Status Overview
Carelane uses the HL7 FHIR ResearchSubject state model for participant status:| Status | Code | Description |
|---|---|---|
| Candidate | candidate | Potential participant, not yet screened |
| Screening | screening | Undergoing eligibility screening |
| Eligible | eligible | Meets eligibility criteria |
| Ineligible | ineligible | Does not meet eligibility criteria |
| Informed Consent Obtained | informed-consent-obtained | Consent documented |
| On Study | on-study | Actively participating |
| On Study Intervention | on-study-intervention | Receiving study intervention |
| On Study Observation | on-study-observation | In observation phase |
| Follow-up | follow-up | In follow-up period |
| Off Study | off-study | Completed study participation |
| Withdrawn | withdrawn | Withdrew from study |
Status Workflow
Typical Flow
Alternative Flows
| Scenario | Flow |
|---|---|
| Screen Failure | Candidate → Screening → Ineligible |
| Early Withdrawal | On Study → Withdrawn |
| Direct Enrollment | Candidate → On Study (if no screening) |
Changing Status
Status Transitions
Not all transitions are valid. The system enforces logical status progressions:Allowed Transitions
| From | To (Allowed) |
|---|---|
| Candidate | Screening, Eligible, On Study |
| Screening | Eligible, Ineligible |
| Eligible | Informed Consent Obtained, On Study |
| On Study | On Study Intervention, On Study Observation, Follow-up, Off Study, Withdrawn |
| Follow-up | Off Study, Withdrawn |
Transition rules may be customized per study. Check your study configuration for specific rules.
Status Reasons
When changing status, record the reason:State Change Reasons
Common reasons for status changes include:| Transition | Example Reasons |
|---|---|
| To Ineligible | Failed inclusion criteria, met exclusion criteria |
| To Withdrawn | Participant request, lost to follow-up, adverse event |
| To Off Study | Completed protocol, study terminated |
Custom Reasons
Studies can define custom reason codes for consistent tracking.Status History
View the complete status history:- All previous statuses
- Transition timestamps
- Reasons for changes
- User who made changes
Viewing Status History
Viewing Status History
Open the participant record and navigate to “Status History” to view all transitions with dates and reasons.
Default Initial Status
Configure the default status for new participants:- Study Settings > Participant Settings > Default Status
- Common defaults: Candidate, Screening, or On Study
Status-Based Actions
Certain actions depend on status:| Status | Available Actions |
|---|---|
| Candidate | Screening activities |
| On Study | Full pathway activities, data collection |
| Off Study | Read-only access |
| Withdrawn | Read-only access |
Reporting by Status
Generate status reports:- Current status distribution
- Status over time
- Screen failure rates
- Withdrawal reasons
Best Practices
Update Promptly
Update Promptly
Change status as soon as the transition occurs for accurate tracking.
Always Record Reasons
Always Record Reasons
Document reasons for all status changes, especially withdrawals and screen failures.
Review Inactive Participants
Review Inactive Participants
Periodically review participants who haven’t had recent status changes.
Use Appropriate Status
Use Appropriate Status
Choose the most specific applicable status (e.g., On Study Intervention vs. generic On Study).
Related
Enrollment
Initial status at enrollment.
Participant Records
Data associated with each status.