What it is
The Monitoring Visit module supports end-to-end site monitoring visit reporting — from configuring visit types and CRF mappings, through report authoring and findings capture, to reviewer and sponsor approval workflows.
Who uses it
| Role | Typical use |
|---|---|
| CRA / Monitor | Plan visits, author monitoring reports, log findings |
| Reviewer | Review and approve monitoring reports |
| Sponsor | Final approval and oversight of site monitoring activities |
| Study Administrator | Configure visit types, recipients, and site branches |
Key capabilities
- Visit type and CRF mapping configuration
- Dashboard counters for report workload by site and visit type
- Report lifecycle with audit-ready status transitions
- Cross-role handoff between Monitor, Reviewer, and Sponsor
- Findings & Issues management — track and resolve monitoring observations
- Protocol deviations & SAEs — linked read-only matrices per visit
- Close-out visit workflow — structured site close-out with checklist
Findings, CAPA & Issue Resolution
Monitoring visits often identify issues that require corrective action. The Monitoring Visit module supports a full CAPA (Corrective and Preventive Action) workflow:
- Identify — CRA creates an Issue during report authoring (with type, level, category)
- Document — Original Action recorded at creation
- Assign — Issue linked to specific report section/division
- Resolve — Updated Action and Resolution Date entered
- Close — Issue marked Completed
- Reopen — Closed issues can be reopened if follow-up is needed
Issue Attributes
| Attribute | Values |
|---|---|
| Type | Deviation, Waiver, Violation |
| Level | High, Normal, Low |
| Category | Protocol, GCP, Documentation, etc. |
| Status | Opened, Completed |
Issues can be viewed across all visits in the Issues Matrix, filtered by site, type, status, and level. The Check Duplicate feature prevents redundant issue creation.