21R1 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 21R1.

Added the following components to support the Document Delete With Audit Trail Access feature:

• Added the following objects:
  • Deletion Event Audit Trail (deleted_document_details__v)
  • Permanently Delete All Document Versions (delete_document_form__v)
  • Related Site/Study (deleted_document_record__v)
• Added the Deletion Reason (deletion_reason__v) picklist that is used in the Deletion Event Audit Trail and Permanently Delete All Document Versions objects.
• Added the Deleted Document Records (study_deleted_document_records__v) subtab to the Reporting (reporting__c) tab.
• Added the Objects: Read Deleted Document Records (deleted_document_records_view__v) permission set.

Added the following components to support the Research Organization Defaulting for Documents & Objects feature:

• Added the Research Organization (org__v) field to the following components:
  • Base Document (base_document__v) (and updated existing documents with a value)
  • Most SiteVault objects (and updated existing records with a value)
• Added the Display Name (short_name__v) field to the Research Organization (org__v) object.
• Made the following updates to the Site (research_site__v) object:
  • Updated the length of the Display Name (short_name__v) field.
  • Updated the Research Organization (org__v) field to be required.

Added the following fields to the Distribution Task (distribution_task__v) object to support the SiteVault: Comments for Document Exchange feature:

• Comments (comments__v)
• Return Comments (return_comments__v)

Added the following fields to the Study (study__v) object to support the Connected Studies Icon feature:

• Active Agreement (active_agreement__v)
• Connected (connected__v)

Added the following components to support the SiteVault & MyVeeva for Patients: eConsent feature:

• Added the Approved ICF Version (approved_icf_version__v) document relationship type.
• Added the Controlled Template (controlled_template__v) document lifecycle with the following states:
  • Draft (draft__v)
  • In Review (in_review__v)
  • Final (final__v)
  • Superseded (superseded__v)
• Added the MyVeeva Account Status (myveeva_account_status__v) picklist to the Patient (patient__v) object.
• Added the Veeva eConsent (myveeva_econsent__v) standard document field.
• Added Veeva eConsent Status (veeva_econsent_status__v) picklist.
• Added the Veeva eForm (veeva_eform__v) document type.
• Added the Veeva eForm (myveeva_eform__v) rendition type.

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

• Added the following fields to the Site (research_site__v) object:
  • Country (country__v)
  • Language (language__v)
  • Timezone (timezone__v)
• Added the following standard document fields to the list of available configurable Field Dependencies:
  • Copy of Original? (scan_or_original__v)
  • End Date (source_end_date__v)
  • Has Redactions? (document_redacted__v)
  • Language (translated_language__v)
  • Monitoring Status (monitoring_status__v)
  • PD or AE Related? (pd_or_ae_related__v)
  • Start Date (source_start_date__v)
• Added a new field for two-letter country code to the Country (country__v) object.