20R3 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 20R3.

We have added the following components to support the Auto-Populate Milestones from Subject Data feature:

  • No New Subjects (no_new_subjects__v) field to the Study Site (site__v) object
  • Added the following values to the Milestone Type (milestone_type__v) picklist:
    • Last Subject Treated (last_subject_treated__v)
    • First Subject Treated (first_subject_treated__v)
    • First Subject Out (first_subject_out__v)

We have added the following components to support the TMF Index Management: Core Data Model feature:

  • Objects:
    • TMF Index Version (tmf_index_version__v)
    • TMF Index Item (tmf_index_item__v)
    • TMF Index Item Requirement (tmf_index_item_requirement__v)
    • TMF Index Item Change Request (tmf_index_change_request__v)
    • Index Change Impact Assessment (index_change_impact_assessment__v)
    • Assessed Index Change Request (assessed_index_change_request__v)
  • Lifecycles:
    • TMF Index Version Lifecycle (tmf_index_lifecycle__v)
    • TMF Index Item Lifecycle (tmf_index_item_lifecycle__v)
    • TMF Index Item Requirement Lifecycle (tmf_index_item_requirement_lifecycle__v)
    • TMF Index Change Request (tmf_index_change_request_lifecycle__v)
    • Index Change Impact Assessment (index_change_impact_assessment_lifecycle__v)
  • Added the following fields to the Expected Documents (edl_item__v) and Template EDL (edl_template__v) objects:
    • TMF Index Item (tmf_index_item__v)
    • TMF Index Item Requirement (tmf_index_item_requirement__v)
    • TMF Index Version (tmf_index_version__v)

We have added the standard Milestone Category (milestone_category__v) field to support the Editable Startup Home Page: Labels & MS Types feature.

We have added the following fields to the Quality Issue (quality_issue__v) object to support the Securing Quality Issues feature:

  • Study (study__v)
  • Content (blinding__v)

We have added the following components to support the Site Connect: Safety Distribution feature:

  • Objects:
    • Safety Distribution (safety_distribution__v)
    • Safety Distribution Default (safety_distribution_default__v)
    • Safety Distribution Support (safety_distribution_support__v)
  • Lifecycles:
    • Safety Distribution Default (safety_dist_default_lifecycle__v)
    • Safety Distribution Lifecycle (safety_distribution_liefcycle__v)
    • Safety Distribution Support (safety_dist_support_lifecycle__v)
  • Added the following navigation tabs:
    • Safety Distribution (safety_distribution__v)
    • Safety Distributions (safety_distributions__v)
    • Safety Defaults (safety_defaults__v)
  • Added the Country (country__v) field on the Study Site (site__v) object
  • Added the CDX ID (cdx__id__v) field to the following objects:
    • Study Product (study_product__v)
    • Study Product Role (study_product_role__v)
  • Added the following fields to the Distribution Task (distribution_task__v) object:
    • Action Status (action_status__v)
    • Connection (connection__v)
  • Added the Safety Distribution (safety_distribution__v) shared document field
  • Added an Acknowledge Receipt (acknowledge_receipt__v) Distribution Task Action record to all Vaults with Vault Site Connect enabled

We have added the following Vault Clinical Docs Artifact records to support the Site Connect: Completed CRFs feature:

  • Completed CRF
  • End of Study Media

We have added the following Vault Clinical Docs Artifact records to support the Site Connect: Payment Letters & Site Invoices feature:

  • Payment Letter
  • Site Invoice

We have added the following components to support the Study Expenses feature:

  • Added the following components to the Fee (fee__v) object:
    • Additional Fee (additional_fee__v) object type
    • Level (level__v) picklist
  • Added the following components to the Payable Item (payable_item__v) object:
    • Additional Fee (additional_fee__v) object type
    • Level (level__v) picklist
    • Item Description (item_description__v) field
  • Added the Level (level__v) picklist to the Study Organization (study_organization__v) object

We have added the following components to support the Trip Report Questions Enhancements feature:

  • Question Comment Required (question_comment_required__v) object
  • Instructions (instructions__v) field on the Question (question__clin) object
  • Added the Highlight Required (highlight_required__v) field to the Monitoring Event (monitoring_event__ctms) object
  • Added the following fields to the Trip Report Question Response (trip_report_question_response__ctms) object:
    • Response Text (long_response_text__v)
    • Comment (long_comment__v)

We have added the following components to support the Doc Type Model Support feature:

  • Added the Clinical Document Type Detail (clinical_document_type_detail__v) object and corresponding records
  • Added the Display in Tmf Viewer (display_in_tmf_viewer__v) field to the Model (model__v) object
  • Added the Document Type Hierarchy (document_type_hierarchy) Model (model_v) record

We have added the following components to support the TMF Viewer Level Support & Additional Enhancements feature:

  • New standard Field Level (field_level__v) field on Base Documents

We have added the following components to support the Data Model Changes to Support Simple Transfer and Site Connect feature:

  • New Objects:
    • Agreement (cdx_agreement__v)
    • Agreement Activity Item (cdx_agreement_activity_item__v)
    • Clinical Network Connection User (cdx_connection_user__v)
    • Configuration Mapping (cdx_configuration_mapping__v)
    • Data Mapping (cdx_data_mapping__v)
    • Document Lifecycle State Mapping (cdx_data_mapping__v)
    • Document Type Sub-Rule (cdx_document_type_subrule__v)
    • Field Default (cdx_field_default__v)
    • Clinical Network Issue (cdx_issue__v)
    • Pending Scope Variable Value (cdx_pending_scope_variable_value__v)
    • Clinical Network Rule (cdx_rule__v)
    • Clinical Network Rule Set (cdx_rule_set__v)
    • Scope Variable (cdx_scope_variable__v)
    • Scope Variable Field Mapping (cdx_scope_variable_field_mapping__v)
    • Scope Variable Value (cdx_scope_variable_value__v)
  • New Lifecycles:
    • CDX Agreement (cdx_agreement_lifecycle__v)
    • CDX Issue Lifecycle (cdx_issue_lifecycle__v)
  • New Document Fields:
    • Source Artifact (source_artifact__v)
    • Blinding (blinding__v)
    • Level (level__v)
    • Study Country (study_country__v)
    • Study Site (study_site__v)
    • Source Doc Type (source_doc_type__v)
    • Source Created Date (source_created_date__v)
    • Source Document Date (source_document_date__v)
    • Source Document Number (source_tmf_document_number__v)
    • Source Product (source_product__v)
    • Source Person (source_person__v)
    • Source Created By (source_created_by__v)
    • Source Document Version (source_document_version__v)
    • Source Document Connection (source_document_connection__v)
    • Title (title__v)
    • Created by Clinical Network (created_by_clinical_network__v)
  • Application Roles:
    • Document Contributor (document_contributor__v)
    • Document Viewer (document_viewer__v)
    • External Inspector (external_inspector__v)
    • Certified Copy Reviewer (paper_certification_reviewer__v)
    • QA /Inspection Readiness (_qa_inspection_readiness__v)
    • QC Reviewer (qc_reviewer__v )
    • eTMF Admin/Manager (etmf_admin_manager__v)
  • Added the TMF Exchange Document Lifecycle (tmf_exchange_document_lifecycle__v) lifecycle
  • Added the Simple Transfer Rule Set (simple_transfer_ruleset__v) field to the Clinical Network Rule Set object