Overview

Use this guide to install and initialize the Randomization (RTSM / IWRS) app for a study.

Prerequisites

Before you begin:

• You have permission to manage study applications.
• The target study already exists.
• The study arms/groups are defined at a high level.

Install the Randomization app

1. Open the study and go to the administration area for app management.
2. Select Randomization (RTSM / IWRS) from the app list.
3. Click Install and wait for installation to complete.
4. Open the Randomization app settings.

Configure randomization design

In the setup flow, configure the algorithm and group balance options.

Big Stick Design

Set the required fields shown in the design:

• Types of Imbalance Evaluation
• Count Based
• Ratio-based
• Cost-weighted (optional)
• Study group table
• Columns: Label, Code, Weight, Description
• Add rows for each arm (example shown: Active / Placebo)
• MTI Value (displayed when Count Based is selected)
• Imbalance Scope
• All Active Subjects
• Exclude Withdrawn Subjects

After configuration, click Submit.

Validate installation

After submitting settings:

1. Re-open the Randomization app and confirm values are saved.
2. Verify study groups and weights are correct.
3. Run a test subject flow to confirm allocation behavior.

Troubleshooting

• If installation is unavailable, verify your role permissions.
• If Submit is disabled, confirm all required fields are completed.
• If allocation results look incorrect, re-check Study group weights and Imbalance Scope.