RIM Application Settings & Configuration Options

Various settings, actions, and configuration options are available across RIM Vaults.

Settings

To enable an application setting, navigate to Admin > Settings > Application Settings and set the appropriate checkbox:

Active Dossier Settings

Active Dossier Template Consolidation: Prevents Vault from creating duplicate Active Dossier Structure records by automatically removing Product Variant and Manufacturer tokens from existing Active Dossier Template records. This setting is visible only when a Vault does not have any Active Dossier Item records. Once you enable this setting, you cannot disable it. See Active Dossier Configuration for more information.

Linked Documents

  • Allow creation of link annotations: Enables or disables link annotations in RIM Vaults.
    • Enable Create & Import Document Links: When enabled, document links appear in the Doc Info page Linked Documents section. Users can create or remove document links without creating annotations.
    • Allow creation of links to whole documents: When enabled, users can link to whole documents when creating references.
  • Bring forward Linked Document relationships to new versions: Allows users to preserve link annotations as Linked Document relationships when versioning the source document.

RIM Settings

  • RIM Dynamic Linking: Dynamic Linking allows Vault to update Microsoft Word DOCX documents to include PDF named destinations for each heading, table, figure, and title style in the document.
  • Synchronize regulatory objective and submission relationship: Enabling this setting ensures that Vault syncs data from the single-select Regulatory Objective value on the Submission record to many-to-many object records. Use this setting to preserve your data before you enable bundling and the many-to-many relationship between Submissions and Regulatory Objective records in your RIM Vault.
  • Automatic creation of Submission Country records: Enables Vault to automatically create a Submission Country record based on the application’s Lead Market country or any Application Country records that already exist when users create a Submission record.
    • Automatic creation of Submission Language join records: Enables Vault to automatically create Submission Language join records when users create new Submission Country records. This option is only available once you set the Automatic creation of Submission Country records checkbox.
  • Automatic creation of Application Country records: Enables Vault to automatically create an Application Country record based on the selected Lead Market country when users create an Application record.
  • Automatic creation of Product Family join records: Enables Vault to automatically create Product Family join records when users populate the Primary Product Family (product__v) field on certain objects.
  • Automate the Sequence ID creation: Enables Vault to automatically calculate and assign a Sequence ID (xml_submission_id__v) when users create a new Submission record.
  • Automatic creation of Commitment Application records: Enables Vault to automatically create Commitment Application records when users populate the Related Application field while creating or updating Commitment records.
  • Enable Application Relationships: This setting applies to RIM customers enabling the Submission Wizard. For Vaults with RIM Registrations, the setting also changes the behavior of the Create Related Records and Bundling wizards and Global Content Plan. Once you enable this one-way setting in any RIM Vault, you cannot disable it.
    • In RIM Submissions, this setting enables the Submission Wizard, which guides users through creating a Submission, Regulatory Objective, and their relationships. This feature also includes two recommended two-way settings: Enable Relationship Triggers enforces validation and data automation on Application, Regulatory Objective, and Submission relationships, and Exclude Submission Lifecycle States allows an Admin to choose Submission lifecycle states in which to prevent related Application relationships from being edited or deleted.
    • In RIM Registrations, this setting updates the wizards to reference Application relationship records as the source of truth while creating Activities, Submissions, and Regulatory Objectives in bulk or bundling Activities or Regulatory Objectives.
  • Activate the standard Translation Relationship: Enabling this two-way setting activates and displays the standard Translation document relationship panel on all document pages. Organizations using custom relationships can disable this setting.

Admins can also add the Pull Objective Data user action on any lifecycle state of the Submission object lifecycle to enable Vault to asynchronously pull any Regulatory Objective join records to any new Submission record.

Registrations Features

  • Use regulatory objective data as source in manage registered details wizard: When enabled, Vault pulls data from Regulatory Objective records rather than Submissions to create registration data.
  • Configure Registration History Report: Enables the Registration History Report. Use the drop-downs to select the fields on the Regulatory Objective, Registration, and registered details objects that you wish to include as columns in the report.
  • Send manage registered details data for verification: Starts a verification workflow upon completion of the Manage Registered Details wizard. Vault won’t create or update any impacted records until users complete the workflow tasks. Use the drop-downs to select the Registration or registered detail object lifecycle state types in which verification should run and the groups that can participate in the workflow, if desired.
  • Enable Configurable Impact Assessment Reports: Allows for the use of user-defined reports and custom report types when generating Impact Assessment Reports. Use the drop-down to select the report types to use for Impact Assessment Reports.
  • Execute Registrations SDK triggers: RIM Registrations Vaults include several Vault Java SDK record triggers that are automatically enabled. Clearing this setting prevents these triggers from running during Vault migrations. We do not recommend turning this setting off during normal business operations.
  • Set naming pattern for Regulatory Objective Name when using Create Related Records wizard: Allows you to set the naming pattern for new Regulatory Objective records created through the Create Related Records wizard. See details about configuring naming patterns.
  • Set naming pattern for Submission Name when using Create Related Records wizard: Allows you to set the naming pattern for new Submission records created through the Create Related Records wizard. See details about configuring naming patterns.
  • Define default Activity scope when using Create Related Records wizard: Allows you to select the default Activity Scope Level for the Create Related Records wizard. Vault automatically selects this scope when users create activities in the wizard, but users can choose a different value.
  • XEVMPD Attachment Only Notification Recipients: Allows you to select the groups who will receive notifications from the EMA related to XEVMPD attachment-only submissions.
  • XEVPRM Message Sender: Allows you to enter the XEVPRM message sender for attachment-only submissions. This is a label that is registered with the EMA.
  • Prompt for IDMP Viewer User: When enabled, users executing the Generate IDMP Data View action can select a single user to send a notification containing a user-specific link to an IDMP viewer session. When disabled, the notification is sent to the user executing the action.
  • Enable Labeling Automations: Enabling this two-way setting allows Vault to automatically copy Labeling Concept records to underlying Activity records, create Labeling Deviation records based upon the outcome of an Activity lifecycle, and calculate Safety Category and Due Date based upon labeling records.
    • Add Labeling Deviation Fields to copy on Dependency Automation Trigger: Vault copies the selected fields’ values to the new records it creates when setting the Deviation Review Disposition to Accepted for Dependent Countries. Fields which Vault already auto-populates are not available for selection.
  • Enable configurable eAF Reports: Allows users to generate variation and product reports for working with eAF web forms in the EMA portal.
  • Default Document Set on Activity: Sets the Document Set on newly-created Activity records based on the Related Application and Impacted Market field values. When enabled, Vault overrides any configured defaults and defaults the Document Set field.
  • Use regulatory objective data as source when bulk creating registrations: When enabled with Activity and Objective Bundling, Vault pulls data from Regulatory Objective records rather than Applications when creating product, investigational, active substance, and manufacturing site registrations in bulk.
  • Enable Activity and Objective Bundling: A one-way setting which enables users to bundle and split Activities and Regulatory Objectives. When selected, Vault sets the Regulatory Objective field on the Submission object to Inactive, enables the Submission Regulatory Objective relationship, and disables synchronization between Submission and Regulatory Objective records. Enabling the flag also allows Admins to configure lifecycle actions on the Regulatory Objective and Activity lifecycles.
    • Restrict Activity bundling by state: Filters the list of Activities in the bundling and splitting wizards based on the Lifecycle States you select.
    • Restrict Regulatory Objective bundling by state: Filters the list of Regulatory Objectives in the bundling and splitting wizards based on the Lifecycle States you select.
    • Restrict Submission copying for worksharing: Adds an option on the bundling wizard’s Define Submissions step to create additional Submission records for EU worksharing. Select Submission Types to filter the list of Submissions that may be copied for worksharing in the bundling wizard.
    • Restrict Submission record creation for US grouping: Adds an option on the bundling wizard’s Define Submissions step to create additional Submission records for US grouping. Select Submission Types to filter the list of Submissions that may be copied for US grouping in the bundling wizard.
    • Mark Submissions as inactive during bundling: Adds an option on the bundling wizard’s Define Submissions step to deactivate Submissions. Select Starting States to filter the list of Submissions that may be deactivated. Select a Target State as the inactive lifecycle state to apply to the Submissions.
    • Default filters for Activity: Adds default filters to the Activity list in the bundling and splitting wizards. Vault applies lifecycle states you selected under Restrict Activity bundling by state as default filters. Select Activity Fields to use as filters for Activities in the bundling and splitting wizards, for example Impacted Market.
    • Default filters for Regulatory Objective: Adds default filters to the Regulatory Objective list in the bundling and splitting wizards. Vault applies lifecycle states you selected under Restrict Regulatory Objective bundling by state as default filters. Select Regulatory Objective Fields to use as filters for Regulatory Objectives in the bundling and splitting wizards.
    • Mark Regulatory Objectives as inactive during bundling: Adds an option on the bundling wizard’s Define Submissions step to deactivate Regulatory Objectives. Select Starting States to filter the list of records that may be deactivated, for example the Planned state. Select a Target State as the inactive lifecycle state to apply to the Regulatory Objective records.
    • Regulatory Objective Naming Pattern: Adds an option to define the naming pattern for new Regulatory Objective records Vault creates during the bundling process. The default naming pattern is {application__rimr.name__v} - Bundle.
    • Mark Activity Labeling Concepts as inactive during bundling: Adds an option on the splitting wizard’s Activity Labeling Concepts record definition page to deactivate Labeling Concepts. Select Starting States to filter the list of records that may be deactivated, for example Active and Rejected. Select a Target State as the inactive lifecycle state to apply to the Labeling Concept records.
    • Activity Naming Pattern: Adds an option to define the default naming pattern for the new Activity records Vault creates during the splitting process. The default naming pattern is {impacted_market__rimr.country_code__rim}-{related_application__rimr.name__v} - Split.
  • Enable Affiliate Home Page: Turns on the Affiliate Home tab. Once you set this checkbox, you can customize what users see on the tab:
    • Select activity lifecycle states to show on home page: Allows you to show only Activity records in the specified lifecycle states on the Affiliate Home tab. We recommend selecting only in progress or active lifecycle states.
    • Select regulatory objective lifecycle states to show on home page: Allows you to show only Regulatory Objective records in the specified lifecycle states on the Affiliate Home tab. We recommend selecting only in progress or active lifecycle states.
    • Select the actions to be displayed on the affiliate home page: Allows you to choose which actions are available in the Quick Actions bar.
    • Select the graphical data widgets to be displayed on the affiliate home page: Allows you to choose which chart panes appear on the Affiliate Home tab.
  • Enable IDMP and UDI Accelerators: Allows Vault to automatically generate related records for certain IDMP objects. Once you enable this feature, set the individual checkboxes to enable each IDMP accelerator:
    • Automatically Generate Medicinal Product Records: Vault creates Medicinal Product and Medicinal Product Registration records when users create new Registration records. You’ll also need to set the Regions and Lead Market Field.
    • Automatically Generate Registered Site Role Records: Vault creates Registered Site Role records when users create certain related records.
    • Automatically Generate Registered Packaged Product Records: Vault creates Registered Packaged Medicinal Product records when users create certain related records.
  • Enable Global to Local Submission Type Mapping: When creating Submission records in bulk, this setting allows users to select a global term for the Submission Type field (such as the term used for the original application) and populate the corresponding local term on the resulting records. See Configuration for Bulk Creating Activities, Submissions & Regulatory Objectives and Configuring Constraints for details on how to map these terms in your Vault.
    • Enable Global to Local Submission Subtype Mapping: When enabled with Enable Global to Local Submission Type Mapping, users can also select a global term for the Submission Subtype field when creating Submission records in bulk.
  • Generate Registered Site Role Loader Files: Each time this setting is enabled, Vault executes an asynchronous job to assess existing Registered Site Role records and generate a CSV for Registered Site Role data migrations.
  • Enable UDI Enhancements: Once you enable this feature, set the individual checkboxes for UDI submissions:
    • Enable UDI Submission Viewer: Allows users to review and manage complex UDI data in a user-friendly format.
    • Enable machine-to-machine UDI submissions to EUDAMED: When enabled and configured with the UDI Submission Viewer, this sub-setting allows users to submit UDI data to EUDAMED directly from Vault Registrations.
    • Enable enhanced UDI attribute locations: Allows Vault to use new source data locations for UDI Submission XML generation, updated in 23R3.
  • Enable Global to Local Manufacturing Site Role Mapping: When creating Submissions and Regulatory Objectives in bulk, this setting allows users to select a global Manufacturing Site Role and populate the corresponding local term on the resulting relationship records. See Configuration for Bulk Creating Activities, Submissions & Regulatory Objectives and Configuring Constraints for details on how to map these terms in your Vault.
  • Enable Create Related Records Review: When creating Activities, Submissions, and Regulatory Objectives in bulk via the Create Related Records wizard, this setting enables users to preview the records Vault will create, then refine the list to remove any unwanted records.

Submissions Archive Features

  • Show Correspondence in Viewer 1: Allows users to view correspondence documents tied to a Submission in the Viewer tab. You can select the Document Type to represent correspondence.
  • Import files not referenced in the eCTD XML: Allows users to upload files that aren’t referenced in the eCTD XML.
  • Include Correspondence documents on bulk export: Allows Vault to include correspondence documents in bulk submission exports.
  • Enable Submission dossier import through Bulk Action: Allows users to import a single dossier to multiple submissions.
  • Allow imports to proceed with invalid XML: Allows users to import submissions with invalid XMLs through the Vault UI. Vault will display a warning but won’t block the submission import.
  • Enable Submission Import from File Manager: Allows users to upload submission content in Vault File Manager for import to Submission records in Vault.
  • Enable identifying empty sections in the viewer 1: Allows Vault to calculate and apply a visual styling in the submissions archive viewer, indicating which sections in a submission do not contain documents.
  • Process Zip imports at the Submission level: Allows Vault to import ZIP files located inside the submission folder when importing a submission. When attachments are enabled, files at the root of the ZIP become attachments of the submission.
  • Show inactive Applications and Submissions in Viewer 1: Allows users to select and view the content of inactive applications and submissions within the Viewer.

  • Leaf source file path correction: When Configuration Mode is enabled, Admins can select this option to allow Vault to correct leaf source file paths based on the Application Dossier Format parameter and the Application Folder Name field. This is useful for maintaining data integrity when an application associated with a previously-imported archive requires an update to its Application Folder Name. See Correcting Leaf Source File Paths for more information.

    1. Setting is available for both the legacy and new Submissions Archive Viewers. If already enabled for the legacy viewer, additional configuration in the new viewer is not required. Conversely, if the feature was not already enabled for the legacy viewer, it must be enabled for the new viewer. See About the New Submissions Archive Viewer for more information.↩

Submissions Features

  • Allow batch import of CRFs: Allows users to import Case Report Forms (CRFs) to Vault in bulk. Select a Document Type to apply to imported CRFs.
  • Allow batch import of datasets: Allows users to import datasets to Vault in bulk. Select a Document Type to apply to imported datasets.
  • RIM to Clinops Connection: Transfer steady and superseded state document versions: Allows Vault to conditionally create or version CrossLink documents via the RIM to Clinical Operations Vault Connection.
  • Enable Dispatch Comparison: When dispatching global content plans, this setting allows users to dispatch one or more sections of a content plan, as well as review and accept or reject the changes Vault will make to the market-specific Submission Content Plan based on a comparison with the source Global Content Plan. You must also select at least one Content Plan Lifecycle State in which Vault can generate a comparison. See Configuring Content Plan Synchronization for configuration details.
  • Enable Application Relationships (RIM Setting): Enables the Submission Wizard, which guides users through creating a Submission, Regulatory Objective, and their relationships. Once you enable this RIM Setting, you cannot disable it. This feature also includes two recommended two-way settings: Enable Relationship Triggers enforces validation and data automation on Application, Regulatory Objective, and Submission relationships, and Exclude Submission Lifecycle States allows an Admin to choose Submission lifecycle states in which to prevent related Application relationships from being edited or deleted. The setting is located under RIM Settings, as it can also be leveraged in Vaults with both the Submissions and Registrations applications for use with various Registrations wizards.

Configuration Options

Generating Compliant Renditions for Source PDFs

When enabled in Admin > Configuration > Rendition Profiles, the Generate compliant rendition for Source PDFs Rendition Profile option allows Vault to render PDF source files according to ICH standards and minimize validation criteria failures prior to publishing.

CrossLink PDF documents are rendered according to the rendition profile configured for the document type.

This configuration option does not apply to secured or signed PDFs, or to PDFAs.

Creating Documents from Emails

The Vault RIM Create Documents from Email processor extracts the content from emails sent to Vault and creates an unclassified document for the email and each attachment in the sender’s Document Inbox. It supports RIM-specific use cases for Vault’s standard email processing capabilities, such as: when a user receives an email from a Health Authority with an attached approval letter, the processor extracts the approval letter and uploads it as its own document, separate from the email and any other attachments. See Email Processing (RIM) for more information and detailed use cases.

The processor is automatically enabled in all RIM Vaults in Admin > Configuration > Email Processors but requires additional configuration steps to use it, including:

  • Creating and testing inbound email addresses, as well as considering business needs for shared inboxes and duplicate content detection. See Configuring Email to Vault for more information.
  • Adding the Created from email shared document field to the document types your organization uses for emailed documents. This step is only required if you wish to display this information to users in the Doc Info panel. Otherwise, Vault still sets the document metadata automatically, allowing full search and filter capabilities.