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

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Study Design Overview

Creating Studies

Create a new study manually or using the AI Study Wizard.

Study Configuration

Configure study settings, status, and metadata.

Study Arms

Define treatment arms and assignment strategies.

Objectives

Set primary and secondary objectives with endpoints.

Pathway Versioning

Draft, Testing, Approved, and Retired lifecycle for participant pathways.

Public Info Hub

Create public-facing study information pages.

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Study Lifecycle

Studies progress through defined lifecycle states:
Studies can be amended while active. Amendments allow updates to study design without disrupting ongoing data collection.

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Key Study Components

A complete study configuration includes:

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Data Collection Instruments

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

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Structure

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

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Configuration

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

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Study Design Workflow

1

Create Study

Use the AI Study Wizard with a protocol or create manually.
2

Configure Basics

Set study name, identifier, and key metadata.
3

Define Structure

Add study arms and objectives.
4

Build Instruments

Create or import questionnaires and pathways.
5

Configure Sites

Set up site onboarding and registration options.
6

Activate

Move the study from Draft to Active when ready.

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Best Practices

Use your study protocol as the foundation. The AI Study Wizard can extract structure from protocol documents.
Build from existing templates to ensure consistency and save time.
Create test sites and participants in draft mode to validate your configuration.
Design with potential amendments in mind. Some configuration changes are easier than others after activation.