Overview
DEOX-MOCK-002 · NOVA-STAR · Phase II NSCLC
Checking API...
DEMO
DU
Demo User
Total Sites
-
Active Subjects
-
Avg SDV%
-
SAEs
-
Enrolment Trend
-
Enrolment by Month
47/120Site Performance Summary
| Site | Enrolled | Active | SDV% | Compliance |
|---|
Recent Activity
Upcoming Milestones
| Milestone | Date | Status |
|---|
Risk Watch Summary
AI Insights
0
Total Contacts
0
Principal Investigators
0
Coordinators
0
CRAs / Monitors
6
Active Sites
47
Total Enrolled
39%
Overall Enrolment
88%
Avg SDV
2
Sites At Risk
? Site-Specific Risks
3
Total SAEs
2
Related to IP
3
Recovered
0
Open SAEs
SAEs — Trending by MoA
SAEs
All Require Review
? Safety-Specific Risks
3
Major
2
Minor
2
CAPA Linked
3
Closed
2
Open
By Site
By Type
Timeline
Tasks
● Offline
| ID | Description | Site | Type | Severity | Status | CAPA | Actions |
|---|
0
Total CAPAs
0
Open / In Flight
0
Closed / Verified
0
Avg Closure
0
Overdue
5
CTQ Factors
3
QTLs Breached
14
Active KRIs
7
Protocol Deviations
4
Actions Taken
3
Actions Pending
Risk Matrix (Impact � Likelihood)
Likelihood ?
Impact ?
Low
Medium
High
Critical
CTQ ? QTL ? KRI Cascade
KRI Signal Summary
| KRI | CTQ | QTL Threshold | Current | Signal | Associated PDs | Actions Taken | Actions Pending |
|---|
Action Tracker - Risk-Linked
| Action ID | Linked KRI | Linked PD | Action | Owner | Due | Status |
|---|
Tasks
● Offline
| ID | Risk | Score | Level | Status | Category |
|---|
847
Entries This Month
5
Active Users
Sites (312)
Most Changed Entity
2026-04-28
Last Audit Review
23
Critical Changes
Electronic Signature Log (21 CFR Part 11)
| Signatory | Role | Document / Action | Signed Date | Meaning | Status |
|---|
Live Session Audit Trail
LIVE6
Report Templates
7
Reports Generated
2
Active Schedules
4
Report Types Used
Report Templates
Click Generate to create a report from current study dataReport History
| Date | Report Type | Generated By | Format | Size | Status |
|---|
Scheduled Reports
Automated report generation and distribution| Report | Frequency | Schedule | Recipients | Status | Actions |
|---|
Obligation Tracker
| ID | Obligation | Risk Level | Due Date | Status |
|---|
Approval Queue - 21 CFR Part 11 Compliant
| Submission ID | Document Type | Title | Classification | Submitted By | Submitted | Status | Actions |
|---|
Document Classification Guide
Approval Workflow
Electronic Signature Log - 21 CFR Part 11
| Timestamp | Approval | Action | Signatory | Role |
|---|
Compliance Checklist
Validation Pack Progress (IQ / OQ / PQ)
Inspection Readiness Score
Gap Analysis Summary
3
Complete
5
On Track
1
At Risk
0
Overdue
67%
Overall Progress
Study Timeline
Milestone Register
| Milestone | Target Date | Actual Date | Status | Category | Owner | Progress |
|---|
Study KPIs
10
Platform Modules
51
API Endpoints
38
Stable
10
Beta
9/10
Integrations
65%
Platform Complete
Change Control
Managed change requests for study documents, processes, and systems.
Change Register
| ID | Description | Type | Requester | Priority | Status | Due Date |
|---|
AI Model Configuration
Knowledge Base
Study Context Loaded
?? Knowledge Graph - Entity Relationships
Interactive map of study entities. Click any node for details, click any edge for relationship context. Drag nodes to rearrange.
AI Working Memory - Today's Digest
Auto-generated from all study activity. Updated continuously as events occur.
232
Days Running
8
Events Today
1
Overdue Actions
3
Predictions
? Urgent Actions
Predictions
Key Trends
AI Recommendations
Cross-Referenced Insights
Mock Day Simulation
Select a day to see how the AI ingested events and generated intelligence.
Active Plans & Strategies
Study plans, review schedule, and document links in one unified view.
-
Total Plans
-
Approved
-
Overdue Review
-
Deviations
Plan Registry
| Plan | Type | Status | Next Review | Owner | Reminder Lead | KRI |
|---|
Document Pipeline
Track document status across the TMF lifecycle
| ID | Document | Category | Status | Owner | Zone | Version | Date | Actions |
|---|
12
Active Shipments
847
Units Received
23
Units Quarantined
96.2%
Accountability Rate
1
Temp Excursions
156
Units Dispensed
IMP Batch Register
| Batch ID | Product | Formulation | Batch No | Received | Dispensed | On-Site | Expiry | Status |
|---|
Shipment Log
| Shipment ID | Batch | From | To Site | Shipped | Received | Condition | Temp (�C) | Status |
|---|
? Temperature Monitoring
| ID | Shipment | Site | Recorded Temp | Limit | Duration | Impact | CAPA | Status |
|---|
IMP Reconciliation
Destruction Records
| ID | Batch | Qty | Reason | Method | Witness | Date | Certificate |
|---|
📊 Restock Calculator
Investigator Site File (ISF)
ISF = site-level | eTMF = sponsor-level
157
Total Documents
127
Filed
14
In Review
4
Missing
90.2%
ISF Completeness
6
Active Sites
Per-Site ISF Summary
ISF Zone Navigator
Document Registry
| Doc ID | Title | Zone | Status | Version | Filed | Owner | Actions |
|---|
Inspection Readiness
Missing Documents Alert
Filing Timeline (Recent)
-
Total Documents
-
Filed
-
In Review
-
Missing
-
Overall Completeness
Categories:
eTMF Folder Structure
eTMF Zone Navigator
Document Registry
-| ID | Title | Category | Status | Version | Author | Date | Actions |
|---|
Inspection Readiness
? Missing Documents
Expected Documents (DIA v3.3.1)
Filing Timeline
Operational Metrics
Enrollment Analytics
Site Analytics
Safety Analytics
Quality Analytics
Screening Funnel
Enrolment vs Target
Site Comparison
Query Analytics
Safety Timeline
KPI Scorecard
CTQ Cascade - Critical-to-Quality Hierarchy
KRI Signal Table
| KRI | CTQ | Threshold | Current | Signal | PDs | Actions Taken | Actions Pending |
|---|
Risk Action Tracker
| Action ID | KRI | PD Ref | Action | Owner | Due | Status |
|---|
Tasks
● Offline
| Task | Assignee | Priority | Due Date | Status | Category |
|---|
Submissions & Timeline
| Type | Description | Status | Due Date | Site/Country |
|---|
Site Regulatory Status
Startup Checklist (GLAC)
⚙️ System Administration
Click the Users tab to load the admin panel