Relationship to eTMF Clinical Tasks
The CTMS Clinical Tasks share one object with the eTMF clinical tasks (Clinical User Task, see Clinical Tasks); they simply live in different tabs: Site Monitoring → Clinical Tasks and Study Management → Clinical Tasks. The CTMS-specific type is the Monitoring Follow Up Item.
Monitoring Follow Up Items
A follow-up item is a task hanging on a monitoring event — "what needs following up after this visit" — managed under Site Monitoring → Monitoring Follow Up Items. It is slimmer than a regular task:
| Field | Notes |
|---|---|
| Name | Follow-up item name (required) |
| Study / Study Country / Study Site | Auto-filled from the monitoring event on creation |
| Monitoring Event | The linked event (required, must belong to the same site) |
| Category / Priority | Category and priority (required) |
| Assigned To | Assignee (usually the CRA or site coordinator) |
| Opened Date / Due Date | Opened date and due date |
| Complete | Completion flag (required field, auto-checked on Resolve) |
Create inline from the Monitoring Follow Up Items section of the Monitoring Event detail page (recommended — study/site fill automatically), or from the tab list and then link an event of the same site manually. The state flow matches regular tasks: Open → Investigating / Implementing / Escalated → Resolved.
Seed Follow Up Items & Visit Reporting
Run All Actions → Seed Follow Up Items on a monitoring event to snapshot two sets of follow-up items onto the event, for writing visit reports / follow-up letters:
- Monitored Open Follow Up Items: items still open at event time;
- Monitored Closed Follow Up Items: items closed since the previous monitoring event.
Note
Seed Follow Up Items only creates link snapshots; it does not create follow-up records — register the items first (or create them inline on the event detail).
Link to Milestone Completeness
Study-side tasks can link a Milestone; required tasks count toward milestone completeness once done (see Milestone Tracking and Milestones).
Troubleshooting
| Symptom | Suggestion |
|---|---|
| Can't pick a Monitoring Event when creating | The item and event must belong to the same study site; pick the right Study Site first |
| Can't see my own items in the list | Make sure Assigned To is set; the My Tasks page shows everything assigned to you |
| Sections stay empty after Seed Follow Up Items | The action only links existing items; create follow-up items on the event detail first |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Clinical User Task (incl. Monitoring Follow Up Item): Create, Read, Edit | Registering and maintaining follow-up items |
| Lifecycle actions | Investigate, Implement, Escalate, Resolve | Advancing tasks to resolution |
| Object action | Monitoring Event: Seed Follow Up Items | Snapshotting follow-up items onto the visit |
CRA, Central Monitor, and CTMS Study Manager can create follow-up items and advance states; CRAs can delete items they created; CTMS Business/System Administrators hold full access.