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 the Active Dossier Structure, Active Dossier Item, and Active Dossier Item Detail records.
When a Regulatory Objective record moves to the Health Authority Approved state, Vault can automatically create the Active Dossier Structure, Active Dossier Item, and Active Dossier Item Detail records for all related submissions.

Note: This feature is only available in Vaults licensed for both RIM Submissions and RIM Submissions Archive.

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 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 with corresponding metadata based on the Active Dossier Template. Vault creates these records automatically based on unique combinations related object reference fields, for example, a unique combination of Active Substance and Manufacturer.
Active Dossier Item captures each individual document and version and the current state of the document per country, as well as the metadata related to the document. Users cannot edit the Country field 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 of the document in a specific country. Users cannot edit the Country field or any fields related to the document.
Active Dossier Loader is a high volume 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.
Create another object workflow that allows Vault to calculate what is current in the Active Dossier when a regulatory objective is approved. See details about object workflow configuration for regulatory objectives below.
Recommended: Create an object workflow and configure the Active Dossier Item Detail and Regulatory Objective lifecycles to clear Submitted Active Dossier records when a regulatory objective is rejected or withdrawn. See details about Configuring the Clear AD Status Workflow below.
On the Regulatory Objective object lifecycle’s Health Authority Approved state, add a Start Workflow entry action for the Calculate AD Status from Reg Objective workflow.
To allow users to generate Active Dossier from an Event record, update the Active Dossier Update Country on ADI workflow to include two new rules and actions.
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.

Configuring Active Dossier Actions

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

Complete these steps on both the Submission object and the Regulatory Objective object:

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 the Clear AD Status Workflow

If a regulatory objective is rejected or withdrawn, the related Active Dossier records remain in the Submitted status. To prevent Vault from displaying them, you can configure the Clear AD Status workflow with supporting object lifecycle entry actions to clear the Active Dossier Status field as follows:

Create a new auto-start object workflow assigned to the Active Dossier Item Detail lifecycle. Enter a Label indicating the workflow result (we recommend “Clear AD Status”) and ensure the Allow auto-start from entry action and event action option is selected in the workflow Details.
Include a system action step to clear the Active Dossier Status field with the following characteristics:
- Label: Clear AD Status
- Type: System Action
- System Action: Set Active Dossier Item Country Status
- Set to value: null (leave blank)
Include a change state action step to update the Active Dossier Item Detail record to Active with the following characteristics:
- Label: Change State to Active
- Type: Action
- A Rule with parameters to always Change State to the Active lifecycle state.
After you save and activate the Clear AD Status workflow, define a new lifecycle state in the Active Dossier Item Detail object lifecycle for Vault to auto-start the workflow. We recommend naming this state Clear Status. Then, create an entry action to always start the newly-created Clear AD Status workflow.
Create an entry action in the Regulatory Objective object lifecycle’s Withdrawn state to always Change related object lifecycle state. Select Active Dossier Item Detail as the Related Object and Clear Status for the lifecycle state.

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 an Active Dossier Workflow for Regulatory Objectives

Vault includes a system action that calculates the Active Dossier’s status automatically after a regulatory objective is approved based on the related submissions and join records. 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 Calculate AD Status from Reg Objective.
In the Lifecycle field, select Regulatory Objective.
Set the Allow auto-start from entry action and event action checkbox.
Click Save to save the workflow and begin adding steps.
Create a Calculate AD Status step and select the System Action type.
In the System Action field, select Update Active Dossier.
Click Save.
Activate the workflow.

Configuring the Active Dossier Update Country on ADI Workflow

To allow updates to an Active Dossier Item Detail record’s Active Dossier Status to cascade to the parent Active Dossier Item’s relevant Country field when the Apply Pending Status Updates action is run, complete the below configurations within the Active Dossier Update Country on ADI workflow.

First, add two new rules to the Is Pending decision step, such that:

If the Active Dossier Status field is blank, Vault clears the status via a new Clear Status placeholder step.
If the Active Dossier Status field equals Dispatched, Vault sets the Active Dossier Item Country Status field to Dispatched via a new Make Dispatched placeholder step.

Then, update the new Clear Status and Make Dispatched steps you created with the following details:

Type: System Action
Next Steps: State Change to Active
System Action: Set Active Dossier Item Country Status
For the Make Dispatched step only: Set to Value: Dispatched

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 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 Setting Up the RIM Reference Model for more information.

If both the Document Type field and the Reference Model field are populated on the Active Dossier Template record, Vault uses the Document Type field value to determine the documents included in the Active Dossier. If neither field is populated, Vault doesn’t reference that Active Dossier Template record when creating the Active Dossier Structure.

Consolidating Active Dossier Sections

Note: For Vaults with at least one active Active Dossier Item record, the Active Dossier Template Consolidation setting can only be enabled after all Active Dossier Item records are first deleted. Veeva plans to enable this feature for existing Active Dossier customers after completing migration of existing Active Dossier records in a future release (24R1 or later). See Enablement & Migration Details.

Active Dossier Template records provisioned by Veeva include tokens, which Vault uses to create repeating Active Dossier Structure records. In Vaults created on or before the 23R2 release, these records include tokens for the Manufacturer and Product Variant objects, causing Vault to create multiple Active Dossier sections for the same product for each combination of product variants and manufacturers submitted across markets. While this correctly reflects a submission’s structure, multiple sections within the Active Dossier Viewer can be difficult to navigate for users unfamiliar with the submission strategy.

Once enabled, Vault consolidates Active Dossier sections based upon the higher-level Product or Active Substance, and Active Dossier Viewer users can use the Product Variant and Product Manufacturer columns to view and filter accordingly. For 3.2.A.1 sections, Vault consolidates Active Dossier sections based on the Manufacturer instead of Product or Active Substance.

Enablement & Migration Details

Enablement will be completed in multiple stages. If your Vault does not have any Active Dossier Item records, the Active Dossier Template Consolidation Application Setting is automatically enabled to prevent duplicate sections, beginning in 23R3 (23R2.2). The setting can only be enabled when a Vault does not have any Active Dossier Item records. Otherwise, you will receive an error when attempting to enable it.

Customers can choose to test this setting in Sandbox environments by first deleting all Active Dossier records and then enabling the setting.

In a future release (24R1 or later), Vaults with existing Active Dossier records will be automatically migrated to the new consolidated structure. Active Dossier Template records will be updated and the enablement setting will be removed from all Vaults.

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.
Application (`application__v`)	Active Dossier Item Detail	Application
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.
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.
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.
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.
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.