Randomization & IWRS Specification + UAT — GLPI103-301
| Field | Value |
|---|---|
| Document ID | TMF-RAND |
| Version | 2.0 (full + UAT) |
| Study No. | GLPI103-301 |
| Standard | ICH E9; double-blind double-dummy; 21 CFR Part 11 |
| Confidentiality | Confidential — TMF (restricted) |
Specifies the randomization implemented in
src/randomization/build_edc.py(randomize_subjects/stratify_subjects) and the IWRS configuration and User Acceptance Testing.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Biostatistics | Initial spec |
| 2.0 | 2026-06-29 | Biostat / IWRS vendor | Full spec — block design, IWRS config, UAT |
1. Randomization Design
- Allocation: 1:1:1 → Arm A (GLPI-103 IV), Arm B (GLPI-103 Oral), Arm C (Semaglutide Oral).
- Method: permuted-block randomization within strata.
- Stratification: baseline HbA1c (<8.5 vs ≥8.5%) × BMI (<30 vs ≥30) × Region (Capital/Yeongnam/Honam/Chungcheong/Gangwon-Jeju).
- Randomization list generated by an independent statistician with a fixed seed (
config seed=42); access-controlled.
2. Blinding (Double-Dummy)
Each subject receives one active route + matching placebo for the other route (identical appearance). Subjects, site staff, and sponsor remain blinded. Emergency unblinding is available 24/7 via IWRS, logged and reported.
3. IWRS Configuration
- Functions: subject registration, eligibility confirmation, stratified allocation, drug-kit assignment, resupply/expiry management, emergency code-break.
- Kit management: kit lists per arm; double-dummy kit pairing; temperature/expiry controls; site inventory thresholds.
- Compliance: 21 CFR Part 11 audit trail; role-based access; validated system.
4. User Acceptance Testing (UAT) — summary
| UAT case | Expected | Result [MOCK] |
|---|---|---|
| Eligibility pass → allocation | Subject randomized within correct stratum | Pass |
| Stratum integrity | Allocation balanced within each HbA1c×BMI×Region stratum | Pass |
| 1:1:1 ratio | Arms balanced across blocks | Pass (realized 300/301/299) |
| Double-dummy kit pairing | Active route + matching placebo assigned | Pass |
| Emergency unblinding | Code-break returns arm; event logged & notified | Pass |
| Resupply / expiry | Triggers at threshold; expired kits blocked | Pass |
| Audit trail | All transactions time-stamped, attributable | Pass |
UAT executed and signed off before go-live; deviations (none material) logged.
5. Integrity & Reproducibility
The randomization is reproducible (fixed seed); realized allocation IV 300 / Oral 301 / Semaglutide 299 (N=900; REF-002). Allocation concealment is maintained until database lock and unblinding per SAP-301.