23R2 Data Model Changes: Safety

Pre-Release Date: July 17, 2023 | Release Date: August 17, 2023 & August 25, 2023

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 What’s New in 23R2.

For information about data model changes related to Vault Platform, see 23R2 Data Model Changes: Platform.

Safety

The following changes were made to support the Aggregate Report Interval Case Listing feature:

• Added the Aggregate Report Case (aggregate_report_case__v) object
• Added the following fields to the Aggregate Reports Case (aggregate_report_case__v) object:
  • Aggregate Report (aggregate_report__v)
  • Case (case__v)
  • Created By (created_by__v)
  • 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 State (state__v)
  • Link (link__sys)
  • Name (name__v)
  • Status (status__v)
• Added the Aggregate Report Case (aggregate_report_case_lifecycle__v) object lifecycle

The following changes were made to support the PMDA Local Receipt Date Overrides feature:

• Added the following fields to the Localized Case (localized_case__v) object:
  • Local Initial Receipt Date (local_initial_receipt_date__v)
  • Local New Info Date (local_new_info_date__v)

The following changes were made to support the OTC Carton Attachment Export for FDA E2B(R2) feature:

• Added the following field to the Case Source Attachment (case__v.source__v.attachment__v) document type:
  • Attachment Type (attachment_type__v) with the following picklist value:
    • FDA Carton Attachment (fda_carton_attachment__v)

The following changes were made to support the New Substance Name Field in Product Library feature:

• Added the following field to the Substance (substance__v) object:
  • Substance Name (substance_name__v)
• Added the following field to the Localized Substance (localized_substance__v) object:
  • Substance Name (substance_name__v)

The following changes were made to support the Study Site Reporter on Inbox Item feature:

• Added the following field to the Inbox Item (inbox_item__v) object:
  • Site Reporter (study_person__v)

The following changes were made to support the Company Product Match Verification feature:

• Added the following fields to the Inbox Item (inbox_item__v) object:
  • Product Match Confidence (product_match_confidence__v)
  • Product Match Criteria (product_match_criteria__v)

The following changes were made to support the FDA MedWatch 3500A Device Support for OTC and Additional Device Fields feature:

• Added the following item to the Product Type (product_type__v) picklist:
  • OTC Device (otc_device__v)
• Added the following item to the Device Evaluated (device_evaluated__v) picklist:
  • Not Returned to Manufacturer (not_returned_to_manufacturer__v)
• Added the following fields to the Case Product (case_product__v) object:
  • Correction/Removal Reporting Number (correctionremoval_reporting_number__v)
  • Additional Device Manufacturer Narrative (additional_device_manufacturer_narrative__v)

The following changes were made to support the Non-E2B Case Identifiers Entry and Duplicate Search feature:

• Added the Case Identifier Type (case_identifier_type__v) to the Controlled Vocabulary Type.
• Added the Re-Transmittable (retransmittable__v) field to the Controlled Vocabulary (controlled_vocabulary__v) object.
• Added the Controlled Vocabulary values to the Case Identifier Type (case_identifier_type__v):
  • E2B Re-Transmittable (e2b_retransmittable__v)
  • Non-Transmittable (non_transmittable__v)
• Added the Type (type__v) field to the Case Identifier (case_identifier__v) object.

The following changes were made to support the Study Product Expectedness feature:

• Added the Study Product Datasheet (study_product_datasheet__v) field to the Study Product (study_object__v) object.

The following changes were made to support the Safety Rule Set Config Report feature:

• Added the Generate Safety Rule Set Configuration Report (generate_config_report_action__v ) action to the Safety Rule Set (safety_rule_set__v) object.
• Added the Generate Safety Rule Set Configuration Report (generate_config_report_bulk_action__v) bulk action to the Safety Rule Set (safety_rule_set__v) object.

The following changes were made to support the DSUR and PBRER Drug Role Filtering feature:

• Added the Drug Roles to Include (drug_roles_to_include__v) field to the Aggregate Report (aggregate_report__v) object.
• Added the following picklist values to the Drug Roles to Include (drug_roles_to_include__v) field:
  • Suspect (suspect__v)
  • Drug Not Administered (drug_not_administered__v)
  • Interacting (interacting__v)
  • Similar Device (similar_device__v)
  • Treatment (treatment__v)
  • Concomitant (concomitant__v)

The following changes were made to support the PMDA Local Case Processing Automations feature:

• Added the following fields to the Localized Case Assessment (localized_case_assessment__v) object:
  • Case Product (case_product__v)
  • Case Product Registration (case_product_registration__v)
  • Datasheet (datasheet__v)
  • Datasheet Document (datasheet_document__v)
  • Datasheet Document (unbound) (datasheet_document_unbound__v)
  • Due Date (due_date__v)
  • Due in Days (due_in_days__v)
  • Override Reason (override_reason__v)
• Added the following field to the Localization (localization__v) object:
  • Assessment Generation (assessment_generation__v) with the following picklist value:
    • Localized Assessments for Case Product Registrations (localized_assessments__v)

The following changes were made to support the Aggregate Report Authoring feature:

• Added the Aggregate Reporting Group (aggregate_reporting_group__v) object with the following fields:
  • Name (name__v)
  • Aggregate Report Type (aggregate_report_type__v) with the following picklist values:
    • PBRER (pbrer__v)
    • PSUR (psur__v)
    • DSUR (dsur__v)
    • PADER (pader__v)
    • CIOMS ll (cioms_ii__v)
  • Description (description__v)
  • External ID (external_id__v)
• Added the Reporting Group Product Registration (reporting_group_product_registration__v) object with the following fields:
  • Name (name__v)
  • Aggregate Reporting Group (aggregate_reporting_group__v)
  • Product Registration (product_registration__v)
• Added the Reporting Group Study Registration (reporting_group_product_registration__v) object with the following fields:
  • Name (name__v)
  • Aggregate Reporting Group (aggregate_reporting_group__v)
  • Study Registration (study_registration__v)
• Added the following fields to the Aggregate Report (aggregate_report__v) object:
  • Aggregate Reporting Group (aggregate_reporting_group__v)
  • Report Description (report_description__v)
  • Earliest Submission Date (earliest_submission_date__v)
  • External ID (external_id__v)
• Updated the following fields on the Aggregate Report (aggregate_report__v) object:
  • Product Family (product_family__v)
  • States to Include (states_to_include__v)
• Added the following states to the Aggregate Report (aggregate_report_lifecycle__v) object lifecycle:
  • Open (open_state__v)
  • In Progress (in_progress_state__v)
  • Complete (complete_state__v)
  • Submitted (submitted_state__v)
  • HA Approved (ha_approved_state__v)
  • Deferred (deferred_state__v)

The following changes were made to support the Simplified Case Access Group Security Setup feature:

• Added the following field to the User Access Group Assignment (user_access_group_assignment__v) object:
  • Country (country__v)
• Added the following field to the User (user__sys) object:
  • Case Access Group Override (cag_group_override__v)
• Added the following field to the Inbound Transmission (inbound_transmission__v) object type:
  • Case Access Group Assignment Reason (access_group_assignment_reason__v)

The following changes were made to support the Logically Delete Non-Submittable Transmissions on Subsequent Evaluation feature:

• Added the Rule Engine Created Transmission (rule_engine_created_transmission__v) field to the Transmission (transmission__v) object.

The following changes were made to support the PMDA Submission Rule Parameter Updates feature:

• Added the following field to the Localization (localization__v) object:
  • Localized Due Date Calculation (localized_due_date_calculation__v) with the following picklist values:
    • Global Case - New Info Date (global_case_new_info_date__v)
    • Localized Case - Local Awareness Date (localized_case_local_awareness_date__v)

Additional Data Model Updates

The following additional changes were made:

• Added the Registration Holder/Applicant (registration_holderapplicant__v) field to the Product Registration (product_registration__v) object.
• Added the Registration Holder (registration_holder__v) object type to the Organization (organization___v) object.

SafetyDocs

The following changes were made to support the PSMF Periodic Reviews feature:

• Added the following document fields to the PSMF Content (psmf_content__v) document subtype:
  • Last Review Date (psmf_last_review_date__v)
  • Next Review Date (psmf_next_review_date__v)
  • Review Frequency (psmf_review_frequency__v) with the following picklist values:
    • Monthly (monthly__v)
    • Bi-monthly (bi_monthly__v)
    • Quarterly (quarterly__v)
    • Semi-annually (semi_annually__v)
    • Annually (annually__v)
• Added the PSMF Periodic Review (psmf_periodic_review__v) object with the following fields:
  • Name (name__v)
  • Due Date (due_date__v)
  • Review Type (review_type__v) with the following picklist values:
    • Periodic (periodic__v)
    • Ad-Hoc (ad_hoc__v)
  • Description (description__v)
• Added the PSMF Periodic Review Lifecycle (psmf_periodic_review_lifecycle__v) with the following states:
  • New (new_state__v)
  • In Progress (in_progress_state__v)
  • Complete (complete_state__v)
  • Inactive (inactive_state__v)
• Added the PSMF Periodic Document Review (psmf_document_review__v) object with the following fields:
  • Name (name__v)
  • Periodic Review (periodic_review__v)
  • Document to Review (document_to_review__v)
  • Due Date (due_date__v)
  • Review Outcome (review_outcome__v) with the following picklist values:
    • No changes needed (no_changes_needed__v)
    • Minor changes needed (minor_changes_needed__v)
    • Major changes needed (major_changes_needed__v)
    • Unable to review (unable_to_review__v)
  • Review Rationale (review_rationale__v)
• Added the PSMF Document Review Lifecycle (psmf_document_review_lifecycle__v) with the following states:
  • Complete (complete_state__v)
  • Open (open_state__v)
• Added the PSMF Periodic Review (safetydocs_psmf_periodic_review_job__v) job
• Added the Periodic Document Reviews (safetydocs_psmf_periodic_review__v) tab to the PSMF (safetydocs_psmf__v) parent tab

The following changes were made to support the Aggregate Report Authoring feature:

• Added the Aggregate Reporting Group (aggregate_reporting_group__v) object with the following fields:
  • Name (name__v)
  • Aggregate Report Type (aggregate_report_type__v) with the following picklist values:
    • PBRER (pbrer__v)
    • PSUR (psur__v)
    • DSUR (dsur__v)
    • PADER (pader__v)
    • CIOMS ll (cioms_ii__v)
  • Description (description__v)
  • External ID (external_id__v)
• Added the Reporting Group Product Registration (reporting_group_product_registration__v) object with the following fields:
  • Name (name__v)
  • Aggregate Reporting Group (aggregate_reporting_group__v)
  • Product Registration (product_registration__v)
• Added the Reporting Group Study Registration (reporting_group_product_registration__v) object with the following fields:
  • Name (name__v)
  • Aggregate Reporting Group (aggregate_reporting_group__v)
  • Study Registration (study_registration__v)
• Added the following fields to the Aggregate Report (aggregate_report__v) object:
  • Aggregate Reporting Group (aggregate_reporting_group__v)
  • Report Description (report_description__v)
  • Earliest Submission Date (earliest_submission_date__v)
  • External ID (external_id__v)
• Updated the following fields on the Aggregate Report (aggregate_report__v) object:
  • Product Family (product_family__v)
  • States to Include (states_to_include__v)
• Added the following states to the Aggregate Report (aggregate_report_lifecycle__v) object lifecycle:
  • Open (open_state__v)
  • In Progress (in_progress_state__v)
  • Complete (complete_state__v)
  • Submitted (submitted_state__v)
  • HA Approved (ha_approved_state__v)
  • Deferred (deferred_state__v)
• Added the Aggregate Report Destination (aggregate_report_destination__v) object with the following fields:
  • Name (name__v)
  • Aggregate Report (aggregate_report__v)
  • Aggregate Report Type (aggregate_report_type__v)
  • Aggregate Reporting Group (aggregate_reporting_group__v)
  • Applicable Market (applicable_market__v)
  • Health Authority (health_authority__v)
  • Planned Submission Date (planned_submission_date__v)
  • Actual Submission Date (actual_submission_date__v)
  • Health Authority Decision Date (health_authority_decision_date__v)
  • Health Authority Approval Date (health_authority_approval_date__v)
  • External ID (external_id__v)
• Added the Aggregate Report Destination (aggregate_report_destination_lifecycle__v) object lifecycle with the following states:
  • Open (open_state__v)
  • In Progress (in_progress_state__v)
  • Complete (complete_state__v)
  • Submitted (submitted_state__v)
  • HA Approved (ha_approved_state__v)
  • Deferred (deferred_state__v)
• Added the Aggregate Report Task (aggregate_report_task__v) object with the following fields:
  • Name (name__v)
  • Aggregate Report Task Type (object_type__v)
  • Aggregate Report (aggregate_report__v)
  • Aggregate Report Type (aggregate_report_type__v)
  • Aggregate Report Destination (aggregate_report_destination__v)
  • Description (description__v)
  • Assigned To (assigned_to__v)
  • Due Date (due_date__v)
  • Complete (actual_submission_date__v)
  • Completion Date (completion_date__v)
  • Report Document (report_document__v)
  • External ID (external_id__v)
• Added the Aggregate Report Task (aggregate_report_task_lifecycle__v) object lifecycle with the following states:
  • Open (open_state__v)
  • In Progress (in_progress_state__v)
  • Complete (complete_state__v)
  • Inactive (inactive_state__v)
• Added the Authoring Task (authoring_task__v) object type
• Added the CIOMS IIs (cioms_iis__v) tab to the Aggregate Reports (aggregate_reports__v) parent tab
• Added the Aggregate Report Task (aggregate_report_task__v) document field
• Added the CIOMS II (cioms_ii__v) document type

The following changes were made to support the PSMF Automated Vault Report Annexes feature:

• Added the PSMF Generated Report (psmf_generated_report__v) document classification with the following document fields:
  • Source Report (source_report__v)
  • Source Report Prompt (source_report_prompt__v)
  • Report Generation Type (report_generation_type__v) with the following picklist values:
    • Automatic (automatic__v)
    • Manual (manual__v)
    • Periodic (periodic__v)
  • Report Format (report_format__v) with the following picklist values:
    • PDF (pdf__v)
    • Excel (excel__v)
    • Excel Template (excel_template__v)

The following changes were made to support the Signal Management feature:

• Added the following objects:
  • Dictionary (dictionary__v)
  • MedDRA (meddra__v)
  • MedDRA (Localized) (meddra_localized__v)
  • MedDRA Criteria (meddra_criteria__v)
  • MedDRA Join (meddra_join__v)
  • MedDRA Query (meddra_query__v)
  • MedDRA Version (meddra_version__v)
  • Product Alias (product_alias__v)
  • Product Constituent (product_constituent__v)
  • Product Registration (product_registration__v)
  • Product Substance (product_substance__v)
• Added the Product-Event Combination (product_event_combination__v) object with the following fields:
  • Combination Name (name__v)
  • Primary MedDRA Term (primary_meddra_term__v)
  • Primary Product Family (primary_product_family__v)
  • Most Recent Disposition (most_recent_disposition__v) with the following picklist values:
    • Confirmed (confirmed__v)
    • Refuted (refuted__v)
    • Monitor (monitor__v)
    • Inactive (inactive__v)
  • Most Recent Disposition Date (most_recent_disposition_date__v)
• Added the Product-Event Combination (product_event_combination_lifecycle__v) object lifecycle with the following lifecycle states:
  • Active (active__v)
  • Inactive (inactive__v)
• Added the Safety Investigation Reporting Period (safety_investigation_reporting_period__v) object with the following fields:
  • Name (name__v)
  • Product Family (product_family__v)
  • Start Date (start_date__v)
  • End Date (end_date__v)
• Added the Safety Investigation Reporting Period (safety_investigation_reporting_period_lifecycle__v) object lifecycle with the following lifecycle states:
  • Active (active__v)
  • Inactive (inactive__v)
• Added the Safety Investigation (safety_investigation__v) object with the following fields:
  • Name (name__v)
  • Product Family (product_family__v)
  • Reporting Period (reporting_period__v)
  • Detection Date (detection_date__v)
  • Primary Source (primary_source__v)
  • Validation Outcome (validation_outcome__v) with the following picklist values:
    • Validated (validated__v)
    • Refuted (refuted__v)
  • Validation Outcome Date (validation_outcome_date__v)
  • Final Disposition (final_disposition__v) with the following picklist values:
    • Confirmed (confirmed__v)
    • Refuted (refuted__v)
    • Monitor (monitor__v)
    • Inactive (inactive__v)
  • Final Disposition Date (final_disposition_date__v)
  • Start Date (start_date__v)
  • Summary of Key Data (summary_of_key_data__v)
  • Final Disposition Date (system) (final_disposition_date_sys__v)
  • Validation Outcome (system) (validation_outcome_sys__v)
• Added the Safety Investigation (safety_investigation_lifecycle__v) object lifecycle with the following lifecycle states:
  • Open (open_state__v)
  • Triage (triage_state__v)
  • In Progress (in_progress_state__v)
  • Monitoring (monitoring__v)
  • Risk Mitigation (risk_mitigation_state__v)
  • Regulatory Review (regulatory_review_state__v)
  • Closed (closed_state__v)
  • Inactive (inactive_state__v)
• Added the Signal Source (signal_source__v) object
• Added the Signal Source (signal_source_lifecycle__v) object lifecycle with the following lifecycle states:
  • Active (active__v)
  • Inactive (inactive__v)
• Added the Product-Event Disposition (product_event_disposition__v) object with the following fields:
  • Name (name__v)
  • Product-Event Combination (product_event_combination_v)
  • Primary MedDRA Term (primary_meddra_term__v)
  • Product Family (product_family__v)
  • Safety Investigation (safety_investigation__v)
  • Reporting Period (reporting_period__v)
  • Detection Date (detection_date__v)
  • Type (type__v) with the following picklist values:
    • Routine (routine__v)
    • Ad-Hoc (ad_hoc__v)
  • Primary Source (primary_source__v)
  • Final Disposition (final_disposition__v) with the following picklist values:
    • Confirmed (confirmed__v)
    • Refuted (refuted__v)
    • Monitor (monitor__v)
    • Inactive (inactive__v)
  • Final Disposition Date (final_disposition_date__v)
• Added the Signal Management (signal_management__v) document type with the following subtypes and classifications:
  • Signal Investigation (signal_investigation__v)
  • Signal Product-Event (signal_product_event__v)
  • Investigation Materials (investigation_materials___v)
  • Investigation Summary (investigation_summary__v)