23R1 Data Model Changes: Safety | Vault Release Notes

Pre-Release Date: May 27, 2023 | Release Date: April 20, 2023 & April 28, 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 23R1.

For information about data model changes related to Vault Platform, see 23R1 Data Model Changes: Platform.

Data Model Updates - Safety

The following changes were made to support the Automatic MedDRA Hierarchy Updates feature:

Added the Superseded by (superseded_by__v) field to the following objects:
- MedDRA (meddra__v)
- MedDRA Localized (meddra_localized__v)
Added the Latest Loaded MedDRA Version (latest_loaded_meddra_version__v) field to the Dictionary (dictionary__v) object

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

Added the Case Access Group (case_access_group__v) object
Added the following fields to the Case Access Group (case_access_group__v) object:
- Name (name__v)
- API Name (api_name__v)
Added the Case Access Group (case_access_group_lifecycle__v) object lifecycle
Added the Access Group (access_group__v) field to the Case Access Group (case_access_group__v) object for the following object types:
- Case (case__v)
- Imported Case (imported_case__v)
- Parent Case (parental_case__v)
Added the User Access Group Assignment (user_access_group_assignment__v) object
Added the following fields to the User Access Group Assignment (user_access_group_assignment__v) object:
- Name (name__v)
- Access Group (access_group__v)
- User (user__v)
- Role (role__v)
- Localization (localization__v)
- User Blinded (user_blinded__v) with the following picklist values:
  - No Unblinded Access (no_unblinded_access__v)
  - Unblinded Access (unblinded_access__v)
- User Blinded (user_blinded__v) with the following picklist values:
  - No PII Access (pii_access__v)
  - PII Access (no_pii_access__v)
Added the User Access Group Assignment (user_access_group_assignment_lifecycle__v) object lifecycle
Added the Case Access Group Assignment (case_access_group_assignment__v) object
Added the following fields to the Case Access Group Assignment (case_version__v) object:
- Name (name__v)
- Access Group (access_group__v)
- Sponsor (sponsor__v)
- Report Type (report_type__v)
- Country (country__v)
- Origin (origin__v)
- Intake Type (intake_type__v)
- Study Type (study_type__v)
- Study (study__v)
Added the Case Access Group Assignment (case_access_group_assignment_lifecycle__v) object lifecycle
Added the following fields to the Case (user_access_group_assignment__v) object:
- Access Group (access_group__v)
- Access Group (child_access_group__v)
Added the Access Group (access_group__v) field to the following objects:
- Inbox Item (inbox_item__v)
- Case Number (case_number__v)
- Transmission (transmission__v)
Added the Access Group (access_group__v) field to all child and grandchild records of the following objects:
- Case (case_version__v)
- Localized Case (localized_case__v)
Added the following groups:
- General Access (general_access_group__v)
- All Access (all_access_group__v)
Added the Case Access Group (access_group__v) document field to the Case (case__v) document type
Added the following application roles:
- Unblinded Editor (unblinded_editor__v)
- Unblinded Viewer (unblinded_viewer__v)
- Unblinded Assigned To (unblinded_assigned_to__v)
- PII Editor (pii_editor__v)
- PII Viewer (pii_viewer__v)
- PII Assigned To (pii_assigned_to__v)

The following changes were made to support the Smart MedDRA Coding feature:

Added the MedDRA Coding (meddra_coding__v) connection type
Added the MedDRA Coding Settings (meddra_coding_settings__v) object
Added the Veeva MedDRA Coding Settings (child_veeva_meddra_coding_settings__v) child record to the MedDRA Coding Settings (meddra_coding_settings__v) object type
Added the Veeva MedDRA Coding Connection (veeva_meddra_coding_connection__v) field to the MedDRA Coding Settings (meddra_coding_settings__v) object type
Added the following fields to the Dictionary (dictionary__v) object:
- Enable Smart MedDRA Coding Predictions (enable_smart_meddra_coding_predictions__v)
- Smart MedDRA Coding Field Exclusions (smart_meddra_coding_field_exclusions__v)
- Enable Smart Auto-Coding (enable_smart_auto_coding__v)

The following changes were made to support the Local Intake Auto-Translation Framework feature:

Added the Intake Translation Complete State (complete_state_intake__v) field with the following picklist values:
- New (new_state__v)
- Active (active_state__v)
- Inactive (inactive_state__v)
- Verification (verification_state__v)
- Translation Verification (translation_verification_state__v)
Added the Complete State (complete_state_intake__v) field to the Translation Settings (translation_settings__v) object. This field is not required.
Updated the Localized Case Translation Settings (localized_case_translation_settings__v) object type to make the Complete State (complete_state_intake__v) field required
Added the Inbox Item Translation Settings (inbox_item_translation_settings__v) object type with the Complete State (complete_state_intake__v) field required
Added the following states to the Inbox Item (inbox_item_lifecycle__v) object lifecycle:
- Translation Requested (translation_requested_state__v)
- Translation Error (translation_error_state__v)
- Translation Verification (translation_verification_state__v)
Added the Inbox Item Translation (inbox_item_translation__v) picklist value to the Safety Automation Task Type (safety_automation_task_type__v) field
Added the Inbox Item Translation (inbox_item_translation__v) child object
Added the Translate Inbox Item (translate_inbox_item__v) action to the Inbox Item (inbox_item__v) object

The following changes were made to support the PMDA Multi-Submission with Localized Case feature:

Added the Local Reporting Details (local_reporting_details__v) object with the following fields:
- Case (case__v)
- Completeness (completeness__v)
- Destination Case ID (destination_case_id__v)
- Immediate Report Type (immediate_report_type__v)
- Localized Case (localized_case__v)
- Name (name__v)
- Organization (organization__v)
- PMDA Reporting Category (pmda_reporting_category__v)
- Primary Case Product (primary_case_product__v)
- Primary Case Product Registration (primary_case_product_registration__v)
- Report UID (report_uid__v)
Added the Local Reporting Details/Product Join (local_reporting_details_product_join__v) object with the following fields:
- Case (case__v)
- Case Product (case_product__v)
- Case Product Registration (case_product_registration__v)
- Drug Role (drug_role__v)
- Localized Case (localized_case__v)
- Name (name__v)
- Organization (organization__v)
- Rank (rank__v)
- Registration Category (registration_category_v)
Deprecated the following fields on the Case Product Registration (case_product_registration__v) object:
- Completeness (completeness__v)
- Immediate Report Type (immediate_report_type__v)
- PMDA Reporting Category (pmda_reporting_category__v)
- Report Overview (report_overview__v)
- Registration Type (registration_type__v)
Added the following fields to the Case Product Registration (case_product_registration__v) object:
- Registration Category (registration_category_v)
- Drug Role (drug_role__v)
- Registration Type (registration_type__v) (changed from picklist to lookup)
Deprecated the following fields on the Localized Case Comment (localized_case_comment__v) object:
- Case Product (case_product__v)
- Case Product Registration (case_product_registration__v)
Added the Local Reporting Details (local_reporting_details__v) field to the Localized Case Comment (localized_case_comment__v) object
Added the Report Overview (report_overview__v) value to the Comments Label (comments_label__v) picklist on the Localized Case Comment (localized_case_comment__v) object
Added the Local Reporting Details (local_reporting_details__v) field to the Transmission (transmission__v) object
Added the Special Report Classification (special_report_classification__v) picklist with the following values:
- Safety Measure Report (safety_measure_report__v)
- Research Report (research_report__v)
Added the Special Report Classification (special_report_classification__v) picklist to the following objects:
- Inbox Item (inbox_item__v)
- Case (case_version__v)
Added the Special Adverse Event (special_adverse_event__v) picklist with the following values:
- Infection (infection__v)
- Non-reportable Event (nonreportable_event__v)
Added the Special Adverse Event (special_adverse_event__v) picklist to the following objects:
- Localized Case (localized_case__v)
- Localized Case Adverse Event (localized_case_adverse_event__v)

The following changes were made to support the Partner AS2 Gateway Connections feature:

Added the Connection Allowed List (connection_allowed_list__v) object with the following fields:
- Name (name__v)
- Connection (connection__v)
- IP (ip_domain__v)
- Description (description__v)
Added the AS2 (as2__v) connection type with the following fields:
- AS2 Additional ACK Stages (as2_additional_ack_stages__v) with the following picklist values:
  - HTTP Handshake (http_handshake__v)
  - PRE-ACK (pre_ack__v)
- AS2 Compress Before Sign (as2_compress_before_sign__v)
- AS2 MDN Setting (as2_mdn_setting__v) with the following picklist values:
  - Sync (sync__v)
  - Async (async__v)
- AS2 Partner URL (as2_partner_url__v)
- AS2 Vault Certificate Expiry (as2_vault_certificate_expiry__v)
- AS2 Partner ID (as2_partner_id__v)
- AS2 Encryption (as2_encryption__v) with the following picklist values:
  - Triple DES (3DES) (3des__v)
  - AES_256_GCM (aes_256_gcm__v)
  - AES_256_CBC (as2_256_cbc__v)
- AS2 Signature (as2_signature__v) with the following picklist values:
  - SHA-1 (sha1__v)
  - SHA-256 (sha256__v)
- AS2 Vault Gateway State (as2_vault_gateway_state__v) with the following picklist values:
  - Unregistered (unregistered__v)
  - Registered (registered__v)
  - Registered - Out of Sync (registered_out_of_sync__v)
- AS2 Vault ID (as2_vault_id__v)
- AS2 Vault URL (as2_vault_url__v)
- AS2 Partner Certificate Expiry (as2_partner_certificate_expiry__v)

The following changes were made to support the Simplified Case Intake for Studies feature:

Added the Blinded Name (study_product_placeholder__v) field to the Study Product (study_product__v) object
Added the Study Product (study_product__v) field to the Inbox Item (inbox_item__v) object for manual Study Case Inbox Items

The following changes were made to support the Pregnancy Case Intake feature:

Added the Pregnancy Case (pregnancy_case__v) field to the Inbox Item (inbox_item__v) object with the following picklist value:
- Pregnancy Case (pregnancy_case__v)

Data Model Updates - SafetyDocs

The following changes were made to support the Literature Process Management feature:

Added the Literature Review (literature_review__v) object with the following fields:
- Name (name__v)
- Review Period Start (review_period_start__v)
- Review Period End (review_period_end__v)
- Product Family (product_family__v)
- Literature Review Type (literature_review_type__v) with the following picklist values:
  - Periodic (periodic__v)
  - Ad-Hoc (ad_hoc__v)
  - Signal Detection (signal_detection__v)
- Review Type (review_type__v)
- Description (description__v)
Added the Literature Review (literature_review_lifecycle__v) object lifecycle
Added the Literature Search Term (literature_search_term__v) object with the following fields:
- Name (name__v)
- Literature Review (literature_review__v)
- Search Database (search_database__v)
- Search Term (search_term__v)
Added the Literature Search Term (literature_search_term_lifecycle__v) object lifecycle
Added the Literature Database (literature_database__v) object
Added the Literature Database (literature_database_lifecycle__v) object lifecycle
Added the Literature Article (literature_article__v) object with the following fields:
- Name (name__v)
- Literature Review (literature_review__v)
- DOI (doi__v)
- Abstract (abstract__v)
- Abbreviated Title of Journal (abbreviated_title_of_journal__v)
- Date of Publication (date_of_publication__v)
- Title of Article (title_of_article__v)
- Vancouver Citation (vancouver_citation__v)
- ICSR Review Outcome (icsr_review_outcome__v)
- Investigation Review Outcome (investigation_review_outcome__v)
- Article Review Notes (article_review_notes__v)
- Search Term (search_term__v)
- Language (language__v)
- Number of Identified Cases (number_of_identified_cases__v)
Added the Literature Article (literature_article_lifecycle__v) object lifecycle
Added the Literature Document (literature_document_lifecycle__v) document lifecycle
Added the Literature (literature__v) document type with the following subtypes:
- Full-Text (full_text_literature__v)
- Summary (summary_literature__v)
- Review Information (review_information_literature__v)
Added the following fields to the Literature (literature__v) document type:
- Literature Review (literature_review__v)
- Literature Article (literature_article__v)
Added the Literature (literature_safetydocs__v) parent tab with the following tabs:
- Literature Reviews (literature_reviews_safetydocs__v)
- Literature Articles (literature_articles_safetydocs__v)

The following changes were made to support the PVA Document and Obligation Management feature:

Added the PVA Relationship (pva_relationship__v) object with the following fields:
- Partner (partner__v)
- Description (description__v)
Added the PVA Relationship (pva_relationship_lifecycle__v) object lifecycle
Added the PV Agreement (pv_agreement__v) object with the following fields:
- Name (name__v)
- Agreement Title (description__v)
- Relationship (relationship__v)
- Agreement Effective Date (agreement_effective_date__v)
- Agreement End Date (agreement_end_date__v)
- Agreement Notes (agreement_notes__v)
- PVA Scope (pva_scope__v)
- Agreement Owner (agreement_owner__v)
Added the PV Agreement (pv_agreement_lifecycle__v) object lifecycle
Added the PVA Product (pva_product__v) object with the following fields:
- Name (name__v)
- PV Agreement (pv_agreement__v)
- Product (product__v)
Added the PVA Study (pva_study__v) object with the following fields:
- Name (name__v)
- PV Agreement (pv_agreement__v)
- Study (study__v)
Added the PVA Country (pva_country__v) object with the following fields:
- Name (name__v)
- PV Agreement (pv_agreement__v)
- Country (country__v)
Added the PVA Contact (pva_contact__v) object with the following fields:
- Name (name__v)
- PV Agreement (pv_agreement__v)
- Vault User (vault_user__v)
- Person (person__v)
- Contract Party (contract_party__v) with the following picklist values:
  - Sponsor (sponsor__v)
  - Partner (partner__v)
- Communication Method (communication_method__v) with the following picklist values:
  - Email (email__v)
  - Manual (manual__v)
  - Vault Task (vault_task__v)
- Added the PVA Contact (pva_contact_lifecycle__v) object lifecycle
Added the PVA Obligation (pva_obligation__v) object with the following fields:
- Name (name__v)
- PV Agreement (pv_agreement__v)
- Partner Contact (partner_contact__v)
- Sponsor Contact (sponsor_contact__v)
- Obligation Category (obligation_category__v)
- Clause Title (clause_title__v) with the following picklist values:
  - Case Processing (case_processing__v)
  - ICSR Reporting (icsr_reporting__v)
  - Periodic Reporting (periodic_reporting__v)
  - PSMF Management (psmf_management__v)
  - Literature (literature__v)
  - Signal Management (signal_management__v)
  - Risk Management (risk_management__v)
- Contract Wording (contract_wording__v)
- Task Instructions (task_instructions__v)
Added the PVA Obligation (pva_obligation_lifecycle__v) object lifecycle
Added the PVA Activity (pva_activity__v) object with the following fields:
- Name (name__v)
- PV Agreement (pv_agreement__v)
- Activity Comments (activity_comments__v)
- Due Date (due_date__v)
- Completion Date (completion_date__v)
- PVA Obligation (pva_obligation__v)
- Obligation Title (obligation_title__v)
- Sponsor Responsible User (sponsor_responsible_user__v)
- Partner Responsible Contact (partner_responsible_contact__v)
- Delivery Method (delivery_method__v)
- Task Instructions (task_instructions__v)
Added the PVA Activity (pva_activity_lifecycle__v) object lifecycle
Added the PVA Reconciliation (pva_reconciliation__v) object with the following fields:
- Name (name__v)
- PV Agreement (pv_agreement__v)
- Obligation (pva_reconciliation__v)
- Obligation Name (obligation_name__v)
- Activity (activity__v)
- PVA Obligation (pva_obligation__v)
- Evaluation (evaluation__v) with the following picklist values:
  - Complete on Schedule (complete_on_schedule__v)
  - Complete Late (complete_late__v)
  - Partially Complete (partially_complete__v)
  - Incomplete (incomplete__v)
  - Cancelled (cancelled__v)
- Reason (reason__v)
Added the Pharmacovigilance Agreements (pharmacovigilance_agreements__v) document type with the following subtypes:
- Master Agreement (master_agreement__v)
- Agreement Documentation (agreement_documentation__v) with the following classifications:
  - PVA Core (pva_core__v)
  - PVA Module (pva_module__v)
  - PVA Appendix (pva_appendix__v)
  - PVA Summary (pva_summary__v)
- Agreement Activities (agreement_activities__v) with the following classifications:
  - PVA Distribution (pva_distribution__v)
  - PVA Correspondence (pva_correspondence__v)
- Added the Agreement Scope (agreement_scope__v) field to the Pharmacovigilance Agreements (pharmacovigilance_agreements__v) document type
- Added the PVA Activity (pva_activity__v) field to the Agreement Activities (agreement_activities__v) document subtype
- Added the PVA Reconciliation (pva_reconciliation__v) field to the Agreement Reconciliation (agreement_reconciliation__v) document subtype
- Added the PVA (safetydocs_pva__v) parent tab with the following tabs:
  - Relationships (safetydocs_relationships__v)
  - PV Agreements (safetydocs_pv_agreements__v)
  - Open PVA Actions (safetydocs_open_pva_actions__v)