Configuration for Bulk Creating Activities, Submissions & Regulatory Objectives

Vault provides a Create Related Records wizard that enables users to create Activity, Submission, or Regulatory Objective records in bulk. Bulk creation allows users to standardize and minimize much of the local affiliate data entry required for global change events.

This feature is automatically enabled for drug products on RIM Registrations Vaults. See details below about configuration needed to bulk create activities, submissions, and regulatory objectives for medical devices.

Configuring Naming Patterns

You can define the naming patterns for new Regulatory Objective and Submission records created in the wizard:

  1. Navigate to Admin > Settings > Application Settings.
  2. Select the Set naming pattern for Regulatory Objective Name when using Create Related Records wizard and Set naming pattern for Submission Name when using Create Related Records wizard checkboxes.
  3. Define the naming patterns for each object in the fields below the checkboxes. You can enter static strings for any Object-, Picklist-, Text-, or Formula-type fields on the Event object as tokens. To enforce uniqueness, your naming pattern should include a numerical token, for example, {##}. Record names should be unique and shouldn’t exceed 128 characters or record creation could fail. We recommend creating a text field on the Event object with a default formula to ensure that record names meet these requirements.
  4. Click Save.
  5. Vault validates your naming patterns and displays a warning if a pattern is not valid.

If system-managed naming is enabled on the Regulatory Objective or Submission objects, Vault names new records based on those patterns rather than the ones defined for the Create Related Records wizard.

Configuring Default Activity Scope

You can select a 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. To set a default scope, navigate to Admin > Settings > Application Settings and select the Define default Activity scope when using Create Related Records wizard checkbox. Then, select the Activity Scope from the drop-down.

Configuring Matching Custom Fields

Vault can copy custom field values from Event join records to the corresponding Submission join records or Regulatory Objective join records for the following field types: Picklist, Object, Date, DateTime, Yes/No, Text, and Number.

In order for Vault to copy matching custom fields, you must configure custom fields with matching names and field types on both objects. You should not configure entry criteria on any matching custom fields on the Regulatory Objective join objects. If you have object types enabled on any of these objects, configure matching custom fields for all object types.

Configuring Enhanced Change Management

When your organization uses Product Change records to track changes to a product as it relates to a specific Event, the Create Related Records wizard can push these Event Change Items out to related Activity records for impacted markets. Then, regulatory teams can track the resulting Activity Change Items to their completion. A single Product Change can be linked to multiple Events and Activities, creating more flexibility to include:

  • Items from more than one change control within the same Event, for example annual reports that include items from multiple changes.
  • The same Product Change for more than one Event, for example when going to market in regional waves.

To do this:

  1. To all applicable Event and Activity object page layouts, add a “Product Changes” related object section, corresponding to the appropriate object types:
    • Event: Event Change Item
    • Activity: Activity Change Item
  2. Create Product Change records to capture individual product changes. A Product Change is an object type of the Change Item object.
  3. Associate Product Change records to one or more Events.

Additionally, the below business logic configuration components are included in your Vault to provide further flexibility in tracking change items to their completion:

Enabling Application Relationships

Vault can reference Application relationship records as the source of truth when creating records in bulk. This is useful, for example, for global Events: The wizard copies data from the Event relationship records to the country-level records for Applications, Regulatory Objectives, and Submissions. For existing relationships, the wizard matches Event data with Application relationship records, then copies the Application relationship to the Regulatory Objective and Submission.

This feature is only available in RIM Vaults enabled with both the Registrations and Submissions applications. It is also controlled by a one-way setting which first requires an Admin to configure and enable the Submission Wizard.

Enabling Dynamic Validation

When Application relationships are enabled, a related setting allows the wizard to run additional validation checks based on existing Event data. This ensures the local data needed to support change management can be propagated quickly and correctly.

Dynamic validation supports a variety of use cases, including:

  • Preventing Shelf Life data from being pushed to Regulatory Objectives or Submissions that do not have the same related Packaging records.
  • Adding a new Packaging Site only where the related Packaging records exist.
  • New product approvals where Registrations do not yet exist.
  • Changes requiring new Registrations to be created.
  • Adding a new investigational product, a frequent case including comparator and reference products, without requiring the relationship between the Application and Product Family.

To enable dynamic validation:

  1. Activate the Update value in the Event Change Action picklist.
  2. Create or update Event Change Types for the new Related Change Type picklist options, for example the options for drug or device manufacturer changes (Add Drug Product Manufacturer Details, Update Device Product Manufacturer Details), or any of the options for updating records (Update Product Details).
  3. Navigate to Admin > Settings > Application Settings and select the Enable dynamic validation for Create Related Records setting.

About Object Type Mapping

Vault uses object type mapping to determine which object types to use for particular records depending on the object types of the Event or Applications the user selects in the bulk creation wizard. This is especially important for objectives and submissions with a combination of drug products and medical device products.

To do this, the wizard checks for active Object Type Mapping records you’ve created and, based on that mapping data, selects the object types. If there are no active records, the wizard automatically selects the target object type by comparing the Names of the source and target object types (for example, device_intended_use__v). If the Name values do not match, Vault prompts the user to select the target object type.

Vault supports name-based object type mapping for creating the following Submission and Regulatory Objective join object records:

  • Active Substance
  • Authorization
  • Clinical Study
  • Inactive Ingredient
  • Indication
  • Nonclinical Study
  • Packaging
  • Packaging Characteristic
  • Product
  • Product Characteristic
  • Product Classification
  • Regulatory Text
  • Site Contact
  • Site Organization
  • Site Role

About the Object Type Mapping Object

The Object Type Mapping object supports customers who want to manually create activities, submissions, or regulatory objectives in bulk for both drug products and medical device products.

See Configuring Object Type Mapping for Registrations for a sample set of mappings. This setup ensures that the correct details will be carried over when users bulk create activities, submission, or regulatory objectives for drug products or for medical device products. You may create similar mappings for custom source registration object types or custom object types on target registered detail objects.

You must add the Applicable Product Type field to all Application object types and populate this field for object type mappings to work.

Configuring Global-to-Local Mapping

You can configure Vault to allow users to select global terms (such as those defined for the original Application) for certain object record fields in the wizard. When Vault creates the resulting records in bulk, it uses the appropriate Constraint and Controlled Vocabulary records to populate the corresponding local term. See also Configuring Constraints for more information.

Submission Type & Submission Subtype

The Enable Global to Local Submission Type Mapping setting and its sub-setting, Enable Global to Local Submission Subtype Mapping allow users to select a global term for the Submission Type and Submission Subtype fields in the wizard when creating Submissions.

When Vault finds a matching term for the selected field via the Constraint and Controlled Vocabulary records, it populates the local term in the resulting Submission records. If Vault cannot locate a matching term or if it finds multiple matches, the selected fields are set to Planned Submission.

See the use case in Configuring Constraints for more information.

Manufacturing Site Role

The Enable Global to Local Manufacturing Site Role Mapping setting allows users to select the global term for the Manufacturing Site Role field in the wizard when creating Submission and Regulatory Objective records.

When Vault finds a matching term for the selected field via Constraint and Controlled Vocabulary records, it populates the local term in the resulting Submission and Regulatory Objective relationship records that specify Manufacturing Site Role, such as Submission Product or Regulatory Objective Packaging.

If Vault cannot locate a matching term or if it finds multiple matches, the Global Manufacturing Site Role value is copied from the Event relationship record to the Manufacturing Site Role field in the new Submission and Regulatory Objective relationship records.

See the use case in Configuring Constraints for more information.

The Create Bulk Records wizard includes additional functionality allowing users to preview the records Vault is proposing to create or update based on the Event and other selected records. Vault displays them in the wizard, allowing users to navigate through each Lead Market’s Application and remove any related records which Vault should not create or update.

To configure related record preview in your Vault:

  1. Within the Event object, add the Review Related Records and Clear Preview actions.
  2. Within the Event object lifecycle:
    • Create a new In Data Review state.
    • Create a new In Data Review state type, then map it to the In Data Review state.
    • To the In Data Review state, add the Review Related Records and Clear Preview user actions.
  3. Review your Vault’s security configuration. In addition to the minimum Read and Create permission to the objects they’re reviewing, users must be assigned a permission set with View and Execute Object Action Permissions for the Event object. In some newer Vaults, users assigned the Change Management - Contributor permission set will have these permissions automatically via the All Object Actions Object Action Permission.
  4. Navigate to Admin > Settings > Application Settings and enable the Enable Create Related Records Review setting.

Configuring Fields for Indications & Orphan Designations

Vault uses the Full Indication Text object and its related objects to track the full text required for therapeutic indications, as documented in section 4.1 of the Summary of Product Characteristics (SmPC).

Additionally, Vault uses the Regulatory Authorisation object to store data related to special authorisations, such as Orphan Designation or Advanced Therapy Medicinal Products (ATMPs).

If your organization requires this IDMP reporting data to be populated during bulk creation, add the Full Indication Text and Orphan Designation fields to the object page layouts of the following objects:

  • Application Indication
  • Event Indication
  • Regulatory Objective Indication
  • Submission Indication

Configuring User Permissions

In order for users to create records in bulk, you must ensure that their security profiles are configured correctly. Users need a permission set with:

  • Create permission on the objects they’re creating, for example, Submission
  • Read permission on the source records from which they initiate the wizard, for example, Event, and the records from which the wizard pulls data, for example, Event Active Substance
  • View and Execute object action permissions for the Create Related Records, Review Related Records, and Clear Preview actions on the Event object.
  • If the objects use Dynamic Access Control, users need at least the Viewer role on the specific records
  • If your Vault uses field-level security, users must have Read permission on the fields from which Vault pulls data