24R3 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 data model. These data model updates are automatically included in all Safety Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 24R3.

24R2.2

Safety

The following changes were made to support the Sender-Based Email Inbox Item Pre-Population feature:

• Added the following fields to the Transmission Profile (transmission_profile__v) object:
  • Pre-Populate Country (prepopulate_country__v)
  • Pre-Populate Report Type (prepopulate_report_type__v)

The following changes were made to support the Inbox Item Enhancements: Report Type & Seriousness feature:

• Added the following fields to the Inbox Item (inbox_item__v) object:
  • Report Type (report_type__v)
  • Seriousness (seriousness__v)

The following changes were made to support the Duplicate E2B XML File Detection feature:

• Added the Enable E2B Document Duplicate Detection (enable_document_duplicate_detection__v) picklist with the following picklist values:
  • Yes (yes__v)
  • No (no__v)
• Added the Enable E2B Document Duplicate Detection (enable_document_duplicate_detection__v) picklist field to the Transmission Profile (transmission_profile__v) object.
• Added the Enable E2B Document Duplicate Detection (enable_document_duplicate_detection__v) document field to the Adverse Event Report (adverse_event_report__v) document classification with the following values:
  • Yes (yes__v)
  • No (no__v)

The following change was made to support the Duplicate Inbox Item Linking feature:

• Added the Linked Inbox Item (linked_inbox_item__v) field to the Inbox Item (inbox_item__v) object.

The following change was made to support the Configurable PII and E2B Masking for NullFlavor Fields feature:

• Add the Null Flavors (null_flavors__v) picklist value to the Exceptions to Patient Content Protection (exceptions_to_patient_content_protection__v) picklist.

The following changes were made to support the EU Convention E2B(R2) feature:

• Added the EU Convention E2B(R2) (eu_convention_e2br2__v) picklist value to the Document Types (document_types__v) picklist.
• Added the EU Convention E2B(R2) (eu_convention_e2br2__v) document classification to the ICSR Individual Case Safety Reports (ICSR) (generated__v) document subtype of the Case (case__v) document type.

The following changes were made to support the MedDRA Bulk Recode Without Case Upversioning feature:

• Added the Approved/Closed Case Bulk Action Scope (closed_case_bulk_action_scope__v) picklist with the following values:
  • All Case Versions (all_case_versions__v)
  • Latest Case Version (latest_case_version__v)
• Added the Approved/Closed Case Bulk Action Scope (closed_case_bulk_action_scope__v) picklist field to the Dictionary Bulk Action (dictionary_bulk_action__v) object.

The following change was made to support the PMDA Post-Market Reports: Filter by Local Awareness Date feature:

• Added the Local Awareness Date (local_awareness_date__v) picklist value to the Filter Cases By (filter_cases_by__v) picklist for the PMDA Post-Market (pmda_postmarket__v) object type of the Aggregate Report (aggregate_report__v) object.

The following changes were made to support the Additional Filters for CIOMS II Aggregate Report feature:

• Added the following fields to the Aggregate Report (aggregate_report__v) object:
  • Case Expectedness (case_expectedness__v)
  • Case Relatedness (case_relatedness__v)
  • Case Serious (case_serious__v)
  • Expectedness Source (expectedness_source__v)
  • Original CIOMS II Logic (original_cioms_ii_logic__v)
  • Report Type (report_type__v)
• Added the Aggregate Report Country (aggregate_report_country__v) object with the following fields:
  • Aggregate Report (aggregate_report__v)
  • Country (country__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 Country (aggregate_report_country_lifecycle__v) object lifecycle.

The following changes were made to support the Safety-EDC Connection: Send SAE Reporter Details to Safety feature:

• Added the following fields to the CDMS Subject Adverse Event (cdms_subject_adverse_event__v) object:
  • Reporter City (reporter_city__v)
  • Reporter Country (reporter_country__v)
  • Reporter Email (reporter_email__v)
  • Reporter First Name (reporter_first_name__v)
  • Reporter Last Name (reporter_last_name__v)
  • Reporter Postal Code (reporter_postal_code__v)
  • Reporter Qualification (reporter_qualification__v)
  • Reporter State / Province (reporter_state_province__v)
  • Reporter Street (reporter_street__v)
  • Reporter Street 2 (reporter_street_2__v)
  • Reporter Telephone (reporter_telephone__v)
  • Reporters Comments (reporters_comments__v)

The following changes were made to support the Country Specific IMP ICSR Reporting feature:

• Added the Study Product Country (study_product_country__v) object with the following fields:
  • 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 Stage (stage__sys)
  • Lifecycle State (state__v)
  • Lifecycle State Stage ID (state_stage_id__sys)
  • Link (link__sys)
  • Name (name__v)
  • Status (status__v)
  • Study (study__v)
  • Study Product (study_product__v)
  • Study Product Role Override (study_product_role_override__v)
  • Study Registration (study_registration__v)
• Added the Study Product Country Lifecycle (study_product_country_lifecycle__v) object lifecycle to the Study Product Country (study_product_country__v) object.

SafetyDocs

The following changes were made to support the Literature Coding to Product Family feature:

• Added the Product Family (product_family__v) field to the following objects:
  • Literature Article (literature_article__v)
  • Literature Review (literature_review__v)
  • Literature Search Term (literature_search_term__v)
  • Literature Standard Search Term (literature_standard_search_term__v)

The following change was made to support the Customize Sender Email Address for PVA Document Distribution feature:

• Added the Originating Email (originating_email__v) field to the PV Agreement (pv_agreement__v) object.

The following changes were made to support the Create Inbox Items from Literature Articles in CRO Vaults feature:

• Added the Organization (organization__v) field to the following objects:
  • Literature Review (literature_review__v)
  • Literature Article (literature_article__v)

The following changes were made to support the Capture Additional Information for Safety Investigations feature:

• Added the following fields to the Safety Investigation (safety_investigation__v) object:
  • Description (description__v)
  • Due Date (due_date__v)
  • Validation Outcome Rationale (validation_outcome_rationale__v)
  • Disposition Rationale (disposition_rationale__v)

24R2.3

Safety

The following changes were made to support the Import Online Questionnaire Responses to Follow-Up Inbox Items feature:

• Added the Standard Question Field Mapping (standard_question_field_mapping__v) object with the following fields:
  • Field Name (field_name__v)
  • Object Name (object_name__v)
• Added the Standard Question Field Mapping (standard_question_field_mapping__v) field to the Question Field Mapping (question_field_mapping__v) object.
• Added the Source Questionnaire (source_questionnaire__v) field to the Inbox Item (inbox_item__v) object.

The following change was made to support the AS2 Connection: Restore AS2 Connections feature:

• Added the AS2 Connection Refresh Job Complete (as2_connection_refresh_job__v) notification template.

The following changes were made to support the AS2 Connection: Transfer AS2 Connections (Environment Management) feature:

• Added the following fields to the AS2 (as2__v) object type of the Connection (connection__sys) object:
  • AS2 Transfer Vault Domain (as2_transfer_vault_domain__v)
  • AS2 Environment Transfer Status (as2_environment_transfer_status__v)
• Added the AS2 Environment Transfer Status (as2_environment_transfer_status__v) picklist with the following values:
  • n/a (na__v)
  • Transferring Out (transferring_out__v)
  • Transferred Out (transferred_out__v)
  • Transferred In (transferred_in__v)
  • Transfer Canceled (transfer_canceled__v)
• Added the AS2 Connection Transfer Job Complete (as2_connection_transfer_job__v) notification template.

The following change was made to support the E2B Readable Renditions feature:

• Added the E2B Readable Rendition (e2b_readable_rendition__v) rendition type.

The following changes were made to support the Copy Datasheet Expectedness Justification to Case Assessments feature:

• Added the Expectedness Justification (expectedness_justification__v) field to the following objects:
  • Case Assessment Expectedness (case_assessment_expectedness__v)
  • Localized Case Assessment (localized_case_assessment__v)
  • MedDRA Criteria (meddra_criteria__v) for the Datasheet Criteria (datasheet_criteria__v) object type

The following changes were made to support the Case Copy with Linking feature:

• Added the Number of Cases (number_of_cases__v) field to the Case (case_version__v) object.
• Added the Copy (copy__v) picklist value to the Intake Method (intake_method__v) picklist.

The following changes were made to support the Case-Level Reportability Indicator feature:

• Added the Case Reportability (case_reportability__v) picklist to the Case (case_version__v) object with the following values:
  • Business Partner (business_partner__v)
  • Health Authority (health_authority__v)
  • Business Partner & Health Authority (business_partner_health_authority__v)
  • Not Reportable (not_reportable__v)

The following changes were made to support the Datasheet Expectedness for Blinded Study Products feature:

• Added the Study Product Placeholder DS Lifecycle (study_product_placeholder_ds_lifecycle__v) object lifecycle with the following states:
  • Active (active_state__v)
  • Inactive (inactive_state__v)
• Added the Study Product Placeholder Datasheet (study_product_placeholder_datasheet__v) object with the following fields:
  • Study Product Placeholder (study_product_placeholder__v)
  • Datasheet (datasheet__v)

The following changes were made to support the Case Version Compare IDs feature:

• Added the Compare ID (compare_id__v) field to the following objects:
  • Case (case_version__v) for the following object types:
    • Child Information (child_information__v)
    • Parent Information (parental_case__v)
  • Case Adverse Event (case_adverse_event__v)
  • Case Assessment (case_assessment__v)
  • Case Assessment Expectedness (case_assessment_expectedness__v)
  • Case Assessment Result (case_assessment_result__v)
  • Case Cause of Death (case_cause_of_death__v) for all object types
  • Case Contact (case_contact__v) for all object types
  • Case Diagnosis (case_diagnosis__v)
  • Case Drug History (case_drug_history__v)
  • Case Drug History Substance (case_drug_history_substance__v)
  • Case Identifier (case_identifier__v)
  • Case Medical History (case_medical_history__v)
  • Case Product (case_product__v) for all object types
  • Case Product Registration (case_product_registration__v) for all object types
  • Case Study Registration (case_study_registration__v)
  • Case Test Result (case_test_result__v)
  • Local Reporting Details (local_reporting_details__v)
  • Local Reporting Details/Product Join (local_reporting_details_product_join__v)
  • Localized Case (localized_case__v)
  • Localized Case Adverse Event (localized_case_adverse_event__v)
  • Localized Case Assessment (localized_case_assessment__v)
  • Localized Case Assessment Result (localized_case_assessment_result__v)
  • Localized Case Cause of Death (localized_case_cause_of_death__v)
  • Localized Case Comment (localized_case_comment__v)
  • Localized Case Contact (localized_case_contact__v)
  • Localized Case Document (localized_case_document__v)
  • Localized Case Drug History (localized_case_drug_history__v)
  • Localized Case Identifier (localized_case_identifier__v)
  • Localized Case Medical History (localized_case_medical_history__v)
  • Localized Case Product (localized_case_product__v)
  • Localized Case Product Device Code (localized_case_product_device_code__v)
  • Localized Case Product Dosage (localized_case_product_dosage__v)
  • Localized Case Product Indication (localized_case_product_indication__v)
  • Localized Case Product Substance (localized_case_product_substance__v)
  • Localized Case Test Result (localized_case_test_result__v)

The following change was made to support the QC Checklist Updates feature:

• Added the Other (other__v) value to the Rule Phase (rule_phase__v) picklist on the Checklist Creation Rule (checklist_creation_rule__v) object.

The following changes were made to support the Select Registrations on Submissions feature:

• Added the following fields to the Transmission (transmission__v) object:
  • Reportable Product (reportable_product__v)
  • Reportable Product Registration (reportable_product_registration__v)
  • Reportable Study (reportable_study__v)
  • Reportable Study Registration (reportable_study_registration__v)
• Added the Study Registration (study_registration__v) field to the Transmission Study (transmission_study__v) object.

The following changes were made to support the Licensing Check for MedDRA feature:

• Added the Dictionary License Status (dictionary_license_status__v) picklist with the following values:
  • Active (active__v)
  • Invalid (invalid__v)
  • Timeout (timeout__v)
  • Internal Error (internal_error__v)
• Added the following fields to the Dictionary (dictionary__v) object:
  • Last Valid License Check Date (last_valid_license_check_date__v)
  • Last Valid License Check Status (last_valid_license_check_status__v)
• Updated the label of the meddra_password__v field on the Dictionary (dictionary__v) object from MedDRA Password to MedDRA API Key.

The following changes were made to support the Safety-EDC Connection: Multiple-EDC Connections on Vault Safety feature:

• Added the EDC Connection (edc_connection__v) field to the following objects:
  • CDMS Subject Information (cdms_subject_information__v)
  • Safety CDMS Outbound Event (safety_connector_origin_safety__v)

The following changes were made to support the Safety-EDC Connection: New Fields & Error Messages feature:

• Added the following fields to the CDMS Subject Adverse Event (cdms_subject_adverse_event__v) object:
  • Highlighted Term (highlighted_term__v)
  • Severity (severity__v)
• Added the Site Narrative (site_narrative__v) field to the Case (case_version__v) object.

The following changes were made to support the Safety Standardization 24R3 feature:

• Added the following object types to the Activity (activity__v) object:
  • User Task (user_task__v)
  • Workflow Task (workflow_task__v)
• Added the following object types to the Aggregate Report (aggregate_report__v) object:
  • DSUR (dsur__v)
  • PBRER (pbrer__v)
  • PMDA Post-Market (pmda_postmarket__v)
• Added the following object types to the Case Collection (case_collection__v) object:
  • CIOMS I PII Masked & Study Blinded (cioms1_pii_masked_study_blinded__v)
  • CIOMS I PII Unmasked & Study Unblinded (cioms1_pii_unmasked_study_unblinded__v)
  • E2B R3 (e2b__v)
• Added the Patient Contact (patient_contact__v) object type to the Case Contact (case_contact__v) object.
• Added the following object types to the Case Product (case_product__v) object:
  • Company Product (company_product__v)
  • Device (device__v)
  • External Product (external__v)
• Added the following object types to the Case (case_version__v) object:
  • Child Information (child_information__v)
  • Imported Case (imported_case__v)
  • Parent Information (parental_case__v)
• Added the following object types to the Case Section (case_version_section__sys) object:
  • Introduction Section (introduction_section__sys)
  • Question Section (question_section__sys)
• Added the Assessment Result Override (assessment_result_override__v) object type to the Controlled Vocabulary (controlled__vocabulary__v) object.
• Added the following object types to the Integration Point (integration_point__sys) object:
  • Inbound (inbound__sys)
  • Outbound (outbound__sys)
• Added the following object types to the Outbound Package (outbound_package__v) object:
  • Migration (migration__sys)
  • Test Data (test_data__sys)
• Added the following object types to the Person (person__sys) object:
  • Email Person (email_person__v)
  • Study Person (study_person__v)
• Added the Product (product__v) object type to the Product (product__v) object.
• Added the following object types to the Reporting Family (reporting_family__v) object:
  • MAH Distribution List (reporting_obligation__v)
  • Partner Distribution List (partner_distribution__v)
  • Product Family (product_family__v)
• Added the following object types to the Reporting Family Member (reporting_family_member__v) object:
  • Product Family (product_family__v)
  • Substance (substance__v)
• Added the following object types to the Scheduled Data Export (scheduled_data_export__sys) object:
  • Daily Data Export (daily_data_export__sys)
  • Full Data Export (full_data_export__sys)
• Added the following object types to the Section (section__sys) object:
  • Introduction Section (introduction_section__sys)
  • Question Section (question_section__sys)
• Added the following object types to the SI Section (si_section__sys) object:
  • Introduction Section (introduction_section__sys)
  • Question Section (question_section__sys)
• Added the following object types to the SRP Section (sirp_section__sys) object:
  • Introduction Section (introduction_section__sys)
  • Question Section (question_section__sys)
• Added the following object types to the Transmission (transmission__v) object:
  • Distribution (distribution__v)
  • Inbound Transmission (inbound_transmission__v)
  • Questionnaire (questionnaire__v)
  • Submission (submission__v)
• Added the Connection Event (connection_event__v) object type to the Transmission Message (transmission_message__v) object.
• Added the following object types to the Transmission Profile (transmission_profile__v) object:
  • AS2 Gateway (as2_gateway__v)
  • Email Profile (email_profile__v)
  • Inbound Email (inbound_email__v)
  • Manual (manual__v)
  • System Gateway (system_gateway__v)
• Added the following object types to the Transmission Section (transmission_section__sys) object:
  • Introduction Section (introduction_section__sys)
  • Question Section (question_section__sys)
• Added the Root (root__v) object type to the XML Element (xml_element__v) object.
• Added the following picklist values to the Therapeutic Area (therapeutic_area__v) picklist:
  • Cardiology/Vascular Diseases (cardiologyvascular_diseases__v)
  • Dental/Maxillofacial Surgery (dentalmaxillofacial_surgery__v)
  • Dermatology/Plastic Surgery (dermatologyplastic_surgery__v)
  • Endocrinology (endocrinology__v)
  • Gastroenterology (gastroenterology__v)
  • Hematology (hematology__v)
  • Immunology/Infectious Diseases (immunologyinfectious_diseases__v)
  • Musculoskeletal (musculoskeletal__v)
  • Nephrology/Urology (nephrologyurology__v)
  • Neurology (neurology__v)
  • Obstetrics/Gynecology (obstetricsgynecology__v)
  • Oncology (oncology__v)
  • Ophthalmology (ophthalmology__v)
  • Otolaryngology (otolaryngology__v)
  • Pediatrics/Neonatology (pediatricsneonatology__v)
  • Pharmacology/Toxicology (pharmacologytoxicology__v)
  • Psychiatry/Psychology (psychiatrypsychology__v)
  • Pulmonary/Respiratory Diseases (pulmonaryrespiratory_diseases__v)
  • Rheumatology (rheumatology__v)
  • Trauma/Emergency Medicine (traumaemergency_medicine__v)
• Added the In Approval (in_approval_state__v) picklist value to the States to Include (states_to_include__v) picklist.
• Added the Business Admin (Quick Access) (business_admin__v) tab with the following subtabs:
  • Organization (organization__v)
  • Dictionaries (dictionaries__v)
  • Product Library (product_library__v)
  • Studies (studies__v)
  • Reporting Families (reporting_families__v)
  • Case Collections (case_collections__v)
• Added the following standard object lifecycles:
  • Case User Assignment Activity Lifecycle (case_user_assignment_activity_lifecycle__v)
  • Inbound Validation Rule Lifecycle (inbound_validation_rule_lifecycle__v)
  • MedDRA Coding Settings Lifecycle (meddra_coding_settings_lifecycle__v)
  • Safety System Settings Lifecycle (safety_system_settings_lifecycle__v)
• Added the Submission (submission_custom_state__v) state to the Aggregate Report (aggregate_report_lifecycle__v) object lifecycle.
• Added the Complete (complete_state__v) state to the Batch Approval (batch_approval__v) object lifecycle.
• Added the In Approval (in_approval_state__v) state to the Case Lifecycle (case_processing_lifecycle__v) object lifecycle.
• Added the Correspondence (correspondence_state__v) state to the Inbox Item Lifecycle (inbox_item_lifecycle__v) object lifecycle.
• Added the following states to the Localized Case Lifecycle (localized_case_lifecycle__v) object lifecycle:
  • Revision (revision_state__v)
  • Translation Entry (translation_entry_state__v)
  • Translation Review (translation_review_state__v)
• Added the Deprecated (deprecated_state__v) state to the following object lifecycles:
  • Product Registration Lifecycle (product_registration_lifecycle__v)
  • Study Registration Lifecycle (study_registration_lifecycle__v)
• Added the following states to the Transmission Lifecycle (transmission_lifecycle__v) object lifecycle:
  • Not Submittable (not_submittable_state__v)
  • Queued for Submission (queued_state__v)
• Added the following states to the User Task Lifecycle (user_task_lifecycle__v) object lifecycle:
  • Open (open_state__v)
  • Complete (complete_state__v).
• Added the Error (error_state__v) state to the Validation Criteria Lifecycle (validation_criteria_lifecycle__v) object lifecycle.
• Removed the following fields from the Child Information (child_information__v) object type of the Case (case_version__v) object:
  • Gestation (gestation_value__v)
  • Gestation (unit) (gestation_unit__v)

Safety Workbench

The following changes were made to support the Workbench Dashboards feature:

• Added the Workbench Dashboard (workbench_dashboard__v) object with the following fields:
  • Description (description__v)
  • Principal View (principal_view__v)
• Added the Workbench Dashboard LC (workbench_dashboard_lc__v) object lifecycle.
• Added the Workbench Dashboard Component (workbench_dashboard_component__v) object with the following fields:
  • Component Layout (component_layout__v)
  • Dashboard Layout (dashboard_layout__v)
  • Workbench Dashboard (workbench_dashboard__v)
  • Workbench View (workbench_view__v)
• Added the Workbench Dashboard Component LC (workbench_dashboard_component_lc__v) object lifecycle.
• Added the Workbench User Dashboard (workbench_user_dashboard__v) object with the following fields:
  • Case Series (case_series__v)
  • Filter (view_filter__v)
  • Last Run Date (last_run_date__v)
  • User (user__v)
  • Workbench Dashboard (workbench_dashboard__v)
• Added the Workbench User Dashboard LC (workbench_user_dashboard_lc__v) object lifecycle.

The following changes were made to support the Case Series feature:

• Added the Workbench Case Series (workbench_case_series__v) object with the following fields:
  • Case Series Data (case_series_data__v)
  • Workbench Report (workbench_report__v)
• Added the Case Version Key (case_version_key__v) field to the Workbench View Column (workbench_view_column__v) object.
• Added the Case Series (case_series__v) field to the Workbench Report (workbench_report__v) object.

Safety Signal

The following changes were made to support the Safety Signal Standardization 24R3 feature:

• Added the following fields to the Signal Source (signal_source__v) object:
  • API Name (api_name__v)
  • Description (description__v)
• Added the Signal Health Authority Database (signal_health_authority_database__v) object with the following fields:
  • API Name (api_name__v)
  • Description (description__v)
• Added the Health Authority Database Lifecycle (health_authority_database_lifecycle__v) object lifecycle.
• Added the Health Authority Database (health_authority_database__v) field to the Statistical Data (statistical_data__v) object.
• Added the following fields to the Literature Data (literature_data__v) object:
  • Database Name (database_name__v)
  • Literature Database (literature_database__v)
• Added the following fields to the PEC Period (product_event_disposition__v) object:
  • Health Authority Database (health_authority_database__v)
  • Literature Database (literature_database__v)
• Added the following fields to the Safety Investigation (safety_investigation__v) object:
  • Health Authority Database (health_authority_database__v)
  • Literature Database (literature_database__v)
• Added the Statistical Data (statistical_data__v) standard tab.
• Added the EVDAS eRMRs (evdas_ermr_data__v) standard tab.

The following changes were made to support the Product-Event Disposition and Statistical Data Updates feature:

• Updated the label of the product_event_disposition__v object from Product-Event Disposition to PEC Period.
• Updated the Reporting Period (reporting_period__v) field on the PEC Period (product_event_disposition__v) object to be required and unique.

SafetyDocs

The following changes were made to support the Literature Multi-Product Support feature:

• Added the Literature Article Product (literature_article_product__v) object with the following fields:
  • ICSR Review Outcome (icsr_review_outcome__v)
  • Investigation Review Outcome (investigation_review_outcome__v)
  • Literature Article (literature_article__v)
  • Number of Identified Cases (number_of_identified_cases__v)
  • Product (product__v)
  • Product Family (product_family__v)
  • Rank (rank__v)
  • Special Report Classification Outcome (special_report_classification_outcome__v)
• Added the Literature Article Product Lifecycle (literature_article_product_lifecycle__v) object lifecycle with the following states:
  • Active (active_state__v)
  • Inactive (inactive_state__v)
• Added the Product Overridden (product_overridden__v) picklist with the following picklist values:
  • Automatic (automatic__v)
  • Overridden (overridden__v)
• Added the Product Overridden? (product_overridden__v) picklist field to the Literature Article (literature_article__v) object.

The following changes were made to support the Product-Event Disposition Updates feature:

• Updated the label of the product_event_disposition__v object from Product-Event Disposition to PEC Period.
• Updated the Reporting Period (reporting_period__v) field on the PEC Period (product_event_disposition__v) object to be required and unique.

The following changes were made to support the SafetyDocs 24R3 Standardization feature:

• Added the Risk Management (risk_management__v) tab with the following subtabs:
  • Core RMPs (core_rmps__v)
  • Local RMPs (local_rmps__v)
  • RMP Documents (rmp_documents__v)
  • Core Risk Measures (core_risk_measures__v)
  • Local Risk Measures (local_risk_measures__v)
  • Risk Measure Tools (risk_measure_tools__v)
  • Core Implementation Strategies (core_implementation_strategies__v)
  • Local Implementation Strategies (local_implementation_strategies__v)
• Added the Risk Management (risk_management__v) tab to the SafetyDocs (safetydocs__v) tab collection.
• Added the Risk Actions (risk_actions__v) permission set.
• Added the Risk Management (risk_management__v) security profile with the Risk Actions (risk_actions__v) permission set.
• Added the Risk Actions (risk_actions__v) permission set to the All SafetyDocs (all_safetydocs__v) security profile.
• Updated the PSMF Coordination Actions (psmf_coordinator_actions__v) permission set.

The following changes were made to support the Risk Management Automations feature:

• Made the following changes to the Risk Measure (rmp_risk_measure__v) object:
  • Set the Value Format of the Name (name__v) field to RMM-{###}.
  • Added the following fields:
    • Local Disposition (rmp_local_disposition__v)
    • Planned Start Date (planned_start_date__v)
    • Actual Start Date (actual_start_date__v)
    • Actual End Date (actual_end_date__v)
    • HA Submission Date (ha_submission_date__v)
    • HA Endorsement Date (ha_endorsement_date__v)
    • Local Disposition (local_disposition__v)
    • Core Implementation Strategy (core_implementation_strategy__v)
    • Local Implementation Strategy (local_implementation_strategy__v)
  • Added the following object types:
    • Core Risk Measure (core_risk_measure__v)
    • Local Risk Measure (local_risk_measure__v)
• Made the following changes to the Risk Measure Tracking (rmp_risk_measure_tracking__v) object:
  • Set the Value Format of the Name (name__v) field to {risk_measure__vr.name__v}-TR{##}.
  • Added the following fields:
    • Target Completion Date (target_completion_date__v)
    • Actual Completion Date (actual_completion_date__v)
• Added the RMP Core Implementation Strategy (rmp_core_implementation_strategy__v) object with the following fields:
  • Based On (based_on__v)
  • Core RMP (core_rmp__v)
  • Core Implementation Plan (core_implementation_plan__v)
  • Product Family (product_family__v)
• Added the RMP Core Implementation Strategy LC (rmp_core_implementation_strategy_lc__v) object lifecycle to the RMP Core Implementation Strategy (rmp_core_implementation_strategy__v) object with the following states:
  • Planned (planned_state__v)
  • In Development (in_development_state__v)
  • Approved (approved_state__v)
  • Inactive (inactive_state__v)
  • Superseded (superseded_state__v)
• Added the RMP Local Implementation Strategy (rmp_local_implementation_strategy__v) object with the following fields:
  • Actual Launch Date (actual_launch_date__v)
  • Based On (based_on__v)
  • Core Implementation Strategy (core_implementation_strategy__v)
  • Core RMP (core_rmp__v)
  • Local Implementation Plan (local_implementation_plan__v)
  • Market (market__v)
  • Pre Launch Date (pre_launch_date__v)
  • Product Family (product_family__v)
• Added the RMP Local Implementation Strategy LC (rmp_local_implementation_strategy_lc__v) object lifecycle to the Object (object__v) object with the following states:
  • Planned (planned_state__v)
  • In Development (in_development_state__v)
  • Approved (approved_state__v)
  • Not Applicable (not_applicable_state__v)
  • Inactive (inactive_state__v)
  • Superseded (superseded_state__v)
• Updated the Risk Measure (risk_measure__v) document field to support selecting multiple values.
• Updated the Risk Measure (risk_measure__v) document field to not be required.
• Added the following document fields to the Implementation Plan (implementation_plan__v) document type:
  • Core Implementation Strategy (core_implementation_strategy__v)
  • Local Implementation Strategy (local_implementation_strategy__v)
• Added the following Notification Templates:
  • Local RMP Data Creation Failure (rmp_local_creation_failure__v)
  • CIS Version Creation Success (rmp_cis_creation_success__v)
  • CIS Version Failure (rmp_cis_creation_failure__v)
  • LIS Creation Success (rmp_lis_creation_success__v)
  • LIS Creation Failure (rmp_lis_creation_failure__v)

Safety & SafetyDocs

The following changes were made to support the Literature E2B Retransmission feature:

• Added the following fields to the Localized Case Document (localized_case_document__v) object:
  • Literature Classification (literature_classification__v)
  • Publication Country (publication_country__v)
  • Retransmit (retransmit__v)
• Added the Vancouver Citation (English) (vancouver_citation_english__v) field to the Literature Article (literature_article__v) object.
• Added the Retransmit (retransmit__v) document field.

Safety Signal & SafetyDocs

The following changes were made to support the Add MedDRA Terms and Queries for Safety Investigations feature:

• Added the Safety Investigation MedDRA Event (safety_investigation_meddra_event__v) object with the following fields:
  • MedDRA Query (meddra_query__v)
  • MedDRA Term (meddra_term__v)
  • Safety Investigation (safety_investigation__v)

Additional Data Model Updates

The following additional changes were made:

• Extended the length of the Local Product Code (local_product_code__v) field to 70 characters on the following objects:
  • Case Product Registration (case_product_registration__v)
  • Product Registration (product_registration__v)
• Removed the Product Selection (product_selection__v) field from the Safety Rule Set (safety_rule_set__v) object.
  This field is removed from all Vaults. Previous values of this field can be obtained from the object audit trail.
• Added the following fields to the Transmission Profile (transmission_profile__v) object:
  • FDA Batch Receiver Identifier (fda_batch_receiver_identifier__v)
  • FDA Message Receiver Identifier (fda_message_receiver_identifier__v)

24R2.4

Safety

The following changes were made to support the FDA MedWatch 3500A: August 2024 Version feature:

• Added the FDA Product Type (fda_product_type__v) picklist with the following picklist values:
  • OTC (otc__v)
  • Generic (generic__v)
  • Biosimilar (biosimilar__v)
  • Compounded (compounded__v)
• Added the FDA Product Type (fda_product_type__v) picklist field to the Product Registration (product_registration__v) object.
• Added the Was device serviced by a third-party? (device_thirdparty_service__v) picklist with the following picklist values:
  • Yes (yes__v)
  • No (no__v)
  • Unknown (unknown__v)
• Added the Third-party servicer for device? (device_thirdparty_service__v) picklist field to the Case Product (case_product__v) object.
• Added the Third Party Servicer (thirdparty_servicer__v) type with E2B Code (e2b_code__v) “5” to the Qualification (qualification__v) object type of the Controlled Vocabulary (controlled_vocabulary__v) object.
• Added the Gender (gender_identity__v) object type to the Controlled Vocabulary (controlled_vocabulary__v) object.
• Added the following Controlled Vocabulary records with type Gender:
  • Cisgender Man (cisgender_man__v)
  • Cisgender Woman (cisgender_woman__v)
  • Transgender Man/FtM (transgender_man_ftm__v)
  • Transgender Woman/MtF (transgender_woman_mtf__v)
  • Other Gender Identity (other_gender__v)
• Added the following control fields to the Case (case_version__v) object:
  • Gender (gender_identity__v)
  • Gender (Other) (gender_other__v)
• Changed the label of the Gender (gender_value__v) control field to Sex on the Case (case_version__v) object.
• Changed the label of the Gender (gender__v) object type to Sex on the Controlled Vocabulary (controlled_vocabulary__v) object.
• Added the Manufacturer Site Number (manufacturer_site_number__v) field to the Organization (organization__v) object.

The following changes were made to support the MFDS E2B(R3) feature:

• Added the MFDS E2B(R3) (mfds_e2br3__v) document classification to the ICSR Individual Case Safety Reports (ICSR) (generated__v) document subtype of the Case (case__v) document type.
• Added the MFDS E2B(R3) (mfds_e2br3__v) value to the following picklists:
  • Additional Transmission Document Type(s) (additional_transmission_documents__v)
  • Transmission Document Type (transmission_document_type__v)
• Added the following picklist values to the Methods of Assessment (methods_of_assessment__v) picklist:
  • KRCT (krct__v)
  • WHO-UMC (who_umc__v)
• Added the Localized Assessment Result (localized_assessment_result__v) field to the Localized Case Assessment Result (localized_case_assessment_result__v) object.

The following changes were made to support the JDrug and WHODrug Cross Reference Tool feature:

• Added the CRT Versions (crt_versions__v) picklist, which is intentionally blank and will be managed through the Fetch Dictionary Updates action.
• Added the WHODrug CRT Japan (whodrug_crt_japan__v) object type to the Dictionary (dictionary__v) object with the following fields:
  • Active Version (active_version__c)
  • Active CRT Version (active_crt_version__v) picklist field
  • Dictionary Type (object_type__v)
• Added the following fields to the Dictionary (dictionary__v) object:
  • Active CRT Version (active_crt_version__v) picklist field
  • Active CRT Version (dictionary_active_crt_version_control__v) control field
• Added the External Product Coding Status (external_product_coding_status__v) picklist with the following values:
  • Coded with Browser (coded_with_browser__v)
  • Coded with CRT (coded_with_crt__v)
  • Could not be coded with CRT (code not found in CRT) (not_coded_not_found_in_crt__v)
  • Could not be coded with CRT (code not found in Dictionary) (not_coded_not_found_in_dictionary__v)
  • Could not be coded with CRT (multiple codes found) (not_coded_multiple_match__v)
  • Coded manually (coded_manual__v)
• Added the External Product Coding Status (external_product_coding_status__v) picklist field to the following objects:
  • Case Product (case_product__v) for the following object types:
    • Base Case Product (base__v)
    • External Product (external__v)
  • Localized Case Product (localized_case_product__v)
• Added the WHODrug Drug Code (whodrug_drug_code__v) field to the Case Product (case_product__v) object for the following object types:
  • Base Case Product (base__v)
  • External Product (external__v)