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 18R3.
As part of Vault’s efforts to provide better functionality, each release introduces various data model items related to features that may not be enabled in every customer vault. These items will appear in Admin, but will not have any related functionality unless the related feature is enabled.
Note: All new objects include a set of system fields (Created By, Created Date, Status, etc.). All object lifecycles include a set of standard roles (Viewer, Editor, and Owner). This list does not include these universal object fields or lifecycle roles.
Added the following items to support Seeding Subject Visits on Monitoring Events:
- Monitored Subject Visit (
monitored_subject_visit__v) with fields:- Event Datetime (
event_datetime__v) - Event Sequence (
event_seq__v) - Event Stop Datetime (
event_stop_datetime__v) - Repeat Key (
repeat_key__v) - Review For SDV (
rev_sdv__v) - SDV Complete Datetime (
sdv_datetime__v) - SDV Complete Date (
sdv_date__v) - SDV Mode (
sdv_mode__v) - Site (
site__v) - Study (
study__v) - Study Country (
study_country__v) - Monitoring Event (
monitoring_event__v) - Monitored Subject (
monitored_subject__v) - Visit (
event_def__v) - Visit Date (
event_date__v) - Visit Status (
event_status__v) - Subject Visit (
event__v) - EDC ID (
edc_id__v)
- Event Datetime (
- Monitored Subject Visits Lifecycle (
monitored_subject_visits_lifecycle__v) with items:- In Progress (
in_progress_state__v) lifecycle state - Complete (
complete_state__v) lifecycle state - Inactive (
inactive_state__v) lifecycle state
- In Progress (
Added the following items to support the Study Startup Specialist Homepage:
- Added Default Days, Site Selected to Greenlight (
default_days_site_selection_to_gl__v) field on the Country (country__v) object - Target _Lag, Site Selection to Greenlight_ (
target_lag_site_selection_to_greenlight__v) field on the Study Country (study_country__v) object - Study Site (
site__v) object with fields:- Planned Greenlight Date (
planned_greenlight_date__v) - Days to Greenlight (
days_to_greenlight__v_) - % Greenlight Activities Complete (
greenlight_activities_complete__v) - Greenlight Completeness (
greenlight_completeness__v_)
- Planned Greenlight Date (
- Risk (
risk__v) field on the Milestone (milestone__v) object
Added the following items to support EDL Version Support:
- Expected Document Version # (
expected_document_version_num__v) field on the Expected Document (edl_item__v) object - Auto-assign Version Number (
auto_assign_version_number__v) field on the Template Expected Document (edl_item_template__v) object - Milestone Item Lifecycle (
milestone_item_lifecycle__v) with items:- Active (
active_state__v) lifecycle state - Inactive (
inactive_state__v) lifecycle state
- Active (
Added the following items to support Standard Quality Objects:
- Quality Issue (
quality_issue__v) object with fields:- # of Days Open (
num_of_days-open__v) - Assigned To (
assigned_to__v) - Days until Due (
days_until_due__v) - Due Date (
due_date__v) - Object Type (
object_type__v) - QC Issue Comments (
qc_issue_comments__v) - QC Issue Type (
qc_issue_type__v) - Quality Issue ID (
name__v) - Related Document (
related_document__v) - Related Document (
unbound) (related_document_unbound__v) - Verdict (
verdict__v) - Verdict Date (
verdict_date__v) - Verdict Reason (
verdict_reason__v)
- # of Days Open (
- Quality Issue lifecycle (
quality_issue_lifecycle__v) with items:- Open (
open_state__v) lifecycle state - Initiated (
initiated_state__v) lifecycle state - Closed (
closed_state__v) lifecycle state - Inactive (
inactive_state__v) lifecycle state - Assigned To (
assigned_to__v) lifecycle role
- Open (
- QC Issue Type picklist (
qc_issue_type__v) with items:- Duplicate (
duplicate__v) - Expired (
expired__v) - Inaccurate Content (
inaccurate_content__v) - Incomplete Metadata (
incomplete_metadata__v) - Misclassified (
_Misfiled_) (misclassified_misfiled__v) - Missing (
missing__v) - Signature Not Present (
signature_not_present__v)
- Duplicate (
- Quality Issue Task workflow (
quality_issue_task__v) - Document fields:
- # of Open Issues (
num_of_open_issues__v) - # of Closed Issues (
num_of_closed_issues__v) - # of Total Issues (
num_of_total_issues__v)
- # of Open Issues (
- Object Messages:
- Quality Issue Task (
quality_issue_task__v) - Quality Issue Verdict (
quality_issue_verdict__v)
- Quality Issue Task (
Added the following items to support Subject Visits:
- Visit Definition (
visit_def__v) object with fields:- Visit Type (
visit_type__v) - External ID (
external_id__v) - EDC ID (
edc_id__v)
- Visit Type (
- Study Arm (
study_arm__v) object with fields:- Study (
study__v)
- Study (
- Visit (
visit__v) object with fields:- Visit Date (
visit_date__v) - Visit Datetime (
visit_datetime__v) - Visit (
visit_def__v) - Visit Sequence (
visit_seq__v) - Visit Status (
visit_status__v) - Visit Stop Datetime (
visit_stop_datetime__v) - Overdue Date (
overdue_date__v) - Planned Date (
planned_date__v) - Planned Datetime (
planned_datetime__v) - Repeat Key (
repeat_key__v) - Review For CFR (
rev_cfr__v) - Review For DMR (
rev_dmr__v) - Review For Frozen (
rev_frozen__v) - Review For Locked (
rev_locked__v) - Review For MMR (
rev_mmr__v) - Review For Signature (
rev_sign__v) - SDV Mode (
sdv_mode__v) - Site (
site__v) - Study (
study__v) - Study Country (
study_country__v) - Subject (
subject__v) - External ID (
external_id__v) - EDC ID (
edc_id__v) - SDV Complete (
rev_sdv__v) - SDV Complete Date (
sdv_date__v) - DMR Complete (
rev_dmr__v) - DRM Complete Datetime (
dmr_datetime__v) - DMR Complete Date (
dmr_date__v) - SDV Complete Datetime (
sdv_datetime__v) - SDV Complete Date (
sdv_date__v)
- Visit Date (
- Arm (
arm__v) field on the Subject (subject__v) object