Visit Types
A Monitoring Event is the planning and execution vehicle for CRA on-site/remote monitoring, with four core visit types out of the box:
| Type | Meaning |
|---|
| PSV (Pre-Study Visit) | Before the study |
| SIV (Site Initiation Visit) | Site initiation |
| IMV (Interim Monitoring Visit) | Interim monitoring |
| COV (Site Close Out Visit) | Site close-out |
Visit States (Main Path)
| State | Meaning | Available actions |
|---|
| Expected | Registered, awaiting scheduling | Plan Visit |
| Planning | Being scheduled | Confirm Visit |
| Confirmed | Confirmed | Start Trip Report |
| In Progress | Visit underway | Start Review etc. |
| In Review → Passed Review → Final | Review to finalization | Complete Review → Finalize |
Creating a Monitoring Visit
- Navigate to Site Monitoring → Monitoring Events → create, and choose a visit type (e.g. Interim Monitoring Visit).
- Fill in:
| Field | Notes |
|---|
| Name | Visit name (e.g. CTMS-IMV-20260802) |
| Study / Study Country / Study Site | All three are required |
| Study Person | Select an onboarded CRA |
| Planned Start / Planned End | Planned dates |
The record is saved in the Expected state.
Advancing the Full Lifecycle
| Step | Action | State change |
|---|
| 1 | Plan Visit, confirm planned dates | Expected → Planning |
| 2 | Confirm Visit | → Confirmed |
| 3 | Start Trip Report, fill Actual Start/End Date | → In Progress |
| 4 | Start Review | → In Review |
| 5 | Complete Review | → Passed Review |
| 6 | Finalize | → Final |
Note
When entering Planning / Confirmed / In Progress, the system may auto-seed Follow-Up / Issues / Monitored Enrollment data; empty lists don't affect the main path.
Viewing on Dashboards
- CRA Homepage → Monitoring Plan: lists scope-filtered visit plans with drill-down into Monitoring Event details.
- Study Management Homepage → Monitoring Status: counts distributed by visit type.
Troubleshooting
| Symptom | Suggestion |
|---|
| Creating a Monitoring Event fails validation | Study, Study Country, and Site are all required |
| Homepage Monitoring Status is empty | Verify the right Study is selected and the visit's Study/Country/Site bindings are correct |
Required Permissions & Roles
| Type | Permission | Controls |
|---|
| Object | Monitoring Event: Create, Read, Edit | Creating and maintaining visits |
| Lifecycle action | Monitoring Event: Plan Visit, Confirm Visit, Start Trip Report, Start Review, Complete Review, Finalize | The full visit lifecycle |
| Object | Study Person: Read | Assigning a CRA (study team must be onboarded) |
Monitoring visits require Study / Country / Site bindings; CRAs typically only see visits assigned to them or within their scope.