Overview
The Randomization module (also known as RTSM / IWRS) manages treatment group allocation and blinding for clinical trial subjects. It ensures subjects are assigned to treatment arms according to the study protocol, with full audit trail and double-blind capability.
Key capabilities:
- Multiple randomization algorithms — Permuted Block, Stratified Permuted Block, Big Stick, and Minimization Design
- Double-blind support — treatment assignments are hidden from site staff; only authorized roles (Sponsor, Study Admin) can view
- Site-stratified allocation — balance treatment arms across multiple sites
- Pre-randomization eligibility checks — enforce inclusion/exclusion criteria before a subject can be randomized
- Automated email notifications — notify designated roles when a subject is randomized
- Real-time list generation — allocation is determined at randomization time, eliminating pre-generated list management
Workflow
- Install the Randomization app on the study.
- Create Subject Group Classes with treatment arm codes (required before algorithm configuration).
- Configure the app: blinding method, algorithm, treatment arms, event, pre-randomization questions, and email notifications.
- Go Live — once in Production, subjects can be randomized at the designated event visit.
Documentation
- Configuration — Step-by-step setup guide covering algorithm options, stratification, additional pre-randomization data, and email notifications
Algorithms
| Algorithm | Description |
|---|---|
| Permuted Block Design | Simple balanced blocks with randomized assignment order — best for single-site trials |
| Stratified Permuted Block Design | Separate block lists per stratum — best for multi-site Phase II/III trials |
| Big Stick Design | Adaptive design with configurable Maximum Tolerated Imbalance — better concealment than fixed blocks |
| Minimization Design | Covariate-adaptive assignment minimizing imbalance across multiple factors simultaneously |