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 24R1.
The following changes were made to Clinical Operations Vaults to support the Recurring Milestones feature:
- Added the new picklist value Date-based (
datebased__v) to the Milestone Creation Trigger picklist. - Added the new Recurring Milestone Schedule Template object with the following fields:
- Activation Event (
activation_event__v) - Inactivation Event (
inactivation_event__v) - Initial Offset (
initial_offset__v) - Interval (
interval__v) - Level (
level__v) - Study (
study__v) - Template Milestone Set (
milestone_list_template__v) - Template Milestone (
template_milestone__v)
- Activation Event (
- Added the new Recurring Milestone Schedule object with the following fields:
- Activation Date (
activation_date__v) - Activation Event (
activation_event__v) - Initial Offset (
initial_offset__v) - Inactivation Date (
inactivation_date__v) - Inactivation Event (
inactivation_event__v) - Interval (
interval__v) - Level (
level__v) - Milestone Type (
milestone_type__v) - Next Create Date (
next_create_date__v) - Previous Create Date (
previous_create_date__v) - Study (
study__v) - Study Country (
study_country__v) - Study Site (
site__v) - Template Milestone Set (
milestone_list_template__v) - Template Milestone (
template_milestone__v)
- Activation Date (
The following changes were made to Clinical Operations Vaults to support the Clinical Operations/CDMS Connection: Study Visit Method feature:
- Added the Visit Method (
visit_method__v) picklist to the following objects:- Subject Visit
- Monitored Subject Visit
- Fee
- Fee Template
The following changes were made to Clinical Operations Vaults to support the TMF Standard Document Fields feature:
- Added the following standard document fields:
- Effective Date (
effective_date__v) - Collected Date (
collected_date__v) - System Created Date (
system_created_date__v) - Inspection Ready Date (
inspection_ready_date__v) - System Approved Date (
system_approved_date__v) - External Document Version (
external_document_version__v)
- Effective Date (
The following changes were made to Clinical Operations Vaults to support the Complex Trial features:
- Added the following object types to the Study Arm (
study_arm__v) object:- Cohort (
cohort__v) - Study Part (
study_part__v) - Substudy (
substudy__v) - Study Element (
study_element__v)
- Cohort (
- Added the following fields to the Study Arm object:
- Description (
description__v) - Masking (
masking__v) - Create Recruitment Plan (
create_recruitment_plan__v) - EUCT Number (
euct_number__v) - Track Enrollment Metrics (
track_enrollment_metrics__v) - Seed Country and Site Subject Groups (
seed_country_and_site_subject_groups__v)
- Description (
- Added the following new objects:
- Study Country Subject Group (
study_country_subject_group__v) - Study Site Subject Group (
study_site_subject_group__v) - Study Product Subject Group (
study_product_subject_group__v)
- Study Country Subject Group (
- Added the new Subject Group field to the following objects:
- Issues
- Subject
- Monitored Subject
The following changes were made to Clinical Operations Vaults to support the Survey Reminder Notifications feature:
- Added the following fields to the Site Survey Invitation (
site_checklist_pal__v) and Outreach Target Invitation (outreach_target_checklist_pal__v) objects:- Date Last Reminder Sent (
date_last_reminder_sent__v) - Next Reminder Date (
next_reminder_date__v) - Reminder Notification Frequency (
reminder_notification_frequency__v) - Reminder Delivery Status (
reminder_delivery_status__v)
- Date Last Reminder Sent (
- Added the following fields to the Survey Template (
checklist-design__sys) object:- Reminder Email Subject (
reminder_email_subject__v) - Reminder Email Text (
reminder_email_text__v) - Reminder Notification Text (
reminder_notification_text__v)
- Reminder Email Subject (
The following changes were made to Clinical Operations Vaults to support the CTMS Transfer feature:
- Added the following fields to the Study Country (
study_country__v) object:- External Transfer (
external_transfer__v)
- External Transfer (
- Added the following fields to the Site (
site__v) object:- External Transfer (
external_transfer__v) - Source Organization (
source_organization__v) - Source Principal Investigator (
source_principal_investigator__v)
- External Transfer (
- Added the following fields to the Metrics (
metrics__ctms) object:- External Transfer (
external_transfer__v)
- External Transfer (
- Added the following fields to the Metrics Over Time (
metrics_over_time__v) object:- External Transfer (
external_transfer__v)
- External Transfer (
- Added the following fields to the Study Arm (
study_arm__v) object:- External Transfer (
external_transfer__v)
- External Transfer (
- Added the following fields to the Enrollment Status Log (
enrollment_status__ctms) object:- External Transfer (
external_transfer__v)
- External Transfer (
- Added the following fields to the Milestone (
milestone__v) object:- External Transfer (
external_transfer__v)
- External Transfer (
- Added the following fields to the Issue (
pdv__ctms) object:- External Transfer (
external_transfer__v)
- External Transfer (
- Added the following fields to the Monitoring Event (
monitoring_event__ctms) object:- External Transfer (
external_transfer__v) - Source Study Person (
source_study_person__v)
- External Transfer (
- Added the following fields to the Protocol Deviation Sub Category (
pd_pv_subcategory__ctms) object:- System ID (
system_id__v) - Standard Sub Category Mapping (
standard_sub_category_mapping__v)
- System ID (
- Added the new Standard Sub Category Mapping (
standard_sub_category_mapping__v) picklist with the following values:- AE/SAE not reported to IRB (
ae_sae_not_reported_to_irb__v) - Consent form missing (
consent_form_missing__v) - Consent form not current approved version (
consent_form_not_current_approved__v) - Consent form not signed and dated (
consent_form_not_signed_and_dated__v) - Failure to obtain informed consent (
failure_to_obtain_informed_consent__v) - Laboratory tests not done (
laboratory_tests_not_done__v) - Missed assessment (
missed_assessment__v) - Missed visit (
missed_visit__v) - Participant does not meet eligibility criteria (
participant_does_not_meet_eligibility__v) - Participant received wrong treatment (
participant_received_wrong_treatment__v) - Participant seen outside of visit window (
participant_seen_outside_visit_window__v) - Randomization of an ineligible participant (
randomization_of_ineligible_participant__v) - Randomization prior to IRB approval of protocol (
randomization_prior_to_irb_approval__v) - SAE not reported within 24 hours (
sae_not_reported_within_24_hours__v) - Use of disallowed concomitant medication (
use_of_disallowed_concomitant_medication__v)
- AE/SAE not reported to IRB (
- Added the following inactive values to the Milestone Type (
milestone_type__v) picklist:- Country Financial Templates Ready (
country_financial_templates_ready__v) - Country Packet Ready (
country_packet_ready__v) - EC/IRB Approval (
ec_irb_approval__v) - EC/IRB Submission (
ec_irb_submission__v) - Final Database Lock (
final_database_lock__v) - Final Tables Ready (
final_tables_ready__v) - Country Selected (
country_selected__v) - Site Activated (
site_activated__v) - First Country Site Initiated (
first_country_site_initiated__v) - First Site Initiated (
first_site_initiated__v) - Health Authority Application (
ha_application__v) - Health Authority Approval (
ha_approval__v) - Study Report Submitted (
study_report_submitted__v) - Interim Analysis (
interim_analysis__v) - Key Results Ready (
key_results_ready__v) - Protocol Concept Approved (
protocol_concept_approved__v) - Protocol Approval (
protocol_approval__v) - Protocol Amendment (
protocol_amendment__v) - Site Contracts Executed (
site_contracts_executed__v) - Site Essential Docs Completed (
site_essential_docs_completed__v) - Site Regulatory Packet Sent (
site_reg_packet_sent__v) - Site Selected (
site_selected__v) - Study Financial Templates Ready (
study_financial_templates_ready__v) - Unblinded Interim Monitoring Visit (
unblinded_interim_monitoring_visit__v) - Unblinded Site Close Out Visit (
unblinded_site_close_out_visit__v) - Key Study Docs Complete (
key_study_docs_complete__v) - EU CTR Part I Application (
eu_ctr_part_i_application__v) - EU CTR Part II Application (
eu_ctr_part_ii_application__v)
- Country Financial Templates Ready (
- Added the following inactive values to the Protocol Deviation / Violation Category (
category_pdv__ctms) picklist:- Other (
other__v)
- Other (
- Added the following inactive values to the Submission Decision (
submission_decision__v) picklist:- Approved (
approved__v) - Approved with Conditions (
approved_with_conditions__v) - Rejected (
rejected__v)
- Approved (
- Added the SDK job Perform CTMS Transfer (
ctms_transfer_job__v) - Added the CTMS Transfer Rule Set
- Added a new admin page Standard Mappings
- Added the following standardized records for the Protocol Deviation Sub Category (
pd_pv_subcategory__ctms) with the accompanying System ID (system_id__v) field value:- AE/SAE not reported to IRB (
ae_sae_not_reported_to_irb__v) - Consent form missing (
consent_form_missing__v) - Consent form not current approved version (
consent_form_not_current_approved__v) - Consent form not signed and dated (
consent_form_not_signed_and_dated__v) - Failure to obtain informed consent (
failure_to_obtain_informed_consent__v) - Laboratory tests not done (
laboratory_tests_not_done__v) - Missed assessment (
missed_assessment__v) - Missed visit (
missed_visit__v) - Participant does not meet eligibility criteria (
participant_does_not_meet_eligibility__v) - Participant received wrong treatment (
participant_received_wrong_treatment__v) - Participant seen outside of visit window (
participant_seen_outside_visit_window__v) - Randomization of an ineligible participant (
randomization_of_ineligible_participant__v) - Randomization prior to IRB approval of protocol (
randomization_prior_to_irb_approval__v) - SAE not reported within 24 hours (
sae_not_reported_within_24_hours__v) - Use of disallowed concomitant medication (
use_of_disallowed_concomitant_medication__v)
- AE/SAE not reported to IRB (
The following changes were made to Clinical Operations Vaults to support the Recurring Milestones Schedules feature:
- Added the new Recurring Milestone Schedule Template object with the following fields:
- Activation Event (
activation_event__v) - Inactivation Event (
inactivation_event__v) - Initial Offset (
initial_offset__v) - Interval (
interval__v) - Level (
level__v) - Study (
study__v) - Template Milestone Set (
milestone_list_template__v) - Template Milestone (
template_milestone__v)
- Activation Event (
- Added the new Recurring Milestone Schedule object with the following fields:
- Activation Event (
activation_event__v) - Inactivation Event (
inactivation_event__v) - Initial Offset (
initial_offset__v) - Inactivation Date (
inactivation_date__v) - Inactivation Event (
inactivation_event__v) - Interval (
interval__v) - Level (
level__v) - Milestone Object Type (
milestone_object_type__v) - Milestone Type (
milestone_type__v) - Next Create Date (
next_create_date__v) - Previous Create Date (
previous_create_date__v) - Study (
study__v) - Study Country (
study_country__v) - Study Site (
site__v) - Template Milestone Set (
milestone_list_template__v) - Template Milestone (
template_milestone__v)
- Activation Event (
The following changes were made to Clinical Operations Vaults to support the Payment Adjustment Override feature:
- Added the Adjustment Override field to the Payable Item object
The following changes were made to Clinical Operations Vaults to support the Clinical Operations License Tracking by Application feature:
- Added the new Study Site License (
site_license__v) object with the following fields:- Study (
study__v) - Study Country (
study_country__v) - Study Site (
site__v) - Study Status (
study_status__v) - Study Site Status (
site_status__v) - CTMS (
ctms__v) - Payments (
payments__v) - Study Startup (
study_startup__v) - Site Connect (
site_connect__v)
- Study (
The following changes were made to Clinical Operations Vaults to support the Oversight Issue Tracking for Outsourced Studies feature:
- Added the new Oversight Category (
oversight_category__v) picklist with the following values:- Enrollment Performance (
enrollment_performance__v) - Milestone Timeliness (
milestone_timeliness__v) - Monitoring Documentation Quality (
monitoring_documentation_quality__v) - Monitoring Visit Report Timeliness (
monitoring_visit_report_timeliness__v) - Monitoring Visit Timeliness (
monitoring_visit_timeliness__v) - Portfolio Performance (
portfolio_performance__v) - Study Issue Management (
study_issue_management__v) - TMF (Trial Master File) Oversight (
tmf_oversight__v) - Vendor Data Quality (
vendor_data_quality__v)
- Enrollment Performance (
- Added the new Oversight Issue (
oversight_issue__v) object with the following fields:- Oversight Issue ID (
name__v) - Study (
study__v) - Study Country (
study_country__v) - Study Site (
site__v) - Study Organization (
study_organization__v) - Organization (
organization__v) - Oversight Category (
oversight_category__v) - Summary (
summary__v) - Description (
description__v) - Date Identified (
date_identified__v) - Date Reported to Vendor (
date_reported_to_vendor__v) - Date Resolved (
date_resolved__v) - Resolution (
resolution__v)
- Oversight Issue ID (
- Added the new Oversight Issue - Monitoring Event (
oversight_issue_monitoring_event__v) object with the following fields:- Oversight Issue (
oversight_issue__v) - Monitoring Event (
monitoring_event__v)
- Oversight Issue (
- Added the new Oversight Issue - Milestone (
oversight_issue_milestone__v) object with the following fields:- Oversight Issue (
oversight_issue__v) - Milestone (
milestone__v)
- Oversight Issue (
- Added the new Oversight Issue - Task (
oversight_issue_task__v) object with the following fields:- Oversight Issue (
oversight_issue__v) - Clinical User Task (
clinical_user_task__v)
- Oversight Issue (
- Added the new Oversight Issue - Issue (
oversight_issue_issue__v) object with the following fields:- Oversight Issue (
oversight_issue__v) - Issue (
issue__v)
- Oversight Issue (
- Added the new Oversight Issue Lifecycle (
oversight_issue_lifecycle__v)
The following changes were made to Clinical Operations Vaults to support the Site Connect Data Model Update on Distribution Task feature:
- Added the following fields to the Distribution Task (
distribution_task__v) object:- Last Downloaded Date (
last_downloaded_date__v) - SiteVault Document Type (
sitevault_document_type__v) - Last Filed to SiteVault Date (
last_filed_to_sitevault_date__v) - SiteVault Document Number (
sitevault_document_number__v) - Recalled by Sponsor/CRO (
recalled_by_sponsorcro__v) - Reason for Recall (
reason_for_recall__v)
- Last Downloaded Date (
- Added a new job Distribution Task Field Migration (
dist_task_field_migration_job__v)
The following changes were made to Clinical Operations Vaults to support the Study Country & Site Metadata Extraction feature:
- Added the following values to the Field Extracted (
field_extracted__sys) picklist:- Study Country (
study_country__v) - Site (
site__v)
- Study Country (
- Added the following values to the Tags (
tags__v) picklist:- Study Country Metadata Extracted (
study_country_metadata_extracted__v) - Site Metadata Extracted (
site_metadata_extracted__v)
- Study Country Metadata Extracted (
The following changes were made to Clinical Operations Vaults to support the Safety-Clinical Operations Connection: Safety Letters feature:
- Added the following standard document fields:
- Case Worldwide Unique ID (
case_worldwide_unique_id__v) - Transmission ID (
transmission_id__v)
- Case Worldwide Unique ID (
- Added the following fields to the Safety Distribution (
safety_distribution__v) object:- Case Worldwide Unique ID (
case_worldwide_unique_id__v) - Safety Due Date (
safety_due_date__v)
- Case Worldwide Unique ID (
- Added the following Integrations (
integration__sys):- Safety Letter Integration (
safety_letter_integration__v) - Safety Distribution Integration (
safety_distribution_integration__v)
- Safety Letter Integration (
- Added the following Integration Points (
integration_point__sys):- Safety Distribution Created (
safety_dist_integration_point__v) - Vault Safety Inbound Crosslink Creation (
safety_document_letter_int_point__v) - Vault Safety Inbound Document Creation (
safety_document_dist_int_point__v)
- Safety Distribution Created (
- Added the following Integration Rules:
- Safety Document Integration Rule (
safety_document_dist_int_rule__v) - Crosslink Inbound Integration Rule (
safety_document_letter_int_rule__v)
- Safety Document Integration Rule (
- Added the following Spark Queues:
- Safety to Clinical Outbound Queue Distribution (
safety_clin_outbound_dist_queue__v)
- Safety to Clinical Outbound Queue Distribution (
The following changes were made to Clinical Operations Vaults to support the Additional Vault Clinical Docs Support feature:
- Added new Vault Clinical Docs artifacts (
hierarchy__v) object records:- IP Treatment Decoding Documentation (
vdc__326) - Safety Report Supporting Document (
vdc__327)
- IP Treatment Decoding Documentation (
- Updated existing Vault Clinical Docs artifacts (
hierarchy__v) object records:- IP Re-labeling Documentation (
vdc__85) - Recruitment Plan (
vdc__1) - System Account Management (
vdc__110)
- IP Re-labeling Documentation (
The following changes were made to Clinical Operations Vaults to support the Mark Document Recalled Tracking feature:
- Added the following fields to the Distribution Task (
distribution_task__v) object:- Recalled by Sponsor/CRO (
recalled_by_sponsorcro__v)- This field is added as a checkbox. This will set a value of FALSE on all existing records, update the Last Modified Date field, and an event will not be recorded in the audit trail.
- Recalled by Sponsor/CRO (
Added the following to standardize data model in Clinical Operations Vaults:
- Added the following picklist values on the Monitoring Event Type (
monitoring_event_type__ctms) picklist:- Unblinded Interim (
unblinded_interim_monitoring_visit__v) - Unblinded Close Out (
unblinded_site_close_out_visit__v)
- Unblinded Interim (
- Added the following Object Types to Trip Report Template (
trip_report_template__ctms) object:- Unblinded Interim Trip Report Template (
unblinded_interim_monitoring_visit__v) - Unblinded Close Out Trip Report Template (
unblinded_site_close_out_visit__v)
- Unblinded Interim Trip Report Template (
The following changes were made to Clinical Operations Vaults to support the Additional eConsent Form Response Fields feature:
- Added the following fields to the Form Response (
form_response__v) object:- Signature Date (
signature_date__v) - Document Description (
document_description__v)
- Signature Date (