19R2 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 data model. These data model updates are automatically included in all Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 19R2.

We have added the following components to support Subject Recruitment Planning:

  • Metric Calculation (metric_calculation__v) field to the Study object.
  • Recruitment Planning Level (recruitment_planning_level__v) field to the _Stud__y_ object.
  • Recruitment Planning Metrics (recruitment_planning_metrics__v) field to the Study object.
  • Planned Roll Up (planned_roll_up__v) field to the Metrics object.
  • Metrics Over Time (metrics_over_time__v) object with fields:
    • Related Metric (related_metric__v)
    • Metric Type (metric_type__v)
    • Start Date (start_date__v)
    • End Date (end_date__v)
    • Study (study__v)
    • Study Country (study_country__v)
    • Site (site__v)
    • Forecast (forecast__v)
    • Baseline (baseline__v)
    • Planned (planned__v)
    • Actual (actual__v)
  • First Subject Screened (first_subject_screened__v), Last Subject Screened (last_subject_screened__v), First Subject Randomized (first_subject_randomized__v), and Last Subject Randomized (last_subject_randomized__v) standard picklist values on the Milestone Type (milestone_type__v) picklist.
  • Recruitment Planning Metrics (recruitment_planning_metrics__v) picklist with values:
    • Screened (screened__v)
    • Randomized (randomized__v)
    • Enrolled (enrolled__v)
  • Recruitment Planning Level (recruitment_planning_level__v) picklist with values:
    • Study (study__v)
    • Country (country__v)
    • Site (site__v)
  • Metric Calculation (metric_calculation__v) picklist with values:
    • Status Snapshot (status_snapshot__v)
    • Date-Based (date_based__v)

We added the following components to support Seeding Follow-Up Items on Monitoring Events:

  • Monitored Open Follow Up Items (monitored_open_follow_up_items__v) object with fields:
    • Monitoring Event (monitoring_event__v)
    • Monitoring Follow-Up Item (monitoring_follow_up_item__v)
  • Monitored Closed Follow Up Items (monitored_closed_follow_up_items__v) object with fields:
    • Monitoring Event (monitoring_event__v)
    • Monitoring Follow-Up Item (monitoring_follow_up_item__v)
  • Previous Monitoring Event (previous_monitoring_event__v) field to the Monitoring Event object

We have added the following objects to support Veeva Clinical Network:

  • CDX Agreement (cdx_agreement__v) with new fields:
    • Connection (connection__v)
    • Rule Set (rule_set__v)
  • CDX Configuration Mapping (cdx_configuration_mapping__v) with fields:
    • CDX Configuration Mapping Type (object_type__v)
    • Connection (connection__v)
    • Incoming Name (incoming_name__v)
    • Local Name (local_name__v)
    • Local Picklist Name (local_picklist_name__v)
    • Object Name Mapping Rule (object_name_mapping_rule__v)
  • CDX Data Mapping (cdx_data_mapping__v) with fields:
    • CDX Data Mapping Type (object_type__v)
    • Connection (connection__v)
    • Incoming ID (incoming_id__v)
    • Local Component Name (local_component_name__v)
    • Local ID (local_id__v)
  • CDX Document Lifecycle State Mapping (cdx_document_lifecycle_state_mapping__v) with fields:
    • Owning Vault State Type (owning_vault_state_type__v)
    • Receiving Vault State Type (receiving_vault_state_type__v)
    • Rule (rule__v)
    • Update Only (update_only__v)
  • CDX Field Default (cdx_field_default__v) with fields:
    • CDX Field Default Type (object_type__v)
    • Connection (connection__v)
    • Field Name (field_name__v)
    • Object Name (object_name__v)
  • CDX Issue (cdx_issue__v) with fields:
    • Agreement (agreement__v)
    • Assignee Vault Document Type (assignee_vault_document_type__v)
    • Assignee Vault Object Name (assignee_vault_object_name__v)
    • CDX Issue Type (object_type__v)
    • Error Message (error_message__v)
    • Initiating Vault Document Type (initiating_vault_document_type__v )
    • Initiating Vault Object Name (initiating_vault_object_name__v)
    • Pending CDX ID (pending_cdx_id__v)
    • Pending Document Name (pending_document_name__v)
    • Pending Document Version Number (pending_document_version_number__v)
    • Pending Record ID (pending_record_id__v)
    • Pending Record Name (pending_record_name__v)
    • Rule (rule__v)
    • Translated Record ID (translated_record_id__v)
  • CDX Rule (cdx_rule__v) with fields:
    • Assignee Vault Doc Type (assignee_vault_doc_type__v)
    • CDX Rule Type (object_type__v)
    • Initiating Vault Doc Type (initiating_vault_doc_type__v)
    • Rendition Behavior (rendition_behavior__v)
    • Rule Set (rule_set__v)
    • Where Clause (where_clause__v)
  • CDX Rule Set (cdx_rule_set__v) with fields:
    • Assignee App Family (assignee_app_family__v)
    • Assignee Role Label (assignee_role_label__v)
    • Initiator App Family (initiator_app_family__v)
    • Initiator Role Label (initiator_role_label__v)
    • Rule Set Version (rule_set_version__v)
  • CDX Scope Variable (cdx_scope_variable__v) with fields:
    • CDX Scope Variable Type (object_type__v )
    • Object Name (object_name__v)
    • Rule Set (rule_set__v)
    • Variable Name (variable_name__v)
  • CDX Scope Variable Field Mapping (cdx_scope_variable_field_mapping__v) with fields:
    • Field Name (field_name__v)
    • Rule (rule__v)
    • Scope Variable (scope_variable__v)
  • CDX Scope Variable Value (cdx_scope_variable_value__v) with fields:
    • Agreement (agreement__v)
    • CDX Scope Variable Value Type (object_type__v)
    • Scope Variable (scope_variable__v)
    • Variable Value (variable_value__v)