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 23R1.
The following changes were made to Clinical Operations Vaults to support the EU CTR Data Model Support feature:
- Added the new OMS ID (
oms_organization_id__v) field on the Organization and Location objects - Added the new EUCT Number (
euct_number__v) field on the Study object
The following changes were made to Clinical Operations Vaults to support the 23R1 Enhanced Configurability feature:
- The “Values must be unique” setting is now editable on the Cohort (
cohort__v) field for the Study Cohort (study_cohort__v) object - The “Maximum value” setting is now editable for the Expected Turnaround Time (
expected_turnaround_time__clin) field for the Template Task object
The following changes were made to Clinical Operations Vaults to support the Clinical Operations to Medical CRM Connection: Study and Site Transfer feature:
- Added new Integrations and Integration Points on the CRM/Clinical Operations Connection (
crm_clinops_connection__v):- CRM Study Outbound Integration (
crm_study_outbound_integration__v) - CRM Site Outbound Integration (
crm_site_outbound_integration__v) - CRM Study Outbound Integration Point (
crm_site_outbound_integration_pt__v) - CRM Site Outbound Integration Point (
crm_site_outbound_integration_pt__v)
- CRM Study Outbound Integration (
The following changes were made to Clinical Operations Vaults to support the Convert Clinical AI Capabilities to Platform feature:
Added new values and modified existing values in the following picklists:
- Model Performance Metric Type picklist
- Classification Performance (
classification_performance__sys) - NEW - Global Weighted Average (
global_weighted_average__sys) - NEW - Global Non-Weighted Average (
global_nonweighted_average__sys) - NEW - Classification Performance (
classification_performance__v) - relabeled Classification Performance (OLD) and made inactive - Global Weighted Average (
global_weighted_average__v) - relabeled Global Weighted Average (OLD) and made inactive - Global Non-Weighted Average (
global_nonweighted_average__v) - relabeled Global Non-Weighted Average (OLD) and made inactive
- Classification Performance (
- Trained Model Type picklist
- Document Classification (
document_classification__sys) - NEW - Document Classification (
document_classification__v) - relabeled Document Classification (OLD) and made inactive
- Document Classification (
Added and modified fields on the following objects:
- Trained Model Object
- Prediction Confidence Threshold (
prediction_confidence_threshold__sys) - NEW, added to page layout - Training Window Start Date (
training_window_start_date__sys) - NEW, added to page layout - Minimum Documents per Document Type (
minimum_documents_per_document_type__sys) - NEW, added to page layout - Prediction Confidence Threshold (
prediction_confidence_threshold__v) - relabeled Prediction Confidence Threshold (OLD), made inactive, and removed from page layout - Training Window Start Date (
training_window_start_date__v) - relabeled Training Window Start Date (OLD), made inactive, and removed from page layout - Minimum Documents per Document Type (
minimum_documents_per_document_type__v) - relabeled Minimum Documents per Doc Type (OLD), made inactive, and removed from page layout
- Prediction Confidence Threshold (
- Trained Model Performance Metric object
- Training Documents (
training_documents__sys) - NEW, added to page layout - Testing Documents (
testing_documents__sys) - NEW, added to page layout - Correct Predictions (
correct_predictions__sys) - NEW, added to page layout - Correct Predictions Above Threshold (
correct_predictions_above_threshold__sys) - NEW, added to page layout - Predictions Above Threshold (
predictions_above_threshold__sys) - NEW, added to page layout - Training Documents (
training_documents__v) - relabeled Training Documents (OLD), made inactive, and removed from page layout - Testing Documents (
testing_documents__v): relabeled Testing Documents (OLD) , made inactive, and removed from page layout - Correct Predictions (
correct_predictions__v): relabeled Correct Predictions (OLD) , made inactive, and removed from page layout - Correct Predictions Above Threshold (
correct_predictions_above_threshold__v): relabeled Correct Predictions above Thres (OLD) , made inactive, and removed from page layout - Predictions Above Threshold (
predictions_above_threshold__v): relabeled Predictions Above Threshold (OLD), made inactive, and removed from page layout
- Training Documents (
Added the following new Notification Templates:
- Model Deploy Failure (
ml_model_deploy_failure__sys) - Model Deploy Success (
ml_model_deploy_success__sys) - Document Extraction Failure (
ml_doc_extract_failure__sys) - Document Extraction Success (
ml_doc_extract_success__sys) - Model Training Success (
model_training_success__sys) - Model Training Failure (
model_training_failure__sys)
Made the following Notification Templates Inactive:
- Model Deploy Failure (
ml_model_deploy_failure__v) - Model Deploy Success (
ml_model_deploy_success__v) - Document Extraction Failure (
ml_doc_extract_failure__v) - Document Extraction Success (
ml_doc_extract_success__v) - Model Training Success (
model_training_success__v) - Model Training Failure (
model_training_failure__v)
The following changes were made to Clinical Operations Vaults to support the Study Metadata Extraction feature:
- Added the Metadata Extraction (
metadata_extraction__sys) value to the Trained Model Type picklist - Added the new Excluded Classification object
- Added the new Field Extracted value to the Trained Model Performance Metric object
- Added the following new Notification Templates:
- Model Testing Success (
ml_model_testing_success__sys) - Model Testing Failure (
ml_model_testing_failure__sys)
- Model Testing Success (
- Made the following changes to page layouts:
- Added Layout Rules to the Trained Model page layout
- Added Layout Rules to the Trained Model Performance Metric page layout
The following changes were made to Clinical Operations Vaults to support the Safety Distribution Gap Pack feature:
- Added the new Include in Gap Pack field to the Safety Distribution Default object
- Added new fields to Safety Distribution
The following changes were made to Clinical Operations Vaults to support the Participant ID Harmonization feature:
- Added a new Subject Record Change (
subject_record_change__v) object
The following changes were made to Clinical Operations Vaults to support the Track Study Site ISF Location feature:
- Added the new ISF Location (
isf_location__v) field to the Study Site object
The following changes were made to Clinical Operations Vaults to support the Study Migration feature:
- Added the new Study Migration (
study_migration__v) field to the following objects:- Activity (
crm_activity__v) - Agreement (
cdx_agreement__v) - Budget (
budget__v) - Central Monitoring Event (
central_monitoring_event__ctms) - Clinical User Task (
clinical_user_task__clin) - Cycle Time (
cycle_time__v) - Enrollment Status Log (
enrollment_status__ctms) - Expected Documents (
edl_item__v) - Expected Document List (
edl__v) - Fee (
fee__v) - Fee Schedule (
fee_schedule__v) - Fee Schedule Template (
fee_schedule_template__v) - Fee Template (
fee_template__v) - Form Answer (
form_answer__v) - Informed Consent Site Effective Tracking (
icf_site_effective_tracking__ctms) - Informed Consent Tracking (
informed_consent_tracking__ctms) - Issues (
pdv__ctms) - Metrics (
metrics__ctms) - Metrics Over Time (
metrics_over_time__v) - Milestone (
milestone__v) - Milestone Package Documents (
milestone_package_document__v) - Monitored Informed Consent Form (
monitored_informed_consent_form__ctms) - Monitored Metrics (
monitored_metrics__ctms) - Monitored Subjects (
monitored_subject__ctms) - Monitored Subject Events (
monitored_subject_event__ctms) - Monitored Subject Visit (
monitored_subject_visit__v) - Monitoring Compliance (
monitoring_compliance__ctms) - Monitoring Event (
monitoring_event__ctms) - Monitoring Schedule (
monitoring_schedule__v) - Monitoring Schedule Template (
monitoring_schedule_template__v) - Payable Item (
payable_item__v) - Payee Override (
payee_override__v) - Payment (
payment__v) - Procedure (
procedure__v) - Procedure Definition (
procedure_def__v) - Quality Issue (
quality_issue__v) - Response (
response__ctms) - Review Comment (
review_comment__v) - Safety Distributions (
safety_distribution__v) - Selected Site (
selected_site__ctms) - Site Fee (
site_fee__v) - Site Fee Definition (
site_fee_def__v) - Site Survey Invitation (
site_checklist_pal__v) - Study Arm (
study_arm__v) - Study Cohort (
study_cohort__v) - Study Communication Log (
study_communication_log__ctms) - Study Country (
study_country__v) - Study Critical Data (
study_critical_data__v) - Study Critical Process (
study_critical_process__v) - Study Organization (
study_organization__v) - Study Personnel (
study_person__clin) - Study Product (
study_product__v) - Study Risk (
study_risk__v) - Study Risk Assessment (
study_risk_assessment__v) - Study Risk Category (
study_risk_category__v) - Study Risk Mitigation (
study_risk_mitigation__v) - Study Site (
site__v) - Study Site Location (
study_site_location__ctms) - Site Section (
site_section__sys) - Study Team Assignment (
team_assignment__v) - Subject (
subject__clin) - Subject Informed Consent Form (
subject_informed_consent_form__v) - Subject Visit (
visit__v) - Template Expected Documents (
edl_item_template__v) - Trip Report Question Responses (
trip_report_question_response__ctms) - Trip Report Template (
trip_report_template__ctms) - Visit Definition (
visit_def__v)
- Activity (