21R1 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 21R1.

Added the following components to support the Comments for Document Exchange feature. These fields are only active in Vaults with Veeva Site Connect enabled:

  • Added the following fields to the Distribution Task (distribution_task__v) object:
    • Comments (comments__v)
    • Return Comments (return_comments__v)
  • Added the following field to the Site Package Document (site_package_document__v) object:
    • Default Comments (default_comments__v)

Added the following components to support the CDMS & Clinical Operations Vault Connection: Repeating Visits feature:

  • Added the Visit Name (visit_name__v) field to the following objects:
    • Monitored Subject Visit (monitored_subject_visit__v)
    • Subject Visit (visit__v)
    • Payable Item (payable_item__v)
  • Added the Visit Label (visit_label__v) field to the Procedures (procedure__v) object
  • Added the Repeating Visit (repeating_visit__v) field to the Visit Definition (visit_def__v) object

Added the following components to support the CDMS & Clinical Operations Vault Connection: Procedures feature:

  • Added the Procedures (procedures__v) integration to the CDMS/Clinical Operations Connection (cdms_clinops_connection__v) with the Procedures Transfer (procedure_transfer__v) integration point and the Procedure Integration Rule (procedure_integration_rule__v)
  • Added the following standard values to the Procedures Status (procedure_status__v) picklist:
    • Planned (planned__v)
    • Blank (blank__v)
    • In Progress (in_progress__v)
    • Submitted (submitted__v)
    • Did Not Occur (did_not_occur__v)

Added the following components to support the RBSM: Automated Risk Mitigation Actions feature:

  • New objects:
    • Risk Mitigation (risk_mitigation__v)
    • Assigned Risk Mitigation (assigned_risk_mitigation__v
    • Study Risk Mitigation (study_risk_mitigation__v)
  • New Picklists:
    • Mitigation Type (mitigation_type__v)
    • Mitigation Source (mitigation_source__v)
  • Added the Study Risk Mitigation Lifecycle (study_risk_mitigation_lifecycle__v) lifecycle
  • Added the following fields to the Issue (pdv__ctms) object:
    • Study Risk Assessment (study_risk_assessment__v)
    • Study Risk (study_risk__v)
    • Study Risk Mitigation (study_risk_mitigation__v)
  • Added the Country Selected Date (country_selected_date__v) field to the Study Country (study_country__v) object
  • Added the Risk Mitigation Action (risk_mitigation_action__v) object type to the Issue (pdv__ctms) object
  • Added the Risk Mitigation Action Detail Page Layout (risk_mitigation_action__v) page layout to the Issue (pdv__ctms) object
  • Added the Mitigation Action Task (mitigation_action_task__c) Object Message
  • Added the Complete Risk Mitigation (complete_risk_mitigation__v) workflow to the Issues (issues_lifecycle__ctms) lifecycle
  • Added the Assign Risk Action (assign_risk_mitigation__v) workflow user action to the Open state of the Issue (issue_lifecycle__ctms) lifecycle
  • Added the Risk Mitigation Library (risk_mitigation_library__v) tab

Added the following components to support the Rule Set-level Field Defaults feature:

  • Added the following object types to the Field Default (cdx_field_default__v) object:
    • Document Field Default (Rule Set) (doc_field_default_rule_set__v)
    • Object Field Default (Rule Set) (obj_field_default_rule_set__v)
  • Added the Rule Set (rule_set__v) field to the Field Default (cdx_field_default__v) object

Added the following components to support the** Issue Management Enhancements** feature:

  • Added the Observation (observation__v) object type to the Issue (pdv__ctms) object
  • Added the standard Monitored Issue (monitored_issue__v) object
  • Added the Resolved Date (resolved_date__v) field to all Issue (pdv__ctms) object types
  • Added custom entry action on the resolved state of the Issues lifecycle that sets Resolved Date (resolved_date__v) to today()

Added the following components to support the Safety Distribution Email Support feature (these changes are active only in Vaults with Veeva Site Connect enabled):

  • Added the Safety Distribution Recipient (safety_dist_recipient__v) field to the Team Role (team_role__v) object
  • Added the following fields to the Distribution Task (distribution_task__v) object:
    • Email (email_id__v)
    • Email Recipient (email_recipient__v)
    • Email Status (email_status__v)
    • Email Recipient Type (email_recip_type__v)
    • Email Detail (email_detail_-v)
    • Person (__v)
  • Added the Email (email__v) value to the Delivery Method (delivery_method__v) picklist on the Distribution Task (distribution_task__v) object
  • Added the Safety Distribution Recipient (safety_distribution_recipient__v) picklist field to the Study Team Role (team_role__v) object
  • The Recipient (recipient__v) field on the Distribution Task Recipient (distribution_task_recipient__v) object is no longer required
  • Added the Viewed (viewed__v) value to the Email Status (email_status__v) picklist
  • Added the Email (email__v) value to the Email Status (email_status__v) on the Distribution Task (distribution_task__v) object
  • Added the _Safety Distribution Email Notificatio_n (safety_distribution_email__v) Object Message

Made the following changes to support the USN Picker feature:

  • The USN (usn__v) field on the Organization (organization__v) object is now a Vault-controlled field and limited to valid values in the Global Directory
  • The Organization (name__v) field on the Organization (organization__v) object is now automatically populated based on the value in the USN (usn__v) field

Added the following components to support future functionality:

  • Added the following fields to the Distribution Task (distribution_task__v) object:
    • Comments (comments__v)
    • Return Comments (return_comments__v)
  • Added the Default Comments (default_comments__v) field to the Site Package Document (site_package_document__v) object

Added the following components to support the Site Connect Enhancements feature:

  • Added the Site Connect Rendition (site_connect_rendition1__c) Rendition Type to all Vaults with Vault Site Connect enabled

Added the following components to support the Site Connect: Additional Vault Clinical Docs Support feature:

  • Added the following Artifact (hierarchy__v) records:
    • Investigator Newsletter
    • Note to File
    • Other Site Staff Medical License
    • Subject Log
    • Visit Log

Added the following components to support the Yuzu: CTN Enhancements feature:

  • Added the Use Study Specific Info / 試験固有の情報を使用 (use_local_info__v) field to the CTN Data / 治験届関連情報(ctn_data__v) object for the following object types:
    • Study Site (study_site__v)
    • Study Organization (study_organization__v)
    • Study Person (study_person__v)
  • Added the Include in CTN / 届出書記載 (include_in_ctn__v) field to the CTN Remarks / 備考 (ctn_remarks__v) object
  • Added the CTN Remarks / 備考 (ctn_remarks__v) field to the CTN Data Change Log (ctn_data_change_log__v) object
  • Added the Study Site (site__v) field to Study Organization (study_organization__v) and Study Person (study_person_v) types of CTN Data / 治験届関連情報 (ctn_data__v) objects
  • Added the CTN IP Name / 治験薬名称 (ctn_ip_name__v) object
  • Converted the IP Name / 治験薬名称 (ip_name__v) field from Text to Object
  • Added the Original CTN (original_ctn__v) field to the Clinical Trial Notification / 治験届 (ctn__v) object
  • Added the following fields to the CTN Data / 治験届関連情報 (ctn_data__v) object:
    • External ID (External ID)
    • 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 lifecycles:
    • CTN Data Lifecycle (ctn_data_lifecycle__v)
    • CTN Data Change Log Lifecycle (ctn_data_change_log_lifecycle__v)
    • CTN Site IP Lifecycle (ctn_site_ip_lifecycle__v)
    • Added the Clinical Trial Notification / 治験届 (ctn__v) shared document field