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
Arm Types
Carelane supports standard clinical trial arm types:| Type | Code | Description |
|---|---|---|
| Experimental | experimental | Receives the experimental intervention |
| Active Comparator | active-comparator | Receives an active treatment for comparison |
| Placebo Comparator | placebo-comparator | Receives a placebo |
| Sham Comparator | sham-comparator | Receives a sham procedure |
| No Intervention | no-intervention | Receives no intervention |
| Other | other-arm-type | Custom arm type |
Creating Arms
Configure Arm
Enter arm details:
- Name (e.g., “Treatment A”)
- Type (select from available types)
- Description of the intervention
Arm Configuration
Each arm can be configured with:| Field | Description |
|---|---|
| Name | Display name for the arm |
| Type | Classification from standard arm types |
| Description | Detailed description of the intervention |
Assigning Participants to Arms
Participants are assigned to arms during or after enrollment:During Enrollment
When adding a participant, select their arm assignment if known at enrollment time.After Enrollment
Update a participant’s arm assignment:- Open the participant record
- Navigate to study information
- Update the arm assignment
- 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.
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
Configuring Arm-Specific Activities
Configuring Arm-Specific Activities
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
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
Best Practices
Use Standard Types
Use Standard Types
Use the predefined arm types when possible for consistency and regulatory clarity.
Clear Naming
Clear Naming
Use descriptive names that clearly identify the arm without ambiguity.
Document Assignment Criteria
Document Assignment Criteria
Clearly document how participants are assigned to arms (randomization, investigator choice, etc.).
Related
Objectives
Define study objectives and endpoints.
Participant Pathways
Configure arm-specific pathways.