Pre-Release Date: October 31, 2022 | Release Date: November 18, 2022 & December 2, 2022

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 Clinical Operations data model. These data model updates are automatically included in all Clinical Operations Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 22R3.

Data Model Updates

Added the new system-managed Oversight menu tab (oversight__v) to support the Oversight Tab feature.

Added a new Study Management Model (study_management_model) picklist to the Study (study__v) object with the following values:

  • Insourced (insourced__v)
  • Outsourced (outsourced__v)
  • Hybrid (hybrid__v)

Added the new Sponsor Template for Site (sponsor_template_for_site__v) shared document field to support the eConsent Sponsor Templates feature. For eConsent customers, Vault is automatically adds this field to any document type leveraging the Veeva eConsent document field. For non-eConsent customers, Vault does not add this field to any document types.

The following changes were made to Clinical Operations Vaults to support the Site Connect to Inbox feature:

  • Added new fields to the Artifact (hierarchy__v) object:
    • Transferred via Site Connect (transferred_via_site_connect__c)
    • Create as Unclassified (create_as_unclassified__c)
  • Added a new user action to the Artifact (hierarchy__v) object:
    • Toggle Create as Unclassified

Created new Vault Clinical Docs artifacts records to support the New Exchangeable Document Types feature:

  • SAE Report Form Template (vdc__318)
  • Pregnancy Report Form Template (vdc__313)
  • Special Events of Interest Form (vdc__314)
  • Participant Adverse Event Log (vdc__315)
  • Protocol Deviations (vdc__316)
  • Investigator Brochure Summary of Changes (vdc__317)

The following changes were made to Clinical Operations Vaults to support the Automated Payment Adjustments feature:

  • Added new fields to the Payable Item (payable_item__v) object:
    • Source Payable Item (source_payable_item__v)
    • Adjustment Reason (adjustment_reason__v)
    • Adjustment Details (adjustment_details__v)
    • Adjustment Payable Item (adjustment_payable_item__v)
    • Related Holdback Item (related_holdback_payable_item__v)
  • Added new Payments Adjusted Reason (payments_adjusted_reason__v) picklist
  • Added the new lifecycle state type Payment Adjusted to the Payable Item Lifecycle
  • Added new lifecycle states to the Payable Item Lifecycle:
    • Paid (paid_state__v)
    • Payment Adjusted (payment_adjusted_state__v)
  • Added a new system action Generates Payable Items

The following changes were made to Clinical Operations Vaults to support the Yuzu Change Log Enhancements feature:

  • Added new fields to the CTN (ctn__v) object:
    • Generate CTN Change Log / 治験届作成変更履歴 (generate_ctn_change_log__v)
    • CTN Document Generation Datetime / 治験届作成日時 (ctn_document_generation_datetime__v)

The following changes were made to Clinical Operations Vaults to support the Safety to Clinical Operations Vault Connection feature:

  • Added new fields to the Study (study__v) object:
    • Masking (masking__v)
    • Study Start Date (study_start_date__v)
    • Study Name (study_name__v)

The following change was made to Clinical Operations Vaults to support the Clinical Operations to Medical CRM: Activity Deletion Support feature:

  • Added the new standard local connection Clinical Operations Local Connection (clinops_local_connection__v)

The following change was made to Clinical Operations Vaults to support the Clinical Operations to Medical CRM: Standard Field Mappings feature:

  • Added new field rules on the CRM/Clinical Operations Connection (crm_clinops_connection__v) for standard fields included in transfer

The following changes were made to Clinical Operations Vaults to support the TMF Bot: Prediction Metrics feature:

  • Added a new Prediction Metrics (prediction_metric__c) object: 
    • Auto-classification success rate (autoclassification_success_rate__c)
    • Correct Predictions (correct_predictions__c)
    • Correct Predictions above Threshold (correct_predictions_above_threshold__c)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Global ID (global_id__sys)
    • Link (link__sys)
    • Metric Subtype (metric_subtype__c)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Model Performance ID (name__v)
    • Number of Documents (number_of_documents__c)
    • Document Subtype (document_subtype__c)
    • Document Type (document_type__c)
    • Metric Type (performance_metric__type)
    • Predictions Above Threshold (predictions_above_threshold__c)
    • Status (status__v)
    • Trained Model (trained_model__c)
  • Updated the Trained Model page layout with a new Prediction Metrics section containing the following columns:
    • Name
    • Created Type
    • Metric Type
    • Metric Subtype
    • Number of Documents
    • Auto-classification Success Rate
    • Correct Predictions
    • Correct Predictions above Threshold
    • Predictions above Threshold

The following changes were made to Clinical Operations Vaults to support the Email to Vault: Create Documents from Attachments feature:

  • Added a new document tag Created from Ingested Email
  • Created two new email notifications for successful creation of attached document from email and failure to create attached document from email:
    • Document Attachments Failure (mail_attachments_doc_creation_failure__v)
    • Document Attachments Created (mail_attachments_doc_creation_success__v)

The following changes were made to Clinical Operations Vaults to support the Increment # Expected from Matched Documents feature:

  • Added a new Update # Expected Based on # Actual (updated_expected_based_on_actual__c) record action on EDL items
  • Added a new notification template Set # Expected to Actual Action Complete (set_expected_to_actual_action_complete__c)

The following changes were made to Clinical Operations Vaults to support the ClinOps to CDMS Connection: Study Pause feature:

  • Added a new CDMS Connectivity (cdms_connectivity__v) object with the following fields:
    • Study (study__v)
    • Connected Status (connected_status__v)
    • Integration Name (integration_name__v)
    • Last Successful Run Time (last_successful_run_time__v)
  • Added a new record action for the Study object: Pause/Resume Connected Study (pause_resume_connected_study__v)