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Study arms represent the different treatment groups or cohorts in your clinical research study. Configure arms to organize participants and enable arm-specific data collection.

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What are Study Arms?

Arms define distinct groups within a study, such as:
  • Treatment vs. placebo groups
  • Different dosing regimens
  • Multiple intervention types
  • Observational cohorts

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Arm Types

Carelane supports standard clinical trial arm types:

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Creating Arms

1

Navigate to Arms

Open Study Design > Arms.
2

Add New Arm

Click “Add Arm” to create a new arm.
3

Configure Arm

Enter arm details:
  • Name (e.g., “Treatment A”)
  • Type (select from available types)
  • Description of the intervention
4

Save

Save the arm configuration.

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Arm Configuration

Each arm can be configured with:

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Assigning Participants to Arms

Participants are assigned to arms during or after enrollment:

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During Enrollment

When adding a participant, select their arm assignment if known at enrollment time.

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After Enrollment

Update a participant’s arm assignment:
  1. Open the participant record
  2. Navigate to study information
  3. Update the arm assignment
  4. Record the reason for assignment or change
Arm assignments are recorded with timestamps and can be changed if the study design allows for crossover or reassignment.

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Arm-Specific Pathways

Pathways can be configured to differ by arm:
  • Different visit schedules per arm
  • Arm-specific questionnaires
  • Conditional activities based on arm assignment
When designing a pathway, you can set activities to only appear for specific arms. This enables:
  • Intervention-specific assessments
  • Different follow-up schedules
  • Arm-conditional CRFs

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Reporting by Arm

Data exports and reports can be filtered and grouped by arm:
  • Export participants by arm
  • Generate arm-specific summaries
  • Compare outcomes across arms

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Best Practices

Use the predefined arm types when possible for consistency and regulatory clarity.
Use descriptive names that clearly identify the arm without ambiguity.
Clearly document how participants are assigned to arms (randomization, investigator choice, etc.).

Objectives

Define study objectives and endpoints.

Participant Pathways

Configure arm-specific pathways.