23R3 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 23R3.

23R2.2

The following change was made to Clinical Operations Vaults to support the Monitoring Schedule Extensibility feature:

  • Added the new Monitoring Visit Method (monitoring_visit_method__v) field to the Monitoring Schedule Item and Monitoring Schedule Template Item objects.

The following change was made to Clinical Operations Vaults to support the “TMF Bot Misclassified” Document Tag feature:

  • Added the new document tag TMF Bot Misclassified (misclassified_by_bot__sys)

The following changes were made to Clinical Operations Vaults to support the Clinical Global & Remote ID Document Fields feature:

  • Added the following document fields:
    • dt_global_id__v
    • dt_global_version_id__v
    • dt_remote_id__v
    • dt_remote_version_id__v
  • A job runs to set these fields automatically during migration. If the system updates a document’s fields via this job, it updates the Last Modified By field on the document as well. Documents that are updated are limited to those that were sent/received via Site Connect.

23R2.3

The following changes were made to support the Quality/ClinOps: Issue Management Connector feature:

  • Added the following fields on the Issue (pdv__ctms) object: 
    • Send to Quality (send_to_quality__v) 
    • Quality Record ID (quality_record_id__v) 
    • Quality Record Name (quality_record_name__v) 
    • Quality Record Link (quality_record_link__v) 

The following changes were made to support the Model Training Filters and Custom Model Automated Retraining feature:

  • Added the following fields on the Trained Model Type object:
    • Training Set Type (training_set_type__sys)
    • Auto-Refresh (auto-refresh__sys)
    • Document Criteria VQL (document_criteria_vql__sys)
    • Deployed Date (deployed_date__sys)
    • Withdrawal Date (withdrawal_date__sys)
    • Training Date (training_date__sys)

The following change was made to support the Relate Trip Report Template to Monitoring Event feature:

  • Added the new Trip Report Template (trip_report_template__v) field on the Monitoring Event (monitoring_event__v) object

The following changes were made to support the Red Flag Survey Questions feature:

  • Added the new Response Flag (response_flag__v) picklist to the following objects:
    • Available Answer Design
    • Site Survey
    • Study Site Available Answer
    • Study Site Response
    • Outreach Survey
    • Outreach Target Available Answer
    • Outreach Target Response

The following changes were made to support the CTMS Content Field Defaulting & Enhanced Monitoring Event Seeding feature:

  • Added two new Unblinded Monitoring Event object types:
    • Unblinded Interim Monitoring Visit
    • Unblinded Site Closeout Visit
  • Added the following fields on the Monitoring Event object:
    • Previous Blinded Monitoring Event (previous_blinded_monitoring_event__v)
    • Previous Unblinded Monitoring Event (previously_unblinded_monitoring_event__v)

The following new field rule has been added to the Clinical Operations to CDMS Connection to support the transfer of Visit Method in a future release.

  • Name: subject_visit_event_visit_method__v
  • Target Object: visit__v
  • Target Object Field: visit_method__v
  • Query Object: event__v
  • Query Field: visit_method__v

The following changes were made to support the planned move of the site experience of Site Connect out of SiteVault and into Clinical Operations Vaults:

  • Added the following field to the Study Person (study_person__clin) object:
    • Site Connect User (site_connect_user__v)