23R1 Vault SafetyDocs Data Model Changes

Note Beginning with 23R3 content and for all subsequent releases, Vault Release Notes is the official site for Vault Safety release notes.

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 SafetyDocs data model. These data model updates are automatically included in all SafetyDocs Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see About the Release.

Data Model Updates

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)