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

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Status Overview

Carelane uses the HL7 FHIR ResearchSubject state model for participant status:

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Status Workflow

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Typical Flow

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Alternative Flows

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Changing Status

1

Open Participant

Navigate to the participant record.
2

Update Status

Click on status to view options.
3

Select New Status

Choose the appropriate new status.
4

Provide Reason

Enter the reason for the status change if required.
5

Confirm

Confirm the change. It is recorded in the audit trail.

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Status Transitions

Not all transitions are valid. The system enforces logical status progressions:

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Allowed Transitions

Transition rules may be customized per study. Check your study configuration for specific rules.

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Status Reasons

When changing status, record the reason:

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State Change Reasons

Common reasons for status changes include:

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Custom Reasons

Studies can define custom reason codes for consistent tracking.

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Status History

View the complete status history:
  • All previous statuses
  • Transition timestamps
  • Reasons for changes
  • User who made changes
Open the participant record and navigate to “Status History” to view all transitions with dates and reasons.

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Default Initial Status

Configure the default status for new participants:
  • Study Settings > Participant Settings > Default Status
  • Common defaults: Candidate, Screening, or On Study

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Status-Based Actions

Certain actions depend on status:

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Reporting by Status

Generate status reports:
  • Current status distribution
  • Status over time
  • Screen failure rates
  • Withdrawal reasons

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Best Practices

Change status as soon as the transition occurs for accurate tracking.
Document reasons for all status changes, especially withdrawals and screen failures.
Periodically review participants who haven’t had recent status changes.
Choose the most specific applicable status (e.g., On Study Intervention vs. generic On Study).

Enrollment

Initial status at enrollment.

Participant Records

Data associated with each status.