18R1 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 data model. These data model updates are automatically included in all Vaults, but Admins must make configuration changes to make them available. For information on feature functionality, see What’s New in 18R1.

As part of standardizing the configuration across all Clinical applications, we’ve made the following changes to standard configuration in all Clinical Operations vaults:

  • Removed the Days, Selected to Initiated (days_selected_to_initiated__clin) field from the Study Site (study_site__v) object.
  • Removed the Template Milestone (template_milestone__v) field from the Template Task (template_task__clin) object.
  • Removed the Vendor Subtype (vendor_subtype__v) field from the Person (person__v) object.
  • Added the default value [today] for Date, Site Fully Qualified (date_site_identified__clin) field on the Study Site (study_site__v) object.
  • Added the default value [No] for Fast-Track Site (fast_track_site__clin) field on the Location (location__v) object.
  • Added the default value [No] for Key Opinion Leader (key_opinion_leader__clin) field on the Person (person__v) object.
  • Added the default value [No] for Debarred (debarred__clin) field on the Person (person__v) object.
  • Added the following fields as standard on the Standard – Milestone (milestone__v.standard__clin) object type:
    • Actual Finish Date (actual_finish_date__v)
    • Actual Start Date (actual_start_date__v)
    • Actual vs Planned Finish Date (actual_vs_planned_finish_date__clin)
    • Actual vs Planned Start Date (actual_vs_planned_start_date__clin)
    • Approval Comments (approval_comments__clin)
    • Approval Date (approval_date__clin)
    • Autocomplete (autocomplete__v)
    • Baseline Finish Date (baseline_finish_date__v)
    • Baseline Start Date(baseline_start_date__v)
    • Completed EDL Item Records (completed_edl_item_records__v)
    • Completed Previous Milestones (completed_previous_milestones__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Documents Complete Date (docs_complete_date__v)
    • Expected Duration (Days) (expected_duration__v)
    • Gating Override Date (gating_override_date__clin)
    • Gating Override Eligible (gating_override_eligible__clin)
    • Instance ID (instance_id__v)
    • Internal Review Failed Date (internal_review_failed_date__clin)
    • Internal Review Issue Comments (internal_review_issue_comments__clin)
    • Internal Review Issue Type (internal_review_issue_type__clin)
    • _Internal Review Passed Dat_e (internal_review_passed_date__clin)
    • Internal Review Start Date (internal_review_start_date__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle State (state__v)
    • Milestone (name__v)
    • Milestone List Template (milestone_list_template__v)
    • Milestone Object Type (object_type__v)
    • Milestone Template (milestone_template__v)
    • Milestone Type (milestone_type__v)
    • Number of Internal Reviews (number_of_times_in_internal_review__clin)
    • Number of Plan Updates (number_of_plan_updates__clin)
    • Planned Finish Date (planned_finish_date__v)
    • Planned Start Date (planned_start_date__v)
    • Sequence (sequence__v)
    • Status (status__v)
    • Story Milestone (story_milestone__v)
    • Study (study__v)
    • Study Country (study_country__v)
    • Study Site (site__v)
    • Sum of Actual Approved Documents (sub_actual_approved_docs__v)
    • Sum of Actual Total Documents (sum_actual_total_docs__v)
    • Sum of Expected Approved Documents (sum_expected_approved_docs__v)
    • Total EDL Item Records (total_edl_item_records__v)
    • Total Previous Milestones (total_previous_milestones__v)
  • Added the following fields as standard on the Event – Milestone (milestone__v.event__v) object type:
    • Actual Finish Date (actual_finish_date__v)
    • Actual Start Date (actual_start_date__v)
    • Actual vs Planned Finish Date (actual_vs_planned_finish_date__clin)
    • Actual vs Planned Start Date (actual_vs_planned_start_date__clin)
    • Autocomplete (autocomplete__v)
    • Baseline Finish Date (baseline_finish_date__v)
    • Baseline Start Date (baseline_start_date__v)
    • Completed EDL Item Records (completed_edl_item_records__v)
    • Completed Previous Milestones (completed_previous_milestones__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Documents Complete Date (docs_complete_date__v)
    • Expected Duration (Days) (expected_duration__v)
    • Gating Override Date (gating_override_date__clin)
    • Gating Override Eligible (gating_override_eligible__clin)
    • Instance ID (instance_id__v)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle State (state__v)
    • Milestone (name__v)
    • Milestone List Template (milestone_list_template__v)
    • Milestone Object Type (object_type__v)
    • Milestone Template (milestone_template__v)
    • Milestone Type (milestone_type__v)
    • Planned Finish Date (planned_finish_date__v)
    • Planned Start Date (planned_start_date__v)
    • Sequence (sequence__v)
    • Status (status__v)
    • Story Milestone (story_milestone__v)
    • Study (study__v)
    • Study Country (study_country__v)
    • Study Site (site__v)
    • Sum of Actual Approved Documents (sub_actual_approved_docs__v)
    • Sum of Actual Total Documents (sum_actual_total_docs__v)
    • Sum of Expected Approved Documents (sum_expected_approved_docs__v)
    • Total EDL Item Records (total_edl_item_records__v)
    • Total Previous Milestones (total_previous_milestones__v)
  • Added the following fields as standard on the Monitoring Event – Milestone (milestone__v.monitoring_event__clin) object type:
    • Actual Finish Date (actual_finish_date__v)
    • Actual Start Date (actual_start_date__v)
    • Actual vs Planned Finish Date (actual_vs_planned_finish_date__clin)
    • Actual vs Planned Start Date (actual_vs_planned_start_date__clin)
    • Autocomplete (autocomplete__v)
    • Baseline Finish Date (baseline_finish_date__v)
    • Baseline Start Date (baseline_start_date__v)
    • Completed EDL Item Records (completed_edl_item_records__v)
    • Completed Previous Milestones (completed_previous_milestones__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Documents Complete Date (docs_complete_date__v)
    • Expected Duration (Days) (expected_duration__v)
    • Gating Override Date (gating_override_date__clin)
    • Gating Override Eligible (gating_override_eligible__clin)
    • Instance ID (instance_id__v)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle State (state__v)
    • Milestone (name__v)
    • Milestone List Template (milestone_list_template__v)
    • Milestone Object Type (object_type__v)
    • Milestone Template (milestone_template__v)
    • Milestone Type (milestone_type__v)
    • Number of Plan Updates (number_of_plan_updates__clin)
    • Planned Finish Date (planned_finish_date__v)
    • Planned Start Date (planned_start_date__v)
    • Sequence (sequence__v)
    • Status (status__v)
    • Story Milestone (story_milestone__v)
    • Study (study__v)
    • Study Country (study_country__v)
    • Study Site (site__v)
    • Sum of Actual Approved Documents (sub_actual_approved_docs__v)
    • Sum of Actual Total Documents (sum_actual_total_docs__v)
    • Sum of Expected Approved Documents (sum_expected_approved_docs__v)
    • Total EDL Item Records (total_edl_item_records__v)
    • Total Previous Milestones (total_previous_milestones__v)
  • Added the following fields as standard on the Submission – Milestone (milestone__v.submission__clin) object type:
    • Actual Finish Date (actual_finish_date__v)
    • Actual Start Date (actual_start_date__v)
    • Actual vs Planned Finish Date (actual_vs_planned_finish_date__clin)
    • Actual vs Planned Start Date (actual_vs_planned_start_date__clin)
    • Approval Comments (approval_comments__clin)
    • Approval Date (approval_date__clin)
    • Autocomplete (autocomplete__v)
    • Baseline Finish Date (baseline_finish_date__v)
    • Baseline Start Date (baseline_start_date__v)
    • Completed EDL Item Records (completed_edl_item_records__v)
    • Completed Previous Milestones (completed_previous_milestones__v)
    • Conditional Approval Comments (conditional_approval_comments__clin)
    • Conditional Approval Date (conditional_approval_date__clin)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Documents Complete Date (docs_complete_date__v)
    • Expected Duration (Days) (expected_duration__v)
    • Expected Duration – Resubmit (Days) (expected_duration_resubmit__clin)
    • Gating Override Date (gating_override_date__clin)
    • Gating Override Eligible (gating_override_eligible__clin)
    • Initial Submission Date (initial_submission_date__clin)
    • Initial Submission to Done (initial_submission_to_done__clin)
    • Expected Duration (Days) (expected_duration__v)
    • Instance ID (instance_id__v)
    • Internal Review Failed Date (internal_review_failed_date__clin)
    • Internal Review Issue Comments (internal_review_issue_comments__clin)
    • Internal Review Issue Type (internal_review_issue_type__clin)
    • Internal Review Passed Date (internal_review_passed_date__clin)
    • Internal Review Start Date (internal_review_start_date__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle State (state__v)
    • Milestone (name__v)
    • Milestone List Template (milestone_list_template__v)
    • Milestone Object Type (object_type__v)
    • Milestone Template (milestone_template__v)
    • Milestone Type (milestone_type__v)
    • Number of Internal Reviews (number_of_times_in_internal_review__clin)
    • Number of Plan Updates (number_of_plan_updates__clin)
    • Number of Queries Received (number_of_queries_received__clin)
    • Number of Rejections (number_of_rejections__clin)
    • Number of Submissions (number_of_submissions__clin)
    • Planned Finish Date (planned_finish_date__v)
    • Planned Start Date (planned_start_date__v)
    • Queries Received Comments (queries_received_comments__clin)
    • Queries Received Date (queries_received_date__clin)
    • Rejection Comments (rejection_comments__clin)
    • Rejection Date (rejection_date__clin)
    • Sequence (sequence__v)
    • Status (status__v)
    • Story Milestone (story_milestone__v)
    • Study (study__v)
    • Study Country (study_country__v)
    • Study Site (site__v)
    • Submission Acknowledged Date (submission_acknowledged_date__v)
    • Submission Decision (submission_decision__clin)
    • Submission Expected Review Date (submission_expected_review_date__v)
    • Sum of Actual Approved Documents (sub_actual_approved_docs__v)
    • Sum of Actual Total Documents (sum_actual_total_docs__v)
    • Sum of Expected Approved Documents (sum_expected_approved_docs__v)
    • Total EDL Item Records (total_edl_item_records__v)
    • Total Previous Milestones (total_previous_milestones__v)
  • Added the following fields as standard on the Event – Template Milestone (milestone_template__v.submission__clin) object type:
    • Autocomplete (autocomplete__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • EDL Template (edl_template__v)
    • Expected Duration (Days) (expected_duration__clin)
    • External ID (external_id__v)
    • Gating Override Eligible (gating_override_eligible__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Level (level__v)
    • Milestone List Template (milestone_list_template__v)
    • Milestone Template (name__v)
    • Milestone Type (milestone_type__v)
    • Sequence (sequence__v)
    • Status (status__v)
    • Template Milestone Type (object_type__v)
  • Added the following fields as standard on the Monitoring Event – Template Milestone (milestone_template__v.monitoring_event__clin) object type:
    • Autocomplete (autocomplete__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • EDL Template (edl_template__v)
    • Expected Duration (Days) (expected_duration__clin)
    • External ID (external_id__v)
    • Gating Override Eligible (gating_override_eligible__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Level (level__v)
    • Milestone List Template (milestone_list_template__v)
    • Milestone Template (name__v)
    • Milestone Type (milestone_type__v)
    • Sequence (sequence__v)
    • Status (status__v)
    • Template Milestone Type (object_type__v)
  • Added the following fields as standard on the Standard – Template Milestone (milestone_template__v.standard__clin) object type:
    • Autocomplete (autocomplete__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • EDL Template (edl_template__v)
    • Expected Duration (Days) (expected_duration__clin)
    • External ID (external_id__v)
    • Gating Override Eligible (gating_override_eligible__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Level (level__v)
    • Milestone List Template (milestone_list_template__v)
    • Milestone Template (name__v)
    • Milestone Type (milestone_type__v)
    • Sequence (sequence__v)
    • Status (status__v)
    • Template IRB/EC Type (template_ec_type__v)
    • Template Milestone Type (object_type__v)
  • Added the following fields as standard on the Submission – Template Milestone (milestone_template__v.submission__clin) object type:
    • Autocomplete (autocomplete__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • EDL Template (edl_template__v)
    • Expected Duration (Days) (expected_duration__clin)
    • Expected Duration – Resubmit (Days) (expected_duration_resubmit__clin)
    • External ID (external_id__v)
    • Gating Override Eligible (gating_override_eligible__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Level (level__v)
    • Milestone List Template (milestone_list_template__v)
    • Milestone Template (name__v)
    • Milestone Type (milestone_type__v)
    • Sequence (sequence__v)
    • Status (status__v)
    • Template IRB/EC Type (template_ec_type__v)
    • Template Milestone Type (object_type__v)
  • Added the following fields as standard on the Study Task – Clinical User Task (clinical_user_task__clin.study_task__clin) object type:
    • Assigned (assigned__v)
    • Assigned To (assigned_to__v)
    • Category (category__clin)
    • Clinical User Task Type (object_type__v)
    • Complete (complete__v)
    • Completion Date (completion_date__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Days Implementing (days_implementing__clin)
    • Days Investigating(days_investigating__clin)
    • Days Open (days_open__clin)
    • Description (description__v)
    • Due Date (due_date__v)
    • First Assigned Date (first_assigned_date__v)
    • First Escalated Date (first_escalated_date__clin)
    • First Implementation Date (first_implementation_date__clin)
    • First Investigation Date (first_investigation_date__clin)
    • Last Assigned Date (last_assigned_date__v)
    • Last Escalated Date (last_escalated_date__clin)
    • Last Implementation Date (last_implementation_date__clin)
    • Last Investigation Date (last_investigation_date__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle State (state__v)
    • Milestone (milestone__v)
    • NULL Date (null_date__clin)
    • Name (name__v)
    • Number of Escalations (number_of_escalations__clin)
    • Opened Date (opened_date__clin)
    • Priority (priority__clin)
    • Requiredness (requiredness__v)
    • Status (status__v)
    • Study (study__clin)
    • Study Communication (study_communication__ctms)
    • Template Milestone Set (milestone_list_template__v)
    • Template Task (template_task__clin)
  • Added the following fields as standard on the Study Country Task – Clinical User Task (clinical_user_task__clin.study_country_task__clin) object type:
    • Assigned (assigned__v)
    • Assigned To (assigned_to__v)
    • Category (category__clin)
    • Clinical User Task Type (object_type__v)
    • Complete (complete__v)
    • Completion Date (completion_date__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Days Implementing (days_implementing__clin)
    • Days Investigating(days_investigating__clin)
    • Days Open (days_open__clin)
    • Description (description__v)
    • Due Date (due_date__v)
    • First Assigned Date (first_assigned_date__v)
    • First Escalated Date (first_escalated_date__clin)
    • First Implementation Date (first_implementation_date__clin)
    • First Investigation Date (first_investigation_date__clin)
    • Last Assigned Date (last_assigned_date__v)
    • Last Escalated Date (last_escalated_date__clin)
    • Last Implementation Date (last_implementation_date__clin)
    • Last Investigation Date (last_investigation_date__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle State (state__v)
    • Milestone (milestone__v)
    • NULL Date (null_date__clin)
    • Name (name__v)
    • Number of Escalations (number_of_escalations__clin)
    • Opened Date (opened_date__clin)
    • Priority (priority__clin)
    • Requiredness (requiredness__v)
    • Status (status__v)
    • Study (study__clin)
    • Study Communication (study_communication__ctms)
    • Study Country (study_country__clin)
    • Template Milestone Set (milestone_list_template__v)
    • Template Task (template_task__clin)
  • Added the following fields as standard on the Study Site Task – Clinical User Task (clinical_user_task__clin.study_site_task__clin) object type:
    • Assigned (assigned__v)
    • Assigned To (assigned_to__v)
    • Category (category__clin)
    • Clinical User Task Type (object_type__v)
    • Complete (complete__v)
    • Completion Date (completion_date__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Days Implementing (days_implementing__clin)
    • Days Investigating(days_investigating__clin)
    • Days Open (days_open__clin)
    • Description (description__v)
    • Due Date (due_date__v)
    • First Assigned Date (first_assigned_date__v)
    • First Escalated Date (first_escalated_date__clin)
    • First Implementation Date (first_implementation_date__clin)
    • First Investigation Date (first_investigation_date__clin)
    • Last Assigned Date (last_assigned_date__v)
    • Last Escalated Date (last_escalated_date__clin)
    • Last Implementation Date (last_implementation_date__clin)
    • Last Investigation Date (last_investigation_date__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle State (state__v)
    • Milestone (milestone__v)
    • NULL Date (null_date__clin)
    • Name (name__v)
    • Number of Escalations (number_of_escalations__clin)
    • Opened Date (opened_date__clin)
    • Priority (priority__clin)
    • Requiredness (requiredness__v)
    • Site (site__clin)
    • Status (status__v)
    • Study (study__clin)
    • Study Communication (study_communication__ctms)
    • Study Country (study_country__clin)
    • Template Milestone Set (milestone_list_template__v)
    • Template Task (template_task__clin)
  • Added the following fields as standard on the Monitoring Follow Up Item – Clinical User Task (clinical_user_task__clin.monitoring_event_follow_up_item__ctms) object type:
    • Assigned (assigned__v)
    • Assigned To (assigned_to__v)
    • Category (category__clin)
    • Clinical User Task Type (object_type__v)
    • Complete (complete__v)
    • Completion Date (completion_date__v)
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Days Implementing (days_implementing__clin)
    • Days Investigating(days_investigating__clin)
    • Days Open (days_open__clin)
    • Description (description__v)
    • Due Date (due_date__v)
    • First Assigned Date (first_assigned_date__v)
    • First Escalated Date (first_escalated_date__clin)
    • First Implementation Date (first_implementation_date__clin)
    • First Investigation Date (first_investigation_date__clin)
    • Include in Site Letters? (include_in_site_letters__ctms)
    • Last Assigned Date (last_assigned_date__v)
    • Last Escalated Date (last_escalated_date__clin)
    • Last Implementation Date (last_implementation_date__clin)
    • Last Investigation Date (last_investigation_date__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Lifecycle (lifecycle__v)
    • Lifecycle State (state__v)
    • Monitoring Event (monitoring_event__ctms)
    • NULL Date (null_date__clin)
    • Name (name__v)
    • Number of Escalations (number_of_escalations__clin)
    • Opened Date (opened_date__clin)
    • Priority (priority__clin)
    • Site (site__clin)
    • Status (status__v)
    • Study (study__clin)
    • Study Country (study_country__ctms)
  • Added the following fields as standard on the Lab Test – Facilities Information (facilities_information__clin.lab_test__clin),  Imaging Equipment – Facilities Information (facilities_information__c.imaging_equipment__clin), and Other Equipment and Facilities – Facilities Information (facilities_information__clin.other_equipment_and_facilities__clin) object types:
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Date, Last Confirmed (date_last_confirmed__clin)
    • Details (details__clin)
    • Facilities Information Type (object_type__v)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Location (location__clin)
    • Name (name__v)
    • Number (number__v)
    • On-Site (onsite__clin)
    • Referable (referable__clin)
    • Serial Number (serial_number__clin)
    • Status (status__v)
    • Type (type__clin)
  • Added the following fields as standard on the Certification – Credentials (credentials__clin.certification__clin) and Education – Credentials (credentials__clin.education__clin) object types:
    • Created By (created_by__v)
    • Created Date (created_date__v)
    • Credential (name__v)
    • Credentials Type (object_type__v)
    • Date Granted (date_granted__clin)
    • Granting Body (granting_body__clin)
    • Last Confirmed (last_confirmed__clin)
    • Last Modified By (modified_by__v)
    • Last Modified Date (modified_date__v)
    • Notes (notes__clin)
    • Person (person__clin)
    • Status (status__v)
  • Added the following picklists associated with the Person & Organization feature:
    • Study Role (study_role__clin)
    • Contact Information Type (contact_information_type__clin)
    • Person Type (person_type__v)
    • Organization Type (organization_type__v)
    • Vendor Subtype (vendor_subtype__clin)
  • Added the following objects associated with the Person & Organization feature:
    • Contact Information (contact_information__clin)
    • Person (person__v)
    • Organization (organization__v)
    • Study Person (study_person__clin)
    • Employment Relationship (person_employment_relationship__clin)
  • Added the following object fields to the Study Site (site__v) object associated with the Person & Organization feature:
    • Principal Investigator (principal_investigator__v) 
    • Organization (organization__clin) 
  • Added the Person Lifecycle  (person_lifecycle__clin) associated with the Person & Organization feature.
  • Added the Organization (organization__v) and Person  (person__v) document fields associated with the Person & Organization feature.
  • Added the TMF Model and Hierarchy Records for the Artifacts (hierarchy__v)object associated with TMF templates.

  • Added the TMF Model and Hierarchy Records for the Artifacts (hierarchy__v) object associated with TMF templates.

  • Added the following tabs associated with the CTMS application:
    • Global Directory (global_directory__ctms)
    • Issue Management (issue_management__ctms)
    • Site Monitoring (site_monitoring__ctms)
    • Study Contacts (study_contacts__ctms)
    • Study Management (study_management__ctms)
  • Added a standard Submission (submission__clin) object type to the Milestone (milestone__v) and Template Milestone (template_milestone__v) objects.
  • Added the following objects associated with the CTMS application:
    • Central Monitoring Event (central_monitoring_event__ctms)
    • Selected Site (selected_site__ctms)
  • Added the following object lifecycles associated with the CTMS application:
    • Central Monitoring Selected Site (central_monitoring_selected_site__ctms)
    • Central Monitoring (central_monitoring_lifecycle__ctms)
  • Added the CTMS Trip Reports (ctms_trip_Reports_lifecycle__ctms) document lifecycle associated with the CTMS application.
  • Added the Create or Update Trip Report (create_or_update_trip_report__ctms) object workflow associated with the CTMS application.
  • Added the following items to support the Site Users in Clinical Vaults feature:
    • Home tab (site_user_home__v) for site users
    • Site User license type
    • Site Users (all_site_users__v) group
  • Added the Completeness Status (completeness_icon__v) object field to the Expected Document (edl_item__v) object

  • Added the Inactive (inactive_state__v) and Active (active_state__v) states to the Milestone (milestone_lifecycle__v) lifecycle

  • Added the Obsolete (obsolete__v) state to the Unclassified (unclassified__v) lifecycle. This allows for automatic matching of placeholders upon classification.
  • Added two (2) standard picklists: Template Behavior (template_behavior__v) and Template Update Scope (template_update_scope__v). EDL Milestone-based templates, if configured, will utilize these picklists.
  • Added four (4) standard picklists: Template IRB/EC Type (template_ec_type__v), Milestone Creation Trigger (milestone_creation_trigger__v), Issue Category (category_issue__clin), and Priority (priority__clin). Milestone templates, if configured, will utilize these picklists.
  • Added the standard picklist, Milestone Autocomplete (milestone_autocomplete__v). Milestone autocompletion, if configured, will utilize this picklist.
  • Added the standard Trip Report Section (trip_report_section__ctms) picklist. Trip reports, when configured, will utilize this picklist.
  • Added the following picklists associated with the Study Startup application:
    • Review Issue Type
    • Submission Decision
    • Assessment Tier
    • Equipment Type
    • Reason Site Will Not Participate
    • Experience (# of Studies)
    • Investigator Hold Reason
    • Location Type
  • Added various standard Clinical application picklists:
    • Indication
    • Location Type
    • Process Name
    • Review Issue Type
    • Study Phase
    • Submission Decision
    • In Progress Location
    • IP Release Issue Type
    • IR Issue Type
    • Signature Format
    • QC Issue Type
  • Added various standard picklists associated with the CTMS application:
    • Contact Category
    • Protocol Deviation / Violation Category
    • Communication Type
    • Metric Type
    • Monitoring Event Type
    • SAE Severity
    • Protocol Violation / Deviation Severity
    • Subject Status

  • Added the following picklist values associated with the CTMS application to the Milestone Type picklist:

    • First Subject In

    • Last Subject In

    • Last Subject Out

    • Pre Study Monitoring Visit

    • Site Initiation Monitoring Visit

    • Interim Monitoring Visit

    • Close Out Monitoring Visit

  • Added the following picklist values associated with Study Startup application to the Milestone Type picklist:  

    • Feasibility Survey Completed

    • Pre Study Monitoring Visit

    • Site Qualified

    • Milestone List Template
    • Milestone Template
  • Added the Milestone Templates data model, which consists of the following objects:
    • Milestone Dependency
    • Milestone Dependency Template
    • Template Milestone Master Set
    • Selected Milestone Set
    • Template Task
    • Story Event
  • Added Milestone List Template and Milestone Master Set fields to the Study object. These fields will automatically display on the Study object page layout.
  • Added the Ethics Committee Type field to the Study Country object. This field will automatically display on the Study Country object page layout.
  • Added the Ethics Committee Type field to the Study Site object. This field will automatically display on the Study Site object page layout.
  • Added various fields to the Milestone object, which will display in the Milestone object page layout:
    • Instance ID
    • Milestone Template
    • Milestone List Template
    • Baseline Start Date
    • Baseline Finish Date
    • Expected Duration (Days)
    • Story Milestone
    • Autocomplete
    • Sum of Expected Approved Documents
    • Sum of Actual Approved Documents
    • Sum of Actual Total Documents
    • Total EDL Item Records
    • Completed EDL Item Records
    • Total Previous Milestones
    • Completed Previous Milestones
    • Documents Complete Date

  • Added various Study Startup fields to the Milestone object.  These fields will be hidden from the Milestone object page layout:

    • Actual vs Forecast Finish

    • Actual vs Forecast Start

    • Approval Comments

    • Approval Date

    • Conditional Approval Comments

    • Conditional Approval Date

    • Expected Duration – Resubmit (Days)

    • Gating Override Date

    • Gating Override Eligible

    • Initial Submission Date

    • Initial Submission to Done

    • Internal Review Failed Date

    • Internal Review Issue Comments

    • Internal Review Passed Date

    • Internal Review Start Date

    • Number of Forecast Updates

    • Number of Queries Received

    • Number of Rejections

    • Number of Submissions

    • Number of Internal Reviews

    • Queries Received Comments

    • Queries Received Date

    • Rejection Comments

    • Rejection Date

    • Submission Acknowledged Date

    • Submission Expected Review Date

    • Internal Review Issue Type

    • Submission Decision

  • Added the Autocomplete field to Milestone Template object, which will display in the Milestone Template object page layout.
  • Made the Dynamic Binder Viewer tab visible within Admin. This tab is only used by the eTMF application.
  • Added document reference fields to the Monitoring Event object:
    • Doc Ref Confirmation Letter (doc_ref_confirmation_letter__v)
    • Doc Ref Follow Up Letter (doc_ref_follow_up_letter__v)
  • Added object workflows for generating Confirmation and Follow Up Letters directly from a Monitoring Event via user action:
    • Create Monitoring Confirmation Letter (create_monitoring_confirmation_letter__v)
    • Create Monitoring Follow Up Letter (create_monitoring_follow_up_letter__v)
  • Added the following Site Management document classifications for each standard Monitoring Event object type, along with associated document fields and templates:
    • Site Selection > Pre Trial Visit Follow Up Letter
    • Site Initiation > Trial Visit Confirmation Letter
    • Site Management > Monitoring Visit Follow Up Letter
    • Site Management > Monitoring Visit Confirmation Letter
    • Site Management > Close-Out Visit Follow Up Letter
    • Site Management > Close-Out Visit Confirmation Letter
    • Site Selection > Pre Trial Visit Confirmation Letter
    • Site Initiation > Trial Initiation Visit Follow Up Letter
  • Added the following fields on the Milestone List Template object, which will display on the Milestone List Template page layout:
    • Story Event
    • Story Milestone Set
    • Story Milestone
  • Added the Date Offset field to both the Milestone Dependency Template and Milestone Dependency objects, which will display on the respective object page layouts.
  • Added the Study Start-Up Packages document type associated with the Study Startup application.
  • Added the following objects associated with the Study Startup application:
    • Credentials
    • Facilities Information
    • Person Location
  • Added standard fields to Study Site object.  These fields will be hidden from the Study Site object page layout:
    • Site Selected Date
    • Actual Selected to Initiated (Days)

  • Added the following Study Startup fields to Study Site object.  These fields will be hidden from the Study Site object page layout:

    • Planned SIV Date

    • Actual SIV Date

    • Actual PSV Date

    • Assessment Tier

    • Date, Decision to Qualify

    • Date, Preliminary Assessment Complete

    • Date, Site Fully Qualified

    • Date, Site Identified

    • Date, Site Rejected

    • Date, Survey Received from Site

    • Days, Decision to Qualify

    • Days, Identification to Fully Qualified

    • Days, Identification to Rejection

    • Days, Identification to Selection

    • Days, Site to Complete Survey

    • Notes, Site Hold

    • Notes, Site Selection

    • Planned PSV Date

    • Projected Enrollment Potential

    • Days, Selected to Initiated

    • Reason for Not Participating

    • Notes, Not Participating

    • Fast-Trak Site

  • Added various standard Study Startup fields to Location object. These fields will be hidden from the Location object page layout:

    • Estimated Active Patients

    • Fast-Track Site

    • # Studies as Clinical Site

    • Therapeutic Expertise

  • Added various standard Study Startup fields to the Person object. These fields will be hidden from the Person object page layout:

    • Debarred

    • Key Opinion Leader
    • NPI Number
    • Research and Focus Areas

  • Therapeutic Expertise

    • Total Trials as PI

    • Total Trials as PI or SI

  • Added various standard Study Startup fields to Milestone Template object.  These fields will be hidden from the Milestone Template object page layout:
    • Expected Duration – Resubmit (Days)
    • Gating Override Eligible
  • Added standard object types to Milestone object:
    • Event
    • Monitoring Event
    • Standard
  • Added standard object types to Milestone Template object:
    • Event
    • Monitoring Event
    • Standard
  • Added standard object types to Clinical User Task object:
    • Monitoring Follow Up Item
    • Study Task
    • Study Country Task
    • Study Site Task
  • Added the CRF Import lifecycle and Final CRF document type to support the CRF Import feature.
  • Added the standard Expected Document and Expected Document List lifecycles.

  • Added standard lifecycle states to the Study Lifecycle:

    • Candidate

    • Planning

    • Cancelled

    • Active

    • Closing

    • Archived

    • In Migration

  • Added standard lifecycle states to the Study Country Lifecycle:

    • Candidate

    • Initiating

    • Cancelled

    • Active

    • Closing

    • Archived

    • In Migration

    • Inactive

  • Added standard lifecycle states to the Study Site lifecycle:

    • Candidate

    • Qualifying

    • Qualifying Hold

    • Initiating

    • Initiating Hold

    • Active

    • Closing

    • Closed

    • Not Selected

    • In Migration

    • Inactive

    • Archived

    • Cancelled

  • Added standard lifecycle states to the Milestone lifecycle:

    • Complete

    • In Internal Review

    • Internal Review Failed

    • Internal Review Passed

    • Unplanned

    • Started

    • Planned

    • Submission Conditionally Approved

    • Submission Queries Received

    • Submission Rejected

  • Added the External ID field to the following objects.  External ID will be hidden from the object page layout, except for the Story Event object:

    • Template Milestone Master Set

    • Story Event

    • Template EDL

    • Template EDL Item

    • Template Task

    • Subject

  • Added various standard fields to the Milestone Dependency object. These fields will be hidden from the Milestone Dependency object page layout.

    • Next Milestone Actual Finish Date

    • Next Milestone Planned Finish Date

    • Previous Milestone Actual Finish Date

    • Previous Milestone Planned Finish Date

  • Added the Tax ID field on the Organization and Person objects. This field will be hidden on the respective object page layouts.
  • Added the Protocol Title field on the Study object. This field will be hidden on the Study object page layout.
  • Added the following fields associated with the CTMS application on the Person object. These field will be hidden on the Person object page layout.
    • Prefix
    • Primary Email
    • Address
    • Suffix
  • Added the following fields associated with the CTMS application on the Event Schedule object. These fields will be hidden on the Event Schedule object page layout.
    • Study Event
    • Event Name

  • Added various standard objects associated with the CTMS application:

    • Enrollment Status Log

    • Event Schedule

    • Informed Consent Site Effective Tracking

    • Informed Consent Tracking

    • Metrics

    • Monitored Informed Consent Form

    • Monitored Metrics

    • Monitored Subject

    • Monitored Subject Event

    • Monitoring Activity

    • Monitoring Compliance

    • Monitoring Event

    • Monitoring Visit Participant

    • PD PV Sub Category

    • Protocol Violation or Deviation

    • Site SAE Tracking

    • Standard Monitoring Activity

    • Study Site Location

    • Subject
  • Added the following standard object lifecycles associated with the CTMS application:
    • Issues
    • Monitored Informed Consent Form
    • Monitored Metrics
    • Monitored Subject Events
    • Monitored Subjects
    • Monitoring Activity
    • Monitoring Event
    • Monitoring Visit Participant
    • Study Person

  • Added standard object types for the following CTMS objects:

    • Enrollment Status Log

    • Event Schedule

    • Metrics

    • Monitoring Compliance

    • Monitoring Event

    • Protocol Violation or Deviation

    • Study Communication Log
  • Added the Enrollment Status and Monitoring Compliance Summary jobs associated with the CTMS application.
  • Added various standard object workflows associated with the Trip Reports feature:
    • Plan Monitoring Event
    • Start Trip Report
    • Trip Report Template Review

  • Added various standard object lifecycles associated with the Trip Report feature:

    • Answer Lifecycle

    • Answer Set Join Lifecycle

    • Question Lifecycle

    • Monitoring Event

    • Trip Report Question Response

    • Trip Report Question Template Lifecycle

    • Trip Report Section Lifecycle

    • Trip Report Template Lifecycle

  • Added various standard objects associated with the Trip Report feature:

    • Answer

    • Answer Set

    • Answer Set Join

    • Question

    • Trip Report Answer

    • Trip Report Question Response

    • Trip Report Question Template

    • Trip Report Section

    • Trip Report Template
  • Added standard Distribution Task and Distribution Task Recipient objects and fields associated with Multi-Site Document Distribution (Study Startup).
  • Added custom page layouts associated with Multi-Site Document Distribution (Study Startup):
    • Distribution Task Detail Page Layout
    • Distribution Task Recipient Detail Page Layout
  • Added standard object lifecycles associated with Multi-Site Document Distribution (Study Startup):
    • Distribution Task Lifecycle
    • Distribution Task Recipient Lifecycle