📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.

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Mock / simulation document

This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.

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About this document — a plain-language guide

What it is. The randomization and IWRS specification (plus user-acceptance testing) — how subjects are assigned to treatments and how the system is validated.

Why it exists. Randomization and blinding are the heart of a controlled trial. This specifies the stratified block scheme, the double-dummy blinding, and the interactive system that assigns treatment, with evidence the system was tested (21 CFR Part 11).

How it is produced here. It is an operational trial document — a plan, charter, or template of the kind kept in the Trial Master File. It describes how the trial is run, rather than reporting the trial's results.

Format & governing standard. ICH E9; double-blind double-dummy; 21 CFR Part 11

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)

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How the blind is kept with two routes

Because the drug is an injection and the comparator a pill, every subject gets both a real product and a matching dummy of the other form. That way neither patients nor staff can tell arms apart by the route — the 'double-dummy' trick that preserves blinding.

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

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Why reproducibility is called out

The treatment assignment is driven by a fixed random seed and a validated system, so the exact allocation can be regenerated and audited. In a controlled trial, a trustworthy, tamper-evident randomization is the foundation everything else stands on.

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.