> ## 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.

# Study Configuration

> Configure study settings, status, and advanced options

Study configuration includes all settings that control how your study operates, from basic metadata to advanced features.

## Study Status

Studies have three primary states:

| Status      | Description                 | Allowed Actions                         |
| ----------- | --------------------------- | --------------------------------------- |
| **Draft**   | Initial configuration state | Full editing, no enrollment             |
| **Active**  | Operational state           | Enrollment, data collection, amendments |
| **Retired** | Archived state              | Read-only access                        |

### Changing Status

<Steps>
  <Step title="Review Configuration">
    Before activating, review all study settings, questionnaires, and pathways.
  </Step>

  <Step title="Navigate to Status">
    Go to Study Settings > Status.
  </Step>

  <Step title="Update Status">
    Select the new status. Confirm the change.
  </Step>
</Steps>

<Warning>
  Moving from Active to Retired is permanent. Ensure all data collection is complete before retiring a study.
</Warning>

## General Settings

### Study Information

| Setting         | Description                                |
| --------------- | ------------------------------------------ |
| **Title**       | Display name shown throughout the platform |
| **Identifier**  | Protocol number or unique study code       |
| **Description** | Summary of study purpose                   |
| **Version**     | Current protocol version                   |

### Sponsor and Contacts

Configure sponsor information and study contacts for:

* Official correspondence
* Shipping addresses
* Primary contact personnel

## Participant Settings

### Default Participant Status

Set the initial status for newly enrolled participants. Common options:

| Status        | Use Case                                 |
| ------------- | ---------------------------------------- |
| **Candidate** | For studies with screening requirements  |
| **On Study**  | For direct enrollment                    |
| **Screening** | For studies with formal screening visits |

### Participant Registration Portal

Enable self-registration for participants:

* Participants can access a public registration page
* Collected information creates candidate records
* Site team reviews and approves registrations

### CRF Signing Requirements

Configure whether CRF signing is required:

* **Enabled**: Records require signature from authorized signers before finalization
* **Disabled**: Records are finalized without signature requirement

## Site Settings

### Self-Registration

Configure site self-registration:

| Option                        | Description                                     |
| ----------------------------- | ----------------------------------------------- |
| **Enabled**                   | Sites can register using a PIN code             |
| **PIN Code**                  | The code sites use to initiate registration     |
| **Pre-Registration Workflow** | Workflow assigned before registration completes |
| **Onboarding Workflow**       | Workflow assigned after registration approval   |

### Service Providers

Enable external service providers:

* Central laboratories
* Core facilities
* Other centralized services

When enabled, sites can select from configured service providers during setup.

## Data Settings

### Protected Health Information

Configure which PHI fields are collected. These settings affect all questionnaires that use PHI fields.

### Sensitive Data Handling

Configure handling of fields marked as sensitive:

* Additional access controls
* Audit logging for sensitive data access

## Feature Toggles

### Participant-Facing Elements

Enable elements visible to participants:

* Participant-facing questionnaires
* Participant portal access
* Self-reported outcomes

### Public Information Hub

Enable public-facing study information:

* Public study page with general information
* Recruitment materials and contact information

## Amendments

Active studies can be amended to update configuration:

<Steps>
  <Step title="Start Amendment">
    Go to Study Settings and click "Start Amendment".
  </Step>

  <Step title="Make Changes">
    Modify study configuration as needed. Changes are tracked separately from the live study.
  </Step>

  <Step title="Review Changes">
    Review all pending changes before applying.
  </Step>

  <Step title="Apply Amendment">
    Apply the amendment to update the active study.
  </Step>
</Steps>

<Note>
  Some changes may require additional steps, such as migrating existing data or updating site configurations.
</Note>

## Related

<CardGroup cols={2}>
  <Card title="Study Arms" icon="code-branch" href="/study-design/study-arms">
    Configure treatment arms.
  </Card>

  <Card title="Public Info Hub" icon="globe" href="/study-design/public-info-hub">
    Set up public study information.
  </Card>
</CardGroup>