Below you’ll find details for changes that were made to the data model. For information on feature functionality, see What’s New in 22R2.

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 RegulatoryOne data model. These data model updates are automatically included in all RegulatoryOne Vaults, but Admins must make configuration changes to make them available.

Data Model Updates - RegulatoryOne Compliance Management

Added and updated components to support the Import Formulation Questionnaires feature:

  • Added the following objects:
    • FQ Regulated Category Mapping (fq_regulated_category_mapping__v)
    • Response Mapping Strategy (response_mapping_strategy__v)
  • Added the Imported (imported__v) field to the FQ Checklist (fq_checklist__sys) object.
  • Added the Import Questionnaire (import_questionnaire_page__v) page component.
  • Updated the Name (name__v) field on the Compliance Assessment (compliance_assessment__v) object to required.

Data Model Updates - RegulatoryOne Registration & Dossier Management

Added components to support the Propagate Fields from Registration Items to Registration & Registration Objective feature:

  • Added the Propagate Fields Job Status (propagate_fields_job_status__v) field to the Registration object.
  • Added the following notification templates:
    • R1: RDM Populate Fields on Registration Successful (populate_fields_on_registration_successful__v)
    • R1: RDM Populate Fields on Registration Failed (populate_fields_on_registration_failed__v)

Added components to support the Root Requirement Selection from Registration Item feature:

  • Added the Select Root Requirement (select_root_requirement__v) field to the Registration Item (request__v) object.

Data Model Updates - RegulatoryOne Regulatory Documents

Added components to support the Regulatory Study Object Data Model to Support Endpoint Studies feature:

  • Added the following objects:
    • Regulatory Study (regulatory_study__v).
    • Regulatory Study Formulation Join (regulatory_study_formulation_join__v)

Data Model Updates - Veeva Claims

Added components to support the Remove Statement & Associated Records from Project feature:

  • Added the Remove Statement and Related Records from Project (remove_statement_from_project_page__v) page.
  • Added the following notification templates:
    • C1: Remove Statement Success (remove_statement_success__v)
    • C1: Remove Statement Failure (remove_statement_failure__v)

Added components to support the Bulk Add Substantiation feature:

  • Added the Bulk Add Substantiation (bulk_substantiation_user input_object__v) object.

Added components to support the Bulk Add Claim Comments and Bulk Add Project Comments features:

  • Added the Bulk Comment User Input (bulk_comment_user input_object__v) object.

Updated components to support the Enhanced Configurability for the Claim Project Join Object feature:

  • Added the ability to enable the attribute Allow hierarchical copy for the Claim (claim__v) field on the Claim Project Join (claim_project_join__v) object.