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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:
FieldDescription
TitleDisplay name for the study
IdentifierUnique protocol identifier (e.g., “STUDY-001”)
DescriptionBrief description of the study purpose
SponsorSponsoring organization
PhaseClinical trial phase (if applicable)
DesignStudy design type (e.g., randomized, observational)

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PHI Configuration

Configure which Protected Health Information fields are collected:
OptionDescription
Subject NameParticipant’s full name
Medical Record NumberMRN from the treating institution
Date of BirthFull date of birth
Year and Month of BirthPartial date (excludes day)
Subject InitialsParticipant’s initials
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.