23R3 Data Model Changes: Safety | Vault Release Notes

Pre-Release Date: October 30, 2023 | Release Date: November 27, 2023 & December 8, 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 23R3.

For information about data model changes related to Vault Platform, see 23R3 Data Model Changes: Platform.

Safety

The following changes were made to support the Support Cross Reporting for Non-Company Scenarios feature:

Added the Non-Company Sponsored Study (non_company_sponsored_study__v) field to the Study (study__v) object
Added the Non-Company Product (non_company_product__v) field to the Product (product__v) object

The following changes were made to support the Japan Drug Dictionary (JDD) feature:

Added the JDrug Dictionary (jdrug_dictionary__v) object type to the Dictionary (dictionary__v) object
Added the Active JDrug Version (active_jdrug_version__v) field to the Dictionary (dictionary__v) object
Added the JDrug Versions (jdrug_versions__v) picklist
Added the following fields to the JDrug Dictionary (jdrug_dictionary__v) object type:
- Active JDrug Version (active_jdrug_version__v)
- Dictionary Type (object_type__v)

The following changes were made to support the Case-Level Nullification and Amendment Reasons for Transmissions feature:

Added the following fields to the Case (case_version__v) object:
- Transmission Reason (transmission_reason__v) with the following picklist values:
  - Nullification (nullification__v)
  - Amendment (amendment__v)
- Transmission Reason Text (transmission_reason_text__v)

The following changes were made to support the EMA Clinical Trial Submissions: Non-Study Suspect Products feature:

Added the Report Type Override (report_type_override__v) field to Transmission (transmission__v) object for the following object types:
- Distribution (distribution__v)
- Submission (submission__v)

The following changes were made to support the Active Case Licensing feature:

Added the Initial Approval Date (initial_approval_date__v) field to the Case (case_version__v) object.

The following changes were made to support the Case Access by Local PV Email feature:

Added the Access Group (case_access_group__v) field to the Person (person__sys) object.
Added the following fields to the Inbound Transmission (inbound_transmission__v) object type:
- Sender (Person) (sender_person__v)
- Sender (User) (sender_user__v)

The following changes were made to support the Criteria Page on Aggregate Reports feature:

Added the Include Criteria page on Documents (include_criteria_page__v) field to the Aggregate Report (aggregate_report__v) object

The following changes were made to support the CIOMS II Line Listing Enhancements feature:

Added the following options to the Comments Field (comments__v) picklist on the Aggregate Report (aggregate_report__v) object:
- Narrative Preview (narrative_preview__v)
- Company Comments (company_comments__v)
- Reporter’s Comments (reporters_comments__v)

The following changes were made to support the DSUR: Generate Masked Appendices feature:

Added the Study Content Protection (study_content_protection__v) field to the following document types:
- Cumulative Tabulation of Serious Adverse Reactions from Clinical Trials (cumulative_sar_trials__v)
- List of Subjects Who Died During the Reporting Period (list_of_subjects_died_trials__v)

The following changes were made to support the DSUR and PBRER: Summary Totals and Separate Log Files feature:

Added the Log (log__v) document type (Classification) to the Summary Tabulation (summary_tabulation__v) document type (Subtype)

The following changes were made to support the Configurable Substance Matching for Cross Reporting feature:

Added the Cross Reporting Substance Lookup Method (cross_reporting_substance_lookup_method__v) field to the Organization (organization__v) object with the following picklist values:
- Subset Match (subset_match__v)
- Exact Match (exact_match__v)
- Partial Match (partial_match__v)

The following changes were made to support the PMDA Due Dates Based on Localized Case Assessments feature:

Added the Rule Execution Level (rule_execution_level__v) value to the Parameter (parameter__v) picklist

The following changes were made to support the PMDA Clinical Trial Reporting Enhancements feature:

Added the Clinical Compound Number (clinical_compound_number__v) field to the Study Registration (study_registration__v) object
Added the Product (Reported) Override (product_reported_override__v) field to the Product Registration (product_registration__v) object
Added the Product (Reported) Override (product_reported_override__v) field to the Case Product Registration (case_product_registration__v) object
Added the Under Partial Change Trial (TIKEN) (under_partial_change_trial_tiken__v) value to the Registration Type (registration_type__v) object type of the Controlled Vocabulary (controlled_vocabulary__v) object
Added the TIKEN (tiken__v) field to the Local Reporting Details (local_reporting_details__v) object
Extended the maximum value of the Number of Clinical Trial Notifications (number_of_clinical_trial_notifications__v) field on the Localized Study (localized_study__v) object to 999

The following changes were made to support the Extend Definition of Suspect to Drug Not Administered feature:

Upgraded the default values for the Drug Roles to Include (drug_roles_to_include__v) field on the Aggregate Report (aggregate_report__v) object to the following:
- Suspect (suspect__v)
- Interacting (interacting__v)
Added the Drug Roles to Include (drug_roles_to_include__v) field to the CIOMS II (cioms_ii__v) object type on the Aggregate Report (aggregate_report__v) object

The following changes were made to support the Safety Inbox Loader: Multi-Case CSV Data Import feature:

Added the Tabular Data Format (tabular_data_format__v) object.
Added the following fields to the Tabular Data Format (tabular_data_format__v) object:
- Format (name__v)
- Status (status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
Added the Import Code Mapping (import_code_mapping__v) object.
Added the following fields to the Import Code Mapping (import_code_mapping__v) object:
- Code Mapping Type (code_mapping_type__v) with the following picklist values:
  - Controlled Vocabulary (controlled_vocabulary__v)
  - Dose Form (dose_form__v)
  - Route of Administration (route_of_administration__v)
  - Unit of Measurement (unit_of_measurement__v)
  - Reason Omitted (reason_omitted__v)
  - Seriousness (seriousness__v)
- Controlled Vocabulary (controlled_vocabulary__v)
- Dose Form (dose_form__v)
- Import Field Mapping (import_field_mapping__v)
- Reason Omitted (reason_omitted__v)
- Route of Administration (route_of_administration__v)
- Seriousness (seriousness__v) with the following picklist values:
  - Results in death (results_in_death__v)
  - Life threatening (life_threatening__v)
  - Caused / prolonged hospitalisation (caused_prolonged_hospitalisation__v)
  - Disabling / Incapacitating (disabling_incapacitating__v)
  - Congenital anomaly / birth defect (congenital_anomaly_birth_defect__v)
  - Other medically important conditions (other_medically_important_condition__v)
- Source Value (name__v)
- Status (status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
- Unit of Measurement (unit_of_measurement__v)
Added the Import Field Mapping (import_field_mapping__v) object.
Added the following fields to the Import Field Mapping (import_field_mapping__v) object:
- Format (name__v)
- Source Column Header (name__v)
- Status (status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
- Tabular Data Format (tabular_data_format__v)
- Target FIeld Name (target_field_name__v)
- Target Object Name (target_object_name__v)
Added the Tabular Data (tabular_data__v) picklist value to the Intake Format (intake_format__v) field.

The following changes were made to support the Safety-RIM Product Connection (Safety) feature:

Added the Product Family Product (product_family_product__v) object
Added the following fields to the Product Family Product (product_family_product__v) object:
- Name (name__v)
- Product Family (product_family__v)
- Product (product__v)
- Deleted in RIM? (deleted_in_rim__v)
- RIM Status (rim_status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
Added the Product Family Product (product_family_product_lifecycle__v) object lifecycle
Added the Product Variant (product_variant__v) object
Added the following fields to the Product Variant (product_variant__v) object:
- Product Variant (name__v)
- Product (product__v)
- RIM Product Variant Type (rim_product_variant_type__v)
- Strength (strength__v)
- Color (color__v)
- Deleted in RIM? (deleted_in_rim__v)
- RIM Status (rim_status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
Added the Product Variant (product_variant_lifecycle__v) object lifecycle
Added the Product Family Substance (product_family_substance__v) object
Added the following fields to the Product Family Substance (product_family_substance__v) object:
- Name (name__v)
- Product Family (product_family__v)
- Substance (substance__v)
- Deleted in RIM? (deleted_in_rim__v)
- RIM Status (rim_status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
Added the Product Family Substance (product_family_substance_lifecycle__v) object lifecycle
Added the following fields to the Organization (organization__v) object for the Registration Holder (registration_holder__v) object type:
- Street Number (street_number__v)
- PO Box (po_box__v)
- Email Address (email_address__v)
- Telephone Country Code (telephone_country_code__v)
- Telephone Number (telephone_number__v)
- DUNS Number (duns_number__v)
- Deleted in RIM? (deleted_in_rim__v)
- RIM Status (rim_status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
Added the following fields to the Product (product__v) object:
- Comparator Product (comparator_product__v)
- Dosage Form (dosage_form__v)
- Device Name (device_name__v)
- Basic UDI-DI (basic_udidi__v)
- FDA Product Code (fda_product_code__v)
- RIM Product Type (rim_product_type__v)
- Deleted in RIM? (deleted_in_rim__v)
- RIM Status (rim_status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
Added the following fields to the Product Constituent (product_constituent__v) object:
- Product Variant (product_variant__v)
- Deleted in RIM? (deleted_in_rim__v)
- RIM Status (rim_status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
Added the following fields to the Product Family (product_family__v) object:
- Product Family Abbreviation (abbreviation__v)
- Generic Name (generic_name__v)
- Deleted in RIM? (deleted_in_rim__v)
- RIM Status (rim_status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
Added the following fields to the Product Registration (product_registration__v) object:
- Registration Status Date (registration_status_date__v)
- Marketing Status (marketing_status__v) with the following picklist values:
  - Marketed (marketed__v)
  - Not Marketed (not_marketed__v)
  - Withdrawn (withdrawn__v)
- Marketing Start Date (marketing_start_date__v)
- Marketing End Date (marketing_end_date__v)
- Registration End Date (registration_end_date__v)
- Expiration Date (expiration_date__v)
- RIM Registration Type (rim_registration_type) with the following picklist values:
  - Marketed Drug Product Registration (marketed_drug_product_registration__v)
  - Marketed Device Product Registration (marketed_device_product_registration__v)
  - Investigational Drug Registration (investigational_registration__v)
  - Investigational Device Registration (investigational_device_registration__v)
- Product Family (product_family__v)
- Product Variant (product_variant__v)
- RIM Lifecycle State (rim_lifecycle_state__v)
- Deleted in RIM? (deleted_in_rim__v)
- RIM Status (rim_status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
Added the following fields to the Substance (substance__v) object:
- Substance Name Long Text (substance_name_long__v)
- Primary Product Family (product_family__v)
- EV Code (ev_code__v)
- SPOR Substance Code (spor_substance_code__v)
- SPOR Term (spor_term__v)
- US Substance Code (us_substance_code__v)
- EUDAMED INN (eudamed_inn__v)
- CAS Number (cas_number__v)
- EC Number (ec_number__v)
- Deleted in RIM? (deleted_in_rim__v)
- RIM Status (rim_status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)

The following changes were made to support the Case Volume Metrics feature:

Added the Process Completion Date (inbox_completion_date__v) field to the Inbox Item (inbox_item__v) object.
Added the Process Completion Date (case_completion_date__v) field to the Case (case_version__v) object.
Added the Case Volume Metrics (case_volume_metrics__v) object.
Added the following fields to the Case Volume Metrics (case_volume_metrics__v) object:
- Case - Active (case_active__v)
- Case - Completed (case_completed__v)
- Case - Initial (case_initial__v)
- Frequency (frequency__v) with the following picklist values:
  - Hourly (hourly__v)
  - Daily (daily__v)
- Inbox - Active (inbox_active__v)
- Inbox - Initial (inbox_initial__v)
- Inbox - Rejected (inbox_rejected__v)
- Name (name__v)
- Scheduled Datetime (scheduled_datetime__v)
- Status (status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
- Timeslot (timeslot__v)
- Total Completed Last 24 Hours (total_completed_last_24_hours__v)
- Total Inbox Items Created (total_inbox_items_created__v)
- Total Received Last 24 Hours (total_received_last_24_hours__v)
- Total Rejected Last 24 Hours (total_rejected_last_24_hours__v)

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

Added the Case Assignment Team (case_assignment_team__v) field to the Case (case_version__v) object for the following object types:
- Case (case__v)
- Child Information (child_information__v)
- Parent Information (parent_case__v)
Added the Safety Phase (standard_safety_phase__v) field to the Case (case_version__v) object with the following picklist values:
- Intake (intake__v)
- Data Entry (data_entry__v)
- Quality Control (quality_control__v)
- Medical Review (medical_review__v)
- Final Review (final_review__v)
- Closure (closure__v)
Added the following fields to the Inbox Item (inbox_item__v) object:
- Case Assignment Team (case_assignment_team__v)
- Locked By User (locked_by_user__v)
- Locked Date (locked_date__v)
- Safety Phase (standard_safety_phase__v) with the following picklist values:
  - Intake (intake__v)
  - Data Entry (data_entry__v)
  - Quality Control (quality_control__v)
  - Medical Review (medical_review__v)
  - Final Review (final_review__v)
  - Closure (closure__v)
Added the Role Assignment Method (role_assignment_method__v) field to the Case Access Group(case_access_group__v) object with the following picklist values:
- All Users in Access Group (all_users_access_group__v)
- Users on Assigned Team (users_on_assigned_team__v)
Added the Case Assignment Team (case_assignment_team__v) object.
Added the following fields to the Case Assignment Team (case_assignment_team__v) object:
- Case Access Group (case_access_group__v)
- Name (name__v)
- Status (status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
- Team Caseload (team_caseload__v)
- Team Leader (team_leader__v)
- Total Team Members (total_team_members__v)
Added the Case User Assignment Activity (case_user_assignment_activity__v) object.
Added the following fields to the Case User Assignment Activity (case_user_assignment_activity__v) object:
- AssignedBy (assignedby__v)
- AssignedTo (assignedto__v)
- Assignment Complete (assignment_complete__v)
- Assignment Start (assignment_start__v)
- Case Access Group (case_access_group__v)
- Case Assignment Team (case_assignment_team__v)
- Case ID (case_id__v)
- Inbox Item ID (inbox_item_id__v)
- Name (name__v)
- Phase From (phase_from__v)
- Phase To (phase_to__v)
- Safety Phase (standard_safety_phase__v) with the following picklist values:
  - Intake (intake__v)
  - Data Entry (data_entry__v)
  - Quality Control (quality_control__v)
  - Medical Review (medical_review__v)
  - Final Review (final_review__v)
  - Closure (closure__v)
- Status (status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
Added the User Assignment Attribute (user_assignment_attributes__v) object.
Added the following fields to the User Assignment Attribute (user_assignment_attributes__v) object:
- Name (name__v)
- Status (status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
- User Current Caseload (user_current_caseload__v)
Added the User Team Assignment (user_team_assignment__v) object.
Added the following fields to the User Team Assignment (user_team_assignment__v) object:
- Assignment Team (assignment_team__v)
- Name (name__v)
- Status (status__v) with the following picklist values:
  - Active (active__v)
  - Inactive (inactive__v)
- User (user__v)
Added the following fields to the User (user__sys) object:
- User Assignment Attributes (user_assignment_attributes__v)
- User Current Caseload (user_current_caseload__v)
Added the Final Review (final_review_state__sys) state type to the Case Lifecycle (case_processing_lifecycle__v)

The following changes were made to support the PMDA Submission Validation Enhancements feature:

Added the following Units of Measurement to the Agency Units of Measurement (agency_unit_of_measurement__v) object for the PMDA Agency and PMDA E2B (R3) File Format:
- kg
- g
- mg
- ug
- ng
- pg
- mg/kg
- ug/kg
- mg/mL
- mg/m^2
- ug/m^2
- L
- mL
- uL
- Bq
- GBq
- MGq
- kBq
- Ci
- mCi
- uCi
- nCi
- mol
- mmol
- umol
- IU
- kIU
- MIU
- IU/kg
- meq
- %
- drops
- dosage form

The following changes were made to support the Validation Query Builder: Simple Expressions feature:

Added Case Data - Expression (case_data_expression__v) value to the Rule Formula Format (rule_formula_format__v) picklist on the Validation Criteria (validation_criteria__v) object

The following changes were made to support the MedDRA Query Building Blocks feature:

Added the Datasheet MedDRA Query (datasheet_meddra_query__v) object with the following fields:
- Active Date End (active_date_end__v)
- Active Date Start (active_date_start__v)
- Created By (created_by__v)
- Created Date (created_date__v)
- Datasheet (datasheet__v)
- Expectedness (expectedness__v)
- Global ID (global_id__sys)
- ID (id__v)
- Last Modified By (last_modified_by__v)
- Last Modified Date (last_modified_date__v)
- Lifecycle (lifecycle__v)
- Lifecycle Stage (stage__sys)
- Lifecycle State (state__v)
- Lifecycle State Stage ID (stage_state_id__sys)
- Link (link__sys)
- MedDRA Query (meddra_query__v)
- Name (name__v)
- Scope (scope__v)
- Seriousness Exclusion (seriousness_exclusion__v)
- Status (status__v)
Added the Datasheet MedDRA Query Lifecycle (datasheet_meddra_query_lifecycle__v) object lifecycle
Added the Watchlist MedDRA Query (watchlist_meddra_query__v) object with the following fields:
- Created By (created_by__v)
- Created Date (created_date__v)
- Global ID (global_id__sys)
- ID (id__v)
- Last Modified By (last_modified_by__v)
- Last Modified By (last_modified_date__v)
- Lifecycle (lifecycle__v)
- Lifecycle Stage (stage__sys)
- Lifecycle State (state__v)
- Lifecycle State Stage ID (stage_state_id__sys)
- Link (link__sys)
- MedDRA Query (meddra_query__v)
- Name (name__v)
- Scope (scope__v)
- Status (status__v)
- Watchlist (watchlist__v)
Added the Watchlist MedDRA Query Lifecycle (watchlist_meddra_query_lifecycle__v) object lifecycle
Added the MedDRA Query Building Block (meddra_query_building_block__v) object with the following fields:
- CMQ (cmq__v)
- Created By (created_by__v)
- Created Date (created_date__v)
- Global ID (global_id__sys)
- ID (id__v)
- Last Modified By (last_modified_by__v)
- Last Modified Date (last_modified_date__v)
- Lifecycle (lifecycle__v)
- Lifecycle Stage (stage__sys)
- Lifecycle State (state__v)
- Lifecycle State Stage ID (stage_state_id__sys)
- Link (link__sys)
- MedDRA Query (meddra_query__v)
- Name (name__v)
- Scope (scope__v)
- Status (status__v)
Added the MedDRA Query Building Block Lifecycle (meddra_query_building_block_lifecycle__v) object lifecycle
Added the Matched Datasheet Criteria (matched_datasheet_criteria__v) field to the Case Assessment Expectedness (case_assessment_expectedness__v) object
Added the following field to the MedDRA Query (meddra_query__v) object:
- MedDRA Query Type (meddra_query_type__v) with the following picklist values:
  - CMQ (cmq__v)
  - Building Block (building_block__v)
Added the following fields to the MedDRA Criteria (meddra_criteria__v) object:
- Matching MedDRA Code (matching_meddra_code__v)
- Matching MedDRA Hierarchy (matching_meddra_hierarchy__v)
- Source MedDRA Query (source_meddra_query__v)

The following changes were made to support the PMDA Local Reporting Details Generation and Submission Linking feature:

Added the Due Date (due_date__v) field to the Localized Case (localized_case__v) object.
Add the following fields to the Case Product Registration (case_product_registration__v) object:
- Due Date (due_date__v)
- Due in Days (due_in_days__v)
Added the Localize Transmission (localize_transmission__v) field to the Transmission Profile (transmission_profile__v) object with the following picklist value:
- Yes (yes__v)
Added the System Generated LRD Category (system_generated_lrd_category__v) field to the Local Reporting Details (local_reporting_details__v) object with the following picklist values:
- Investigational (investigational__v)
- Marketing (marketing__v)

Additional Data Model Updates

The following additional changes were made:

Added the Device Follow-Up Type (device_multi_followup_type__v) field to the Case (case_version__v) object
Added the following fields to the Local Reporting Details (local_reporting_details__v) and Local Reporting Details/Product Join (local_reporting_details_product_join__v) objects
- Access Group (access_group__v)
- Localization (localization__v)
Added the Serious Injury (serious_injury__v) value to the Device Report Type (device_report_type__v) picklist

SafetyDocs

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

Added the Aggregate Report Template (aggregate_report_template__v) object with the following fields:
- Aggregate Report Type (aggregate_report_type__v)
- Core Template (core_template__v)
- Applicable Market (applicable_market__v)
- Health Authority (health_authority__v)
- External ID (external_id__v)
- Vault Safety UUID (vault_safety_uuid__v)
- Created By (created_by__v)
- Created Date (created_date__v)
- Global ID (global_id__sys)
- ID (id__v)
- Last Modified By (last_modified_by__v)
- Last Modified Date (last_modified_date__v)
- Lifecycle (lifecycle__v)
- Lifecycle Stage (stage__sys)
- Lifecycle State (state__v)
- Lifecycle State Stage ID (stage_state_id__sys)
- Link (link__sys)
- Name (name__v)
- Status (status__v)
Added the Global Aggregate Report Template (global_aggregate_report_template__v) object type to the Aggregate Report Template (aggregate_report_template__v) object with the following fields:
- Aggregate Report Type (aggregate_report_type__v)
- External ID (external_id__v)
- Vault Safety UUID (vault_safety_uuid__v)
- Created By (created_by__v)
- Created Date (created_date__v)
- Global ID (global_id__sys)
- ID (id__v)
- Last Modified By (last_modified_by__v)
- Last Modified Date (last_modified_date__v)
- Lifecycle (lifecycle__v)
- Lifecycle Stage (stage__sys)
- Lifecycle State (state__v)
- Lifecycle State Stage ID (stage_state_id__sys)
- Link (link__sys)
- Name (name__v)
- Status (status__v)
Added the Local Aggregate Report Template (local_aggregate_report_template__v) object type with the following fields:
- Aggregate Report Type (aggregate_report_type__v)
- Core Template (core_template__v)
- Applicable Market (applicable_market__v)
- Health Authority (health_authority__v)
- External ID (external_id__v)
- Vault Safety UUID (vault_safety_uuid__v)
- Created By (created_by__v)
- Created Date (created_date__v)
- Global ID (global_id__sys)
- ID (id__v)
- Last Modified By (last_modified_by__v)
- Last Modified Date (last_modified_date__v)
- Lifecycle (lifecycle__v)
- Lifecycle Stage (stage__sys)
- Lifecycle State (state__v)
- Lifecycle State Stage ID (stage_state_id__sys)
- Link (link__sys)
- Name (name__v)
- Status (status__v)
Added the Aggregate Report Template Lifecycle (aggregate_report_template_lifecycle__v) with the following states:
- Active (active_state__v)
- Inactive (inactive_state__v)
Added the Aggregate Report Template Item (aggregate_report_template_item__v) object with the following fields:
- Parent Template (parent_template__v)
- Task Type (object_type__v)
- Aggregate Report Type (aggregate_report_type__v)
- Document Template (document_template__v)
- Item Order (item_order__v)
- External ID (external_id__v)
- Vault Safety UUID (vault_safety_uuid__v)
- Created By (created_by__v)
- Created Date (created_date__v)
- Global ID (global_id__sys)
- ID (id__v)
- Last Modified By (last_modified_by__v)
- Last Modified Date (last_modified_date__v)
- Lifecycle (lifecycle__v)
- Lifecycle Stage (stage__sys)
- Lifecycle State (state__v)
- Lifecycle State Stage ID (stage_state_id__sys)
- Link (link__sys)
- Name (name__v)
- Status (status__v)
Added the Authoring Task (authoring_task__v) object type to the Aggregate Report Template Item (aggregate_report_template_item__v) object with the following fields:
- Parent Template (parent_template__v)
- Task Type (object_type__v)
- Aggregate Report Type (aggregate_report_type__v)
- Document Template (document_template__v)
- Item Order (item_order__v)
- External ID (external_id__v)
- Vault Safety UUID (vault_safety_uuid__v)
- Created By (created_by__v)
- Created Date (created_date__v)
- Global ID (global_id__sys)
- ID (id__v)
- Last Modified By (last_modified_by__v)
- Last Modified Date (last_modified_date__v)
- Lifecycle (lifecycle__v)
- Lifecycle Stage (stage__sys)
- Lifecycle State (state__v)
- Lifecycle State Stage ID (stage_state_id__sys)
- Link (link__sys)
- Name (name__v)
- Status (status__v)
Added the Aggregate Report Template Item Lifecycle (aggregate_report_template_item_lifecycle__v) with the following states:
- Active (active_state__v)
- Inactive (inactive_state__v)
Added the Aggregate Report Template (aggregate_report_template__v) field to the Aggregate Report (aggregate_report__v) object
Added the following fields to the Aggregate Report Task (aggregate_report_task__v) object:
- Aggregate Report Template (aggregate_report_template__v)
- Aggregate Report Template Item (aggregate_report_template_item__v)
- Task Order (task_order__v)
Added the following object types to the Aggregate Report Task (aggregate_report_task__v) object:
- PBRER (pbrer__v)
- PSUR (psur__v)
- DSUR (dsur__v)
- PADER (pader__v)
- CIOMS ll (cioms_ii__v)
Added the Authoring Task (authoring_task__v) object type to the Aggregate Report Task (aggregate_report_task__v) object with the following fields:
- Aggregate Report Template (aggregate_report_template__v)
- Aggregate Report Template Item (aggregate_report_template_item__v)
- Task Order (task_order__v)

The following changes were made to support the Aggregate Reporting: Extract Report to Document feature:

Added the following fields to the Aggregate Report Task (aggregate_report_task__v) object:
- Report Format (report_format__v)
- Source Report (source_report__v)
- Source Report Prompt (source_report_prompt__v)
Added the Vault Report (vault_report__v) object type to the Aggregate Report Task (aggregate_report_task__v) object with the following fields:
- Aggregate Report Destination (aggregate_report_destination__v)
- Aggregate Report Template (aggregate_report_template__v)
- Aggregate Report Template Item (aggregate_report_template_item__v)
- Aggregate Report Type (aggregate_report_type__v)
- Aggregate Report Task Type (object_type__v)
- Assigned To (assigned_to__v)
- Complete (complete__v)
- Completion Date (completion_date__v)
- Description (description__v)
- Due Date (due_date__v)
- External ID (external_id__v)
- Report Document (report_document__v)
- Task Order (task_order__v)
- Report Format (report_format__v)
- Source Report (source_report__v)
- Source Report Prompt (source_report_prompt__v)
- Created By (created_by__v)
- Created Date (created_date__v)
- Global ID (global_id__sys)
- ID (id__v)
- Last Modified By (last_modified_by__v)
- Last Modified Date (last_modified_date__v)
- Lifecycle (lifecycle__v)
- Lifecycle Stage (stage__sys)
- Lifecycle State (state__v)
- Lifecycle State Stage ID (stage_state_id__sys)
- Link (link__sys)
- Name (name__v)
- Status (status__v)
Added the following fields to the Aggregate Report Template Item (aggregate_report_template_item__v) object:
- Report Format (report_format__v)
- Source Report (source_report__v)
- Source Report Prompt (source_report_prompt__v)
Added the Vault Report (vault_report__v) object type to the Aggregate Report Template Item (aggregate_report_template_item__v) object with the following fields:
- Aggregate Report Type (aggregate_report_type__v)
- External ID (external_id__v)
- Item Order (item_order__v)
- Vault Safety UUID (vault_safety_uuid__v)
- Report Format (report_format__v)
- Source Report (source_report__v)
- Source Report Prompt (source_report_prompt__v)
- Created By (created_by__v)
- Created Date (created_date__v)
- Global ID (global_id__sys)
- ID (id__v)
- Last Modified By (last_modified_by__v)
- Last Modified Date (last_modified_date__v)
- Lifecycle (lifecycle__v)
- Lifecycle Stage (stage__sys)
- Lifecycle State (state__v)
- Lifecycle State Stage ID (stage_state_id__sys)
- Link (link__sys)
- Name (name__v)
- Status (status__v)
- Task Type (object_type__v)

The following changes were made to support the Import Literature References from Database Files feature:

Added the Literature Author (literature_article_author__v) object
Added the following fields to the Literature Author (literature_article_author__v) object:
- Literature Article (literature_article__v)
- Value (raw__v)
- First Name (first_name__v)
- Last Name (last_name__v)
- Author Type (author_type__v) with the following picklist values:
  - Primary (primary__v)
  - Non-Primary (non_primary__v)
  - Editor (editor__v)
  - Translator (translator__v)
Added the Literature Additional Info (literature_additional_info__v) object
Added the following fields to the Literature Additional Info (literature_additional_info__v) object:
- Literature Article (literature_article__v)
- Tag (tag__v)
- Value (value__v)
Added the following fields to the Literature Article (literature_article__v) object:
- Reference Type (reference_type__v) with the following picklist values:
  - Abstract (abstract__v)
  - Audio Visual Material (audiovisual_material__v)
  - Aggregated Database (aggregated_database__v)
  - Ancient Text (ancient_text__v)
  - Art Work (art_work__v)
  - Bill (bill__v)
  - Blog (blog__v)
  - Whole book (whole_book__v)
  - Case (case__v)
  - Book chapter (book_chapter__v)
  - Chart (chart__v)
  - Classical Work (classical_work__v)
  - Computer Program (computer_program__v)
  - Conference Proceeding (conference_proceeding__v)
  - Conference Paper (conference_paper__v)
  - Catalog (catalog__v)
  - Datafile (data_file__v)
  - Online Database (online_database__v)
  - Dictionary (dictionary__v)
  - Electronic Book (electronic_book__v)
  - Electronic Book Section (electronic_book_section__v)
  - Edited Book (edited_book__v)
  - Electronic Article (electronic_article__v)
  - Web Page (web_page__v)
  - Encyclopedia (encyclopedia__v)
  - Equation (equation__v)
  - Figure (figure__v)
  - Generic (generic__v)
  - Government Document (government_document__v)
  - Grant (grant__v)
  - Hearing (hearing__v)
  - Internet Communication (internet_communication__v)
  - In Press (in_press__v)
  - Journal (full) (full_journal__v)
  - Journal (journal__v)
  - Legal Rule or Regulation (legal_rule__v)
  - Manuscript (manuscript__v)
  - Map (map__v)
  - Magazine Article (magazine_article__v)
  - Motion Picture (motion_picture__v)
  - Online Multimedia (online_multimedia__v)
  - Music Score (music_score__v)
  - Newspaper (newspaper__v)
  - Pamphlet (pamphlet__v)
  - Patent (patent__v)
  - Personal Communication (pcomm__v)
  - Report (report__v)
  - Serial Publications (serial_pub__v)
  - Slide (slide__v)
  - Sound Recording (sound_recording__v)
  - Standard (standard__v)
  - Statute (statute__v)
  - Thesis/Dissertation (thesis__v)
  - Unenacted Bill (unbill__v)
  - Unpublished Work (unpb__v)
  - Video Recording (video__v)
- Accession Number (accession_number__v)
- Call Number (call_number__v)
- Database Name (database_name__v)
- Database Provider (database_provider__v)
- End Page (end_page__v)
- Edition (edition__v)
- Reference ID (reference_id__v)
- Issue Number (issue_number__v)
- Keywords (keywords__v)
- Link (PDF) (url_pdf__v)
- Link (Full Text) (url_full_text__v)
- Link (url__v)
- Article Notes (article_notes__v)
- ISBN/ISSN (isbn_issn__v)
- Start Page (start_page__v)
- Access Date (access_date__v)
- Volume (volume__v)
- Title (English) (title_english_v)
- Publisher (publisher__v)
- Section (section__v)
Added the Literature Search Term (literature_search_term__v) document field to the Literature-Review Document-Database Export document classification
Added the following lifecycle states to the Literature Document (literature_document_lifecycle__v) document lifecycle
- Importing (importing__v)
- Error (error__v)
Added the following lifecycle states to the Literature Search Term (literature_search_term_lifeycle__v) object lifecycle
- Importing (importing__v)
- Imported (imported__v)
- Error (error__v)

The following changes were made to support the Literature Abstract Auto-Translation feature:

Added the following objects:
- Translation Connection Languages (translation_connection_language__v)
- Translation Localization (translation_localization__v)
- Translation Settings (translation_settings__v)
Added the following fields to the Literature Article (literature_article__v) object:
- Abstract Language (abstract_language__v)
- Abstract (English) (abstract_english__v)
Added the following lifecycle states to the Literature Article (literature_article_lifecycle__v) lifecycle:
- Abstract Translation Requested (abstract_translation_requested__v)
- Abstract Translation Complete (abstract_translation_complete__v)
- Translation Error (translation_error__v)
Added the following value to the Type (type__v) field on the Automation Task (automation_task__v) object:
- Literature Article Translation (literature_article_translation__v)
Added the Literature Abstract Translation (literature_abstract_translation__v) child object to the Automation Task (automation_task__v) object with the following fields:
- Name (name__v)
- Automation Task (automation_task__v)
- Literature Article (literature_article__v)
Added the Literature Article Translation Settings (lit_article_translation_settings__v) object type to the Translation Settings (translation_settings__v) object with the following fields:
- Translation Connection (translation_connection__v)
- Maximum Number of Characters per Request (maximum_number_of_characters_per_request__v)
- Maximum Number of Requests per Month (maximum_number_of_requests_per_month__v)
- Number of Requests in Current Month (number_of_requests_in_current_month__v)