For shared IMP settings that apply to both Purpose-of-use tracks, see IMP Setup — Overview. For the PSP (Patient Support Program) track, see IMP Setup — PSP Mode.
Overview
This track applies when Purpose of use is set to Randomization on the IMP configuration page. Use it for studies where investigational product is dispensed against a Subject's randomized treatment arm — for example, a blinded or open-label trial where the Randomization module assigns each Subject to a treatment group before dispensing occurs.
If the study instead dispenses one or more licensed products outside of a randomized treatment assignment, use PSP Mode.
Prerequisites
The Randomization module must be fully configured for the study before a product can be added under Purpose of use: Randomization. Configure treatment arms, randomization algorithm, and study group parameters in Randomization Setup first.
Settings Reference — Randomization Mode
| Setting | Effect | Roles Affected |
|---|---|---|
| Product limit | Randomization mode supports only one (1) investigational product per study. Adding a second product is not available in this mode. | Study Administrator, System Administrator |
| Tracking | Automatically locked to By Unique Serial Number. The Tracking option is not shown as a choice in Randomization mode — every unit dispensed is tracked by its own serial number, matching the level of accountability required for blinded, per-Subject randomized dispensing. | Study Administrator, System Administrator |
| Dispensing section label | The dispensing section is titled Dispensing Medication for Randomization in this mode (Dispensing Events & Schedule in PSP mode). | Study Administrator, System Administrator |
Randomization mode dispenses product against an individual Subject's assigned treatment arm, so each unit must be traceable to a specific serial number for audit and unblinding purposes. Studies that need a different Tracking method (by lot, or no tracking) should use PSP mode instead.
Dispensing Medication for Randomization
This section links the product to the CRF event(s) where dispensing is recorded for randomized Subjects.
Study Administrator, System Administrator.