Common Subject States
| State | Meaning |
|---|---|
| Consented | Informed consent obtained |
| In Screening | In screening |
| Screen Failure | Screening failed |
| Enrolled | Enrolled |
| Withdrawn | Withdrawn |
Registering & Enrolling
- Open the Subjects list → Create.
- Fill in:
| Field | Notes |
|---|---|
| Subject ID | Subject identifier (e.g. CTMS-OV-20260802-001) |
| Study | The owning study |
| Study Country | Study country |
| Study Site | Study site — must be an Active site |
| Subject Status | First Consented, then In Screening, finally Enrolled (can save in steps) |
| Initial Consent Date | Consent date |
| Screened Date | Screening date |
| Enrolled Date | Enrollment date |
Screen Failure (Exception Path)
Create another subject record with Subject Status = Screen Failure, fill in Screen Failed Date, and save. Exception paths are recorded alongside successful enrollments and can be referenced by issue/deviation records.
Relationship to Deviations & Visits
Subject records are the anchor for enrollment progress and deviation traceability:
- A Protocol Deviation / Issue can link a Subject field to show which subject the problem concerns (see Issues & Protocol Deviations).
- Enrollment data recorded in monitoring visits shares the same source as subject records, useful for scope-based verification (see Monitoring Visits).
Note
Some dashboard/metric aggregations depend on backend seeding and frontend aggregation; a trial environment may show 0 or empty charts — a known difference. What matters is that subject records themselves can be created, queried, and referenced by deviations.
Required Permissions & Roles
| Type | Permission | Controls |
|---|---|---|
| Object | Subject: Create, Read, Edit | Registering subjects and advancing status |
| Field | Subject status fields (Subject Status etc.): Edit | Consented → In Screening → Enrolled progression |
Subjects must hang under an Active site; users without Read access to a site will not see its subjects in lists.