20R1 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 20R1.

Made the following changes to support the Submissions to eTMF Connection feature:

  • Added the Site Country (site_country__v) field on the Site (clinical_site__v) object
  • Added the Inbound Transfer Document State Type to document lifecycles
  • Added the Clinical to RIM Connection Document Type Group

Made the following changes to support the Vault EDC/CTMS Connection with Spark feature:

  • Added Connect to Vault CDMS (connect_to_vault_cdms__v) field on Study/Study Country/Site objects
  • Added Site Timezone (site_timezone__v) field on Site object
  • Added Site Name (site_name__v) lookup field on Site object
  • Added Integration Lifecycle (integration_lifecycle__v) with Active (active_state__v) and Inactive (inactive_state__v) lifecycle states
  • Added “Inactivate” User Action on Active Integration lifecycle state
  • Added “Activate” User Action on Inactive Integration lifecycle state
  • Added Refresh Inbound Data workflow (refresh_inbound_data__v) on Integration lifecycle
  • Added “Refresh Inbound Data” User Action on Active Integration lifecycle state
  • Added “Reprocess Request” Action available to be added to User Exception Message object

Added the following components to support Yuzu: Japanese Clinical Trial Notification Generation:

  • New objects:
    • Clinical Trial Notification / 治験届 (ctn__v)
    • CTN Attached Document / 届出書添付資料 (ctn_attached_document__v)
    • CTN Remarks / 備考 (ctn_remarks__v)
    • Clinical Registry Vocabulary (clinical_registry_vocabulary__v)
    • CTN Site IP / 治験施設治験薬情報 (ctn_site_ip__v)
    • CTN Data / 治験届関連情報 (ctn_data__v)
    • CTN Data Change Log (ctn_data_change_log__v)
    • CTN / CTN Data Change Log (ctn_ctn_data_change_log__v)
  • New fields on Person object:
    • CTN Name / 治験届出用氏名 (ctn_name__v)
    • CTN Person for Japan (ctn_flag__v)
    • CTN Related Information / 治験届関連情報 (ctn_data__v)
    • Currently Used in CTN (ctn_used__v)
  • New fields on Organization object:
    • CTN Organization for Japan (ctn_flag__v)
    • CTN Org Name / 治験届出用組織名称 (ctn_org_name__v)
    • CTN Related Information / 治験届関連情報 (ctn_data__v)
    • Currently Used in CTN (ctn_used__v)
  • New fields on Product object:
    • _CTN Product for Japa_n (ctn_flag__v)
    • CTN Related Information / 治験届関連情報 (ctn_data__v)
  • New fields on Study Site (site__v) object
    • CTN Related Information / 治験届関連情報 (ctn_data__v)
  • New fields on Study Person (study_person__clin) object:
    • CTN Related Information / 治験届関連情報 (ctn_data__v)
  • New fields on Study Organization (study_organization__v) object:
    • CTN Related Information / 治験届関連情報 (ctn_data__v)
  • New roles:
    • Application Roles: Applicant Representative / 治験届出担当者, Trial Coordinating Doctor / 治験調整医師
    • Study Team Roles: Applicant Representative / 治験届出担当者, Trial Coordinating Doctor / 治験調整医師
    • Study Organization Roles: Foreign Manufacturer / 外国製造業者, Manufacturer or Importer / 製造所又は営業所, Trial Applicant / 治験届出者

Made the following object field changes to support Multi-Status Fees:

  • Fields on Fee (fee__v) and Fee Template (fee_template__v) objects converted to multi-value picklist fields:
    • Site Fee Status (site_fee_status__v)
    • Procedure Status (procedure_status__v)
    • Visit Status (event_status__v)

Made the following changes to support Agreement Wizard:

  • Added the Description (description__v) field on the Rule Set object
  • System manages field value (read-only) setting is now editable in the Name (name__v) field for the following objects:
    • Visit Definition (visit_def__v)
    • Site Fee Definition (site_fee_def__v)
    • Fee Template (fee_template__v)
    • Fee (fee__v)

We added the following components to support Streamlined Reuse for Product/Person/Org Documents:

  • Document Type Groups:
    • Person Profile
    • Organization Profile
    • Product Profile

We added the following components to support Fee Schedule Date Effectivity:

  • Procedure Date (procedure_date__v) field on the Procedure (procedure__v) object

Made the following changes to improve functionality:

  • Updated Application Owner role give to include Edit permission on major and minor versions