21R2 Data Model Changes: SiteVault

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 21R2.

Added the following components to support the Extensible SiteVault Permissions feature:

  • Added a standard Users (users__v) tab
  • Added the User Access Assignment (user_access_assignment__v) and Access Level(access_type__v) objects
  • Added Application Role(application_role__v) and Access Type(access_type__v) standard object records
  • Updated the following lifecycles with new standard component roles:
    • Deleted Document Details Lifecycle(deleted_document_details_lifecycle__v)
    • Draft to Fully Executed(draft_to_fully_executed__v)
    • Organization Lifecycle(organization_lifecycle__v)
    • Organization Profile(orgnization_profile__v)
    • Participant Lifecycle(subject_lifecycle__v)
    • Participant Visit Lifecycle(participant_visit_lifecycle__v)
    • Patient Lifecycle(patient_lifecycle__v)
    • Person Lifecycle(person_lifecycle__v)
    • Person Profile(person_profile__v)
    • Product Lifecycle(product_lifecycle__v)
    • Research Organization(org_lifecycle__v)
    • Site Lifecycle(research_site_lifecycle)
    • Study Lifecycle(study_lifecycle__v)
    • Study Organization Lifecycle(study_organization_lifecycle__v)
    • Study Person Lifecycle(study_person_lifecycle__v)
    • Study Product Lifecycle(study_product_lifecycle__v)
    • Vault Membership(vault_membership_lifecycle__sys)

Added the following components to support the Digital Delegation Log feature:

  • Added the following objects:
    • SiteVault Standard Responsibility (sitevault_standard_responsibility__v)
    • Responsibility (responsibility__v)
    • Person Responsibility (person_responsibility__v)
    • PI Approval (piapproval__v)
    • Study Staff Delegation (study_staff_delegation__v)
    • Study Responsibility (study_responsibility__v)
  • Added the Start Date, End Date, Localized Start Date, and Localized End Date fields to the Study Assignment (study_person__v) object
  • Added the Responsibilities (responsibilities__v) subtab under the Profiles tab that maps to the Responsibility(responsiblity__v) object
  • Added the following permission sets:
    • Objects: Create & Edit DDL
    • Objects: Read DDL
  • Updated the Objects: Create & Edit Object Data permission set

Added the following components to support the SiteVault Settings Framework feature:

  • Feature Flag (feature_flag__v) and Feature Flag Visibility (feature_flag_visibility__v) objects
  • A custom Settings section is available for the Study (study__v) object page layout

Added the following objects to support the Veeva eConsent: Form Responses feature:

  • Form Answer (form_answer__v)
  • Form Question (form_question__v)
  • Form Response (form_response__v)

Added the Patient Declined (patient_declined__v) value to the Veeva eConsent Status (veeva_econsent_status__v) picklist to support the Veeva eConsent: Patient Declines Consent feature.

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

  • Added the following standard fields to the Study (study__v) object:
    • Full Protocol Title (scientific_title__v)
    • Public Protocol Title (brief_title__v)
  • Updated the Language(translated_language__v) field on the Patient (patient__v) object to use a picklist instead of an object reference field