Schedule design
Randomization schedules and stratification factors designed in step with study design and sample size assumptions.
What's included
What goes into the specification
- Allocation method (block, stratified, adaptive) selected and justified against the study design
- Stratification factors and block sizes defined and documented for schedule generation
- Allocation ratio and any re-randomization or dose-escalation rules specified
- Blinding and access control requirements written for handoff to IxRS build
- Specification reviewed and signed off before schedule generation begins
Specified before generation
Allocation method and stratification rules documented and signed off before schedule generation, coordinated with SAP unblinding procedures.