20R2 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 20R2.

We have made the following changes in support of Archive TMF:

  • The Archive study lifecycle state is an active state instead of archived.
  • In previous releases, archiving a study switched the record to Inactive status. In the current release, records in the Archived lifecycle state have Active status.
  • Setting a study to Archived cascades the archived status to the country and site. In previous releases, the status cascaded to site only.

We have added the following components to support EDL Automation for Study Personnel, Organizations, & Products:

  • Added the following values to the EDL Matching Field (edl_matching_field__v) picklist:
    • Person (person__v)
    • Organization (organization__v)
    • Product (product__v)
  • Added the following object types to the Template EDL (edl_template__v) object:
    • Person (person__v)
    • Organization (organization__v)
    • Product (product__v)
  • Added the following object types to the Template Expected Document (edl_item_template__v) object:
    • Person (person__v)
    • Organization (organization__v)
    • Product (product__v)
  • Added the following fields to the Template Expected Document (edl_item_template__v) object:
    • Application Role and Study Team Role (team_role__v)
    • Study Organization Role (study_organization_role__v)
    • Study Product Role (study_product_role__v)
  • Added the following object types to the Template EDL (edl_item__v):
    • Person (person__v)
    • Organization (organization__v)
    • Product (product__v)
  • Added the following fields to the Template EDL (edl_item__v):
    • Person (person__v)
    • Study Person (study_person__v)
    • Organization (organization__v)
    • Study Organization (study_organization__v)
    • Product (product__v)
    • Study Product (study_product__v)
  • Added the Selected Study Organization Role Lifecycle (selected_organization_role_lifecycle__v) lifecycle to the Selected Study Organization Role (selected_organization_role__v) object.

We have added the following components to support Milestone Evolution and Standard Metrics:

  • New objects:
    • Global Milestone Type (global_milestone_type__v)
    • Global Milestone Offset (global_milestone_offset__v)
    • Global Milestone Mapping (global_milestone_mapping__v)
    • Cycle Time (cycle_time__v)
  • Added Point in Time (point_in_time__v) object type to the following objects:
    • Milestone (milestone__v)
    • Template Milestone (milestone_template__v)
  • New fields on Milestone Dependency (milestone_dependency__v) object:
    • Previous Template Milestone (previous_milestone_type__v)
    • Next Template Milestone (next_milestone_type__v)
    • Baseline Finish-to-Finish (Days) (baseline_finishtofinish_days__v)
    • Actual Finish-to-Finish (Days) (actual_finishtofinish_days__v)
    • Planned Finish-to-Finish (Days) (planned_finishtofinish_days__v)
  • New fields on the Template Milestone Dependency (milestone_dependency_template__v) object:
    • Previous Template Milestone (previous_milestone_type__v)
    • Next Template Milestone (next_milestone_type__v)
  • Added Block Automatic Updates (block_automatic_updates__v) field to the Milestone (milestone__v) object.

We have added the following components to support Investigator Initiated Research:

  • Investigator Initiated Study (investigator_initiated_study__v) object
  • Investigator Initiated Study Lifecycle (investigator_initiated_study_lifecycle__v) lifecycle
  • Investigator Initiated Study Documents (investigator_initiated_Study_documents__v) document type
  • Investigator Initiated Study (investigator_initiated_study__v) field
  • Added the following picklists:
    • Publication Type (publication_type__v)
    • Type of Support Requested (type_of_support_requested__v)

We have added the following objects to support Clinical Network: Rule Set Override:

  • Clinical Network Rule Override (cdx_rule_override__v)
  • Override Agreement (cdx_override_agreement__v)

We have added the following components to support RBSM: Clinical Risk Assessments:

  • New objects:
    • Risk (risk__v)
    • Risk Category (risk_category__v)
    • Risk Template (risk_template__v)
    • Risk Assessment Template (risk_assessment_template__v)
    • Study Risk (study_risk__v)
    • Study Risk Category (study_risk_category__v)
    • Study Risk Assessment (study_risk_assessment__v)
  • New picklists:
    • Impact (impact__v)
    • Probability (probability__v)
    • Detectability (detectability__v)
    • Response Type (response_type__v)
  • New lifecycles:
    • Risk Assessment Template Lifecycle (risk_assessment_template_lifecycle__v)
    • Risk Assessment Template Lifecycle (study_risk_assessment_lifecycle__v)
    • Study Risk Category Lifecycle (study_risk_category_lifecycle__v)
    • Study Risk Lifecycle (study_risk_lifecycle__v)

We have made the following changes to support Yuzu: Japanese Clinical Trial Notification Generation:

  • Added the CTN IP Name / 治験薬名称 (ctn_ip_name__v) object
  • Removed the IP Name / 治験薬名称 (ip_name__v)field
  • Added the Clinical Trial Notification / 治験届 (ctn__v) shared document field
  • Added the Original CTN (original_ctn__v) field on the Clinical Trial Notification / 治験届 (ctn__v) object
  • Added CTN Data Change Logs / 変更履歴 section to the Clinical Trial Notification / 治験届 Detail Page Layout (clinical_trial_notification_detail__c) on the Clinical Trial Notification / 治験届 (ctn__v) object
  • Added the Hide Change Log (hide_change_log__c) layout rule to the Clinical Trial Notification / 治験届 Detail Page Layout on the Clinical Trial Notification / 治験届 (ctn__v) object
  • The Number of Amendment / 変更回数 (amendment_count__v) field has been removed from the following object types on the Clinical Trial Notification / 治験届 (ctn__v) object:
    • Trial Completion Notification / 治験終了届 (trial_completion_notification__v)
    • Trial Termination Notification / 治験中止届 (trial_termination_notification__v)
    • Protocol Notification / 治験計画届 (protocol_notification__v)
  • Added the External ID (external_id__v) field to the CTN Data / 治験届関連情報 (ctn_data__v) object and all object types
  • Added the CTN Data Lifecycle (ctn_data_lifecycle__v) lifecycle to the CTN Data / 治験届 関連情報 (ctn_data__v) object
  • Added the following page layouts to the CTN Data / 治験届関連情報 (ctn_data__v) object:
    • Organization Detail Page Layout (ctn_data_org_detail_layout__c)
    • Person Detail Page Layout (ctn_data_person_detail_layout__c)
    • Product Detail Page Layout (ctn_data_product_detail_layout__c)
    • Study Organization Detail Page Layout (ctn_data_study_org_detail_layout__c)
    • Study Person Detail Page Layout (ctn_data_study_person_layout__c)
    • Study Site Detail Page Layout (ctn_data_site_layout__c)
  • Added the following fields to the CTN Data (ctn_data__v) object:
    • Study Organization Name (study_organization_name__v)
    • Study Organization Site (study_organization_site__v)
    • Study Person Name (study_person_name_v)
    • Study Person Role (study_person_role__v)
    • Study Person Site (study_person_site__v)
  • Added the following fields to the Study Person (study_person__v) object type for the CTN Data / 治験届関連情報 (ctn_data__v) object:
    • Study Person Name (study_person_name__v)
    • Study Person Role (study_person_role__v)
    • Study Person Site (study_person_site__v)
  • Added the following fields to the Study Organization (study_organization__v) object type for the CTN Data / 治験届関連情報 (ctn_data__v) object:
    • Study Organization Name (study_organization_name__v)
    • Study Organization Site (study_organization_site__v)
  • Added the CTN Data Change Log Lifecycle (ctn_data_change_log_lifecycle__v) lifecycle to the CTN Data Change Log (ctn_data_change_log__v) object
  • Added the CTN Site IP Lifecycle (ctn_site_ip_lifecycle__v) lifecycle to the CTN Site IP/ 治験施設治験薬情報 (ctn_site_ip__v) object

We have added the following Artifact (hierarchy__v) records to support Vault Clinical Docs Update:

  • Operational Procedure Manual
  • Expedited Safety Report
  • Pre-Study Visit Follow Up Letter
  • Pre-Study Visit Confirmation Letter
  • Site Initiation Visit Confirmation Letter
  • Site Initiation Visit Follow Up Letter
  • Interim Monitoring Visit Confirmation Letter
  • Interim Monitoring Visit Follow Up Letter
  • Close-Out Visit Confirmation Letter
  • Close-Out Visit Follow Up Letter
  • Remote Monitoring Visit Confirmation Letter
  • Remote Monitoring Visit Follow Up Letter

We have removed the following object types from the Study Organization (study_organization__v) object in support of Person & Organization Migration:

  • Study Organization (study_organization__v)
  • Study Country Organization (study_country_organization__v)
  • Study Site Organization (study_site_organization__v)

We have added the following lifecycles and assigned them to the corresponding objects unless a custom lifecycle is already assigned to that object:

  • Location Lifecycle (location_lifecycle__v) to the Location (location__v) object
  • Organization Lifecycle (organization_lifecycle__v) to the Organization (organization__v) object

We have added the Pending Decision (pending_decision_v) value to the EDL Requiredness (edl_item_requiredness__v) picklist.

We have added the following components to support Simple Transfer, which are only unlocked when the Enable CDX feature is enabled on the Application Settings page:

  • TMF Document (tmf_document__v) document type
  • Simple Transfer Rule Set (simple_transfer_ruleset__v) field on the Clinical Network Rule Set (cdx_rule_set__v) object
  • Object Creation State (object_creation_state__v) field on the Clinical Network Rule (cdx_rule__v) object
  • Simple Transfer Study (simple_transfer__v) field on the following objects:
    • Study (study__v)
    • Study Country (study_country__v)
    • Study Site (site__v)
  • Added the following lifecycles:
    • TMF Exchange Document Lifecycle (tmf_exchange_document_lifecycle__v)
    • CDX Agreement (cdx_agreement_lifecycle__v)
    • CDX Issue Lifecycle (cdx_issue_lifecycle__v)
  • Added the following objects:
    • Agreement (cdx_agreement__v)
    • Agreement Activity Item (cdx_agreement_activity_item__v)
    • Clinical Network Connection User (cdx_connection_user__v)
    • Clinical Network Issue (cdx_issue__v)
    • Clinical Network Rule (cdx_rule__v)
    • Clinical Network Rule Set (_cdx_rule_set__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)
    • Pending Scope Variable Value (cdx_pending_scope_variable_value__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 document fields:
    • Created by Clinical Network (created_by_clinical_network__v)
    • Level (level__v)
    • Source Artifact (source_artifact__v)
    • Source Create By (source_created_by__v)
    • Source Created Date (source_created_date__v)
    • Source Doc Type (source_doc_type__v)
    • Source Document Connection (source_document_connection__v)
    • Source Document Date (source_document_date__v)
    • Source Document Number (source_tmf_document_number__v)
    • Source Document Version (source_document_version__v)
    • Source Person (source_person__v)
    • Source Product (source_product__v)

We have added the following objects to support Rule Set Override:

  • Clinical Network Rule Override (cdx_rule_override__v)
  • Clinical Network Override Agreement (cdx_override_agreement__v)

We have added the following components to support Site Packages:

  • New objects:
    • Site Packages Definition (site_package_definition__v)
    • Site Package Document (site_package_document__v)
  • New fields on the Distribution Task (distribution_task__v) object:
    • Action (action__v)
    • CDX ID (cdx_id__v)
    • Complete (complete__v)
    • Completion Date (completion_date__v)
    • Cycle Time (Days) (cycle_time__v)
    • Delivery Method (delivery_method__v)
    • Document Type (doc_type_details__v)
    • Due Date (due_date__v)
    • Organization (organization__v)
    • Return Document Version (return_version__v)
    • Return Document Version (unbound) (return_version_unbound__v)
    • Source (source__v)
    • Source ID (source_id__v)