.
If the Decision/Status is set to Current, then the Approval Type is displayed/available for configuration.
Click Save.

Configuring Active Dossier Generation from a Global Content Plan Dispatch

When Global Content Plan creation, dispatch, and synchronization are configured in your Vault, enable the Populate Active Dossier action to generate Active Dossier records from a dispatch.

In the Content Plan lifecycle, update the configured Dispatch Global Content Plan user actions to use the Populate Active Dossier configuration option. When following the recommended configuration for Content Plan Synchronization, these actions appear in the Draft and Baselined states.
In the Event lifecycle, update the configured Dispatch Global Content Plan user actions to use the Populate Active Dossier configuration option. When following the recommended configuration for generating Global Content Plans, these actions appear in the Planned, In Progress, In Regulatory Assessment, and Regulatory Assessment Complete states.
Ensure Attachments are allowed on the Submission and Event objects, and the Enable Dispatch Comparison setting in Admin > Settings > Application Settings is enabled. This feature is not otherwise supported without these enablements.
Optional: Use the Active Dossier Loader object to set the relevant Event, Activity, and Needs Submission values in existing Active Dossier Item Detail records.

About the Populate Active Dossier Action

During configuration, Vault lists disposition scenarios with defaulted Local Disposition picklist values. Each disposition corresponds to the Local Disposition value set on the target Activity, and Vault references the value when creating Active Dossier records. Custom disposition picklist values can additionally be configured in the appropriate category. Active Dossier records will only be created for Activities with a Local Disposition that is configured in one of the disposition categories.

While dispatch and Active Dossier generation logic allow you to relabel the default Local Disposition values, we do not recommend rearranging the defaulted values for each scenario.

Working with Active Dossier Templates

Active Dossier Template records representing the Active Dossier outline are provisioned and maintained by Veeva. The sections below provide the recommended configuration for managing the existing records in your Vault.

Updating Active Dossier Templates

Note: For Veeva to properly maintain Active Dossier records, you cannot delete Active Dossier Template records, nor update a record’s RIM UUID field.

The Active Dossier Template object includes the Document Type and Reference Model fields. Vault uses these fields to determine which documents to add to the Active Dossier.

By default, Vault references the value in the Document Type field to determine the document types to include in the Active Dossier structure. You can populate the Document Type field by navigating to Business Admin > Active Dossier Template and assigning a Document Type to each record.

If the Document Type field is blank, Vault instead references the value in the Reference Model field when creating the Active Dossier Structure. The Active Dossier Template records provisioned by Veeva include values in the Reference Model field by default, but you must configure the RIM Reference Model in order for Vault to use it when creating the Active Dossier.

See How Active Dossier Uses the RIM Reference Model for more information.

Loading Active Dossier Records

If your organization is adopting Active Dossier to replace an existing custom solution or an external system for tracking submitted documents in Vault, you can use the Active Dossier Loader object to generate the necessary records. We recommend leveraging Vault Loader to create Active Dossier Loader records in bulk.

Once you’ve migrated source documents into your Vault Library, prepare a CSV input file containing the required and optional object fields to load to the Active Dossier Loader object.

When you load data to the Active Dossier Loader object, Vault uses it as an intermediate staging object to assess the standing of Active Dossier Item, Active Dossier Item Detail, and Active Dossier Structure object records in your Vault. Following the assessment, Vault creates or updates these records according to the input file.

The CSV output file Vault sends once the load is complete does not include the Active Dossier Item, Active Dossier Item Detail, and Active Dossier Structure records it created based on the Active Dossier Loader object data. You can confirm these records directly in your Vault, or extract the data from each object using Vault Loader.

The sections below outline the Active Dossier Loader required and optional object fields to include in your CSV input file, as well as the target objects and fields Vault creates, populates, and updates during the loading process.

Required Fields

The table below describes the fields required to load to the Active Dossier Loader object.

Note: To prevent invalid metadata combinations, only one of the fields marked with an asterisk (*) can be populated. For example, the Active Substance field should remain blank when the Product field is populated.

Active Dossier Loader Field	Target Object(s)	Target Field(s)
Source Document (`document__v`)	Active Dossier Item, Active Dossier Item Detail	ADI: Document, Document Number, Document Title, Document Version ID ADID: Document, Document ID, Document Major Version, Document Minor Version
Country (`country__v`)	Active Dossier Item Detail	Relevant country field
Active Substance* (`active_substance__v`)	Active Dossier Item	Active Substance
Product* (`product__v`)	Active Dossier Item	Product Note: If the Inactive Ingredient field is populated, Product must also be populated.
Product Family (`product_family__v`)	Active Dossier Item, Active Dossier Item Detail	ADI: Product Family ADID: Product Family

About XML Fields

The following fields are used to locate the correct Submissions Archive node and are required when there is more than one valid node for the Application and Submission, for example when a document is used in multiple sections within the same Submission:

XML Product (xml_product__v)
XML Manufacturer (xml_manufacturer__v)
XML Product Dosage Form (xml_product_dosage_form__v)
XML Drug Substance (xml_drug_substance__v)
XML Excipient (xml_excipient__v)

Optional Fields

The table below describes fields that are optional to include in the loader file.

Active Dossier Loader Field	Target Object(s)	Target Field(s)	Additional Considerations
Active Dossier Status (`active_dossier_status__v`)	Active Dossier Item, Active Dossier Item Detail	Active Dossier Status
Active Substance Manufacturer (`active_substance_manufacturer__v`)	Active Dossier Item	Active Substance Manufacturer	When populated, Active Substance must also be populated.
Activity (`activity__v`)	Active Dossier Item Detail	Activity	When enabling Active Dossier generation from a Global Content Plan, use this field to set a related Activity.
Application (`application__v`)	Active Dossier Item Detail	Application
Event (`event__v`)	Active Dossier Item Detail	Event	When enabling Active Dossier generation from a Global Content Plan, use this field to set a related Event.
Inactive Ingredient (`inactive_ingredient__v`)	Active Dossier Item	Inactive Ingredient	When populated, the Product field must also be populated. See also Required Fields.
Inactive Ingredient Manufacturer (`inactive_ingredient_manufacturer__v`)	Active Dossier Item	Inactive Ingredient Manufacturer	When populated, Inactive Ingredient must also be populated.
Needs Submission (`needs_submission__v`)	Active Dossier Item Detail	Needs Submission	When enabling Active Dossier generation from a Global Content Plan, the “Yes” picklist value denotes records with dispositions requiring submission before implementation.
Product Manufacturer (`product_manufacturer__v`)	Active Dossier Item	Product Manufacturer	When populated, Product must also be populated.
Product Variant (`product_variant__v`)	Active Dossier Item	Product Variant	When populated, Product must also be populated.
Regulatory Objective (`regulatory_objective__v`)	Active Dossier Item Detail	Regulatory Objective
Submission (`submission__v`)	Active Dossier Item Detail	Submission
Submissions Archive Document (`archive_document__v`)	Active Dossier Item Detail	Submission Metadata, Submissions Archive Document, Is eCTD	When populated, Application and Submission must also be populated. In some cases, XML fields must also be populated in order to locate the correct Submission Archive node. See About XML Fields.
Template (`template__v`)	Active Dossier Item Detail	Template, Section	When blank, the source document’s Document Type determines which template section in which to add records. Otherwise, the Template field is required if the document type is not mapped in the Active Dossier Template or RIM Reference Model.
Translation Document (`translation_document__v`)	Active Dossier Item Detail	Translation Document

The sections below describe the minimum object permissions required for users to work within both the Active Dossier Viewer and Editor. All permissions are located in Admin > Users & Groups > Permission Sets.

Objects & Tabs

The permissions described below are located in the Objects or Tabs permission set tabs. For objects, you can also set these by clicking on the object and making selections under the Object Permissions heading.

Note: If Dynamic Access Control is enabled in your Vault for any of the below objects, a corresponding matching or custom sharing rule must be in place to ensure users can view and work with records.

Object or Tab	Permission	Controls
Active Dossier Item, Active Dossier Item Detail	Read, Create, Edit	Read: View Active Dossier records in the Viewer. Create, Edit: Ability to access the Add to Active Dossier dialog from the Editor and create Active Dossier records. Note: Create and Edit functions are also controlled by field permissions. See Object Fields below.
Country Decision Detail	Read	Ability to view Active Dossier records in the Viewer and Editor.
Tabs: Active Dossier	View	Ability to access the Viewer from the tab.

Object Fields

The Active Dossier Item and Active Dossier Item Detail object fields listed below are minimally required to access and perform tasks within the Viewer and Editor.

The permissions described are located in the permission set tab Objects > [Object] > Object Field Permissions.

Note: Fields marked with an asterisk (*) are collectively the minimally-required fields to which users must have Edit access in order to create Active Dossier records in the Editor. If a user is missing Edit permission to any of them, the drag-and-drop action fails.

Field	Permission	Controls
Active Substance*	Read, Edit	Read: View and filter by column. Edit: Add metadata.
Active Substance Manufacturer*	Read, Edit	Read: View and filter by column. Edit: Add metadata.
Activity	Edit	When the Editor is opened from an Event, ability to add metadata upon drag and drop.
Application*	Read, Edit	Read: View and filter by column, as well as view the field in the hovercard in the Viewer. Edit: Add metadata.
Document	Read, Edit	Read: View and filter by column, as well as view document details in the hovercard in the Viewer. Edit: Add documents. Note: Users must also have corresponding permissions to view the document.
Event	Edit	When the Editor is opened from an Event, ability to add metadata upon drag and drop.
Inactive Ingredient*	Read, Edit	Read: View and filter by column. Edit: Add metadata.
Inactive Ingredient Manufacturer*	Read, Edit	Read: View and filter by column. Edit: Add metadata.
Latest Change Comments	Edit	Edit is required in order to enter optional comments when performing an edit or delete in the Active Dossier Editor
Product*	Read, Edit	Read: View and filter by column. Edit: Add metadata.
Product Family*	Read	Ability to load the Viewer or Editor.
Product Manufacturer*	Read, Edit	Read: View and filter by column. Edit: Add metadata.
Product Variant*	Read, Edit	Read: View and filter by column. Edit: Add metadata.
Region	Read	Ability to load the Viewer or Editor.
Reason for Change	Edit	Edit is required in order to enter the required reason when performing an edit or delete in the Active Dossier Editor
Regulatory Objective*	Read, Edit	Read: View and filter by column, as well as view the field in the hovercard in the Viewer. Edit: Add metadata.
Submission*	Read, Edit	Read: View and filter by column, as well as view the field in the hovercard in the Viewer. Edit: Add metadata.
Submissions Archive Document	Read, Edit	Read: View and filter by column, as well as view document details in the hovercard in the Viewer. Edit: Add documents. Note: Users must also have corresponding permissions to view the document.
Translation Document	Read, Edit	Read: View and filter by column, as well as view document details in the hovercard in the Viewer. Edit: Add documents. Note: Users must also have corresponding permissions to view the document.
Any applicable country field, for example Afghanistan (AF)*	Read, Edit	Read: View and filter by column. Edit: Add metadata.

Object Actions

The permissions described below are located in the permission set tab Objects > [Object] > Object Action Permissions.

Object	Action	Permission	Controls
Submission	View Active Dossier	View, Execute	Ability to open the Viewer, filtered by the submission’s relationships.
Submission	Edit Active Dossier	View, Execute	Ability to open the Editor, filtered by the submission’s relationships.
Regulatory Objective	View Active Dossier	View, Execute	Ability to open the Viewer, filtered by the regulatory objective’s relationships.
Regulatory Objective	Edit Active Dossier	View, Execute	Ability to open the Editor, filtered by the regulatory objective’s relationships.