24R2 Data Model Changes: Safety

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 Safety and SafetyDocs data model. These data model updates are automatically included in all Safety and SafetyDocs Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see New in 24R2 Limited Release.

24R1.2

Safety

The following changes were made to support the Sender-Based Email Attachment Handling feature:

  • Added the Email Attachment Handling Method (email_attachment_handling_method__v ) picklist with the following values:
    • Separate (separate__v)
    • Single-File Import (singlefile_import__v)
    • Manual (manual__v)
  • Added the Transmission Profile Email (transmission_profile_email__v) object with the following fields:
    • Created Date (created_date__v)
    • Global ID (global_id__sys)
    • ID (id)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle Stage (stage__sys)
    • Lifecycle State (state__v)
    • Lifecycle State Stage ID (state_stage_id__sys)
    • Link (link__sys)
    • Name (name__v)
    • Person (person__v)
    • Status (status__v)
    • Transmission Profile (transmission_profile__v)
  • Added the Inbound Email Profile (email_profile__v) object type to the Transmission Profile (transmission_profile__v) object.

The following change was made to support the Rule Level Control of Auto-Submit feature:

  • Added the Auto-Submit Override (auto_submit_override__v) picklist value to the Safety Rule Parameter Name (safety_rule_parameter_name__v) picklist.

The following changes were made to support the Safety-RIM Connection: PSMF Annex H Support feature:

  • Added the following picklists:
    • Additional Monitoring (additional_monitoring__v)
    • Non-Standard Aggregate Periodicity (nonstandard_aggregate_periodicity__v)
  • Added the following fields to the Product Registration (product_registration__v) object:
    • Additional Monitoring (additional_monitoring__v)
    • Application Lead Market (application_lead_market__v)
    • Application Number (application_number__v)
    • Non-Standard Aggregate Periodicity (nonstandard_aggregate_periodicity__v)
    • Procedure Type (procedure_type__v)
    • Procedure Number (procedure_number__v)

The following change was made to support the Safety-EDC Connection: SAE Transfer Enhancements feature:

  • Added the EDC Reason (edc_reason__v) field to the Inbox Item (inbox_item__v) object.

The following changes were made to support the Reporting Family Configuration Scenarios feature:

  • Added the Product Family (product_family__v) object type to the Reporting Family Member (reporting_family_member__v) object.
  • Added the Product Family (product_family__v) field to the Product Family (product_family__v) object type.
  • Added the Coded Product Registration Only (coded_product_registration_only__v) field to the Product Registration (product_registration__v) object type.
  • Added the following fields to the Partner Distribution List (partner_distribution__v) object type:
    • All Products (all_products__v)
    • All Studies (all_studies__v)
    • Distribution Substance Lookup Method (distribution_substance_lookup_method__v)

The following changes were made to support the PMDA E2B(R3): Export Substance Codes from JDrug Codes feature:

  • Added the Japan Product Code Type (japan_product_code_type__v) field to the following objects:
    • Case Product Registration (case_product_registration__v)
    • Localized Case Product (localized_case_product__v)

The following changes were made to support the Include Source Document in Email Transmission feature:

  • Added the Attach Source Document(s) (attach_source_documents__v) field to the Email Profile (email_profile__v) object type with the following picklist values:
    • Exclude Unredacted Source Documents for PII Mask (exclude_unredacted_source_documents__v)
    • Any Source Document (any_source_document__v)
  • Added the Outbound Transmissions (outbound_transmissions__v) document field to the Source (source__v) document type.

The following change was made to support the Reporting Rule Level Control of Auto-Submit for Transmissions feature:

  • Added the Auto-Submit Override (auto_submit_override__v) picklist value to the Safety Rule Parameter Name (safety_rule_parameter_name__v) picklist.

The following change was made to support the Adverse Event in Jurisdiction Parameter Country Differentiation feature:

  • Added the AE in Jurisdiction Source (ae_in_jurisdiction_source__v) picklist value to the Safety Rule Parameter Name (safety_rule_parameter_name__v) picklist.

Additional Data Model Updates

The following additional change was made:

  • Increased the maximum number of custom validation rules for the Safety System Setting max_custom_validation_rules__v from 50 to 1,000.

SafetyDocs

The following changes were made to support the Signal Management Disposition and Reporting Period Changes feature:

  • Added the Priority (safety_investigation_priority__v) picklist to the Safety Investigation (safety_investigation__v) object with the following values:
    • Critical (critical__v)
    • High (high__v)
    • Medium (medium__v)
    • Low (low__v)
  • Added the Monitoring (monitoring_state__v) state to the Product-Event Disposition Lifecycle (product_event_disposition_lifecycle__v) object lifecycle.
  • Added the Signal Reporting Period Checklists (signal_reporting_period_checklists__v) checklist type.
  • Added the Safety Investigations Checklists (safety_investigation_checklists__v) checklist type.
  • Updated the Safety Investigation Reporting Period (safety_investigation_reporting_period__v) object label to Signal Reporting Period (safety_investigation_reporting_period__v).
  • Updated the Safety Investigation Reporting Period Lifecycle (safety_investigation_reporting_period__v) object lifecycle label to Signal Reporting Period Lifecycle (safety_investigation_reporting_period__v).
  • Updated the Refuted (refuted__v) picklist value to Non-Validated (non_validated__v) on the Validation Outcome (validation_outcome__v) picklist.
  • Inactivated the Reporting Period (reporting_period__v) field on the Safety Investigation (safety_investigation__v) object.

The following changes were made to support the Code Product-Event Combinations to MedDRA Queries feature:

  • Added the MedDRA Query (meddra_query__v) field to the following objects:
    • Product-Event Combination (product_event_combination__v)
    • Product-Event Disposition (product_event_disposition__v)
  • Updated the Primary MedDRA Term (primary_meddra_term__v) field on the Product-Event Combination (product_event_combination__v) object to not be required.