19R3 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 19R3.

We have introduced the following components to support Person & Organization Migration:

  • Source Person (source_person__v) field to the User object. This field will be hidden from the User object’s page layout.

Additionally, the Person & Organization Migration feature will now be auto-on for all customers.

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

  • Arm (arm__v) field to the Metrics Over Time, Metrics, and Milestone objects.
  • Arm Based Metrics? (arm_based_metrics__v) field to the Study object.
  • Recruitment Planning Frequency (recruitment_planning_frequency__v) picklist field
  • Recruitment Planning Frequency (recruitment_planning_frequency__v) field to the Study object.
  • Screened Date (screened_date__v) field to the Monitored Subject object.
  • Screen Failed Date (screen_failed_date__v) field to the Monitored Subject object.
  • Enrolled Date (enrolled_date__v) field to the Monitored Subject object.
  • Randomized Date (randomized_date__v) field to the Monitored Subject object.
  • Withdrawn Date (withdrawn_date__v) field to the Monitored Subject object.
  • End of Treatment Date (end_of_treatment_date__v) to the Monitored Subject object.
  • End of Study Date (end_of_study_date__v_ field to the Monitored Subject object.

We have introduced the following components to support Standard Monitoring Event Approval Complete Date:

  • Approval Complete Date (approval_complete_date__v) field to the Monitoring Event object.
  • Standard entry action on the final state of the Monitoring Event lifecycle that sets Approval Complete Date to today().

We have introduced the following components to support Surfacing Monitoring Reviewer Comments Resolved By:

  • Resolved By (resolved_by__v) field to the Review Comment object

We have introduced the following components to support Vault Payments:

  • Payee Override (payee_override__v) object. This object is only available in vaults with Vault Payments enabled.
  • Maximum Count (max_count__v), Rate (rate__v), Override Payee (override_payee__v), and Rate Metric (rate_metric__v) fields to the Fee (fee__v) object.
  • Primary Payee (primary_payee__v) and Location (location__v) fields to the Study Organization (study_organization__v) object.

We have introduced the following components to support Multi-Product Studies:

  • New Study Product (study_product__v) object.
  • Study Product Role (study_product_role__v) object.

This release also introduces Enhanced Configurability to various components in Clinical Operations vaults. Enhanced Configurability introduces the ability for applications to determine which field attributes in a standard object’s configuration an Admin should be able to edit. Depending on your vault application’s data model, you may be able to edit additional settings, such as system-managed naming or if the field is required, or editing may be blocked on some of these attributes.

  • On the Study (study__v) object, edited attributes for the following fields:
    • Product (product__v)
    • Protocol Title (protocol_title__clin)
  • On the Template Task (template_task__v) object, edited attributes for the following fields:
    • Expected Turnaround Time (expected_turnaround_time__clin)
    • Priority (priority__clin)
    • Category (category__clin)
  • On the Clinical User Task object, edited attributes for the following fields:
    • Priority (priority__clin)
    • Category (category__clin)
  • On the Location (location__v) object, edited attributes for the following fields:
    • Address Line 1 (address_line_1__clin)
    • Address Line 2 (address_line_2__clin)
    • Address Line 3 (address_line_3__clin)
    • Postal / Zip Code (postal_zip_code__clin)
    • Town / City (town_city__clin)
  • On the Study Site (site__v) object, edited attributes for the following fields:
    • Active Agreement (active_agreement__v)
    • Principal Investigator (principal_investigator__v)
  • On the Milestone (milestone__v) object, edited attributes for the following fields:
    • Actual vs Planned Finish (actual_vs_planned_finish__clin)
    • Actual vs Planned Start (actual_vs_planned_start__clin)