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 SiteVault data model. These data model updates are automatically included in all SiteVault Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 22R1.

  • Added the User Account Login Method (user_account_login_method__v) and User Account Federated ID (user_account_federated_id__v) fields to the User (person__sys) object to support the User Administration with Multiple Security Policies feature
  • Added the Middle Name (middle_name__v) field to the Signatory (signatory__v) object to support the Veeva eConsent: Additional Signatory Enhancements feature
  • Added the Patient Update Request (patient_update_request__v) and Signatory Update Request (signatory_update_request__v) objects to support the Veeva eConsent: Contact Information Update Request feature
  • Added the following document fields to support the Sponsor/CRO Information on Documents feature:
    • Last Sent to Sponsor/CRO Date (last_sent_to_sponsor_date__v)
    • Received from Sponsor/CRO Date (received_from_sponsor_date__v)
    • Sent to Sponsor/CRO (sent_to_sponsor__v)
  • To support the Digital Delegation: Email Notifications feature, updated all of the Digital Delegation feature-related custom (__c) components to standard (__v) components
  • To support the Standard Participant Workflow feature, updated all of the custom  (__c) state change Participant Lifecycle (subject_lifecycle__v) workflows to standard (__v) workflows. In addition, added the Change State to First Visit Scheduled (change_state_to_first_visit_scheduled__v) workflow.
  • To support the Veeva eConsent: In-person eConsent feature, added the MyVeeva ID (myveeva_id__v) field to the Subject (subject__v) object.

In addition to the changes supporting new features, we added or updated the following components:

  • Added Criteria VQL on the following fields:
    • Organization (organization__v) field on the Study Organization (study_organization__v) object
    • Patient (patient__v) field on the Participant (subject__v) object
    • Product (product__v) field on the Study Product (study_product__v) object
  • Updated the User (person__sys) object to User Profile (person__sys)
  • Updated the User (sys) (user__sys) object to User Account (user__sys)
  • Updated the Users (sys) (users__c) subtab to User Accounts (user_sys__v)
  • Added the Originating User (originating_user__v) field to the Distribution Task (distribution_task__v) object
  • Updated the Research Organization (research_organization__v) and Site (research_site__v) fields on the User Access Assignment (user_access_assignment__v) object to lookup fields
  • If not already granted, all permission sets for the Study Team security profile are updated to grant Read permissions to the User (sys) (user__sys) object
  • If not already enabled, the Use Action Security to Control Sharing Settings option is enabled for the Participant (subject__v) object
  • If not already granted, view access to the Patients (patient__c) tab is added to the eConsent permission set
  • Added the following permission sets to the Research Organization Administrator (org_admin__c) and Regulatory (regulatory__c) security profiles:
    • Budgets & Contracts (budgets_contracts__c)
    • Objects: Create & Edit Profile Data (objects_create_edit_profile_data__c)
    • Patients & Recruiting (patients_recruiting__c)
    • If not already updated, the Veeva Admin (veeva_admin__c) tab is updated to the Admin (site_vault_admin__v) tab with the following subtabs:
      • Research Organizations (org__v)
      • Sites (research_site__v)
      • Users (sys) (user_sys__v)
      • User Role Setup (user_role_setup__v)
      • Access Assignments (access_type__v)
  • The default security on the Global ID (global_id__sys) document field on the Base Document (base_document__v) is updated to read-only
  • If present, updated the name of the following document atomic security components to remove the number 1:
    • draft_to_current_draft1__c 
    • draft_to_current_received_from_spons1__c
    • draft_to_final_draft1__c
    • draft_to_final_received_from_spons1__c
    • organization_profile_draft1__c
    • person_profile_draft1__c
    • organization_profile_received_from_spon1__c