AI for Biometrics
IRT / RTSM UAT Snapshot
Read-only shareable snapshot, computed from the validated UAT data (test_scripts.csv, defect_log.csv, traceability_matrix.csv). It does not connect to the IRT. The interactive tool is the Run & build the Shiny app page, and the visual guide explains it. Operations-only, synthetic, no PHI. We say participant, not subject.
29
Test scripts
22
Passed
2
Failed
3
Open defects
97%
Requirements traced
Go-live sign-off gate
NOT ready - blocked
✘2 critical test(s) not yet passing
✘2 open critical/major defect(s)
✘1 requirement(s) without a test
Conjunctive: all three must hold. The gate packages the evidence, a named human signs.
Execution by area
Test scripts
| Test | Area | Priority | Title | Status |
|---|---|---|---|---|
| RAND-01 | Randomization | Critical | Allocation matches the approved randomization schedule | Pass |
| RAND-02 | Randomization | Critical | Stratified allocation respects entered strata | Pass |
| RAND-03 | Randomization | High | Within-block allocation balance | Pass |
| RAND-04 | Randomization | Critical | Randomization-number uniqueness under concurrency | Fail |
| RAND-05 | Randomization | High | Allocation reproducible from the frozen list | Pass |
| RAND-06 | Randomization | Critical | Allocation concealment until dosing | Pass |
| COH-01 | Dose-escalation cohorts | Critical | Sentinel dosing hold enforced | Pass |
| COH-02 | Dose-escalation cohorts | High | Cohort enrollment cap enforced | Pass |
| COH-03 | Dose-escalation cohorts | Critical | Next-cohort gate requires SRC approval | In Progress |
| COH-04 | Dose-escalation cohorts | Critical | Correct dose level per active cohort | Pass |
| ENR-01 | Enrollment / screening | Medium | Unique screening numbers | Pass |
| ENR-02 | Enrollment / screening | High | Screen-fail cannot randomize | Pass |
| ENR-03 | Enrollment / screening | Medium | Re-screening permitted per protocol | Not Run |
| ENR-04 | Enrollment / screening | High | Study enrollment cap enforced | Pass |
| DISP-01 | Drug dispensing | Critical | Dispensed kit matches allocated arm | Pass |
| DISP-02 | Drug dispensing | High | Correct kit type by visit | Pass |
| DISP-03 | Drug dispensing | Medium | Dispensing blocked outside visit window | Blocked |
| DISP-04 | Drug dispensing | High | Dispensing reconciles to dosing | Pass |
| SUP-01 | Resupply / inventory | High | Automatic resupply at threshold | Pass |
| SUP-02 | Resupply / inventory | Critical | Expired kits not dispensable | Pass |
| SUP-03 | Resupply / inventory | High | Temperature-excursion kits quarantined | Fail |
| SUP-04 | Resupply / inventory | Medium | Inventory reconciliation | Pass |
| UNBL-01 | Emergency unblinding | Critical | Emergency unblind with audit trail | Pass |
| UNBL-02 | Emergency unblinding | Critical | Unblinding role permissions | Pass |
| UNBL-03 | Emergency unblinding | High | Post-unblind safety notification | In Progress |
| NOT-01 | Notifications / reports | Medium | Enrollment notification delivered | Pass |
| NOT-02 | Notifications / reports | Medium | Low-stock alert delivered | Not Run |
| INT-01 | Data integration (EDC) | High | IRT<->EDC participant reconciliation | Pass |
| INT-02 | Data integration (EDC) | High | Randomization data transfer to biostatistics | Pass |