23R2 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 23R2.

  • Updated the following components to support the Global-to-Local Mappings for Submission Subtypes and Site Roles feature:
    • Added the following values to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist:
      • Global Submission Subtype (global_submission_subtype__v)
      • Global Site Role (global_site_role__v)
    • Relabeled the Controlled Vocabulary Type picklist value Manufacturing Site Role to Local Manufacturing Site Role (manufacturing_site_role__v).
    • Added the Domain (domain__v) field to the Constraint (constraint__rim) object and its following object types:
      • Global to Local Submission Type (global_to_local_submission_type__rim)
      • Site Role (manufacturing_site_role__v)
  • Added the Cleanup Status (cleanup_status__v) picklist and field to the Content Plan (edl__v) object to support the Update to Inactive Content Plan Records Cleanup Job Deletion Criteria feature.
  • Updated the following components to support the Active Dossier Support for Product Family Level Documents feature:
    • Added the Product Family (product_family__v) field to the following objects:
      • Active Dossier Item (active_dossier_item__v)
      • Active Dossier Item Detail (active_dossier_item_detail__v)
    • Activated the Product Family (prodct_family__v) field within the Active Dossier Loader (active_dossier_loader__v) object.
  • Added the following components to support the Redacted Document Field and Relationship feature:
    • Redacted (redacted__v) document field
    • Redaction (redaction__v) document relationship type
  • Updated the Document Set (submission_grouping__v) field to be multi-select on the following objects for the Support Multi-Select on Document Set feature:
    • Activity (activity__rim)
    • Application (application__v)
    • Content Plan Item (edl_item__v)
    • Country (country__v)
  • Updated the following components in all RIM Vaults:
    • Enabled the Values must be unique configuration for the below fields:
      • SPOR Referential ID (spor_rms_id__v) in the Controlled Vocabulary (controlled_vocabulary__rim), Country (country__v), and Language (language__rim) objects
      • Identifier (substance_id__v) in the Active Substance (drug_substance__v) object
    • Enabled the User must always enter a value (required) configuration for the below object fields:
      • Description (description__v) in the Submission (submission__v) object
      • Submission Type (submission_type__rim) in the Submission (submission__v) object This data model update was deferred to a later release.
      • Dependency Action (dependency_action__v) in the Activity Dependency (activity_dependency__v) object
      • Product Variant (product_variant__v) in the Application Nomenclature Code (application_product_classification__v) object
    • Enabled hierarchical copy on the following object fields:
      • Product Variant (product_detail__rim) in the Product Variant Manufacturer (product_detail_manufacturer__rim) object
      • Submission (submission__v) in the Submission Shelf Life or Condition (submission_shelf_life_storage__v) object
      • Full Indication Text (full_indication_text__v) in the Indication Translation (indication_translation__v) object
    • Enabled the System manages field value (read-only) configuration for the Name (name__v) field in the following objects:
      • IDMP Full Indication Text (full_indication_text_idmp__v)
      • Indication Grouping (indication_grouping__v)
      • Pack Size (pack_size__v)
      • Registration (registration__rim)
    • Enabled the Allow user to select multiple values configuration for the following object fields:
      • CCDS Section (ccds_section__v) field in the Labeling Deviation (labeling_deviation__v) and Labeling Concept (labeling_concept__v) objects
      • Applicable Product Type (applicable_product_type__v) field in the Event (event__rim), Activity (activity__rim), and Product (drug_product__v) objects
    • Enabled Admins to update the Picklist Status Value for standard values in the following picklists:
      • Activity Status (activity_status__rim)
      • Applicable Product Type (applicable_product_type__v)
      • Assigned Department (assigned_department__rim)
      • CCDS Section (ccds_section__v)
      • Commitment Type (commitment_type__rim)
      • Controlled Vocabulary Type (controlled_vocabulary_type__rim)
      • Dependency Action (dependency_action__v)
      • Deviation Review Disposition (deviation_review_disposition__v)
      • HA Code Source (ha_code_source__rim)
      • Local Disposition (local_disposition__rim)
      • Manufacturer Type (manufacturer_type__rim)
      • Marketing Status (marketing_status__rim)
      • Organization Type (organization_type__rim)
      • Reason for Deviation (reason_for_deviation__v)
  • Added or updated the following components to support the EUDAMED Machine-to-Machine UDI Submissions feature:
    • Added the UDI Submission Error (udi_submission_error__v) object.
    • Added the Health Authority Message (health_authority_message__v) object and its object type, AS4 Message (as4_message__v).
    • Added the UDI Submission Message (udi_submission_message__v) object to join the Health Authority Message and UDI Submission objects.
    • Enabled Attachments for the UDI Submission (udi_submission__v) object.
    • Added the Sending to HA (sending_to_ha__v) state to the UDI Submission (udi_submission__v) document lifecycle.
    • Increased the Device Model or Version (device_model_or_version__v) field length from 120 to 255 characters in the following objects:
      • Product (drug_product__v)
      • Application Product Characteristic (application_product_characteristic__v)
      • Event Product Characteristic (event_product_characteristic__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 Reference Deviation (reference_deviation__v) field to the Labeling Deviation (labeling_deviation__v) object to support the Labeling Deviation Trigger Enhancements feature.
  • Added the following components to support the Pharmaceutical Form Name Override feature:
    • Added the XML Application Pharmaceutical Form Name (xml_application_pharmaceutical_form_name__v) field to the Application Pharmaceutical Form (application_pharmaceutical_form__v) object.
    • Added the XML Submission Pharmaceutical Form Name (xml_submission_pharmaceutical_form_name__v) field to the Submission Pharmaceutical Form (submission_pharmaceutical_form__v) object.
  • Added the following components to support the RIM Document Classification Bot (AI) feature:
    • Added the following objects:
      • Predictions (predictions__sys)
      • Prediction Metric (prediction_metric__sys)
      • Trained Models (trained_models__sys)
    • Added the Trained Model (trained_model_lifecycle__sys) object lifecycle
    • Added the RIM Auto-Classification (rim_autoclassification__v) shared document picklist field
    • Added the RIM Document Auto-Classification Status (rim_document_autoclassification_status__v) picklist
  • Added the following components to support the Synchronize Content Plans: Iterative & Section-Level Dispatch feature:
    • Added the following objects:
      • Dispatch Message (dispatch_message__v)
      • Dispatch Message Content Plans (dispatch_message_content_plans__v)
    • Added the Mandatory for Dispatch Acceptance (mandatory_for_dispatch_acceptance__v) field to the following objects:
      • Content Plan (edl__v)
      • Content Plan Template (edl_template__v)
      • Content Plan Item (edl_item__v)
      • Content Plan Item Template (edl_item_template__v)
    • Added the Last Dispatch Date (last_dispatch_date__v) field to the Submission (submission__v) object.
    • Added a new Application Role (application_role__v) object record for the system-provided Submission Owner role. This role is also added to the Application and Submission object lifecycles when configured.
  • Added the UA (ua__v) value to the HA Code Source (ha_code_source__rim) picklist to support the Ukraine eCTD 1.0 Pilot feature.
  • Added the Use for Registrations (use_for_registrations__v) field to the following objects in all RIM Vaults to support the “Use for Registrations” in Create Registrations and Manage Registered Details feature:
    • Application Active Substance (application_active_substance__v)
    • Application Clinical Study (application_clinical_study__v)
    • Application Inactive Ingredient (application_inactive_ingredient__v)
    • Application Indication (application_indication__rim)
    • Application Nonclinical Study (application_nonclinical_study__v)
    • Application Product (application_pharmaceutical_product__v)
    • Event Active Substance (event_active_substance__rim)
    • Event Clinical Study (event_clinical_study__v)
    • Event Inactive Ingredient (event_inactive_ingredient__rim)
    • Event Indication (event_indication__rim)
    • Event Nonclinical Study (event_nonclinical_study__v)
    • Event Product (event_drug_product__rim)
    • Regulatory Objective Active Substance (regulatory_objective_active_substance__v)
    • Regulatory Objective Clinical Study (regulatory_objective_clinical_study__v)
    • Regulatory Objective Inactive Ingredient (regulatory_objective_inactive_ingredient__v)
    • Regulatory Objective Indication (regulatory_objective_indication__v)
    • Regulatory Objective Nonclinical Study (regulatory_objective_nonclinical_study__v)
    • Regulatory Objective Product (regulatory_objective_drug_product__v)
    • Submission Active Substance (submission_active_substance__rim)
    • Submission Clinical Study (submission_clinical_study__rim)
    • Submission Inactive Ingredient (submission_inactive_ingredient__rim)
    • Submission Indication (submission_indication__rim)
    • Submission Nonclinical Study (submission_nonclinical_study__rim)
    • Submission Product (submission_pharmaceutical_product__rim)
  • Added the following components to support the UPD Submission Data Aggregation feature:
    • Added the following objects:
      • Concerned Member State (concerned_member_state__v)
      • UPD Registered Distributor (upd_registered_distributor__v)
      • UPD Species (upd_species__v)
      • UPD Withdrawal Period (upd_withdrawal_period__v)
    • Added the following values as Inactive to the Applicable Product Type (applicable_product_type__v) picklist:
      • Vet Drug (vet_drug__v)
      • Vet Device (vet_device__v)
    • Added the Applicable Product Type (applicable_product_type__v) picklist field to the following objects:
      • IDMP Admin Ingredient Manufacturer (idmp_admin_ingredient_manufacturer__v)
      • IDMP Admin Product Ingredient Element (idmp_admin_product_ingredient_element__v)
      • IDMP AP Reference Strength (idmp_ap_reference_strength__v)
      • IDMP Attachment (idmp_attachment__v)
      • IDMP Attachment Language (idmp_attachment_language__v)
      • IDMP Authorised Pharmaceutical Form (idmp_authorised_pharmaceutical_form__v)
      • IDMP Classification System (idmp_classification_system__v)
      • IDMP Manuf. Item Ingredient Manufacturer (idmp_manuf_item_ingredient_manufacturer__v)
      • IDMP Manufactured Item (idmp_manufactuered_item__v)
      • IDMP Manufactured Item Ingredient (idmp_manufactured_item_ingredient__v)
      • IDMP Manufacturing Site (idmp_manufacturing_site__v)
      • IDMP Marketing Authorisation Element (idmp_marketing_authorisation_element__v)
      • IDMP Master File (idmp_master_file__v)
      • IDMP Medicinal Product Element (idmp_medicinal_product_element__v)
      • IDMP Medicinal Product Full Name (idmp_medcinal_product_full_name__v)
      • IDMP Name Part (idmp_name_part__v)
      • IDMP Pack Size (idmp_pack_size__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 Pharmaceutical Product Element (idmp_pharmaceutical_product_element__v)
      • IDMP Product Cross Reference (idmp_product_cross_reference__v)
      • IDMP Product Data Submission (idmp_product_data_submission__v)
      • IDMP PV Reference Strength (idmp_pv_reference_strength__rim)
      • IDMP Route of Administration (idmp_route_of_administration__v)
    • Added the following fields to the IDMP Attachment (idmp_attachment__v) object:
      • Country (country__v)
      • Country Code (country_code__v)
      • Country Code Text (country_code_text__v)
      • Country Term (country_term__v)
      • Country Term Text (country_term_text__v)
      • Permanent ID (permanent_id__v)
      • Permanent ID Text (permanent_id_text__v)
      • Title (title__v)
      • Title Text (title_text__v)
      • UPD Identifier (upd_identifier__v)
      • UPD Identifier Text (upd_identifier_text__v)
      • UPD Status (upd_status__v)
      • UPD Status Text (upd_status_text__v)
    • Added the following fields to the IDMP Master File (idmp_master_file__v) object:
      • Master File (master_file_unbound__v)
      • Master File Code (idmp_master_flle__v)
      • Master File Code Text (idmp_master_flle__v)
    • Added the following fields to the IDMP Medicinal Product Element (idmp_medicinal_product_element__v) object:
      • Product Record Status (product_record_status__v)
      • Product Record Status Code (product_record_status_code__v)
      • Product Record Status Code Text (product_record_status_code_text__v)
      • Product Record Status Term (product_record_status_term__v)
      • Product Record Status Term Text (product_record_status_term_text__v)
      • Product Version Number (product_version_number__v)
      • Product Version Number Text (product_version_number_text__v)
      • QPPV Family Name (qppv_family_name__v)
      • QPPV Family Name Text (qppv_family_name_text__v)
      • QPPV Given Name (qppv_given_name__v)
      • QPPV Given Name Text (qppv_given_name_text__v)
      • QPPV Location (qppv_location_id__v)
      • QPPV Location Text (qppv_location_id_text__v)
      • QPPV Organization (qppv_organization__v)
      • Registration (registration__v)
      • UPD Permanent ID (upd_permanent_id__v)
      • UPD Permanent ID Text (upd_permanent_id_text__v)
      • UPD Product ID (upd_id__v)
      • UPD Product ID Text (upd_id_text__v)
    • Added the following fields to the IDMP Packaged Medicinal Product Element (idmp_packaged_medicinal_product_element__v):
      • UPD ID (upd_id__v)
      • UPD ID Text (upd_id_text__v)
    • Added the following fields to the IDMP Product Cross Reference (idmp_product_cross_reference__v) object:
      • Reference Product Permanent ID (reference_product_permanent_id__v)
      • Reference Product Permanent ID Text (reference_product_permanent_id_text__v)
      • Source Product Permanent ID (source_product_permanent_id__v)
      • Source Product Permanent ID Text (source_product_permanent_id_text__v)