20R3 Data Model Changes: Regulatory

With every release, we update the data model to better support evolving needs and new feature functionality. With this release, we’ve added the following components to the Regulatory data model. These data model updates are automatically included in all Regulatory Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 20R3.

Added the following components to support the Additional Registration Scopes in Create Registrations and Additional Registration Scopes in Manage Registered Details features:

  • Added additional values to the following picklists:
    • Registration Scope Type (registration_scope_type__v)
    • Impacted Record (impacted_record__v)
  • Added the following fields to the Registration (registration__rim) object:
    • Active Substance (active_substance__v)
    • Manufacturing Site (manufacturing_site__v)
    • Site Product Type (site_product_type__v)
  • Added the following object types to the Registration (registration__rim) object:
    • Active Substance Registration (active_substance_registration__v)
    • Manufacturing Site Registration (manufacturing_site_registration__v)
  • Added the following fields to the Event (event__rim) object:
    • Impacted Active Substance (impacted_active_substance__v)
    • Impacted Manufacturing Site (impacted_manufacturing_site__v)
  • Added the following fields to the Activity (activity__rim) object:
    • Impacted Active Substance (impacted_active_substance__v)
    • Impacted Manufacturing Site (impacted_manufacturing_site__v)
  • Added the following object types to the Constraint (constraint__rim) object:
    • Manufacturing Site Role (manufacturing_site_role__v)
    • Manufacturing Site Contact Role (manufacturing_site_contact_role__v)
    • Manufacturing Site Organization Role (manufacturing_site_organization_role__v)
  • Added the following objects:
    • Registered Site Role (registered_site_role__v)
    • Event Site Role (event_site_role__)
    • Submission Site Role (submission_site_role__v)
    • Regulatory Objective Site Role (regulatory_objective_site_role__v)
    • Registered Site Contact (registered_site_contact__v)
    • Event Site Contact (event_site_contact__v)
    • Submission Site Contact (submission_site_contact__v)
    • Regulatory Objective Site Contact (regulatory_objective_site_contact__v)
    • Registered Site Organization (registered_site_organization__v)
    • Event Site Organization (event_site_organization__v)
    • Submission Site Organization (submission_site_organization__v)
    • Regulatory Objective Site Organization (regulatory_objective_site_organization__v)
  • Added the Manufacturing Site Role (manufacturing_site_role__v) and the Site Product Type (site_product_type__v) fields to the following objects:
    • Registered Product (registered_drug_product__rim)
    • Event Product (event_drug_product__rim)
    • Submission Product (submission_pharmaceutical_product__rim)
    • Regulatory Objective Product (regulatory_objective_drug_product__v)
    • Registered Active Substance (registered_active_ingredient__rim)
    • Event Active Substance (event_active_substance__rim)
    • Submission Active Substance (submission_active_substance__rim)
    • Regulatory Objective Active Substance (regulatory_objective_active_substance__v)
    • Registration Packaging (registration_packaging__rim)
    • Event Packaging (event_packaging__rim)
    • Submission Packaging (submission_packaging__rim)
    • Regulatory Objective Packaging (regulatory_objective_packaging__v)
    • Registered Inactive Ingredient (registered_inactive_ingredient__rim)
    • Event Inactive Ingredient (event_inactive_ingredient__rim)
    • Submission Inactive Ingredient (submission_inactive_ingredient__rim)
    • Regulatory Objective Inactive Ingredient (regulatory_objective_inactive_ingredient__v)

Added the following components to support the Save Views in Hierarchy Viewer feature:

  • Added the system-managed RIM View (rim_view__v) object.

Added the following components to support the Update Hyperlinking Creation Logic feature:

  • Added the Allow Cross Application Linking (allow_cross_application_linking__v) field to the Country (country__v) object.

Added the following components to support the Configurable Impact Assessment Reports feature:

  • Added the Registrations Impact Assessment value to the Report Tags (report_tags__sys) picklist.

Added the following components to support the Jordan eCTD DTD 1.1 Publishing & Validation feature:

  • Added additional values to the Controlled Vocabulary Type (controlled_vocabulary_type__rim)

Added the following components to support the IDMP Phase 2: Data Model feature:

  • Added the following objects:
    • Full Indication Text (IDMP) (full_indication_text_idmp__v)
    • Indication Grouping (indication_grouping__v)
    • IDMP Therapeutic Indication Element (idmp_therapeutic_indication_element__v)
    • IDMP Marketing Authorisation Element (idmp_marketing_authorisation_element__v)
    • IDMP Manufacturing Site (idmp_manufacturing_site__v)
    • IDMP Medicinal Product Indication (idmp_medicinal_product_indication__v)
    • Indication Translation (indication_translation__v)
    • IDMP Admin Product Ingredient Element (idmp_admin_product_ingredient_element__v) with object types:
      • Administered Product Active Substance
      • Administered Product Inactive Ingredient
    • IDMP Admin Ingredient Manufacturer (idmp_admin_ingredient_manufacturer__v)
    • Active Substance Shelf Life and Storage (active_substance_shelf_life_and_storage__v)
    • Inactive Ingredient Shelf Life Storage (inactive_ingredient_shelf_life_storage__v)
    • Product Shelf Life and Storage (product_shelf_life_and_storage__v) with object types:
      • Bulk Product
      • Device
    • Registered Shelf Life and Storage (registered_shelf_life_and_storage__v) with object types:
      • Bulk Ingredient
      • Bulk Product
      • Bulk Substance
      • Device
      • Packaged Product
    • Event Shelf Life and Storage (event_shelf_life_and_storage__v) with object types:
      • Packaged Product
      • Device
      • Bulk Substance
      • Bulk Product
      • Bulk Ingredient
    • Regulatory Objective Shelf Life Storage (regulatory_objective_shelf_life_storage__v) with object types:
      • Bulk Ingredient
      • Device
      • Bulk Substance
      • Bulk Product
    • IDMP Component (idmp_component__v)
    • IDMP Component Material (idmp_component_material__v)
    • IDMP Container (idmp_container__v)
    • IDMP Container Data Carrier (idmp_container_data_carrier__v)
    • IDMP Container Material (idmp_container_material__v)
    • IDMP Container Reference Item (idmp_container_reference_item__v) with object types:
      • Device
      • Manufactured Item
      • Package Item
    • IDMP Manufactured Item (idmp_manufactured_item__v)
    • IDMP Manufactured Item Ingredient (idmp_manufactured_item_ingredient__v) with object types:
      • Product Variant Inactive Ingredient
      • Product Variant Active Substance
    • IDMP Manuf. Item Ingredient Manufacturer (idmp_manuf_item_ingredient_manufacturer__v)
    • IDMP Package Authorisation Status (idmp_package_authorisation_status__v )
    • IDMP Package Description (idmp_package_description__v)
    • IDMP Package Marketing Status (idmp_package_marketing_status__v)
    • IDMP Packaged Medicinal Product Element (idmp_packaged_medicinal_product_element__v)
    • IDMP Shelf Life (idmp_shelf_life__v)
    • IDMP Storage Precautions (idmp_storage_precautions__v)
    • Registered Packaged Medicinal Product (registered_packaged_medicinal_product__v)
  • Added additional values to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist.
  • Added the SPOR Organization ID (spor_oms_id__v) field to the Health Authority (health_authority__rim) object.
  • Added the Regulatory Objective (regulatory_objective__v) field to the IDMP Product Data Submission (idmp_product_data_submission__v) object.
  • Added the Lead Indication (lead_registration__v) field to the Medicinal Product Registrations (medicinal_product_registration__v) object.
  • Added the IDMP Authorisation Status (idmp_authorisation_status__v) field to the Registration (registration__rim) object.
  • Added the Authorisation Effective Date (authorisation_effective_date__v) to the Registered Site Role (registered_site_role__v) object.
  • Added the SPOR Substance Code (spor_substance_code__v) field to following objects:
    • Active Substance (drug_substance__v) and the Substance object type.
    • Inactive Ingredient (excipient__v)
  • Added the Role (role__v) field to the following objects:
    • Administered Product Active Substance (admin_prod_active_substance__rim)
    • Administered Product Inactive Ingredient (administered_product_inactive_ingredient__rim)
    • Product Variant Active Substance (product_detail_active_substance__rim)
    • Product Variant Inactive Ingredient (product_detail_inactive_ingredient__rim)
  • Added the following fields to the Shelf Life (shelf_life__rim) object:
    • High Value (high_value__v)
    • Low Value (low_value__v)
    • Shelf Life Unit of Measurement (shelf_life_unit_of_measurement__v)
    • Special Precautions for Storage (special_precautions_for_storage__v)
  • Added the following object types to the Shelf Life (shelf_life__rim) object:
    • Packaged Medicinal Product
    • Packaged Device Product
    • Bulk Ingredient
    • Bulk Product
  • Added the Product (product__v) field to the Packaging Product Variant (packaging_product_detail__rim) object.
  • Added the following fields to the Packaging Shelf Life (packaging_shelf_life__rim) object:
    • Administration Device (administration_device__v)
    • Container (container__v)
    • Product (product__v)
    • Product Variant (product_variant__v)
    • Storage Condition (storage_condition__v)
  • Added the following object types to the Packaging Shelf Life (packaging_shelf_life__rim) object:
    • Packaging Level
    • Container Level
  • Added the Quantity Unit (quantity_unit__v) field to the following object:
    • Packaging Administration Device (packaging_administration_device__rim)
    • Packaging Container (packaging_container__rim)
  • Added the following fields to the Packaging Product Variant (packaging_product_detail__rim) object:
    • Unit of Presentation (unit_of_presentation__v)
    • Quantity Unit (quantity_unit__v)

In addition to the changes supporting new features, we added or updated the following components:

  • Updated the Upload Package ID (upload_package_id__v) field on the Submission (submission__v) object to be read-only. Vault populates this field when a user imports a dossier via Vault File Manager.
  • On the Organization (organization__rim) object, renamed the telelphone_extension__rim field to telephone_extension__rim.
  • Added the Vault RIM UUID (vault_rim_uuid__v) field to the Country Language (country_language__v) object.
  • Added the External ID (external_id__v) required field to the following objects:
    • Classification (classification__v)
    • Clinically Relevant Size (clinically_relevant_size__v)
    • Data Carrier (data_carrier__rim)
    • Organization (organization__rim)
    • Packaging (packaging__rim)
    • Shelf Life (shelf_life__rim)
  • Added additional values to the Constraint Scope (constraint_scope__v) picklist.
  • Added the Risk Class (risk_class__v) field to the Constraint (constraint__rim) object.
  • Added the Risk Class (risk_class__v) object type to the Constraint (constraint__rim) object.
  • Added the Primary Risk Class (primary_risk_class__v) field to the Application (application__v) object.
  • Added the following fields to the Submission (submission__v) object:
    • Application Lead Market (application_lead_market__v)
    • Primary Risk Class (primary_risk_class__v)
  • Added the following fields to the Regulatory Objective (regulatory_objective__rim) object:
    • Application Lead Market (application_lead_market__v)
    • Application Region (application_region__v)
    • Risk Class (risk_class__v)

In this release, we have also enabled the Required attribute on additional standard objects and fields. This allows organizations to configure these components according to their business requirements without needing to contact Veeva Support or Product Management to make these configuration changes. In order to utilize these newly-enabled attributes, Admins must perform the desired configuration to make them available for users.