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.
- 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.
- 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 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
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.
About Consolidated Active Dossier Sections
Active Dossier Template records provisioned by Veeva include tokens, which Vault uses to create repeating Active Dossier Structure records.
As of the 24R1 release (23R3.2), Active Dossier sections are automatically consolidated 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.
Note: In Vaults created on or before the 23R3 release, Active Dossier Template records included 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 were difficult to navigate for users unfamiliar with the submission strategy. See What’s New in 24R1 for a brief overview of this feature’s implementation.
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 |
Related Permissions
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. |
| 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. |