20R1 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 20R1.

Added the following components to support the Enhancements to Create Related Records Wizard feature:

• Added the Event Regulatory Objective (event_regulatory_objective__v) join object[^*]
• Added the Complex Product Type (applicable_product_type__v) field to the Product (drug_product__v) object
• Added the Source Applicable Product Type (source_applicable_product_type__v) field to the Object Type Mapping (object_type_mapping__v) object
• Added the Applicable Product Type (applicable_product_type__v) field to the Activity (activity__v) object
• Added the following object types to the Object Type Mapping (object_type_mapping__v) object:
  • Event Mapping (object_type_mapping__v.event_mapping__v) object type
  • Application Mapping (object_type_mapping__v.application_mapping__v) object type
• Added the Applicable Product Type (applicable_product_type__v) picklist field to the following objects and object types:
  • Event (event__rim) object
  • Labeling Event (event__rim.labeling__rim) object type
  • Manufacturing Event (event__rim.manufacturing__rim) object type
  • Other Event (event__rim.other__rim) object type
  • Regulatory Event (event__rim.regulatory_event__rim) object type
  • Activity (activity__rim) object

Added the following components to support the Switzerland eCTD Publishing CH 1.4 feature:

• Added the Application Pharmaceutical Form (application_pharmaceutical_form__v) object with fields:
  • Application (application__v)
  • Pharmaceutical Form (pharmaceutical_form__v)
  • Pharmaceutical Form Translation (pharmaceutical_form_translation__v)
    • Swissmedic Number (swissmedic_number__v)
  • Translation (translation__v)
  • Translation Language (translation_language__v)
• Added the Submission Pharmaceutical Form (submission_pharmaceutical_form__v) object with fields:
  • Application (application__v)
  • Pharmaceutical Form (pharmaceutical_form__v)
  • Submission (submission__v)
  • Swissmedic Number (swissmedic_number__v)
  • Translation (translation__v)
  • Translation Language (translation_language__v)
  • Use for Content Planning (use_for_content_planning__v)
  • Controlled Vocabulary (controlled_vocabulary__v)
• Added the Controlled Vocabulary Translation (controlled_vocabulary_translations__) object with fields:
  • Language (language__v)
  • Language Vault RIM UUID (language_vault_rim_uuid__v)
  • Translation (translation__v)
• Added the following field to the Language (language__rim) object:
  • Vault RIM UUID (vault_rim_uuid__v)
• Added the following fields to the Content Plan (edl__v) and Content Plan Item (edl_item__v) objects:
  • Submission Pharmaceutical Form (submission_pharmaceutical_form__v)
  • Pharmaceutical Form (pharmaceutical_form__v)
• Added the following shared document field:
  • Pharmaceutical Forms (pharmaceutical_form__v)

Added the following components to support the Content Plan Hierarchy Viewer: Tree Grid feature:

• Added the Hierarchy Path (hierarchy_path__v) field 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 Notes (notes__v) field to the following objects:
  • Content Plan (edl__v)
  • Content Plan Item (edl_item__v)
• Added the Hierarchy Level (hierarchy_level__v) field to the following objects:
  • Content Plan (edl__v)
  • Content Plan Item (edl_item__v)

Added the following components to support the XEVMPD Bulk Updates feature:

• Added the Bulk Action ID (bulk_action_id__v) field to the following objects:
  • Product Data Submission (product_data_submission__v)
  • Product Data Message (product_data_message__v)
• Added the following fields to the Product Data Submission object:
  • Change Summary (change_summary__v)
  • Most Recent Submitted (most_recent_submitted__v)
• Added the XEVMPD Submitted (xevmpd_submitted__v) Lifecycle State Type

Added the following components to support the Australia eCTD XSD 3.1 Publishing & Validation feature:

• Added the following field to the Organization (organization__rim) object:
  • eBS Client ID (ebs_client_id__v)

Added the following components to the support the Submissions to eTMF Connection feature:

• Added the Site Country (site_country__v) field on the Site (clinical_site__v) object
• Added the Inbound Document State Type to document lifecycles
• Added the RIM to Clinical Connection Document Type Group

We’ve also added the following component to the RIM data model:

• Added an External ID (external_id__v) field to the Regulatory Objective (regulatory_objective__rim) object

In this release, we have also enabled numerous attributes, such as Required, System Managed Name, and more, on many standard objects and fields. These attributes allow organizations to configure these components according to their business requirements without needing to contact Veeva Support or Product Management to make these configuration changes. In order to utilize these newly-enabled attributes, Admins must perform the desired configuration to make them available for users.