> ## 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 Design

> Design and configure clinical research studies in Carelane

Study design in Carelane involves creating and configuring all aspects of a clinical research study, from basic metadata to detailed data collection instruments.

## Study Design Overview

<CardGroup cols={2}>
  <Card title="Creating Studies" icon="plus" href="/study-design/creating-studies">
    Create a new study manually or using the AI Study Wizard.
  </Card>

  <Card title="Study Configuration" icon="gear" href="/study-design/study-configuration">
    Configure study settings, status, and metadata.
  </Card>

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

  <Card title="Objectives" icon="bullseye" href="/study-design/objectives">
    Set primary and secondary objectives with endpoints.
  </Card>

  <Card title="Pathway Versioning" icon="code-branch" href="/study-design/pathway-versioning">
    Draft, Testing, Approved, and Retired lifecycle for participant pathways.
  </Card>

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

## Study Lifecycle

Studies progress through defined lifecycle states:

| State       | Description                                         |
| ----------- | --------------------------------------------------- |
| **Draft**   | Initial state for study setup and configuration     |
| **Active**  | Study is operational; sites can enroll participants |
| **Retired** | Study is archived; no further data collection       |

<Note>
  Studies can be amended while active. Amendments allow updates to study design without disrupting ongoing data collection.
</Note>

## Key Study Components

A complete study configuration includes:

### Data Collection Instruments

* **Questionnaires**: Forms for collecting participant data (CRFs)
* **Workflows**: Sequences of tasks for site operations
* **Pathways**: Schedules of activities for participants

### Structure

* **Arms**: Treatment groups or cohorts
* **Objectives**: Research goals and endpoints
* **Schedule of Activities**: Timeline of data collection points

### Configuration

* **Sites**: Participating research locations
* **PHI Settings**: Protected health information requirements
* **Export Settings**: Data export configurations

## Study Design Workflow

<Steps>
  <Step title="Create Study">
    Use the AI Study Wizard with a protocol or create manually.
  </Step>

  <Step title="Configure Basics">
    Set study name, identifier, and key metadata.
  </Step>

  <Step title="Define Structure">
    Add study arms and objectives.
  </Step>

  <Step title="Build Instruments">
    Create or import questionnaires and pathways.
  </Step>

  <Step title="Configure Sites">
    Set up site onboarding and registration options.
  </Step>

  <Step title="Activate">
    Move the study from Draft to Active when ready.
  </Step>
</Steps>

## Best Practices

<AccordionGroup>
  <Accordion title="Start with the Protocol">
    Use your study protocol as the foundation. The AI Study Wizard can extract structure from protocol documents.
  </Accordion>

  <Accordion title="Use Templates">
    Build from existing templates to ensure consistency and save time.
  </Accordion>

  <Accordion title="Test Before Activation">
    Create test sites and participants in draft mode to validate your configuration.
  </Accordion>

  <Accordion title="Plan for Amendments">
    Design with potential amendments in mind. Some configuration changes are easier than others after activation.
  </Accordion>
</AccordionGroup>