24R2 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 24R2.

24R1.3

The following changes were made to Clinical Operations Vaults to support the Site Connect Site Users in ClinOps feature:

  • Added the following new objects:
    • Study Site Invitation (site_connect_study_invitation__v)
    • Site Connect Study Site Settings (site_connect_study_site_settings__v)
    • Site Home Access (site_home_access__v)
    • PAL Site Connect Document Viewer (pal_site_connect_doc_viewer__v)
    • PAL Site Connect Login (pal_site_connect_login__v)
  • Added the following new lifecycles:
    • Site Connect Study Site Settings (site_connect_site_settings_lifecycle__v)
    • Site Connect Study Invitation (site_connect_study_invitation__v)
    • Site Home Access (site_connect_access__v)
  • Added the Site Home (site_home__v) tab
  • Added the following new pages:
    • Site Connect Document Viewer (document_viewer__v)
    • Site Connect Document Viewer PAL (document_viewer_pal__v)
    • Site Connect Login (site_connect_login__v)
    • Site Home (site_home_page__v)
  • Added the new Site Connect Site User (site_connect_site_user__v) security profile
  • Added the new Site Connect Site User (site_connect_site_user__v) permission set
  • Added the new Site Connect Site User (site_connect_site_user__v) application role
  • Added the new Site Connect Site User (site_connect_site_user__v) document lifecycle

The following change was made to Clinical Operations Vaults to support the eSignature in Site Connect feature:

  • Added the new Site Connect eSignature (siteconnect_site_esignature__v) workflow

The following change was made to Clinical Operations Vaults to support the Study Admin section for Sites feature:

  • Added the new Site Home Access Request (site_home_access_request__v) workflow

The following changes were made to Clinical Operations Vaults to support the Study Announcements section for Sites feature:

  • Added the new Study Announcement (study_announcement__v) object
  • Added the new Study Announcement Lifecycle (study_announcement_lifecycle__v)
  • Added the new Study Announcements (study_announcements__v) tab

The following changes were made to Clinical Operations Vaults to support the Study Contacts section for Sites:

  • Added the new Study Contact (study_contact__v) object
  • Added the new Study Contact Lifecycle (study_contact_lifecycle__v)
  • Added the new Study Contacts (study_contacts__v) tab

The following changes were made to Clinical Operations Vaults to support the CTMS/Payments Standardization Data Model feature:

  • Updated the following cloning rules:
    • Answers with Conditional Requirements (question_comment_required__v) cloning rule updated from FALSE to TRUE
    • Study Team Role Constraint (study_team_role_constraint__v) cloning rule updated from FALSE to TRUE
  • Made the following component security updates:
    • The Pre-default on non-required field when only one reference record is available attribute is now editable on the following objects:
      • Study Organization > Study Country (study_country__v)
      • Informed Consent Tracking > Study Country (study_country__ctms)
      • Study Person > Primary Contact Information (contact_information__clin)
  • Added the following new fields to the Payment Request (payment__v) object:
    • Payment Letter (doc_ref_payment_letter__v)
    • Payment Letter (unbound) (doc_ref_payment_letter_unbound__v)

The following changes were made to Clinical Operations Vaults to support the eTMF/SSU Data Standardization feature:

  • Added the following new fields to the Study (study__v) object:
    • Study Type (clinical_study_type__v)
    • Study Subtype (study_subtype__v)
    • Type of Control (type_of_control__v)
  • Added the following new picklists:
    • Study Type (clinical_study_type__v)
    • Study Subtype (study_subtype__v)
    • Type of Control (type_of_control__v)
  • Added the new Description (description__v) field to the Template Task (template_task__clin) object
  • Added the following new fields to the Study Site (site__v) object:
    • Awaiting CDA (awaiting_cda__v)
    • Date, Interest Confirmed (date_interest_confirmed__v)
    • Date, Survey Sent to Site (date_survey_sent_to_site__v)
    • Feasibility Score (feasibility_survey_score__v)
    • PSV Required (psv_required__v)
  • Added the new External ID (external_id__v) field to the _Selected Milestone Set__ (selected_milestone_set__v) object
  • Added the following new fields to the Organization (organization__v) object:
    • MSA Expiration Date (msa_expiration_date__v)
    • MSA in Place (msa_in_place__v)
  • Added the following new fields to the Milestone (milestone__v) object:
    • Submission Decision Date (submission_decision_date__v)
    • Instructions (instructions__v)
  • Added the new Instructions (instructions__v) field to the Template Milestone (milestone_template__v) object
  • Added the new Last PSV Date (last_psv_date__v) field to the Location (location__v) object

The following change was made to Clinical Operations Vaults to support the Clinical Operations-Medical CRM Connection: Specify CRM Account Identifier per Connection feature:

  • Added the new CRM Identifier Mapping (crm_connection_identifier_mapping__v) object with the following fields:
    • Connection (connection__v)
    • Connection API Name (connection_api_name__v)
    • CRM Account Identifier (crm_account_identifier__v)
    • Clinical Person Identifier (clinical_person_identifier__v)

The following changes were made to Clinical Operations Vaults to support the CTMS Transfer: Deletion in Source feature:

  • Added the new boolean field Deleted in Source System (deleted_in_source_system__v) to the following objects:
    • Study Country (study_country__v)
    • Site (site__v)
    • Subject Group (study_arm__v)
    • Milestone
      • All
    • Issue
      • observation__v
      • protocol_deviation__ctms
      • risk_mitigation_action__v
    • Monitoring Event (monitoring_event__ctms)
      • All
    • Metrics (metrics__ctms)
      • study__ctms
      • study_country__ctms
      • site__ctms
    • Metrics Over Time (metrics_over_time__v)
      • study__v
      • study_country__v
      • site__v
    • Enrollment Status Log (enrollment_status__ctms)
      • study__ctms
      • study_country__ctms
      • site__ctms