Overview
The Monitoring Visit Report (MVR) app enables CRAs and Site Monitors to document and manage site monitoring activities within ClinicalDataS. It connects monitoring workflows with EDC, Query, Task, Notification, and Subject modules — using a single user account across all modules.
Key Capabilities
- Create visit plans and monitoring reports per study-site
- Record checklist findings and observations
- Create and manage issues with classification by type, level, and category
- Link data issues to EDC queries with two-way traceability
- Perform SDV and sync verification status bidirectionally with EDC
- Assign actions with owners and due dates, integrated with Task Center
- Execute report lifecycle: Draft → Completed → Reviewed → Finalized → Approved
- E-signature with audit trail, content snapshot, and reopen controls
- Dashboard analytics: issue aging, site risk, SDV completion
Integration Principles
- Single Identity — one user account for all CDS modules
- Reuse Data — study/site/subject/visit/form data prefilled from CDS core, no re-entry
- Linked Workflow — MVR issues can create EDC queries with traceability both ways
- Central Inbox — all actions appear in one place (My Work, My Tasks, Notifications)
- One Source of Truth — SDV, subject, and query statuses synced across modules
- Audit by Default — every edit, assignment, signature, and reopen is recorded
Documentation
- Configuration — Report templates, visit types, recipients, SDV integration, e-signature
- Monitoring Visit Overview — Dashboard, workflow phases, user roles
- Monitoring Visit User Guide — Create reports, manage issues, link EDC queries, sign reports
- Monitoring Visit Setup — Configure visit types, dependency rules, notifications, issue templates