24R3 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 24R3.

In support of the Clinical Operations Standard Checkbox Defaulting feature, Vault will automatically set the below standard checkbox fields to No (false) upon record creation. This behavior only applies when the field is not configured with a default value.

• CTN Combination Equipment (ctn_combination_equip__v) object: Include in CTN (include_in_ctn__v)
• CTN Combination Product (ctn_combination_product__v) object: Include in CTN (include_in_ctn__v)
• CTN CP / Organization (ctn_cp_organizations__v) object: Include in CTN (include_in_ctn__v)
• Clinical Registry Vocabulary Mapping (ctn_crv_mapping__v) object: Include in CTN (include_in_ctn__v)
• CTN Data (ctn_data__v) object:
  • CTN Internal IRB (ctn_internal_irb__v)
  • Include in CTN (include_in_ctn__v)
  • Use Study Specific Info (use_local_info__v)
• CTN Reference CTN (ctn_reference_ctn__v) object: Include in CTN (include_in_ctn__v)
• CTN Remarks (ctn_remarks__v) object: Include in CTN (include_in_ctn__v)
• Template EDL (edl_template__v) object: Country Override (country_override__v)
• Fee (fee__v) object: Site Advance (site_advance__v)
• Fee Template (fee_template__v) object: Site Advance (site_advance__v)
• Artifact (hierarchy__v) object:
  • Authenticate Document Links (authenticate_document_links__v)
  • Create as Unclassified (create_as_unclassified__v)
  • Transferred via Site Connect (transferred_via_site_connect__v)
• Organization (organization__v) object:
  • CTN Organization for Japan (ctn_flag__v)
  • Currently Used in CTN (ctn_used__v)
• Payable Item (payable_item__v) object: Site Advance (site_advance__v)
• Person (person__sys) object:
  • CTN Person for Japan (ctn_flag__v)
  • Currently Used in CTN (ctn_used__v)
• Product (product__v) object: CTN Product for Japan (ctn_flag__v)
• Safety Distribution (safety_distribution__v) object: Include in Gap Pack (include_in_gap_pack__v)
• Safety Distribution Default (safety_distribution_default__v) object: Include in Gap Pack (include_in_gap_pack__v)
• Study Site (site__v) object:
  • Auto-document exchange (autodocument_exchange__v)
  • Email Safety when Connected (email_safety_connected__v)
  • No New Subjects (no_new_subjects__v)
• Study Person (study_person__clin) object: Site Connect User (site_connect_user__v)
• TMF Index Item (tmf_index_item__v) object:
  • Retired (retired__v)
  • Track Document Date? (track_document_date__v)
  • Track Expiration Date? (track_expiration_date__v)
  • Tracking Organization? (organization__v)
  • Tracking Person? (person__v)
  • Tracking Product? (product__v)

The following changes were made to support the Auto-Manage Number Expected on EDL Items feature:

• Added the Auto-Manage # Expected (automanage_expected__v) field to the following objects:
  • Template Expected Document (edl_item_template__v) 
  • Expected Document (edl_item__v)

The following changes were made to support the Clinical Operations-EDC Connection: Protocol Deviations Link to CDMS feature: 

• Added the EDC Protocol Deviation Link (edc_pd_link__v) field to the Issue (pdv__ctms) object.

The following changes were made to support the Safety-Clinical Operations Connection: CRO Support feature:

• Added the Sponsor Organization (sponsor_organization__v) field to the Study (study__v) object.

The following changes were made to support the Automated Document Exchange feature:

• Added the following standard shared document fields:
  • Auto-Distribute Document Action (autodistribute_document_action__v)
  • Sponsor/CRO Comments (sponsorcro_comments__v)
• Added the Auto-Document Exchange (autodocument_exchange__v) field on the Study Site (site__v) object.
• Added the following new fields on the Expected Document (edl_item__v) object: 
  • Auto-Request from Site (autorequest_from_site__v)
  • Sponsor/CRO Comments (sponsorcro_comments__v)

The following changes were made to support the Authenticated Document Links feature:

• Added the Authenticate Document Links (authenticate_document_links__v) field on the Artifact (hierarchy_item__v) object.
• Added the Toggle Authenticate Document Links user record action on the Artifact (hierarchy_item__v) object.

The following changes were made to support the System Links for Sites feature:

• Added the Site System Link (site_system_link__v) object.
• Added the Site System Link (site_system_links_lifecycle__v) object lifecycle.
• Added the Site System Links (site_system_links__v) tab.

The following changes were made to support the CTMS Transfer Expanded Scope: Subjects & Subject Groups feature:

• Added the inactive Unsubmitted (unsubmitted__v) value to the Submission Decision (submission_decision__v) picklist.
• Added the Deleted in Source System (deleted_in_source_system__v) field to the following objects:
  • Subject (subject__clin)
  • Study Country Subject Group (study_country_subject_group__v)
  • Study Site Subject Group (study_site_subject_group__v)
• Added the Deleted in Source System (deleted_in_source_system__v) field to the following Subject Group (study_arm__v) object types:
  • Study Cohort (study_cohort__v)
  • Study Element (study_element__v)
  • Study Part (study_part__v)
  • Substudy (substudy__v)
• Added the External Transfer (external_transfer__v) field to the following objects:
  • Subject (subject__clin)
  • Study Country Subject Group (study_country_subject_group__v)
  • Study Site Subject Group (study_site_subject_group__v)
• Added the External Transfer (external_transfer__v) field to the following Subject Group (study_arm__v) object types:
  • Study Cohort (study_cohort__v)
  • Study Element (study_element__v)
  • Study Part (study_part__v)
  • Substudy (substudy__v)

The following changes were made to support the Document Deletion Log of Documents in Clinical feature:

• Added the Document Deletion (document_deletion__v) object.
• Added the Document Deletion Details (document_deletion__v) field on the Quality Issue (quality_issue__v) object.
• Added the Document Deletion Study Details (document_deletion_study_details__v) join object.
• Added the Document Deletion Reason (document_deletion_reason__v) picklist.

The following changes were made to support the Clinical Subartifacts feature:

• Added the Subartifact (subartifact__v) object.
• Added the Subartifact (subartifact__v) document field on the Base Document.
• Added the Subartifact (subartifact__v) field on the Template Expected Document (template_edl_item__v) object.
• Added the Subartifact (subartifact__v) field on the Expected Document (edl_item__v) object.

The following changes were made to support the Site Feasibility: Veeva Standard Questions and Reusable Responses feature:

• Added the following new fields on Library Question (library_question__sys) object:
  • Reusable Question Type (reusable_question_type__v)
  • Reusable Response (reusable_repsonse__v)
  • Reusable Response Expiration (Years) (reusable_response_expiration_years__v)
  • Veeva Standard Question (veeva_standard_question__v)
  • Question Category (question_category__v)
• Added the new Response ID (response_id__v) field on the Answer Library Design (answer_library_design__sys) object.
• Added the new USN Required (usn_required__v) field on the Survey Template (checklist_design__sys) object.
• Added the new USN (usn__v) field on the Site Survey (study_site_checklist__sys) object.
• Added the new Stored Response (stored_response__v) object.

The following changes were made to support the Clinical Operations-EDC: Display Protocol Deviation EDC ID feature:

• Added the EDC ID (edc_id__v) field on the Issue (pdv__ctms) object.

The following changes were made to support the Complex Trials: Payments feature:

• Added the following fields to the Fee Template (fee_template__v) and Fee (fee__v) objects:
  • Study Cohort (study_cohort__v)
  • Study Part (study_part__v)
  • Substudy (substudy__v)
  • Study Element (study_element__v)
  • Rate Subject Group (rate_subject_group__v)

The following changes were made to support the Configurable eConsent Field Defaults feature:

• Added the eConsent Field Default (econsent_field_default__v) object.

The following changes were made to support the Payable Event Date feature:

• Added the Payable Event Date (payable_event_date__v) field to the following Payable Item (payable_item__v) object types:
  • Additional Fee (additional_fee__v)
  • Procedure Fee (procedure_fee__v)
  • Site Fee (site_fee__v)
  • Visit Fee (visit_fee__v)

The following changes were made to support the Payments Information in Site Connect feature:

• Added the Payment Information (payment_information__v) value to the Connected Study Type (connected_study_type__v) picklist.
• Added the following new fields to the Payment Request (payment_request__v) object:
  • Site Reconciled (site_reconciled__v)
  • Site Note (site_note__v)
• Added the Responsibilities (responsibilities__v) field to the Site Home Access (site_home_access__v) object.
• Added the Responsibilities (responsibilities__v ) picklist with Site Reimbursements (site_reimbursements__v) picklist value.

The following changes were made to support the release of Vault Disclosures:

• Added the Disclosures (disclosure__v) object.
• Added the Disclosures Tab (disclosures_menu__v) and Disclosures Subtab (disclosures__v).
• Added the following new fields to the Study (study__v) object:
  • NCT Number (nct_id__v)
  • WHO Universal Trial Number (UTN) (who_id__v)
  • ISRCTN Number (isrctn_id__v)
  • NIH Grant Number (nih_grant_id__v)
  • Study Design Type (study_design_type__v)
  • Disclose Study on ClinicalTrial.gov (disclosed_on_ctg__v)
  • Reason for ClinicalTrials Registration (reason_for_ctg__v)
  • Comment for ClinicalTrials.gov (comment_on_ctg__v)
• Added the following new field to the Study Site (study_site__v) object:
  • Recruitment Status (site_recruitment_status__v)
  • Include in Disclosures (include_in_disclosures__v)
• Added the Disclosure Specialist (disclosure_specialist__v) and Disclosure Reviewer (disclosure_reviewer__v) application roles.
• Added the Include in Disclosures (include_in_disclosures__v) field to the Investigator (investigator__v) Person Object type.
• Added the new Disclosure Created (disclosure_created__v) and Disclosure Updated (disclosure_updated__v) workflows.
• Added the new Disclosure (disclosure_lifecycle__v) lifecycle.
• Added the new Disclosure (disclosure__v) shared document field.

The following component security updates were made to standardize the data model in Clinical Operations Vaults:

• The Pre-default on non-required field when only one reference record is available attribute is now editable on the Study Organization > Location (location__v) object.
• The System manages field value (read-only) attribute is now editable on the Investigator Initiated Study > Investigator Initiated Study ID (name__v) object.

The following changes were made were made to standardize the data model in Clinical Operations Vaults:

• Added the new External ID (external_id__v) field to the following objects:
  • Answer (answer__clin)
  • Answer Set (answer_set__clin)
  • Answers with Conditional Requirements (question_comment_required__v)
  • Budget (budget__v)
  • Budget Category (budget_category__v)
  • Budget Item (budget_item__v)
  • Critical Process (critical_process__v)
  • Fee Schedule (fee_schedule__v)
  • Risk (risk__v)
  • Risk Assessment Template (risk_assessment_template__v)
  • Risk Category (risk_category__v)
  • Risk Mitigation (risk_mitigation__v)
  • Study Team Role (team_role__v)
  • Study Team Role Role Dependency (role_dependency__v)
• Added the new Superseded (superseded__v) lifecycle state added to the following object lifecycles:
  • Monitoring Schedule (monitoring_schedule_lifecycle__v)
  • Monitoring Schedule Items (monitoring_schedule_items_lifecycle__v)
  • Monitoring Schedule Template (monitoring_schedule_template_lifecycle__v)
  • Monitoring Schedule Template Items (monitoring_sched_template_item_lifecycle__v)