22R3 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 22R3.

Data Model Updates

  • Added the following fields to the Country Dependency object to support Activity Country Dependency Enhancements:
    • Product (product__v)
    • Product Variant (product_variant__v)
    • Packaging (packaging__v)
  • Added or updated the following components to support the XEVMPD Support for Investigational Products feature:
    • Added the following object types to the Product Report Item (product_report_item__v) object:
      • Development Product Element (development_product_element__v )
      • Development Presentation Name Element (development_presentation_name_element__v )
      • Development Classification Element (development_classification_element__v )
      • Development Presentation Name Element (development_presentation_name_element__v)
    • Added the Development Product Element (development_product_element__v) object type to the Product Report (product_report__v) object.
    • Added the Alias (alias__v) field to the Medicinal Product Full Name (medicinal_product_full_name__rim) object.
    • Added the Authorisation Type (authorisation_type__v) field to the Product Data Submission (product_data_submission__v) object.
    • Added the following fields to the Product Report Item (product_report_item__v) object:
      • Other Name (other_name__v)
      • Other Name Text (other_name_text__v)
  • Enabled the Values must be unique configuration for the below object fields (listed by object):
    • Organization (organization__rim) object: EV Code (ev_code__v) 
    • Controlled Vocabulary (controlled_vocabulary__rim) object: EV Code (ev_code__v)
    • Medicinal Product (medicinal_product__rim) object: Product Variant (product_variant__v)
    • Contact (contact__rim) object: QPPV Code (qppv_code__v)
  • Enabled the User must always enter a value (required) configuration for the below object fields (listed by object):
    • Administered Product Description (admin_product_description__v) object:
      • Description (description__v)
      • Language (language__v)
    • Application (application__v) object: Dossier Format (dossier_format__v)
    • Contact (contact__rim) object: QPPV Code (qppv_code__v)
    • Event Shelf Life or Condition (event_shelf_life_and_storage__v) object: Storage Condition (storage_condition__v)
    • Indication Grouping (indication_grouping__v) object: Full Indication Text (full_indication_text__v)
    • Indication Translation (indication_translation__v) object: Full Indication Text (full_indication_text__v)
    • Labeling Deviation (labeling_deviation__v) object: CCDS Section (ccds_section__v)
    • Medicinal Product (medicinal_product__rim) object: 
      • Country (country__v)
      • Product Family (product__rim)
      • Product (product__v)
      • _Product Variant _(product_variant__v)
    • Pack Size (pack_size__v) object: 
      • Unit (unit__v)
      • Value (value__v)
    • Product Component (product_component__rim) object: Simple Product (simple_drug_product__rim)
    • Registered Shelf Life or Condition (registered_shelf_life_and_storage__v) object: Storage Condition (storage_condition__v)
    • Regulatory Objective (regulatory_objective__rim) object: _Procedure Tracking Number _(procedure_tracking_number__rim)
    • Regulatory Objective ShelfLife Condition (regulatory_objective_shelf_life_storage__v) object: 
      • Packaging (packaging__v)
      • Product (product__v)
      • Storage Condition (storage_condition__v)
    • Submission (submission__v) object: 
      • Applicant (applicant__v)
      • Procedure Tracking Number (procedure_tracking_number__rim)
    • Submission Shelf Life or Condition (submission_shelf_life_storage__v) object:
      • Packaging (packaging__v)
      • Product (product__v)
      • Storage Condition (storage_condition__v)
  • Enabled hierarchical copy on the Packaging Product Variant (packaging_product_detail__rim) object field Product Detail (product_detail__rim)
  • Enabled the System manages field value (read-only) configuration for the Name (name__v) field within the following objects:
    • Activity Labeling Deviation (activity_labeling_deviation__v)
    • Administered Product Description (admin_product_description__v)
    • Administered Product Reference Strength (admin_prod_reference_strength__rim)
    • Clinical Study Product (clinical_study_product__v)
    • Container Component (container_component__rim)
    • Country Language (country_language__v)
    • Indication Translation (indication_translation__v) 
    • Manufacturer (manufacturer__v)
    • Packaging Regulatory Text (packaging_regulatory_text__v)
    • Product Regulatory Authorization (product_regulatory_authorization__v)
    • Product Regulatory Text (product_regulatory_text__v)
    • Registration Scope (registration_scope__v)
  • Updated configuration to allow Admins to activate/inactivate (change the Status of) the following object fields (listed by object):
    • Application Active Substance (application_active_substance__v) object: 
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__v)
      • XML Drug Substance (xml_drug_substance__v)
      • XML Drug Substance Manufacturer (xml_drug_substance_manufacturer__v)
    • Application Clinical Study (application_clinical_study__v) object: 
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__v)
      • XML Clinical Study ID (xml_clinical_study_id__v)
      • XML Clinical Study Title (xml_clinical_study_title__v)
      • XML Type of Control (xml_type_of_control__v)
    • Application Country (application_country__rim) object: 
      • Use for Content Planning (use_for_content_planning__v)
      • XML Country Code (xml_country_code__v)
    • Application Inactive Ingredient (application_inactive_ingredient__v) object:
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__v)
      • XML Excipient (xml_excipient__v)
    • Application Indication (application_indication__rim) object: 
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__v)
      • XML Indication (xml_indication__v)
    • Application Nonclinical Study (application_nonclinical_study__v) object: 
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__v)
      • XML Duration (xml_duration__v)
      • XML Nonclinical Study ID (xml_nonclinical_study_id__v)
      • XML Nonclinical Study Title (xml_nonclinical_study_title__v)
      • XML Route of Administration (xml_route_of_administration__v)
      • XML Species (xml_species__v)
    • Application Pharmaceutical Form (application_pharmaceutical_form__v) object: Use for Content Planning (use_for_content_planning__v)
    • Application Product (application_pharmaceutical_product__v) object: 
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__v)
      • XML Product (xml_drug_product__v)
      • XML Product Dosage Form (xml_drug_product_dosageform__v)
      • XML Product Manufacturer (xml_drug_product_manufacturer__v)
    • Country Language (country_language__v) object: Use for Content Planning (use_for_content_planning__v)
    • Event Active Substance (event_active_substance__rim) object: Use for Content Planning (use_for_content_planning__v)
    • Event Clinical Study (event_clinical_study__v) object: Use for Content Planning (use_for_content_planning__v)
    • Event Product (event_drug_product__rim) object: Use for Content Planning (use_for_content_planning__v)
    • Event Inactive Ingredient (event_inactive_ingredient__rim) object: Use for Content Planning (use_for_content_planning__v)
    • Event Indication (event_indication__rim) object: Use for Content Planning (use_for_content_planning__v)
    • Event Nonclinical Study (event_nonclinical_study__v) object: Use for Content Planning (use_for_content_planning__v)
    • Event Pharmaceutical Form (event_pharmaceutical_form__v) object: Use for Content Planning (use_for_content_planning__v)
    • Submission Active Substance (submission_active_substance__rim) object: 
      • Event Source (event_source__v)
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__rim)
      • XML Drug Substance (xml_drug_substance__v)
      • XML Drug Substance Manufacturer (xml_drug_substance_manufacturer__v)
    • Submission Clinical Study (submission_clinical_study__rim) object: 
      • Event Source (event_source__v)
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__rim)
      • XML Clinical Study ID (xml_clinical_study_id__v)
      • XML Clinical Study Title (xml_clinical_study_title__v)
      • XML Type of Control (xml_type_of_control__v)
    • Submission Country (submission_country__rim) object: 
      • Use for Content Planning (use_for_content_planning__rim)
      • XML Country Code (xml_country_code__v)
    • Submission Inactive Ingredient (submission_inactive_ingredient__rim) object:
      • Event Source (event_source__v)
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__rim)
      • XML Excipient (xml_excipient__v)
    • Submission Indication (submission_indication__rim) object: 
      • Event Source (event_source__v)
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__rim)
      • XML Indication (xml_indication__v)
    • Submission Language (submission_language__rim) object: 
      • Use for Content Planning (use_for_content_planning__rim)
      • XML Language Code (xml_language_code__v)
    • Submission Nonclinical Study (submission_nonclinical_study__rim) object: 
      • Event Source (event_source__v)
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__rim)
      • XML Duration (xml_duration__v)
      • XML Nonclinical Study ID (xml_nonclinical_study_id__v)
      • XML Nonclinical Study Title (xml_nonclinical_study_title__v)
      • XML Route of Administration (xml_route_of_administration__v)
      • XML Species (xml_species__v)
    • Submission Pharmaceutical Form (submission_pharmaceutical_form__v) object:
      • Event Source (event_source__v)
      • Use for Content Planning (use_for_content_planning__v)
    • Submission Product (submission_pharmaceutical_product__rim) object: 
      • Event Source (event_source__v)
      • Output Name (output_name__v)
      • Use for Content Planning (use_for_content_planning__rim)
      • XML Product (xml_drug_product__v)
      • XML Product Dosage Form (xml_drug_product_dosageform__v)
      • XML Product Manufacturer (xml_drug_product_manufacturer__v)
  • Enabled the Audit data changes in this object configuration on the following objects:
    • Activity Labeling Concept (activity_labeling_concept__v)
    • Commitment Application (commitment_application__v)
    • Correspondence Event (correspondence_event__v)
    • Country Language (country_language__v)
  • Updated the Auto-Create Submission Country SDK trigger to set the Use for Content Planning (use_for_content_planning__rim) field value on Submission Country (submission_country__rim) records based on the value set on the Application Country (application_country__rim) record

  • Updated the Global Version ID (global_version_id__sys) document field to be visible in the Content Plan Viewer

  • To support the Create Content Plan as Inactive feature, added the Create as Active (create_as_active__v) field to the Content Plan Item Template (edl_item_template__v) object and its following object types:
    • Regional (Module 1) (module_1__rim)
    • Nonclinical (Module 4) (module_4__rim)
    • Clinical (Module 5) (module_5__rim)
  • Added the following object fields to support the EUDAMED Business Rule Validation feature:
    • UDI Submission (udi_submission__v) object:
      • Validation Criteria Version (validation_criteria_version__v)
      • Validation Errors (validation_errors__v)
    • Controlled Vocabulary (controlled_vocabulary__rim) object:
      • Requires Description (requires_description__v)
      • UDI Validation Criteria Version (udi_validation_criteria_version__v)
  • Added the following fields to support the IDMP / DADI Data Model Updates feature, listed by object:
    • IDMP Container Reference Item (idmp_container_reference_item__v) object: 
      • Device Identifier (device_identifier1__v)
      • Type of Combination (type_of_combination1__v)
    • IDMP Marketing Authorisation Element (idmp_marketing_authorisation_element__v) object:
      • Date of First Authorisation (date_of_first_authorisation1__v)
      • Procedure End Date (procedure_end_date1__v)
    • Product Variant (product_detail__v): Device Trade Name (device_trade_name__v)
  • Added the Shelf Life (shelf_life__rim) field to the Application Packaging (application_packaging__v) object.
  • Added the Types of Changes (types_of_changes__v) picklist field to the Regulatory Objective (regulatory_objective__rim) object and its Worksharing (worksharing__v) object type to support the DADI Output Report feature.
  • Added the following fields to the Submission Metadata (submission_metadata__v) object to support the New Submissions Archive Viewer feature:
    • Hierarchy Level (hierarchy_level__v)
    • Hierarchy Path (hierarchy_path__v)
    • Parent (parent__v)