22R2 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 22R2.

Data Model Updates

Added the following fields to the Monitored Subject (monitored_subject__ctms) object to support the Vault Clinical Operations to CDMS Connection: Arms & Cohorts feature:

  • Cohort (cohort__v)
  • Arm (arm_v)

The following changes were made to support the Clinical CRM Connection feature:

  • Removed Requiredness on the Subject field on the Activity (crm_activity__v) object
  • Added the new standard external connection: CRM/Clinical Operations Connection (crm_clinops_connection__v)
  • Added the new Enter Connected App Details (connection_details__v) action on Connection Authorization object (connection_authorization__sys)

The following items were added to support the CTMS Oversight Metrics feature:

  • New Picklist items Metrics Only (metrics_only__v) and Transferred Metrics (transferred_metrics_v) to the Metric Calculation Picklist (metric_calculation__v)
  • New field Subject Metrics Only Level (subject_metrics_only_level__v) on the Study object

Added the new Content (blinding__v) field on the following objects to support the Standard Content Fields on CTMS Objects feature :

  • Monitoring Event (monitoring_event__ctms)
  • Clinical User Task (clinical_user_task__clin)
  • Monitored Informed Consent Form (monitored_informed_consent_form__ctms)
  • Monitored Metrics (monitored_metrics__ctms)
  • Monitored Subject (monitored_subject__ctms)
  • Monitored Subject Visit (monitored_subject_visit__v)
  • Monitoring Visit Participant (monitoring_visit_participant__ctms)
  • Trip Report Question Response (trip_report_question_response__ctms)
  • Trip Report Answer (trip_report_answer__ctms)
  • Review Comment (review_comment__v)
  • Site SAE Tracking (site_sae_tracking__ctms)
  • Subject Visit (visit__v)
  • Visit Definition (visit_def__v)

Added the following components to support the ePRO in Clinical Operations feature:

  • New record action (launch_epro__v) for the Study object
  • New field _ePRO Code (epro_code__v) on the Study object

Added the following components to support the Connected Studies for ePRO & eConsent feature:

  • New Connected Study Type (connected_study_type__v) field on Study (study__v)  object
  • New picklist Connected Study Type (connected_study_type__v) with the following values:
    • Document Exchange (document_exchange__v)
    • Safety Distribution (safety_distribution__v)
    • ePRO (epro__v)
    • eConsent (econsent__v)

Added new Unblinded Subject Visit Data (unblinded_subject_visit_data__v) object to support the Vault Clinical Operations to CDMS Connection: Restricted Data feature with the following fields:

  • Complete Visit Status (visit_status__v)
  • DMR Complete Date (dmr_date__v)
  • DMR Requiredness (dmr_mode__v) 
  • EDC ID (edc_id__v)
  • Parent Subject Visit (parent_visit__v)
  • SDV Complete Date (sdv_date__v )
  • SDV Complete? (rev_sdv__v)
  • SDV Requiredness (sdv_mode__v) 

Added the following items to support the TMF Bot: Document QC Step feature:

  • Document fields:
    • New picklist TMF Bot QC (tmf_bot_qc__v) with the following values:
      • “QC in Progress…”
      • “No Suggestions”
      • “Suggestions Found”
    • New Yes/No field TMF Bot QC Viewed (tmf_bot_qc_viewed)
  • New field Suggestions (suggestions__sys) on the Predictions (predictions__v) object

Added the following object fields to support the Email Checklist to Study Person feature:

  • New Survey Respondent (survey_respondent_v) field on Study Person (study_person__v)
  • New Study Person (study_person_v) field on Site Survey Invitation (site_checklist_pal__sys)
  • New Survey Respondent (survey_respondent_v) field on Site Survey (site_checklist_sys)
  • New Survey Respondent Type (survey_respondent_type_v) field to the Outreach Target Checklist object (outreach_target_checklist_sys)

Added the following items to support the Clinical Application Management feature

  • Milestone Package Document (milestone_package_document__v) object with the following fields: 
    • Comments (comments__v)
    • Department (etmf_department__v)
    • Document (document__v)
    • Document (unbound) (document_unbound__v)
    • Export Name (export_name__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle State (state__v)
    • Milestone (milestone_v)
    • Name (name_v)
    • Review Date (review_date__v)
    • Status (status__v)
    • Study (study__v)
    • Study Country (study_country__v)
    • Study Site (site__v)
  • Request for Information (request_for_information__v) object with the following fields:
    • Close Date (close_date__v)
    • Department (etmf_department__v)
    • Identifier (identifier__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle Stage (stage__sys)
    • Lifecycle State (state__v)
    • Received Date (received_date__v)
    • Request Details (request_details__v)
    • Response (response__v)
    • Response Due Date (response_due_date__v)
    • Response Ready Date (response_ready_date__v)
    • Status (status__v)
    • Submit Date (submit_date__v)
    • System Name (name__v)
  • RFI Relevant Milestone (rfi_relevant_milestone__v) object with the following fields:
    • Milestone (milestone__v)
    • Name (name__v)
    • Request for Information (request_for_information__v)
    • Status (status__v)
    • Request Details (request_details__v)
    • Response (response__v)
    • Response Due Date (response_due_date__v)
    • Response Ready Date (response_ready_date__v)
  • RFI Included Document (rfi_included_document__v) object with the following fields:
    • Milestone Package Document (milestone_package_document__v)
    • Name (name__v)
    • Request for Information (request_for_information__v)
    • Status (status__v)
  • New lifecycles:
    • Request for Information Lifecycle (request_for_information_lifecycle__v)
    • Milestone Package Document Lifecycle (milestone_package_document_lifecycle__v)
  • New Seed Package Document (seed_package_documents__v) action on the Milestone (milestone__v) object

Added the following fields to support the Reference Sites feature

  • New Yes/No field Reference Site (reference_site__v) to the Site (site__v) object
  • New Yes/No field Has Reference Site? (has_reference_site__v) field to the Study Country (study_country__v) object

Added the following fields to support Site Connect Enhancements:

  • Email Address (email_address__v) on the on the Distribution Task Recipient (distribution_task_recipient__v) object
  • Is Sending (is_sending__v) on the Safety Distribution (safety_distribution__v) object

Added following fields to the Milestone (milestone__v) object to support future functionality:

  • Actual Submission Date (actual_submission_date__v)
  • Initial Planned Submission Date (initial_planned_submission_date__v)
  • Planned Submission Date (planned_submission_date__v)