How a Study Runs on Health Wizz CTMS

From protocol setup to final report -- every step in one platform

Phase A -- Study Setup
STEP 1
Create a Study
Protocol, phase, indication, dates
STEP 1b
Add Sites
PI, location, enrollment target
STEP 2a
Upload Protocol
eTMF Binder -- ICH E6 R2
eTMF
STEP 2b
Visit Schedule
Windows, procedures, SMART Assist
STEP 2c
IRB Submission
Approvals, renewals, alerts
STEP 2d
Drug Accountability
IMP chain of custody
21 CFR Part 11
Create a Study
Studies > + New Study
  • Study name, protocol number, sponsor, phase (I-IV), indication, therapeutic area
  • Planned start and end dates with target enrollment
  • Status: Recruiting / Active / On Hold / Closed
  • Study card shows live enrollment progress, site count, and open queries
Add Sites
Study detail > Sites tab > + Add Site
  • Site name, Principal Investigator, city/state, enrollment target
  • Per-site enrollment progress and status badges
  • SMART Assist generates site readiness insights automatically
Upload Protocol to eTMF
Sidebar > eTMF > Study > Zone 1, Section 1.1
  • ICH E6 R2-compliant structure: 8 zones, 30+ sections
  • Upload triggers automatic zone completion percentage update
  • Secure download via pre-signed URL
  • Full metadata and audit trail on every document
Create Visit Schedule
Study detail > Protocol tab > Visit Schedule
  • Define visit name, day, and window tolerance (e.g. Day 28 +/- 3 days)
  • Per-visit procedure checklist
  • SMART Assist suggests standard visit windows based on the indication
  • Feeds automatically into patient visit tracking and the calendar
IRB / IEC Submission Tracker
Sidebar > Regulatory > IRB/IEC Tracker
  • Log initial approval, continuing reviews, amendments, and safety reports
  • Automatic expiry and renewal alerts with color-coded badges
  • Dashboard: total, approved, pending, and expiring within 30 days
  • Full submission history per study
Drug Accountability (IMP)
Sidebar > Drug Accountability
  • Track shipment receipt, dispensing to patients, returns, and destruction
  • Live on-hand inventory: received minus dispensed plus returned
  • Color-coded expiry warnings
  • E-signature on every transaction -- ICH GCP 5.14 and 21 CFR Part 11 compliant
Study configured -- ready to enroll
Phase B -- Patient Enrollment
STEP 3
Import Patients
From Journey -- no re-entry
Journey
STEP 4
Informed Consent
Full ICF lifecycle, e-signature
21 CFR Part 11
Import Patients from Journey
Sidebar > Patients > Import from Journey
  • Pulls all enrolled members from the matching Journey study automatically
  • Patient name, email, and phone are pre-populated -- no manual entry
  • Each patient gets a detail page: visit schedule, deviations, consent status
Patients are recruited in Journey and managed in CTMS -- one ecosystem, no duplicate data entry.
Informed Consent (eConsent)
Sidebar > eConsent > + Record Consent
  • Full lifecycle: Pending, Consented, Re-Consent Needed, Re-Consented, Declined, or Withdrawn
  • Dashboard shows consent rate percentage, pending, declined, and withdrawn counts
  • E-signature capture -- 21 CFR Part 11 compliant
  • Bulk flag for re-consent when a protocol amendment is issued
  • Full consent history per patient in a detail drawer
Patients enrolled -- study is running
Phase C -- Active Study Operations
STEP 5
Patient Visits
Log visits and deviations
STEP 6
SDV Queries
Open, Answered, Closed
STEP 7
Monitoring Visits
Schedule, findings, SMART report
STEP 8
Adverse Events
CTCAE grading, SAE alerts
STEP 9
Calendar
All events in one view
Patient Visits and Deviation Tracking
Patient detail > Visits tab / Deviations tab
  • Scheduled vs actual visit date, status: Completed / Missed / Pending
  • Procedure checklist completion per visit
  • Protocol deviation log linked to each visit (minor / major / critical)
SDV Queries
Sidebar > Queries
  • CRA raises a query on any data point; site responds; CRA closes or escalates
  • Full workflow: Open, Answered, Closed
  • Open query count shown as a dashboard widget on the homepage
Monitoring Visits
Sidebar > Monitoring
  • Schedule: date, site, CRA, type (remote / on-site / co-monitoring)
  • Pre-visit checklist, during-visit findings, post-visit report
  • SMART Assist drafts the monitoring visit report narrative
  • Open findings tracked to resolution
Adverse Events
Sidebar > Adverse Events > + Report AE
  • Event term, CTCAE severity grade, relatedness, action taken, resolution date
  • SAE flag with 24-hour reporting alert
  • Tamper-evident audit trail on every change
Calendar -- All Events in One View
Sidebar > Calendar
  • Auto-aggregates: monitoring visits, patient visits, IRB expiries, AE deadlines, milestones
  • Month / Week / Agenda views -- color-coded by event type
  • Add one-off events via the Add Event modal
Operations running -- generate deliverables
Phase D -- Oversight and Reporting
STEP 10
PDF Reports
3 sponsor-ready reports
Live data
STEP 11
Audit Log
21 CFR Part 11 trail
STEP 12
SMART Assist
Insights across every module
SMART Assist
Reports
Sidebar > Reports > Generate
  • Study Status Report -- enrollment vs target, site performance, open queries, AE summary
  • Patient Enrollment Report -- per-site timeline, screen fail rate, randomization
  • Monitoring and SDV Report -- visit log, findings, query resolution rates
  • PDF downloads instantly -- Health Wizz branded, powered by live data
Audit Log
Sidebar > Audit Log
  • Every action logged: who, what, when, and IP address
  • Filter by user, action type, or date range
  • Tamper-evident and FDA inspection-ready (21 CFR Part 11)
SMART Assist
SMART Assist button on every major module
  • Analyzes current record data and surfaces actionable insights
  • Apply button pre-fills form fields with suggested values
  • Supports multiple AI providers -- configurable per organization
  • BAA-ready for HIPAA compliance
Click any step to learn more -- click again to close
Phase A: Setup
Phase B: Enrollment
Phase C: Operations
Phase D: Reporting

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