Generated to spec, not around it
The schedule follows the randomization specification directly — stratification and block structure carried through without reinterpretation.
What's included
What goes into schedule generation
- Schedule generated in validated software against the signed-off randomization specification — block sizes, stratification factors, and allocation ratio exactly as specified
- Seed, generation method, and program output documented and archived for audit traceability
- Independent QC of the generated schedule against the specification before release
- Access to the schedule restricted to the unblinded team, with permissions documented per the DMC charter and study blinding plan
- Schedule formatted and handed off for load into the IxRS system
Secured before it's ever loaded
Access is firewalled to the unblinded team from the moment the schedule exists, and it's tested end-to-end in IxRS UAT before any site sees it.