19R3 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 data model. These data model updates are automatically included in all Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 19R3.

  • Added the shared Ready for Matching (ready_for_matching__v) document field
  • Added the Ready for Matching (ready_for_matching__v) field to the Content Plan Item (edl_item__v) object
  • Added the Ready for Matching (ready_for_matching__v) picklist
  • Added the Applicable Product Type (applicable_product_type__v) field to the following objects:
    • Constraint (constraint__rim)
    • Application (application__v)
    • Submission (submission__v)
  • Added the Applicable Product Type (applicable_product_type__v) picklist

In addition, these data model updates support features delivered in 19R3:

Added components to RIM Registrations vaults to support the Enhancements to Create Registrations Wizard feature:

  • Added the Object Type Mapping (object_type_mapping__v ) object with fields:
    • Source Object Name (source_object_name__v)
    • Source Object Type Name (source_object_type_name__v)
    • Target Object Name (target_object_name__v)
    • Target Object Type Name (target_object_type_name__v)
    • Vault RIM UUID (vault_rim_uuid__v)
    • External ID (external_id__v)
  • Added the following object type and page layout to the Object Type Mapping object:
    • Registration Mapping (registration_mapping___v)
  • Added the Registration Scope (registration_scope__v) object with fields:
    • Country (country__v)
    • Registration Object Type Name (registration_object_type_name__v)
    • Registration Scope (registration_scope__v)
    • Vault RIM UUID (vault_rim_uuid__v)
    • External ID (external_id__v)
  • Added the Registration Scope Type picklist

Added components to support the Registrations Spark Connection: Change Control & Variation Management feature:

  • Added the following fields to the Event (event__rim) object:
    • Change Event GUID (change_event_guid__v)
    • Impact Assessment GUID (impact_assessment_guid__v)

Added components to support the Create Inactive Records Using Content Plan Template Constraints feature:

  • Added the following field to the Content Plan Template Constraint (content_plan_template_constraint__v) object:
    • Constraint Option (constraint_option__v)
  • Added the Constraint Option (constraint_option__v) picklist

Added components to support the Canada XSD 2.2 & Validation feature:

  • Added the Regulatory Activity Lead (regulatory_activity_lead__v) field to the following objects:
    • Application (application__v)
    • Submission (submission__v)
  • Added the following value to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist:
    • Regulatory Activity Lead (regulatory_activity_lead__v)
  • Added the following value to the HA Code Source (ha_code_source__rim) picklist:
    • HC (hc__v)
  • Added the following value to the Group (group__v) picklist:
    • XML Analysis (xml_analysis__v)
    • ICH Backbone (ich_backbone__v)

This release also introduces Enhanced Configurability to various components in RIM vaults. Enhanced Configurability introduces the ability for applications to determine which field attributes in a standard object’s configuration an Admin should be able to edit. Depending on your vault application’s data model, you may be able to edit additional settings, such as system-managed naming or if the field is required, or editing may be blocked on some of these attributes.

On RIM Registrations vaults:

  • Added the ability for Admins to enable system-managed naming for the Name (name__v) field on the following objects:
    • Event Active Substance (event_active_substance__rim)
    • Event Clinical Study (event_clinical_study__v)
    • Event Product (event_drug_product__rim)
    • Event Inactive Ingredient (event_inactive_ingredient__rim)
    • Event Indication (event_indication__rim)
    • Event Indication (event_nonclinical_study__v)
    • Event Packaging (event_packaging__rim)
    • Event Submission (event_submission__rim)
    • Registered Active Ingredient (registered_active_ingredient__rim)
    • Registered Clinical Study (registered_clinical_study__v)
    • Registered Product (registered_drug_product__rim)
    • Registered Inactive Ingredient (registered_inactive_ingredient__rim)
    • Registered Indication (registered_indication__rim)
    • Regulatory Objective Clinical Study (regulatory_objective_clinical_study__v)
    • Regulatory Objective Product (regulatory_objective_drug_product__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)
    • Reg Objective Product Classification (reg_objective_product_classification__v)
    • Reg Objective Product Characteristic (reg_objective_product_characteristic__v)
    • Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v)
    • Registered Product Classification (registered_product_classification__v)
    • Registered Product Characteristic (registered_product_characteristic__v)
    • Registered Packaging Characteristic (registered_packaging_characteristic__v)
    • Event Product Classification (event_product_classification__v)
    • Event Product Characteristic (event_product_characteristic__v)
    • Event Packaging Characteristic (event_packaging_characteristic__v)
    • Submission Product Classification (submission_product_classification__v)
    • Submission Product Characteristic (submission_product_characteristic__v)
    • Submission Packaging Characteristic (submission_packaging_characteristic__v)