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

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AI Study Wizard

The AI Study Wizard analyzes your protocol document and automatically generates study configuration.
1

Start the Wizard

From your organization dashboard, click “Create Study” and select “Use AI Study Wizard”.
2

Upload Protocol

Upload your study protocol as a PDF or Word document. The AI will extract key information.
3

Review Extraction

Review the AI-extracted information including:
  • Study title and identifiers
  • Objectives and endpoints
  • Study arms
  • Schedule of activities
4

Refine Configuration

Adjust any extracted details and add additional configuration as needed.
5

Create Study

Confirm and create the study. It will be created in Draft status.
The AI Study Wizard works best with well-structured protocol documents. Include clear headings for objectives, arms, and visit schedules.

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Manual Creation

For full control over study configuration, use manual creation.
1

Start Creation

From your organization dashboard, click “Create Study” and select “Manual Setup”.
2

Enter Basic Information

Provide required study details:
  • Study title
  • Study identifier (e.g., protocol number)
  • Description
3

Configure Settings

Set initial configuration options:
  • PHI collection settings
  • Site registration method
  • Service provider options
4

Create Study

Create the study in Draft status to continue configuration.

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Study Details

When creating a study, you can specify:

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PHI Configuration

Configure which Protected Health Information fields are collected:
PHI configuration affects data collection forms across all sites. Changes after study activation may require amendments.

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Site Registration Options

Choose how sites will join your study:

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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

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Manual Registration

Study team manually creates sites:
  • Full control over site creation
  • Direct invitation of site personnel
  • Faster setup for known sites

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After Creation

Once created, continue configuring your study:

Study Configuration

Configure detailed study settings.

Study Arms

Define treatment arms.

Templates

Add questionnaires and pathways.