23R1 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 23R1.

With this release, we’ve added the below Registration (registration__rim) object types in all RIM Vaults. See 23R1 Announcements for more information.

• Investigational Vet Device Registration (investigational_vet_device_registrati__v)
• Investigational Vet Drug Registration (investigational_vet_drug_registration__v)
• Marketed Vet Device (marketed_vet_device_registration__v)

• Marketed Vet Drug (marketed_vet_drug_registration__v)

• Enabled the Values must be unique configuration for the below fields (listed by object):
  • Content Plan Template Constraint (content_plan_template_constraint__rim) object: External ID (external_id__v)
  • Registered Packaged Product (registered_packaged_medicinal_product__v) object: PCID (pcid__v)
• Enabled the User must always enter a value (required) configuration for the below fields (listed by object):
  • Contact (contact__rim) object:
    • Email Address (email_address__rim)
    • Telephone Number (telephone_number__rim)
  • Indication Grouping (indication_grouping__v) object: Intended Effect (intended_effect1__v)
  • Medicinal Product Full Name (medicinal_product_full_name__rim) object:
    • Country (country__rim)
    • Language (language__rim)
  • Medicinal Product Registration (medicinal_product_registration__v) object:
    • Country (country__v)
    • Language (language__v)
• Enabled hierarchical copy on the following fields (listed by object):
  • Activity Registration (activity_registration__rim) object: Registration (registration__rim)
  • Indication Grouping (indication_grouping__v) object: Full Indication Text (full_indication_text__v)
  • Medicinal Product Registration (medicinal_product_registration__v) object: Medicinal Product (medicinal_product__v)
  • Registered Active Substance (registered_active_ingredient__rim) object: Registration (registration__rim)
  • Registered Authorization (registered_authorization__v) object: Registration (registration__v)
  • Registered Clinical Study (registered_clinical_study__v) object: Registration (registration__v)
  • Registered Indication (registered_indication__rim) object: Registration (registration__rim)
  • Registered Packaged Product (registered_packaged_medicinal_product__v) object: Registration (registration__v)
  • Registered Packaging (registration_packaging__rim) object: Registration (registration__rim)
  • Registered Product (registered_drug_product__rim) object: Registration (registration__rim)
  • Registered Regulatory Text (registered_regulatory_text__v) object: Registration (registration__v)
  • Registration Regulatory Objective (registration_regulatory_objective__rim) object: Registration (registration__rim)
• Enabled the System manages field value (read-only) configuration for the Name (name__v) field in the following objects:
  • Product Variant (product_detail__v) (Note: The name__v field label is Product Variant.)
  • Product Variant Description (product_variant_description__v)
  • Report Level Content Plan (report_level_content_plan__v)
• Enabled the Audit data changes in this object configuration on the following objects:
  • Administered Product Description (admin_product_description__v)
  • IDMP Manufactured Item Description (idmp_manufactured_item_description__v)
  • IDMP Pack Size (idmp_pack_size__v)
  • IDMP Pharmaceutical Product Description (idmp_pharmaceutical_product_description__v)
  • Pack Size (pack_size__v)
  • Product Variant Description (product_variant_description__v)
• Added the Created from email (created_from_email__v) shared document field to support the RIM Email to Vault Processor feature.
• Increased the Device Model or Version (device_model_or_version__v) field length to 255 characters (from 120) in the following objects to support the EUDAMED UDI XML Generation Updates feature:
  • Application Product Characteristic (application_product_characteristic__v)
  • Event Product Characteristic (event_product_characteristic__v)
  • Product (drug_product__v)
  • Reg Objective Product Characteristic (reg_objective_product_characteristic__v)
  • Registered Product Characteristic (registered_product_characteristic__v)
  • Submission Product Characteristic (submission_product_characteristic__v)
• Added the following components to support the Submission Type Defaulting with Object Type Mapping feature:
  • Global Submission Type (global_submission_type__rim) value added to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist.
  • Global to Local Submission Type (global_to_local_submission_type__rim) object type added to the Constraint (constraint__rim) object.
• Added the Active Dossier Loader (active_dossier_loader__v) high-volume object to support the Active Dossier Loader feature.
• Added the Template Constraint Type (template_constraint_type__v) picklist to support the Additional Granularity for Content Plan Template Constraints feature. The picklist is added as a field in the following objects:
  • Submission (submission__v)
  • Constraint (constraint__v)
  • Event (event__v)
• Added the Copy Content Plan (copy_content_plan__v) field to the Report Level Content Plan (report_level_content_plan__v) object to support the Copy Report Level Content Plan feature.
• Added the Exclude from Auto-Matching (exclude_from_automatching__v) field to the Content Plan (edl__v) and Content Plan Template (edl_template__v) objects to support the Content Plan & Content Plan Template: Exclude from Auto-Matching feature. The field is also added to the following object types in both objects:
  • Regional (Module 1) (module_1__rim)
  • Summary (Module 2) (module_2__rim)
  • Quality (Module 3) (module_3__rim)
  • Nonclinical (Module 4) (module_4__rim)
  • Clinical (Module 5) (module_5__rim)
  • Device Submission Plan (device_submission_plan__v)
  • Other (other__v)
  • Report (report__v)
  • Report Level Plan Clinical Study (report_level_plan_clinical_study__v)
  • Report Level Plan Nonclinical Study (report_level_plan_nonclinical_study__v)
• Added the following components to support the FHIR Message Handling in IDMP Viewer feature:
  • Added the IDMP (idmp__v) document type and its document subtype eAF FHIR Output (eaf_fhir_output__v)
  • Added the FHIR Message Version (fhir_message_version__v) document field
• Added the following components to support the UPD Data Model Updates feature:
  • Added the following object types to the Registration (registration__rim) object:
    • Investigational Vet Device Registration (investigational_vet_device_registrati__v)
    • Investigational Vet Drug Registration (investigational_vet_drug_registration__v)
    • Marketed Vet Device Registration (marketed_vet_device_registration__v)
    • Marketed Vet Drug Registration (marketed_vet_drug_registration__v)
  • Added the Distributor Type (distributor_type__v) picklist and field to the following objects:
    • Application Organization (application_site_organization__v)
    • Event Organization (event_site_organization__v)
    • Registered Organization (registered_site_organization__v)
    • Regulatory Objective Organization (regulatory_objective_site_organization__v)
    • Submission Organization (submission_site_organization__v)
  • Added the Withdrawal Period (withdrawal_period__v) field to the following objects:
    • Application Product (application_pharmaceutical_product__v)
    • Event Product (event_drug_product__rim)
    • Registered Product (registered_drug_product__rim)
    • Regulatory Objective Product (regulatory_objective_drug_product__v)
    • Submission Product (submission_pharmaceutical_product__rim)
  • Added the Doc Reference Status (doc_reference_status__v) value to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist.
  • Added the following fields to the Medicinal Product (medicinal_product__rim) object:
    • UPD Product ID (upd_product_id__v)
    • UPD Permanent ID (upd_permanent_id__v)
  • Added the following fields to the Product Cross Reference (product_cross_reference__v) object:
    • Reference Product Permanent ID (reference_product_permanent_id__v)
    • Source Product Permanent ID (source_product_permanent_id__v)
  • Added the UPD ID (upd_id__v) field to the Registered Packaged Product (registered_packaged_medicinal_product__v) object.
  • Added the Product Version (product_version__v) field to the Registration (registration__rim) object.
  • Added the following fields to the Product Cross Reference (product_cross_reference__v) object:
    • Reference Product Permanent ID (reference_product_permanent_id__v)
    • Source Product Permanent ID (source_product_permanent_id__v)
  • Added the following document fields:
    • Document Reference Status (document_reference_status__v)
    • Master File Code (master_file_code__v)
    • UPD ID (upd_id__v)
• Added or updated following components to support the IDMP Data Model Updates feature:
  • Added the following objects:
    • IDMP Authorised Pharmaceutical Form (idmp_authorised_pharmaceutical_form__v)
    • IDMP Device Description (idmp_device_description__v), including the Device Description (device_description__v) and Device Intended Use (device_intended_use__v) object types
    • IDMP Device Manufacturer (idmp_device_manufacturer__v)
    • IDMP Ingredient Master File (idmp_ingredient_master_file__v)
    • IDMP Manuf. Item Ingredient Master File (idmp_manuf_item_ingredient_master_file__v)
    • IDMP Package Manufacturer (idmp_package_manufacturer__v)
  • Added the following object types to the Product Variant Description (product_variant_description__v) object:
    • Device Description (device_description__v)
    • Device Intended Use (device_intended_use__v)
    • Manufactured Item Description (manufactured_item_description__v)
  • Added the IDMP PMS URL (idmp_pms_url__v) document field.
  • Added the Identifier System (identifier_system__v) field to the Data Carrier (data_carrier__v) object.
  • Added the following fields to the IDMP Admin Ingredient Manufacturer (idmp_admin_ingredient_manufacturer__v) object:
    • Role (role__v)
    • Role Code (role_code__v)
    • Role Code Term (role_code_term__v)
    • Role Code Term Text (role_code_term_text__v)
    • Role Code Text (role_code_text__v)
  • Added the following fields to the IDMP Attachment (idmp_attachment__v) object:
    • PMS URL (pms_url__v)
    • PMS URL Text (pms_url_text__v)
  • Added the following fields to the IDMP Container Data Carrier (idmp_container_data_carrier__v) object:
    • Identifier System (identifier_system__v)
    • Identifier System Code (identifier_system_code__v)
    • Identifier System Code Text (identifier_system_code_text__v)
    • Identifier System Term (identifier_system_term__v)
    • Identifier System Term Text (identifier_system_term_text__v)
  • Added the following fields to the IDMP Container Reference Item (idmp_container_reference_item__v) object:
    • Device Classification (device_classificaton__v)
    • Device Classification Code (device_classification_code__v)
    • Device Classification Code Text (device_classification_code_text__v)
    • Device Classification Term (device_classification_term__v)
    • Device Classification Term Text (device_classification_term_text__v)
    • Quantity Operator (quantity_operator__v)
    • Quantity Operator Code (quantity_operator_code__v)
    • Quantity Operator Code Text (quantity_operator_code_text__v)
    • Quantity Operator Term (quantity_operator_term__v)
    • Quantity Operator Term Text (quantity_operator_term_text__v)
  • Added the following fields to the IDMP Manufactured Item (idmp_manufactured_item__v) object:
    • Quantity Operator (quantity_operator__v)
    • Quantity Operator Code (quantity_operator_code__v)
    • Quantity Operator Code Text (quantity_operator_code_text__v)
    • Quantity Operator Term (quantity_operator_term__v)
    • Quantity Operator Term Text (quantity_operator_term_text__v)
  • Added the following fields to the IDMP Manufactured Item Ingredient (idmp_manufactured_item_ingredient__v) object:
    • Ingredient Role (ingredient_role__v)
    • Ingredient Role Code (ingredient_role_code__v)
    • Ingredient Role Code Text (ingredient_role_code_text__v)
    • Ingredient Role Term (ingredient_role_term__v)
    • Ingredient Role Term Text (ingredient_role_term_text__v)
  • Added the following fields to the IDMP Manufacturing Site (idmp_manufacturing_site__v) object:
    • Confidentiality Indicator (confidentiality_indicator1__v)
    • Effective Date (effective_date1__v)
    • Health Authority (health_authority1__v)
    • Manufacturer (manufacturer1__v)
    • Manufacturing Authorisation Number (manufacturing_authorisation_number1__v)
    • Manufacturing Operation Start Date (manufacturing_operation_start_date1__v)
    • Manufacturing Operation Stop Date (manufacturing_operation_stop_date1__v)
    • Operation Type (operation_type1__v)
    • Organization ID (organization_id__v)
    • Organization ID Text (organization_id_text__v)
  • Added the following fields to the IDMP Marketing Authorisation Element (idmp_marketing_authorisation_element__v) object:
    • Authorisation Status (authorisation_status1__v)
    • Authorisation Status Date (authorisation_status_date1__v)
    • Marketing Auth Regulator Org ID Text (marketing_auth_regulator_org_id_text__v)
    • Marketing Auth Regulatory Org ID (marketing_auth_regulatory_org_id__v)
  • Added the following fields to the IDMP Pack Size (idmp_pack_size__v) object:
    • Quantity Operator (quantity_operator__v)
    • Quantity Operator Code (quantity_operator_code__v)
    • Quantity Operator Code Text (quantity_operator_code_text__v)
    • Quantity Operator Term (quantity_operator_term__v)
    • Quantity Operator Term Text (quantity_operator_term_text__v)
  • Added the Concentration Type (concentration_type__v) field to the Pack Size (pack_size__v) object.
  • Added the Concentration Type (concentration_type__v) field to the Packaging Container (packaging_container__rim) object.
  • Added the following fields to the Packaging Product Variant (packaging_product_detail__rim) object:
    • Co-Packaged or Integral Device (copackaged_or_integral_device__v)
    • Concentration Type (concentration_type__v)
    • Device Classification (device_classification__v)
  • Added the Variation Scope (variation_scope__v) field to the Regulatory Objective (regulatory_objective__rim) object.
  • Added the following fields to the Registered Active Substance (registered_active_ingredient__rim) object:
    • Confidentiality Indicator (confidentiality_indicator__v)
    • Effective Date (effective_date__v)
    • Health Authority (health_authority__v)
    • Manufacturing Authorisation Number (manufacturing_authorisation_number__v)
    • Manufacturing Site Role End Date (manufacturing_site_role_end_date__v)
    • Manufacturing Site Role Start Date manufacturing_site_role_start_date__v)
  • Added the following fields to the Registered Inactive Ingredient (registered_inactive_ingredient__rim) object:
    • Confidentiality Indicator (confidentiality_indicator__v)
    • Effective Date (effective_date__v)
    • Health Authority (health_authority__v)
    • Manufacturing Authorisation Number (manufacturing_authorisation_number__v)
    • Manufacturing Site Role End Date (manufacturing_site_role_end_date__v)
    • Manufacturing Site Role Start Date manufacturing_site_role_start_date__v)
  • Added the following fields to the Registered Packaging (registration_packaging__rim) object:
    • Confidentiality Indicator (confidentiality_indicator__v)
    • Effective Date (effective_date__v)
    • Health Authority (health_authority__v)
    • Manufacturing Authorisation Number (manufacturing_authorisation_number__v)
    • Manufacturing Site Role End Date (manufacturing_site_role_end_date__v)
    • Manufacturing Site Role Start Date manufacturing_site_role_start_date__v)
  • Added the following fields to the Registered Product (registered_drug_product__rim) object:
    • Co-Packaged or Integral Device (copackaged_or_integral_device__v)
    • Confidentiality Indicator (confidentiality_indicator__v)
    • Effective Date (effective_date__v)
    • Health Authority (health_authority__v)
    • Manufacturing Authorisation Number (manufacturing_authorisation_number__v)
    • Manufacturing Site Role End Date (manufacturing_site_role_end_date__v)
    • Manufacturing Site Role Start Date manufacturing_site_role_start_date__v)
  • Added the following objects to support the QMS <> RIM: Processing Enhancements feature:
    • QMS-RIM Transaction (qms_rim_transaction__v) object
    • QMS-RIM Transaction Log (qms_rim_transaction_log__v) object
  • Added the following components to RIM Vaults to support the RIM/Quality: Registered Product for Change Control feature:
    • Added the following fields to the Product Family (product__v) object:
      • Generic Name (generic_name__v)
      • Therapeutic Area (therapeutic_area__v)
      • Product Family Abbreviation (abbreviation__v)
    • Added the RIM-Quality: Product Integration (standard_product_integration__v) to the QMS RIM Connection (qms_rim_connection__v)
    • Added the following integration points to the RIM-Quality: Product Integration (standard_product_integration__v):
      • RIM-Quality: Product Family (product_family_int_point__v) Integration Point
      • RIM-Quality: Product (product_int_point__v) Integration Point
      • RIM-Quality: Product Family Product (product_family_product_int_point__v) Integration Point
      • RIM-Quality: Product Variant (product_variant_int_point__v) Integration Point
      • RIM-Quality: Complex Product Component (product_component_int_point__v) Integration Point
    • Added the RIM to QMS Product Outbound queue (rim_qms_product_outbound_queue__v)