> ## 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.

# Creating Studies

> Create new clinical research studies using the AI wizard or manual setup

Carelane offers two methods for creating new studies: the AI Study Wizard for automated setup from protocol documents, or manual creation for full control.

## AI Study Wizard

The AI Study Wizard analyzes your protocol document and automatically generates study configuration.

<Steps>
  <Step title="Start the Wizard">
    From your organization dashboard, click "Create Study" and select "Use AI Study Wizard".
  </Step>

  <Step title="Upload Protocol">
    Upload your study protocol as a PDF or Word document. The AI will extract key information.
  </Step>

  <Step title="Review Extraction">
    Review the AI-extracted information including:

    * Study title and identifiers
    * Objectives and endpoints
    * Study arms
    * Schedule of activities
  </Step>

  <Step title="Refine Configuration">
    Adjust any extracted details and add additional configuration as needed.
  </Step>

  <Step title="Create Study">
    Confirm and create the study. It will be created in Draft status.
  </Step>
</Steps>

<Tip>
  The AI Study Wizard works best with well-structured protocol documents. Include clear headings for objectives, arms, and visit schedules.
</Tip>

## Manual Creation

For full control over study configuration, use manual creation.

<Steps>
  <Step title="Start Creation">
    From your organization dashboard, click "Create Study" and select "Manual Setup".
  </Step>

  <Step title="Enter Basic Information">
    Provide required study details:

    * Study title
    * Study identifier (e.g., protocol number)
    * Description
  </Step>

  <Step title="Configure Settings">
    Set initial configuration options:

    * PHI collection settings
    * Site registration method
    * Service provider options
  </Step>

  <Step title="Create Study">
    Create the study in Draft status to continue configuration.
  </Step>
</Steps>

## Study Details

When creating a study, you can specify:

| Field           | Description                                         |
| --------------- | --------------------------------------------------- |
| **Title**       | Display name for the study                          |
| **Identifier**  | Unique protocol identifier (e.g., "STUDY-001")      |
| **Description** | Brief description of the study purpose              |
| **Sponsor**     | Sponsoring organization                             |
| **Phase**       | Clinical trial phase (if applicable)                |
| **Design**      | Study design type (e.g., randomized, observational) |

## PHI Configuration

Configure which Protected Health Information fields are collected:

| Option                      | Description                       |
| --------------------------- | --------------------------------- |
| **Subject Name**            | Participant's full name           |
| **Medical Record Number**   | MRN from the treating institution |
| **Date of Birth**           | Full date of birth                |
| **Year and Month of Birth** | Partial date (excludes day)       |
| **Subject Initials**        | Participant's initials            |

<Warning>
  PHI configuration affects data collection forms across all sites. Changes after study activation may require amendments.
</Warning>

## Site Registration Options

Choose how sites will join your study:

### Self-Registration

Sites can register themselves using a PIN code:

* Study team provides registration PIN to interested sites
* Sites enter PIN to access registration workflow
* Self-registration includes capability and feasibility surveys
* Study team reviews and approves registrations

### Manual Registration

Study team manually creates sites:

* Full control over site creation
* Direct invitation of site personnel
* Faster setup for known sites

## After Creation

Once created, continue configuring your study:

<CardGroup cols={2}>
  <Card title="Study Configuration" icon="gear" href="/study-design/study-configuration">
    Configure detailed study settings.
  </Card>

  <Card title="Study Arms" icon="code-branch" href="/study-design/study-arms">
    Define treatment arms.
  </Card>

  <Card title="Templates" icon="copy" href="/templates">
    Add questionnaires and pathways.
  </Card>
</CardGroup>