What Is a Clinical Task
A Clinical User Task is a to-do/issue item on the study hierarchy: assigned to someone, with a category, priority, and due date, tracked until resolved. Tasks appear in several places — on the eTMF side mainly Planning → Clinical Tasks; CTMS monitoring follow-up items are built on the same object (see Monitoring Follow Up Items & CTMS Clinical Tasks).
Task Types (Object Types)
The type determines which level the task hangs on and whether it links to a monitoring event:
| Type | Level | Notes |
|---|---|---|
| Study Task (default) | Study | Study-level task; can link milestones and template tasks |
| Study Country Task | Study Country | Country-level task |
| Study Site Task | Study Site | Site-level task |
| Monitoring Follow Up Item | Study Site | CTMS monitoring follow-up; must link a monitoring event of the same site |
The Study Tasks / Study Country Tasks / Study Site Tasks sections on study/country/site detail pages filter tasks by type.
Creating a Task
- Go to Planning → Clinical Tasks → create, and pick a type (default Study Task).
- Fill in:
| Field | Notes |
|---|---|
| Name | Task name (required) |
| Study / Study Country / Study Site | Cascading selection by type |
| Category | Required; one of 12 values such as Essential Documents/ISF, Informed Consent, Data Collection/Data Entry/Query Resolution |
| Priority | Required: Low / Medium / High |
| Assigned To | Assignee |
| Opened Date | Required; must not be after today |
| Due Date | Must not be before Opened Date |
| Required | Whether the task is required |
| Milestone | Optional link so the task counts toward milestone completeness |
- After saving, the task is in Open state and the assignee is notified; the My Tasks page centralizes everything assigned to you.
States & Actions
| State | Available actions |
|---|---|
| Open | Investigate, Implement, Escalate, Resolve |
| Investigating | Implement, Escalate, Resolve |
| Implementing | Escalate, Resolve |
| Escalated | Investigating, Implementing, Resolve |
| Resolved | None (terminal, record becomes read-only) |
Note
Entering Escalated accumulates escalation counts and dates; Resolve automatically checks Complete and stamps Completion Date, and computes Days Open / Days Investigating / Days Implementing.
Validation Rules
- Opened Date must not be after today;
- Due Date must not be before Opened Date.
Troubleshooting
| Symptom | Suggestion |
|---|---|
| No Milestone field when creating | Use the default Study Task type; the Monitoring Follow Up Item type has a slimmer field set |
| Want to edit after Resolved | Resolved is a terminal read-only state; create a new task instead |
| Assignee gets no notification | Make sure Assigned To is set; assignment and reassignment notifications go to the assignee |
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Clinical User Task: Create, Read, Edit | Creating and maintaining tasks |
| Lifecycle actions | Investigate, Implement, Escalate, Resolve | Advancing tasks to resolution |
| Object | Milestone: Read | Linking milestones and affecting their completeness |
Clinical Application Administrator and Document Contributor can both edit tasks and run all lifecycle actions; task visibility is trimmed by study sharing, and assignees typically see tasks assigned to them.