> ## 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.

# Participants

> Manage participant enrollment, records, and status throughout the study

Participants are the research subjects enrolled in your clinical study. Carelane provides tools to manage the full participant lifecycle from enrollment through study completion.

## Participants Overview

<CardGroup cols={2}>
  <Card title="Enrollment" icon="user-plus" href="/participants/enrollment">
    Add new participants to your study.
  </Card>

  <Card title="Participant Records" icon="file-medical" href="/participants/participant-records">
    Manage participant data and CRFs.
  </Card>

  <Card title="Participant Pathways" icon="route" href="/participants/participant-pathways">
    Define the participant journey through the study.
  </Card>

  <Card title="Participant Status" icon="circle-check" href="/participants/participant-status">
    Track and manage participant status transitions.
  </Card>

  <Card title="CRF Signing" icon="signature" href="/participants/crf-signing">
    Electronic signature workflows for CRFs.
  </Card>
</CardGroup>

## Participant Lifecycle

Participants progress through defined states:

| Stage              | Status Examples                                       |
| ------------------ | ----------------------------------------------------- |
| **Pre-Enrollment** | Candidate                                             |
| **Screening**      | Screening, Eligible, Ineligible                       |
| **Consent**        | Informed Consent Obtained                             |
| **On Study**       | On Study, On Study Intervention, On Study Observation |
| **Follow-up**      | Follow-up                                             |
| **Completion**     | Off Study, Withdrawn                                  |

See [Participant Status](/participants/participant-status) for the complete status reference.

## Participant Identification

Each participant is identified by:

| Identifier         | Description                                 |
| ------------------ | ------------------------------------------- |
| **Participant ID** | System-generated unique identifier          |
| **Pseudonym**      | Study-specific identifier (e.g., "001-001") |
| **PHI Fields**     | Optional: Name, MRN, DOB (as configured)    |

<Note>
  PHI collection is configured at the study level. Only enabled PHI fields are available for data entry.
</Note>

## Working with Participants

### Viewing Participants

Access participants from:

* **Study > Participants**: All participants across sites
* **Site > Participants**: Participants at a specific site

Filter by:

* Status
* Site
* Arm assignment
* Pathway progress

### Participant Details

Click a participant to view:

* Basic information and identifiers
* Current status and history
* Pathway progress
* CRF completion status
* Query status

## Data Collection

Participant data is collected through:

* **Questionnaires**: Structured data collection forms (CRFs)
* **Pathways**: Scheduled sequences of questionnaires
* **Ad-hoc Forms**: Additional data collection as needed

## Participant Data Flow

```
Enrollment → Pathway Assignment → Data Entry → Review → Verification → Sign-off
```

<Steps>
  <Step title="Enrollment">
    Site creates participant record with basic information.
  </Step>

  <Step title="Pathway Assignment">
    Participant is assigned a pathway defining their data collection schedule.
  </Step>

  <Step title="Data Entry">
    Site team enters data into questionnaires per the pathway.
  </Step>

  <Step title="Review">
    Study team reviews submitted data.
  </Step>

  <Step title="Verification">
    Data reviewer verifies data quality.
  </Step>

  <Step title="Sign-off">
    Authorized signer approves completed CRFs.
  </Step>
</Steps>

## Best Practices

<AccordionGroup>
  <Accordion title="Consistent Identifiers">
    Use consistent pseudonym formats across sites (e.g., "Site-Participant" numbering).
  </Accordion>

  <Accordion title="Timely Data Entry">
    Enter data promptly after collection to maintain data quality.
  </Accordion>

  <Accordion title="Status Tracking">
    Keep participant status current to accurately reflect their study progress.
  </Accordion>

  <Accordion title="Query Resolution">
    Address data queries promptly to maintain clean data.
  </Accordion>
</AccordionGroup>