Overview
Configure the Monitoring Visit Report app from Home → select your study → Monitoring Visit Report (under Installed Apps) → Setting.
Configuration URL: https://[instance]/home/study/[studyId]/apps/monitoring-visit-report
Visit Types
Define which visit types are available for monitoring reports.
| Visit Type | Typical Use |
|---|---|
| Site Qualification Visit (SQV) | Pre-study site assessment |
| Site Initiation Visit (SIV) | Study start-up and site activation |
| Site Monitoring Visit (SMV) | Routine interim monitoring |
| Contact Report | Phone/email follow-up between visits |
| Site Close-Out Visit (COV) | Study close-out and site deactivation |
Configure a Visit Type
- In Visit Configuration, click Edit on a visit type
- Set Active toggle to enable or disable the visit type
- Enter Visit name — display name used across the system
- Select CRF name — the CRF used as the report template
- Choose CRF version default — the default version for new reports
- Click Submit
Without a CRF name and default version, users cannot create reports for that visit type.
Report Templates
Each visit type uses a CRF as its report template. The CRF defines the sections, fields, and structure of the monitoring report.
Template Sections
A typical monitoring report CRF includes these sections:
- Visit Info — metadata: date, attendees, location
- SDV — source data verification checklist per subject/visit/form
- Findings — checklist of observations per category
- Issues & Actions — findings requiring follow-up
- Data Snapshot — screening failures, discontinuations, SAE summary
- Summary & Signature — conclusions, next steps, e-signature
Recipients & Notifications
Configure who receives notifications when report statuses change.
Role-Based Recipients
Select roles from the Email the recipient when the report status updates dropdown:
- Study Administrator
- Study Sponsor
- Reviewer
- CRA / Monitor
- Data Manager
Specific People
Add individual email addresses separated by semicolons (;) for ad-hoc recipients not covered by role-based selections.
Notification Events
| Event | Default Notified |
|---|---|
| Report created | Study Manager |
| Report submitted for review | Reviewer, Study Manager |
| Report signed | Study Manager, Sponsor |
| Report reopened | Report author, Study Manager |
SDV Integration
Link MVR with the EDC Source Data Verification module.
- Sync SDV status to EDC — status changes in MVR reflect on EDC dashboards
- SDV Delta View — compare current vs. previous visit SDV status
- Risk-based sampling — enable subject selection strategies (random, high-risk, overdue)
E-Signature
Enable and configure e-signature for report completion.
- Require e-signature for report approval — enforce signing before Approved status
- Capture metadata — record IP and device information in audit trail
- Content snapshot — store a hash of report content at signing time
- Reopen approval — enforce approval workflow for post-signature edits
Issue Templates
Standardize findings with pre-defined templates per visit type. Templates ensure consistent classification across reports.
Each template can specify:
- Category — Protocol, GCP, Documentation, Consent, Safety, Process, Data
- Default Level — High, Normal, Low
- Default Type — Deviation, Waiver, Violation
- Description Template — pre-filled text for the finding
- Suggested Action — recommended corrective action