23R2 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 23R2.

The following change was made to Clinical Operations Vaults to support the Clinical Operations to CDMS Connection: Support for Screening Subjects Outside of CDMS feature:

  • Added the new RTSM ID (rtsm_id__v) field on the Subject object

The following changes were made to Clinical Operations Vaults to support the Fee Schedules for Study Organizations feature:

  • Added the new Primary Organization (primary_organization__v) field to the Fee Schedule object
  • Added the new Primary Payee (primary_payee__v) field to the Fee Schedule object

The following changes were made to Clinical Operations Vaults to support the Prediction Metrics for Metadata Extraction feature:

  • Added the following new fields to the Prediction Metrics object:
    • Field Extracted (field_extracted__sys)
    • Incorrect Predictions Above Threshold (incorrect_predictions_above_threshold__sys)
    • Trained Model Type (trained_model_type__sys)
    • Partial Predictions Above Threshold (partial_predictions_above_threshold__sys)
  • Added Layout Rules to the Prediction Metrics page layout
  • Updated the Auto-classification Success Rate (autoclassification_success_rate__sys) field to the new Success Rate (sucess_rate__sys) field

The following change was made to Clinical Operations Vaults to support the Redacted Document Field feature:

  • Added the Redacted (redacted__v) document field

The following changes were made to Clinical Operations Vaults to support the Clinical CRM: Automated Clinical Activities feature:

  • Added the new Monitoring Visit Method (monitoring_visit_method__v) picklist
  • Added the following fields to the Activity (crm_activity__v) object:
    • Monitoring Event (monitoring_event__v)
    • Study Communication (study_communication__v)
  • Added the following fields to the Monitoring Event (monitoring_event__v) object:
    • Monitoring Visit Method (monitoring_visit_method__v)
    • Activity Update Required (activity_update_required__v)
  • Added the following field to the Study Communication Log (study_communication_log__v) object:
    • Activity Update Required (activity_update_required__v)

The following changes were made to Clinical Operations Vaults to support the Clinical Operations to CDMS Connection: Single-Click Navigation to EDC Casebooks feature:

  • Added new Casebook URL (casebook_url__v) field on the Subject, Visit, Monitored Subject, and Monitored Visit objects

The following changes were made to Clinical Operations Vaults to support the Subject History feature:

  • Added the new Subject Transfer Record (subject_transfer_record__v) object with the following fields:
    • Transfer ID
    • Transferred Subject
    • Transferred Date
    • Transfer Reason
    • Subject Status at Transfer
    • Old Study
    • Old Country
    • Old Site
    • New Study
    • New Country
    • New Site

The following changes were made to Clinical Operations Vaults to support the Subject Visit Method feature:

  • Added the new Visit Method (visit_method__v) picklist to the Subject Visit, Monitored Subject Visit, Fee Template, and Fee objects with the following values:
    • On Site Visit (on_site_visit__v)
    • Virtual Visit (virtual_visit__v)
    • At Home Visit (at_home_visit__v)
    • Alternate Facility Visit (alternate_facility_visit__v)
    • Telephone Interview (telephone_interview__v)

The following changes were made to Clinical Operations Vaults to support the Custom Email Senders for Feasibility Surveys feature:

  • Added the new Survey Sender Type (survey_sender_type__v) picklist to the Study Person object
  • Added the following new fields to the Site Survey Invitation (site_checklist_pal__v) object:
    • Sender Address (sender_address__v)
    • Survey Email Sender (survey_email_sender__v)

The following changes were made to Clinical Operations Vaults to support the Clinical EDL Template Overrides features:

  • Added the new Country Override (country_override__v) field to the EDL Template (edl_template__v) object.

The following changes were made to Clinical Operations Vaults to support the Study Person Role Constraints feature:

  • Added the new Study Team Role Constraint (study_team_role_constraint__v) object
  • Added the new Study Team Role (team_role__v) field on the Study Person object
  • Added the new Allowed Person Role (allowed_person_type__v) field to the Study Team Role (team_role__v) object that utilizes the existing Person Type (system_person__v) picklist

The following changes were made to Clinical Operations Vaults to support the TMF Transfer: Match on Country Code feature:

  • Added the following fields to the Country (country__v) object:
    • CDX ID (cdx_id__v)