What it is
The Randomization module (also referred to as RTSM or 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 a full audit trail and support for single- and double-blind designs.
When integrated with IMP, randomization can also drive investigational product assignment.
Who uses it
| Role | Typical use |
|---|---|
| Study Administrator | Configure algorithm, blinding, stratification, and eligibility |
| Investigator / CRC | Randomize subjects at the designated study event during data capture |
| Sponsor | View treatment assignments in blinded or unblinded studies |
Key capabilities
- Multiple algorithms: Permuted Block, Stratified Permuted Block, Big Stick, Minimization
- Double-blind support with role-based visibility of treatment codes
- Site-stratified allocation and pre-randomization eligibility checks
- Real-time allocation at randomization time with automated notifications
Algorithms
| Algorithm | Description |
|---|---|
| Permuted Block Design | Balanced blocks with shuffled treatment assignments |
| Stratified Permuted Block Design | Permuted blocks maintained within each stratum |
| Big Stick Design | Adaptive allocation with a maximum tolerated imbalance |
| Minimization Design | Covariate-adaptive allocation that minimizes imbalance |