24R1 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 24R1.

• Added and updated various components to support the Wizard Support for IDMP Manufacturing Details and RIM Registrations Data Model Updates features in RIM Registrations. See each feature’s description above for details.

• Added the following components to support the Content Plan Creation to Respect DTD/XSD Version feature:
  • Added object fields XML ICH DTD / XSD Version (xml_ich_dtd_xsd_version__v) and XML Regional DTD / XSD Version (xml_reg_dtd_xsd_version__v) to the following objects:
    • Content Plan (edl__v)
    • Content Plan Item (edl_item__v)
    • Content Plan Template (edl_template__v)
    • Content Plan Item Template (edl_item_template__v)
  • Added the above-listed object fields to the below object types. (All items in this list are object types of the above-listed 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)
    • Other (other__v)
• In all RIM Vaults, increased the field length of the following fields to the indicated character limit:
  • Submission (submission__v) object: Description (description__v) field increased to 1500 characters
  • Packaging (packaging__rim) object: Package Description (package_description__rim) field increased to 1500 characters
  • Risk Class (risk_class__v) object: Health Authority Code (health_authority_code__v) field increased to 25 characters
• In all RIM Vaults, enabled the User must always enter a value (required) configuration for the following fields:
  • Clinical Study (clinical_study__v) object fields:
    • Type of Control (type_of_control__rim)
    • Route of Administration (route_of_administration__rim)
  • Organization (organization__rim) object: Address (address__rim) field
  • Product Variant Reference Strength (product_detail_reference_strength__rim) object: Reference Substance (reference_substance__rim) field
• In all RIM Vaults, enabled hierarchical copy on the following object fields:
  • Submission Product (submission_pharmaceutical_product__rim) object: Product (pharmaceutical_product__rim) field
  • Application (application_pharmaceutical_product__v) object: Product (pharmaceutical_product__v) field
  • Compatible Platform (compatible_platform__v) object: Product Variant (product_variant__v) field
  • Medicinal Product Full Name (medicinal_product_full_name__rim) object: Medicinal Product (medicinal_product__rim) field
  • Application Country (application_country__rim) object: Country (country__rim) field
  • Packaging Regulatory Text (packaging_regulatory_text__v) object: Packaging (packaging__v) field
• In all RIM Vaults, enabled the System manages field value (read-only) configuration for the Name (name__v) field on the following objects:
  • Regulatory Objective (regulatory_objective__rim)
  • Application (application__v)
  • Active Substance Translation (active_substance_translation__v)
  • Inactive Ingredient Translation (inactive_ingredient_translation__v)
• In all RIM Vaults, enabled the Allow user to select multiple values configuration for the following fields:
  • Labeling Components Included (labeling_components_included__v) document field
  • Product Family (product__v) object: Therapeutic Area (therapeutic_area__v) field
• In all RIM Vaults, enabled Admins to update the Picklist Status Value for the identified values in the following picklists:
  • MedDRA Version (meddra_version__v) picklist values:
    • - (default_version__v)
    • 18.0 (180__v)
    • 18.1 (181__v)
    • 19.0 (190__v)
    • 19.1 (191__v)
    • 20.0 (200__v)
    • 20.1 (201__v)
    • 21.0 (210__v)
  • Identifier Type (identifier_type__v) picklist values:
    • Product Code (finished_product_code__v)
    • Basic UDI-DI (basic_udidi__v)
    • UDI DI (udi_di__v)
    • EUDAMED ID (eudamed_id__v)
  • Applicable Product Type (applicable_product_type__v) picklist values:
    • Vet Device (vet_device__v)
    • Vet Drug (vet_drug__v)
• Added or updated the following components to support the Bulk Create & Manage Event Details feature:
  • Added the following picklists:
    • Event Change Action (event_change_action__v)
    • Related Change Type (related_change_type__v)
    • Special Record Classification (special_record_classification__v)
  • Added the Related Change Type (related_change_type__v) picklist field to the following Event, Submission, and Regulatory Objective relationship objects (for example, Event Active Substance):
    • Active Substance
    • Authorization
    • Clinical Study
    • Inactive Ingredient
    • Indication
    • Nomenclature Code
    • Nonclinical Study
    • Packaging
    • Packaging Characteristic
    • Pharmaceutical Form
    • Product
    • Product Characteristic
    • Regulatory Text
    • Shelf Life
    • Site Contact
    • Site Organization
    • Site Role
  • Added the Special Record Classification (special_record_classification__v) picklist field to the following objects and indicated object type:
    • Manufacturer (manufacturer__v)
    • Product (drug_product__v) and its object type, Simple Drug Product (simple_product__rim)
    • Product Variant (product_detail__v)
    • Inactive Ingredient (excipient__v)
• In all RIM Registrations Vaults, enabled the Values must be unique configuration for the UDI Attribute Set (udi_attribute_set__v) object’s External ID (external_id__v) field.
• Added the Placeholder Value (placeholder_value__v) field to the Controlled Vocabulary (controlled_vocabulary__rim) object for the Enhanced Support for Packaging Shelf Life Field feature.
• Added the Additional Error Details (additional_error_details_v) field to the UDI Submission Error (udi_submission_error__v) object to support the Identification of Global Site Role Values That Could Not Be Mapped feature.
• Added the Source File Path (source_file_path__v) field to the Submission Metadata (submission_metadata__v) object to support the Leaf Source File Path Display in the Submissions Archive Viewer feature.
• Added the following fields to the Content Plan (edl__v) and/or Content Plan Template (edl_template__v) objects to support the Section Level Merge for RLCP feature:
  • Merge Section (merge_section__v)
  • Section Merge Published Output Location (section_merge_pol__v)
  • Content Plan only: 
    • Merged Document (merged_document__v)
    • Merged Document (unbound) (merged_document_unbound__v)
• Updated the following to support the Document Type Definition for RLCP Published Output feature:
  • Added the Output Document Type (output_document_type__v) field to the Report Level Content Plan (report_level_content_plan__v) object and all of its standard object types.
  • Added the RLCP Output Document Type (rlcp_output_document_type__v) field to the following:
    • Content Plan Item (edl_item__v) object
    • Content Plan Item Template (edl_item_template__v) object and its below object types:
      • 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 Published by RLCP (published_by_rlcp__v) shared document field
• Updated the following to support the Generate Active Dossier from Global Content Plan Dispatch feature:
  • Added the Needs Submission (needs_submission__v) field to the Active Dossier Item Detail (active_dossier_item_detail__v) object.
  • Added the following fields to the Active Dossier Loader (active_dossier_loader__v) object:
    • Event (event__v)
    • Activity (activity__v)
    • Needs Submission (needs_submission__v)
• Added the Additional Error Details (additional_error_details__v) field to the UDI Submission Error (udi_submission_error__v) object for the EUDAMED XSD Version 2.0.11 Support feature.
• Added the following to support the RIM-PromoMats Connection: CrossLink Document Transfer Integration feature:
  • Added the RIM Connection Document Source Event (rim_connection_document_source_event__v) object
  • Added the Target Vault (target_vault__v) value to the Document Event Type (document_event_type__v) picklist
• In support of the Content Plan Creation to Respect DTD/XSD Version feature, added the XML ICH DTD / XSD Version (xml_ich_dtd_xsd_version__v) and XML Regional DTD / XSD Version (xml_reg_dtd_xsd_version__v) fields to the below objects and their listed object types:
  • Objects:
    • Content Plan (edl__v)
    • Content Plan Item (edl_item__v)
    • Content Plan Template (edl_template__v)
    • Content Plan Item Template (edl_item_template__v)
  • Object Types:
    • 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)
    • Other (other__v)
• To support the Global-to-Local Site Role Mapping in Bundling feature, added the Placeholder Value (placeholder_value__v) field to the Controlled Vocabulary (controlled_vocabulary__rim) object.