24R3 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 24R3.

In support of the Vault RIM Standard Checkbox Defaulting feature, Vault will automatically set the below standard checkbox fields to No (false) upon record creation. This behavior only applies when the field is not configured with a default value.

• Automated Linking Group object (automated_linking_group__v): Quit On Failed Match field (quit_on_failed_match__v)
• Controlled Vocabulary object (controlled_vocabulary__rim): Requires Description field (requires_description__v)
• Dispatch Message object (dispatch_message__v) fields:
  • Copy Relationships (copy_relationships__v)
  • Ignore Template Constraints (ignore_template_constraints__v)
• Active Substance object (drug_substance__v): Allergen field (allergen__v)
• Content Plan object (edl__v): Mandatory for Dispatch Acceptance field (mandatory_for_dispatch_acceptance__v)
• Content Plan Item Template object (edl_item_template__v): Repeat on Document Set field (repeat_on_submission_grouping__v)
• Content Plan Template object (edl_template__v): Mandatory for Dispatch Acceptance field (mandatory_for_dispatch_acceptance__v)
• Packaging Product Variant object (packaging_product_detail__rim): Co-Packaged or Integral Device field (copackaged_or_integral_device__v)
• Product Variant Active Substance object (product_detail_active_substance__rim): Colorant field (colorant__v)
• Registered Product object (registered_drug_product__rim): Co-Packaged or Integral Device field (copackaged_or_integral_device__v)

To support the Configurable Procedure Countries for Create Registrations feature, added the Procedure Type Country picklist value (procedure_type_country__v) to the Constraint Scope picklist (constraint_scope__v).

In all RIM Publishing Vaults, enabled Admins to activate/inactivate (change the Picklist Value Status of) the South Korea (KR kr__v) value in the HA Code Source (ha_code_source_v) picklist.

In all RIM Publishing Vaults, associated the following existing Content Plan (edl__v) object fields to its Device Submission Plan (device_submission_plan__v) object type:

• Module/Section (modulesection__v)
• XML Attribute (xml_attribute__v)
• XML Attribute Type (xml_attribute_type__v)
• XML Element ID (xml_element_id__v)
• XML Element Name (xml_element_name__v)

In all RIM Publishing Vaults, associated the following existing Content Plan Item (edl_item__v) object fields to its Device Submission Plan Item (device_submission_plan_item__v) object type:

• Module/Section (modulesection__v)
• XML Keywords (xml_keywords__v)
• XML Leaf Attribute (xml_leaf_attribute__v)
• XML Leaf Attribute Type (xml_leaf_attribute_type__v)
• XML Leaf ID (xml_leaf_id__v)
• XML Modified File (xml_modifiedfile__v)
• XML Operation (xml_operation__v)

For the NeeS EAEU Publishing Support feature, added or updated the following components:

• Added the Extended Leaf Attributes (extended_leaf_attributes__v) object.
• Added the following values to the Controlled Vocabulary Type (controlled_vocabulary_type__rim) picklist:
  • Drug Registration Document Code (document_registration_code__v)
  • Extended Leaf Attribute (extented_leaf_attribute__v)
  • Product Subtype (product_subtype__v)
• To the HA Code Source (ha_code_source__v) picklist, added the EAEU (eaeu__v) value.
• To the Node Type (node_type__v) picklist, added the R.022 (r022__v) value.
• Added the Registration File Indicator (eaeu_reg_file_indicator__v) picklist.
• Added the Registration File Indicator (eaeu_reg_file_indicator__v) picklist field to the following objects and their listed object types:
  • Objects:
    • Content Plan Item (edl_item__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)
• Added the EAEU Publishing Document Expiry Date (expiry_date__v) shared document field.

To support the Publishing WHO eCTD Version 1.1 feature, added or updated the following components:

• To the HA Code Source (ha_code_source__v) picklist, added the WHO (who__v) value.
• Added the below fields to the Application (application__v) object and its indicated object types:
  • Fields:
    • Product Type (product_type__v)
    • Product Subtype (product_subtype__v)
  • Object types:
    • Investigational Drug Application (investigational_drug_application__v)
    • Marketing Drug Application (marketing_drug_application__v)
• Added the Product Subtype (product_subtype__v) field to the Submission (submission__v) object and the following object types:
  • Investigational Drug Application (investigational_drug_application__v)
  • Marketed Drug Application (marketed_drug_application__v)

For the Support Source Document Overlay Resolution feature, added or updated the following components:

• Added the Source of Published Overlay (source_of_pub_overlay__v) picklist.
• Added the Source of Published Overlay (source_of_pub_overlay__v) picklist field to the Publishing Element (publishing_element__v) object.

In all RIM Publishing Vaults, added or updated the following components in support of moving Submission Validation Results to raw object data stores in 25R1:

• Added the Rule Severity (rule_severity__v) picklist.
• Added the Rule Severity (rule_severity__v) picklist field to the Validation Result (submission_validation_result__v) object.

The following data model changes are automatically included in all Regulatory Vaults for the Registrations application, but Admins must make configuration changes to make them available.

• Added the following Registrations objects to the Submissions, Submissions Archive, and Publishing manifests for eCTD 4.0:
  • Submissions
    • Component (component__rim)
    • Container Component (container_component__rim)
    • Packaging Container Component (packaging_container_component__rim)
    • Product Variant Container (product_detail_container__rim)
  • Submissions Archive:
    • Component (component__rim)
    • Container Component (container_component__rim)
    • Packaging Container Component (packaging_container_component__rim)
    • Product Variant Container (product_detail_container__rim)
  • Publishing:
    • Component (component__rim)
    • Container (container__rim)
    • Container Component (container_component__rim)
    • Packaging Container (packaging_container__rim)
• Updated configuration to allow Admins to activate/inactivate (change the Picklist Value Status of) values in the Name Part Type (name_part_type__rim) picklist.
• Updated configuration to allow Admins to activate/inactivate (change the Status of) the Make Contact Details Public (make_contact_details_public__v) field in all Organization relationship objects:
  • Application Organization (application_site_organization__v)
  • Event Organization (event_site_organization__v)
  • Registered Organization (registered_site_organization)
  • Regulatory Objective Organization (regulatory_objective_site_organization__v)
  • Submission Organization (submission_site_organization__v)
• Added full support in Registrations for the Indication Translation (indication_translation__v) field:
  • Added the field as inactive to the Event Indication (event_indication__rim) and Submission Indication (submission_indication__rim) objects.
  • Added the field to the above objects’ Full Indication Text (full_indication_text__v) object types (Event Full Indication Text, Submission Full Indication Text), without adding the field to object page layouts.
  • Updated configuration to allow Admins to activate/inactivate (change the Status of) the field.

For the Activity Dependency Enhancements feature, added or updated the following components:

• Added the Local Labeling Impact field (local_labeling_impact__v) to the Activity object (activty__rim).
• Added the following fields to the Activity Dependency (activity_dependency__v) and Country Dependency (country_dependency__v) objects:
  • Dependent Application (dependent_application__v)
  • Reference Application (reference_application__v)

For the Create Related Records: Validation Enhancements feature, added or updated the following components:

• Added the Replacement Pair (replacement_pair__v) field to most Event relationship objects, for example, Event Active Substance (event_active_substance__rim). This field was not added to the Event Regulatory Objective or Event Submission relationship objects.
• Added the Update (update__v) value to the Event Change Action (event_change_action__v) picklist.
• Added the following values to the Related Change Type (related_change_type__v) picklist:
  • Add Drug Product Manufacturer Details
  • Update Drug Product Manufacturer Details
  • Replacing Drug Product Manufacturer Details
  • Replaced by Drug Product Manufacturer Details
  • Withdraw Drug Product Manufacturer Details
  • Add Device Product Manufacturer Details
  • Update Device Product Manufacturer Details
  • Replacing Device Product Manufacturer Details
  • Replaced by Device Product Manufacturer Details
  • Withdraw Device Product Manufacturer Details
  • Add Drug Packaging Manufacturer Details
  • Update Drug Packaging Manufacturer Details
  • Replacing Drug Packaging Manufacturer Details
  • Replaced by Drug Packaging Manufacturer Details
  • Withdraw Drug Packaging Manufacturer Details
  • Add Device Packaging Manufacturer Details
  • Update Device Packaging Manufacturer Details
  • Replacing Device Packaging Manufacturer Details
  • Replaced by Device Packaging Manufacturer Details
  • Withdraw Device Packaging Manufacturer Details
  • Add Active Substance Manufacturer Details
  • Update Active Substance Manufacturer Details
  • Replacing Active Substance Manufacturer Details
  • Replaced by Active Substance Manufacturer Details
  • Withdraw Active Substance Manufacturer Details
  • Add Inactive Ingredient Manufacturer Details
  • Update Inactive Ingredient Manufacturer Details
  • Replacing Inactive Ingredient Manufacturer Details
  • Replaced by Inactive Ingredient Manufacturer Details
  • Withdraw Inactive Ingredient Manufacturer Details
  • Add Product Variant Details
  • Replacing Product Variant Details
  • Replaced by Product Variant Details
  • Withdraw Product Variant Details
  • Update Product Variant Details
  • Update Product Details
  • Update Active Substance Details
  • Update Inactive Ingredient Details
  • Update Indication Details
  • Update Clinical Study Details
  • Update Nonclinical Study Details
  • Update Details

For the Create Related Records: Support for Enhanced Change Management feature, added or updated the following components:

• Added the below objects and object types. Each object type also includes an object page layout.
  • Change Item (change_item__v) object with the Product Change (product_change__v) object type.
  • Event Change Item (event_change_item__v) object with the Event Product Change (product_change__v) object type.
  • Activity Change Item (activity_change_item__v) with the Activity Product Change (product_change__v) object type.
• Added the following object lifecycles:
  • Change Item (change_item_lifecycle__v)
  • Event Change Item (event_change_item_lifecycle__v)
  • Activity Change Item (activity_change_item_lifecycle__v)
• Added the following lifecycle stage groups:
  • Change Item Lifecycle Stage Groups (change_item_lifecycle_stage_groups__v)
  • Activity Change Item Lifecycle Stage Groups (activity_change_item_lifecycle_stage_gro__v)

For the GCP Dispatch Validation feature, added or updated the following components:

• Added the Matched Documents are Locked (matched_docs_locked__v) field to the Dispatch Message (dispatch_message__v) object.

For the Auto-Match RLCP Documents into GCP feature, added or updated the following components:

• Added a Report Level Content Plan (report_level_content_plan__v) object reference field to the following objects:
  • Event Clinical Study (event_clinical_study__v)
  • Event Nonclinical Study (event_nonclinical_study__v)

With each release, the RIM data model is updated to open up the configurability of various objects, fields, picklists, and other components. Use the tabs in this workbook to evaluate 24R3 updates for your organization’s requirements.

We are also implementing additional data model changes in 24R3 to support faster and more accurate Vault RIM implementations.