> ## 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.

# Enrollment

> Add new participants to your clinical study

Enrollment is the process of adding new participants to your study. Sites create participant records and assign them to pathways for data collection.

## Enrollment Methods

### Manual Enrollment

Site team creates participant records directly:

<Steps>
  <Step title="Navigate to Participants">
    Open Site > Participants or Study > Participants.
  </Step>

  <Step title="Add Participant">
    Click "Add Participant".
  </Step>

  <Step title="Enter Information">
    Provide required information:

    * Pseudonym (study identifier)
    * PHI fields (if enabled)
    * Initial status
  </Step>

  <Step title="Assign Pathway">
    Select the participant pathway.
  </Step>

  <Step title="Create">
    Create the participant record.
  </Step>
</Steps>

### Participant Self-Registration

When the participant registration portal is enabled:

1. Potential participants access the public registration page
2. Participants provide contact and screening information
3. Record is created as a "Candidate"
4. Site team reviews and contacts qualified candidates
5. Site converts candidate to enrolled participant

<Tip>
  Self-registration reduces site burden for initial screening while maintaining control over final enrollment decisions.
</Tip>

## Enrollment Information

### Required Fields

| Field         | Description                           |
| ------------- | ------------------------------------- |
| **Pseudonym** | Study-specific participant identifier |
| **Status**    | Initial participant status            |
| **Pathway**   | Assigned participant pathway          |

### Optional Fields (Study-Configured)

| Field                     | When Available             |
| ------------------------- | -------------------------- |
| **Subject Name**          | If PHI enabled             |
| **Medical Record Number** | If PHI enabled             |
| **Date of Birth**         | If PHI enabled             |
| **Year/Month of Birth**   | If PHI enabled             |
| **Subject Initials**      | If PHI enabled             |
| **Arm Assignment**        | If study has multiple arms |

## Pseudonym Format

Pseudonyms uniquely identify participants within the study:

* Typically formatted as "Site-Sequence" (e.g., "001-001")
* Must be unique within the study
* Cannot be changed after creation

<Warning>
  Choose pseudonym formats carefully before enrollment begins. Changing formats mid-study creates inconsistency.
</Warning>

## Initial Status

Select the appropriate starting status:

| Status        | When to Use                                  |
| ------------- | -------------------------------------------- |
| **Candidate** | For potential participants pending screening |
| **Screening** | For participants entering formal screening   |
| **On Study**  | For direct enrollment without screening      |

The default initial status is configured at the study level.

## Arm Assignment

If your study has multiple arms:

<Steps>
  <Step title="During Enrollment">
    Optionally assign the arm during enrollment if known.
  </Step>

  <Step title="After Randomization">
    Update arm assignment after randomization occurs.
  </Step>
</Steps>

Arm assignment can be updated after enrollment if the study design allows.

## Pathway Assignment

Pathways define the participant's schedule of activities:

<Steps>
  <Step title="Select Pathway">
    Choose from available pathways during enrollment.
  </Step>

  <Step title="Pathway Creates Activities">
    The pathway generates scheduled questionnaires and visits.
  </Step>

  <Step title="Modify if Needed">
    Pathways can be adjusted for individual participants if needed.
  </Step>
</Steps>

<Note>
  Different arms may have different pathways. Ensure the correct pathway is selected for the participant's arm.
</Note>

## Enrollment Validation

The system validates enrollment data:

* Pseudonym uniqueness
* Required field completion
* PHI format validation (if applicable)

## Enrollment Metrics

Track enrollment progress:

| Metric             | Description                         |
| ------------------ | ----------------------------------- |
| **Total Enrolled** | All participants added to the study |
| **By Site**        | Enrollment counts per site          |
| **By Status**      | Distribution across statuses        |
| **Over Time**      | Enrollment rate trends              |

## Best Practices

<AccordionGroup>
  <Accordion title="Verify Eligibility First">
    Confirm eligibility criteria before creating participant records.
  </Accordion>

  <Accordion title="Consistent Data Entry">
    Train all site staff on enrollment procedures for consistency.
  </Accordion>

  <Accordion title="Double-Check Pseudonyms">
    Verify pseudonym accuracy before creating the record.
  </Accordion>

  <Accordion title="Document Consent">
    Ensure informed consent is documented before enrolling.
  </Accordion>
</AccordionGroup>

## Related

<CardGroup cols={2}>
  <Card title="Participant Status" icon="circle-check" href="/participants/participant-status">
    Status transitions after enrollment.
  </Card>

  <Card title="Participant Pathways" icon="route" href="/participants/participant-pathways">
    Configure participant journeys.
  </Card>
</CardGroup>