> ## Documentation Index
> Fetch the complete documentation index at: https://docs.carelane.io/llms.txt
> Use this file to discover all available pages before exploring further.

# Participant Status

> Track and manage participant status throughout the study

Participant status tracks where a participant is in their study journey, from initial candidacy through study completion or withdrawal.

## 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| **Withdrawn**                 | `withdrawn`                 | Withdrew from study                     |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

```
Candidate → Screening → Eligible → Consent → On Study → Follow-up → Off Study
```

### Alternative Flows

| Scenario              | Flow                                   |
| --------------------- | -------------------------------------- |
| **Screen Failure**    | Candidate → Screening → Ineligible     |
| **Early Withdrawal**  | On Study → Withdrawn                   |
| **Direct Enrollment** | Candidate → On Study (if no screening) |

## Changing Status

<Steps>
  <Step title="Open Participant">
    Navigate to the participant record.
  </Step>

  <Step title="Update Status">
    Click on status to view options.
  </Step>

  <Step title="Select New Status">
    Choose the appropriate new status.
  </Step>

  <Step title="Provide Reason">
    Enter the reason for the status change if required.
  </Step>

  <Step title="Confirm">
    Confirm the change. It is recorded in the audit trail.
  </Step>
</Steps>

## 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                                                         |

<Note>
  Transition rules may be customized per study. Check your study configuration for specific rules.
</Note>

## 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

<Accordion title="Viewing Status History">
  Open the participant record and navigate to "Status History" to view all transitions with dates and reasons.
</Accordion>

## 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

<AccordionGroup>
  <Accordion title="Update Promptly">
    Change status as soon as the transition occurs for accurate tracking.
  </Accordion>

  <Accordion title="Always Record Reasons">
    Document reasons for all status changes, especially withdrawals and screen failures.
  </Accordion>

  <Accordion title="Review Inactive Participants">
    Periodically review participants who haven't had recent status changes.
  </Accordion>

  <Accordion title="Use Appropriate Status">
    Choose the most specific applicable status (e.g., On Study Intervention vs. generic On Study).
  </Accordion>
</AccordionGroup>

## Related

<CardGroup cols={2}>
  <Card title="Enrollment" icon="user-plus" href="/participants/enrollment">
    Initial status at enrollment.
  </Card>

  <Card title="Participant Records" icon="file-medical" href="/participants/participant-records">
    Data associated with each status.
  </Card>
</CardGroup>