Tested against the spec, not the vendor's defaults
Test scripts trace back to the randomization specification line by line, not to the IxRS vendor's generic test suite.
What's included
What goes into IxRS UAT
- Test scripts written to exercise every stratification factor, block size, and allocation ratio in the randomization specification
- Edge cases covered — stratum exhaustion, unequal randomization, re-randomization, and screen-failure handling
- Drug/kit assignment logic tested alongside allocation, where the IxRS also manages supply
- Test execution and results documented for the trial master file and audit traceability
- Defects tracked to resolution and re-tested before the system is released for site use
Confirmed again mid-study
The same allocation logic verified here is checked again during conduct in randomization reconciliation, comparing IxRS to the clinical database.