22R1 Data Model Changes: Clinical Operations

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 22R1.

Added the following items to support Site Connect Enhancements:

New document section: Site Information (site_information__v)
New document fields:
- Sent to Site(s) (sent_to_sites__v)
- Initial Sent to Site Date (initial_sent_to_sites_date__v)
- Last Sent to Site Date (last_sent_to_sites_date__v)
- Received from Site Date (received_from_site_date__v)
New field on Distribution Task: Originating User (originating_user__v)
New message template: Received from SiteVault (received_from_sitevault__v)

The following changes were made to improve configurability of Clinical Operations Vaults:

System managed field value (read-only) setting is now editable in the Name (name__v) field for the Employment Relationship (person_employment_relationship__clin) object
Maximum value setting is now editable for the following fields on these objects:
- Clinical User Task (clinical_user_task__clin)
  - Days Open (days_open__clin)
  - Days Implementing (days_implementing__clin)
  - Days Investigating (days_investigating__clin)
- Quality Issue (quality_issue__v)
  - Verdict Reason (verdict_reason__v)
  - QC Issue Comments (qc_issue_comments__v)
- Study Site (site__v)
  - Days to Greenlight (days_to_greenlight__v)
  - Days, Decision to Qualify (days_decision_to_qualify__clin)
  - Days, Identification to Fully Qualified (days_identification_to_fully_qualified__clin)
  - Days, Identification to Rejection (days_identification_to_rejection__clin)
  - Days, Identification to Selection (days_identification_to_selection__clin)
  - Days, Site to Complete Survey (days_site_to_complete_survey__clin)

Added the following items to support Monitoring Schedule Planning:

Monitoring Schedule Template (monitoring_schedule_template_v) object
Monitoring Schedule Template Items (monitoring_schedule_template_items__v) object
Monitoring Schedule (monitoring_schedule__v) object
Monitoring Schedule Items (monitoring_schedule_items__v) object
Monitoring Schedule Parameter (monitoring_schedule_parameter__v) picklist

Added the following items to support Site Payment Holdbacks:

Add Holdback Percentage (default_holdback_percentage__v) field on the Fee Schedule (fee_schedule__v) and Fee Schedule Template (fee_schedule_template__v) objects
Add Include Holdback (Y/N) (include_holdback__v) and Holdback Percentage (holdback_percentage__v) fields on the Fee (fee__v), Fee Template (fee_template__v), and Payee Override (payee_override__v) objects for Site Fee, Visit Fee, and Procedure Fee types
Add Holdback (Y/N) holdback__v field to the Payable Item (payable_item__v) object for Site Fee, Visit Fee, and Procedure Fee types

Added the following items to support Site Overhead Calculation:

Add Overhead Percentage (default_overhead_percentage__v) field to Fee Schedule Template (fee_schedule__v) and Fee Schedule Template (fee_schedule_template__v) objects
Add Include Overhead, Overhead Percentage, and Base Amount (fee_base_amount__v) fields on the Fee (fee__v) and Fee Template (fee_template__v) objects for Site Fee, Visit Fee, and Procedure Fee types

Added the following fields to the Fee (fee__v) and Fee Template (fee_template__v) objects to support Subject Payment Tracking Rules:

Subject Status (_subject_status__v) field as a multi-select picklist
SDV Complete (Y/N) (sdv_complete__v) field
SDV Complete When SDV Required (Y/N) (sdv_complete_when_sdv_required__v) field

Added the following components to support the Clinical Email Ingestion: Relevant Communications feature:

Study Communication Log (study_communication_log__v) document field
Created via Correspondence Email (created_via_correspondence_email__v) tag
Study Communication Log (study_communication_log__ctms) items:
- Ingested Email (ingested_email__v) object type
- Relevant Document (relevant_document__v) field
- Email Message ID (email_message_id__v) field
Study Item:
- Email Subaddress (email_subaddress__v) field

Added a new message template to support the Summary Notification of Returned Documents feature:

Received from SiteVault (received_from_sitevault__v)

Added the following components to support the RBSM: Critical Data & Processes feature:

New Objects:
- Critical Process (critical_process__v)
- Study Critical Data (study_critical_data__v)
- Study Critical Process (study_critical_process__v)
- Study Risk Critical Data (study_risk_critical_data__v)
- Study Risk Critical Process (study_risk_critical_process__v)
New Lifecycles:
- Study Critical Data Lifecycle (study_critical_data_lifecycle__v)
- Study Critical Process Lifecycle (study_critical_process_lifecycle__v)
New Picklist:
- Critical Data Category (critical_data_category__v)

Added the following components to support the CDMS/ClinOps: Support for Multiple CDMS Vaults feature:

New CDMS Connection (cdms_connection__v) field on the Study (study__v) object.
New report type Connection with Study (connection_with_study__v)
New report Connection Study Report (connection_study_report__v)

Added the Signatory Role (signatory_role_v) field to the following objects to support Form Response Data Shared With Sponsor. See the MyVeeva for Patients What’s New for more information about the feature functionality.

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

In addition to the above changes to support new features, we also added the following:

New Study Cohort (study_cohort__v) object
New Study Cohort Lifecycle (study_cohort_lifecycle__v)
New field on Subject (subject__clin):
- Cohort (cohort__v)
Maximum value setting is now editable for the following field:
- Person (person__sys) > Suffix (suffix__v)