21R2 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 21R2.

Added the following components to support Support for EU Regulatory Agency Issue Notification Tracking:

  • New fields on the Issue(pdv__ctms) object:
    • Notification Type (notification_type__v)
    • Date Reported (date_reported__v)
    • Deadline for Compliant Notification (deadline_for_compliant_notification__v)
  • Added the Notification Type (notification_type__v) picklist

Added and updated the following components to support the Conditional Actions on Trip Report Questions feature:

  • Changed the label of the Question Comment Required (_question_comment_required__v) object to Answer with Conditional Requirements and added the following fields:
    • Required Comment(required_comment__v)
    • Follow Up Item Requiredness (follow_up_item_requiredness__v)
    • Issue Requiredness (issue_requiredness__v)
    • Issue Type (issue_type__v)
  • Added the following picklists:
    • Issue Type (issue_type__v)
    • Issue and Follow Up Item Requiredness(issue_and_follow_up_item_requiredness__v)
  • Added the following objects:
    • Response Issue (response_issue__v)
    • Response Follow Up Item (response_follow_up_item__v)

Added the following components to support the CDMS & Clinical Operations Vault Connection: Protocol Deviationsfeature:

  • Added the following components to the Issues (pdv__ctms) object:
    • Content (blinding__v) field
    • Content (blinding__v) picklist

Added and updated the following components to support the eConsent Authoring in Clinical Operations feature:

  • Added the Veeva eConsent (myveeva_econsent__v) document field
  • Added the Veeva eForm(veeva_eform__v) rendition type

Added the following Artifacts to vaults with Veeva Site Connect enabled to support the Site Connect: Additional Vault Clinical Docs Support feature:

  • Protocol Clarification Letter
  • Protocol Summary of Changes

Added the following components to vaults with Vault Payments enabled to support the Study Budgetsfeature:

  • Budget Approval Workflow (budget_approval_workflow__v)
  • Lifecycles
    • Budget Lifecycle(budget_lifecycle__v)
    • Budget Item Lifecycle (budget_item_lifecycle__v)
    • Budget Category Lifecycle (budget_category_lifecycle__v)
  • Objects
    • Budget (budget__v)
    • Budget Category (budget_category__v)
    • Budget Item (budget_item__v)
  • Added the Budget Category (budget_category__v) field to the Fee Template, Fee, and Payable Item objects

Added the following components to support the Milestone-Specific Expected Documentsfeature:

  • Added the Owning Milestone Type (owning_milestone_type_v) field to the following objects:
    • _Expected Document (_edl_item__v)
    • Template Expected Document (edl_item_template__v)
    • TMF Index Item Requirement(tmf_index_item_requirement__v)
  • Added the Owning Milestone Type (owning_milestone__v) document field to the Base Document (base_document__v) document type
  • Added the Owning Milestone Type (owning_milestone_c) value to the EDL Matching Field(edl_matching_field_v) picklist

Added the following components to support the Support for Subject Informed Consent Formsfeature:

  • Added the Subject Informed Consent Form(subject_informed_consent_form__v) object
  • Added the Subject Informed Consent Form (subject_informed_consent_form__v) field on the Monitored Informed Consent Form (monitored_informed_consent_form__ctms) object

Added the following components to support the TMF Bot features:

  • Added the Prediction object with the following fields:
    • Prediction ID (name__v)
    • Related Record (related_record__sys)
    • Predictions (predictions__sys)
    • Feedback (feedback__sys)
    • Additional Details(additional_details__sys)
    • Related Record Unique ID (unique_id__sys)
  • Added the Trained Model object with the following new fields:
    • Trained Model ID (name__v)
    • Lifecycle State (state__v)
    • Trained Model Type (training_model_type__sys)
    • Advanced Model Parameters (advanced_model_parameters__sys)
    • Training Window Start Date (training_window_start_date__v)
    • Prediction Confidence Threshold (prediction_confidence_threshold__v)
    • Minimum Documents per Document Type (minimum_documents_per_document_type__v)
    • Unique Model ID (unique_model_id__sys)
  • Added the Trained Model Performance Statistics object with the following fields:
    • Model Performance ID (name__v)
    • Trained Model (trained_model__sys)
    • Metric Type (performance_metric_type__sys)
    • Metric Subtype (performance_metric_subtype__sys)
    • Precision (precision__sys)
    • Recall (recall__sys)
    • F1-Score (f1_score__sys)
    • Training Documents (training_documents__v)
    • Testing Documents (testing_document__v)
    • Correct Predictions (correct_predictions__v)
    • Correct Predictions Above Threshold (correct_predictions_above_threshold__v)
    • Predictions Above Threshold (predictions_above_threshold__v)
  • Added the Trained Model Lifecycle
  • New Object Notifications:
    • Document Extraction Success (ml_doc_extract_success__v)
    • Document Extraction Failure (ml_doc_extract_failure__v)
    • Model Training Success (ml_model_training_success__v)
    • Model Training Failure (ml_model_taining_failure__v)
    • Model Deploy Success (ml_model_deploy_success__v)
    • Model Deploy Failure (ml_model_deploy_failure__v)
  • Added New Picklist TMF Bot(tmf_bot__v) with the following Picklist Items:
    • Queued… (queued__v)
    • Performing OCR… (performing_ocr__v)
    • Done (done__v)
  • Added Picklist Item TMF Bot Auto-classified (tmf_bot_autoclassified__v) to the Tags Picklist.
  • Added new Document Field TMF Bot(tmf_bot__v).

Added the following components to support the Send Survey to Non-Users feature:

  • New Objects:
    • Outreach Campaign (outreach_campaign__v)
    • Outreach Target(outreach_target__v)
    • Site Survey Invitation (site_survey_invitation__v)
    • Outreach Survey Invitation (outreach_survey_invitation__v)
  • New Object Lifecycles:
    • Outreach Campaign Lifecycle (outreach_campaign_lifecycle__v)
    • Outreach Target Lifecycle (outreach_target_lifecycle__v)
    • Outreach Survey Invitation Lifecycle (outreach_checklist_pal_lifecycle__v)
    • Site Survey Invitation Lifecycle (site_checklist_pal_lifecycle__v)
  • New Picklists:
    • Add picklist Delivery Status (delivery_status__v)
    • Add picklist Survey Respondent Type (survey_respondent_type__v)
  • New Checklist Types (only visible in Study Startup Vaults):
    • Site Survey (site_survey__v), with target object of site__v
    • Outreach Survey (outreach_survey__v), with target object of outreach_target__v
  • New Standard (System-Managed) Security Components:
    • Permission Set: Clinical Survey Respondent (clinical_survey_respondent__v)
    • Security Profile: Clinical Survey Respondents (clinical_survey_respondents__v)
    • User: Clinical Survey Respondent (username: clinicalsurveyrespondent@{domain}.com)
  • Added the following fields to the Checklist Design object:
    • Complete Survey Document (complete_survey_document__v)
    • Study (study__v)
    • Outreach Campaign (outreach_campaign__v)
    • Study Type (study_type__v)
    • Therapeutic Area (therapeutic_area__v)
  • Added the following fields to the Dependency Design object :
    • Controlling Answer (controlling_answer__v)
    • Controlling Question Text (controlling_question_text__v)
    • Dependent Question Text (dependent_question_text__v)
  • Added the following fields to the Study Site and Outreach Target Checklists:
    • Date Survey Sent
    • Date Survey Received
    • Days to Complete Survey
  • Added the following fields to the Site Section object:
    • Study
    • Study Country
    • Site
    • Checklist Category
    • Weighted Score
  • Added the following fields to the Outreach Target Section object:
    • Outreach Campaign
    • Outreach Target
    • Checklist Category
    • Weighted Score

Added the Survey Respondent Type field (survey_respondent_type__v) to the Contact Information object