19R2 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 19R2.

Medical Device Data Model

In support of medical devices and in vitro diagnostics, we’ve made the following updates to the regulatory data model. These data model changes align with the Unique Device Identification (UDI) regulations and guidance from the FDA, EU, and IMDRF.

  • Converted the following objects from RIM Registrations application objects to core RIM objects:
    • Packaging (packaging__rim)
    • Submission Packaging (submission_packaging__rim)
    • Regulatory Objective Packaging (regulatory_objective_packaging__v)
    • Data Carrier (data_carrier__rim)
  • Added seven (7) new picklists:
    • Classification Status (classification_status__v)
    • Identifier Issue (identifier_issue__v)
    • Identifier Type (identifier_type__v)
    • MRI Safety Status (mri_safety_status__v)
    • Production Control Method (production_control_method__v)
    • Device Classification System (device_classification_system__v)
    • Platform Type (platform_type__v)
  • Added the following new values to the Organization Type picklist:
    • Notified Body (notified_body__v)
    • Hardware or Software Platform Manufacturer (hw_or_sw_platform_manufacturer__v)
  • Added the following new values to the Code System picklist:
    • EAN (ean__v)
    • Code 39 (code_39__v)
    • Code 128 (code_128__v)
    • ITF (itf__v)
    • Codabar (codabar__v)
    • GS1 DataBar (gs1_databar__v)
    • Datamatrix (datamatrix__v)
  • Added the following new values to the Controlled Vocabulary picklist:
    • Clinically Relevant Size (clinically_relevant_size__v)
    • Device Unit of Measure (device_unit_of_measure__v)
    • Storage and Handling Type (storage_and_handling_type__v)
    • Product Characteristic Type (product_characteristic_type__v)
    • Product Characteristic Value (product_characteristic_value__v)
    • Packaging Characteristic Type (packaging_characteristic_type__v)
    • Packaging Characteristic Value (packaging_characteristic_value__v)
  • Added the following new value to the HA Code Source picklist:
    • UCUM (ucum__v)
  • Added the following new core RIM objects to all RIM vaults:
    • Classification (classification__v)
    • Hardware or Software Platform (hardware_or_software_platform__v)
    • Compatible Platform (compatible_platform__v)
    • Risk Class (risk_class__v)
    • Reg Objective Packaging Characteristic (reg_objective_packaging_characteristic__v)
    • Submission Packaging Characteristic (submission_packaging_characteristic__v)
    • Reg Objective Product Characteristic (reg_objective_product_characteristic__v)
    • Submission Product Characteristic (submission_product_characteristic__v)
    • Reg Objective Product Classification (reg_objective_product_classification__v)
    • Submission Product Classification (submission_product_classification__v)
    • Storage and Handling Condition (storage_and_handling_condition__v)
    • Clinically Relevant Size (clinically_relevant_size__v)
  • Added the following new objects to RIM Registrations vaults:
    • Event Packaging Characteristic (event_packaging_characteristic__v)
    • Registered Packaging Characteristic (registered_packaging_characteristic__v)
    • Event Product Characteristic (event_product_characteristic__v)
    • Registered Product Characteristic (registered_product_characteristic__v)
    • Event Product Classification (event_product_classification__v)
    • Registered Product Classification (registered_product_classification__v)
  • Enabled object types on the following objects:
    • Event Packaging (event_packaging__rim)
    • Registration Packaging (registration_packaging__rim)
    • Regulatory Objective Packaging (regulatory_objective_packaging__v)
    • Submission Packaging (submission_packaging__rim)
    • Product Variant (product_detail__v)
    • Event Drug Product (event_drug_product__rim)
    • Registered Drug Product (registered_drug_product__rim)
    • Regulatory Objective Drug Product (regulatory_objective_drug_product__v)
    • Submission Pharmaceutical Product (submission_pharmaceutical_product__rim)
    • Regulatory Objective (regulatory_objective__rim)
  • Added the Notified Body (notified_body__v) field to the Application object.
  • Added the following fields to the Data Carrier object:
    • Identifier Type (identifier_type__v)
    • Issuer (issuer__v)
  • Added the following fields to the Event Packaging, Registration Packaging, Regulatory Objective Packaging, and Submission Packaging objects:
    • Finished Product Code (finished_product_code__v)
    • Packaging UDI-DI (packaging_udidi__v)
    • DI Contained Within (di_contained_within__v)
  • Added the following fields on the Product (drug_product__v) object:
    • Basic UDI-DI (basic_udidi__v)
    • Catalog Number (catalog_number__v)
    • Contains CMR Substances (contains_cmr_substances__v)
    • Contains DEHP (contains_dehp__v)
    • Contains Dry Natural Latex (contains_dry_natural_latex__v)
    • Contains Endocrine-Disrupting Substances (contains_endocrine_disrupting_substances__v)
    • Contains Natural Rubber Latex (contains_natural_rubber_latex__v)
    • Model or Version (model_or_version__v)
    • MRI Safety Status (mri_safety_status__v)
    • Primary UDI-DI (primary_udidi__v)
    • Previous Primary UDI-DI (previous_primary_udidi__v)
    • Secondary UDI-DI (secondary_udidi__v)
    • Unit of Use UDI-DI (direct_mark_udidi__v)
    • Direct Mark UDI-DI (direct_mark_udidi__v)
    • Description (description__v)
    • Production Control Method (production_control_method__v)
  • Added the following fields to the Product Variant (product_detail__v) object:
    • Build Number (build_number__v)
    • Catalog Number (catalog_number__v)
    • Color (color__v)
    • Description (description__v)
    • Model or Version (model_or_version__v)
    • Primary UDI-DI (primary_udidi__v)
    • Previous Primary UDI-DI (previous_primary_udidi__v)
    • Production Control Method (production_control_method__v)
    • Secondary UDI-DI (secondary_udidi__v)
    • Unit of Use UDI-DI (direct_mark_udidi__v)
    • Direct Mark UDI-DI (direct_mark_udidi__v)
  • Added the following fields to the Event Drug Product, Registered Drug Product, Regulatory Objective Drug Product, and Submission Pharmaceutical Product objects:
    • Product Information URL (product_information_url__v)
    • Risk Class (risk_class__v)
  • Added the Vault RIM UUID (vault_rim_uuid__v) field to the Organization object.

Note that Admins must add new fields to object page layouts manually in existing vaults.

Additional Regulatory Data Model Updates

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.

  • Converted the Shelf Life (shelf_life__rim) and Packaging Shelf Life (packaging_shelf_life__rim) objects from RIM Registrations application objects to core RIM objects.
  • Added the Therapeutic Indication (therapeutic_indication__v) shared document field.
  • Increased the character limit of the XML Submission ID (xml_submission_id__v) field on the Submission (submission__v) object from 7 to 64.
  • Added the Device Event (device_event__v) object type to the _Eve_nt (event__rim) object.
  • Added the Device Submission Plan (device_submission_plan__v) object type to the following objects:
    • Content Plan (edl__v)
    • Content Plan Template (edl_template__v)
  • Added the Device Submission Plan Item (device_submission_plan_item__v) object type to the following objects:
    • Content Plan Item (edl_item__v)
    • Content Plan Item Template (edl__item_template__v)
  • Added the following object types to the _Registratio_n (registration__rim) object:
    • Marketed Drug Product Registration (marketed_drug_product_registration__v)
    • Marketed Device Product Registration (marketed_device_product_registration__v)
    • Investigational Device Registration (investigational_device_registration__v)
  • Added the following object types to the Constraint (constraint__rim) object:
    • Product Characteristic (product_characteristic__v)
    • Packaging Characteristic (packaging_characteristic__v)
    • UDI Storage and Handling (udi_storage_and_handling__v)
    • UDI Clinically Relevant Size (udi_clinically_relevant_size__v)
  • Added the following picklist entry to the HA Code Source (ha_code_source__rim) picklist:
    • EC (ec__v)

Data Model Updates

These data model updates support features delivered in 19R2.

Added components to support the Report Level Content Plan for Product Family feature:

  • Added the Report Level Plan Product Family (report_level_plan_product_family__v) object.
  • Added the Report Level Plan Product Family (report_level_plan_product_family__v) field to the Content Plan and Content Plan Item objects.
  • Added the Report (report__v) object type to the following objects:
    • Content Plan
    • Content Plan Item
    • Content Plan Template
    • Content Plan Item Template
    • Report Level Content Plan
  • Added the Report (report__v) document subtype under the Submission Ready document type.

Added components to support the Simplified Import: Dossier Formats feature:

  • Added the Parameter (parameter__v) field to the Controlled Vocabulary object

Added components to support the Content Plan Usability Enhancements feature:

  • Added the following field to the Content Plan Item (edl_item__v) object:
    • Progress Icon (progress_icon__v)

Added components to support the Unreferenced Files in Submissions Publishing feature:

  • Added the Other (other__v) object type 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 components to support the Inline Validation Results feature:

  • Added the Submission Validation Result (submission_validation_result__v) object with the following fields:
    • Application (application__v)
    • Content Plan (edl__v)
    • Content Plan Item (edl_item__v)
    • Corrective Action (corrective_action__v)
    • Description (description__v)
    • Occurrences (occurrences__v)
    • Problem (problem__v)
    • Publishing Validation Criteria (publishing_validation_criteria__v)
    • Report Level Content Plan (report_level_content_plan__v)
    • Severity (severity__v)
    • Submission (submission__v)
    • Validation Result Status (validation_result_status__v)
    • Validation Result Type (validation_result_type__v)
  • Added the following fields to the Publishing Validation Status object:
    • Application (application__v)
    • Submission (submission__v)
  • Added the Last Published Date (last_published_date__v) field to the Report Level Content Plan object
  • Added the Open Validation Results (open_validation_results__v) field to the Content Plan Item (edl_item__v) object
  • Added the Validation Result Type (validation_result_type__v) picklist

Added components to support the XEVMPD Gateway Submission feature:

  • Added the following fields to Product Data Message object:
    • MDN Received (mdn_received__v)
    • Level 1 Acknowledgement Received (level_1_acknowledgement_received__v)
    • Level 1 Result (level_1_result__v)
    • Level 2 Acknowledgement Received (level_2_acknowledgement_received__v)
    • Level 2 Result (level_2_result__v)
    • Level 3 Acknowledgement Received (level_3_acknowledgement_received__v)
    • Level 3 Result (level_3_result__v)
    • XEVPRM Submission Status (xevprm_submission_status__v)
  • Added new picklists:
    • Level 1 Result (level_1_result__v)
    • XEVPRM Submission Status (xevprm_submission_status__v)

Added components to support the Affiliate Home Tab feature:

  • Added the Country Decision Detail (country_decision_detail__v)* object and associated object page layout.
  • Added the Country Decision Detail Count (country_decision_detail_count__v) field to the Regulatory Objective object.
  • Added the Product Family (product_family__v) lookup field to the following objects:
    • Registration
    • Activity
    • Regulatory Objective
  • Added the Product Family (product_family__v) lookup field to Registration object’s Investigational Registration object type.
  • Added the Regulatory Objective Status (regulatory_objective_status__v) picklist.
  • Added the Affiliate Home (affiliate_home__v) tab.

* Vault automatically creates and populates Country Decision Detail object records and updates the Country Decision Detail Count field when users create Regulatory Objective records, even if this object is hidden. Admins should not create new required fields on the Country Decision Details object.