📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
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.
What it is. The Study Data Reviewer's Guide (SDRG) — the human-readable guide to the SDTM (collected) datasets.
Why it exists. SDTM datasets are standardized but still need explanation: what was collected, any conformance deviations, and how to navigate them. The SDRG orients a reviewer to the raw standardized data.
How it is produced here. It is generated from the standardized study datasets (the SDTM and ADaM data and their define.xml 'data dictionary'), so the guide always describes the exact datasets a regulator would receive.
Format & governing standard. SDTMIG (v3.x) · Define-XML 2.1 · MedDRA (AE coding)
Where the ADRG covers the analysis data, the SDRG covers the collected ('SDTM') data — what was gathered, how it maps to the standard, and any quirks a reviewer should know before opening the datasets.
| Field | Value |
|---|---|
| Document ID | DEF-301-SDRG |
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| Version | 1.0 |
| Status | Final (portfolio) |
| Study No. | GLPI103-301 |
| CDISC STUDYID | GLPI103 |
| Standards | SDTMIG (v3.x) · Define-XML 2.1 · MedDRA (AE coding) |
| Confidentiality | Confidential — portfolio use |
Companion to
define.xml. Describes the submitted SDTM datasets, conformance, and any reviewer-relevant notes. Generated bytools/build_define.pyfrom the actual datasets.
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Data Management / Biostatistics | Initial version |
This SDRG supports review of the tabulation (SDTM) datasets for Study GLPI103-301, a Phase 3, randomized, double-blind, double-dummy, active-controlled trial of GLPI-103 (IV and Oral) versus oral semaglutide in T2DM (PROT-301).
1:1:1 randomization (N=900 actual), stratified by baseline HbA1c (<8.5 vs ≥8.5%), BMI (<30 vs ≥30), and Region; 52-week treatment; primary endpoint CFB HbA1c at Week 52 (PROT-301, REF-002).
The simulated patients are Korean, but CDISC submissions require standardized English terms and a specific transport format. Source values (sex, race, region, and so on) are mapped to the standard English controlled terminology so the datasets are submission-legal.
| Item | Value |
|---|---|
| SDTM IG | 3.x |
| Define-XML | 2.1 (define.xml) |
| Controlled Terminology | CDISC CT (SEX, RACE, AE severity NY, SC EDLEVEL/MARISTAT) |
| MedDRA | AE AEDECOD/AEBODSYS coded (PT/SOC) |
| Dataset | Class | Records | Structure |
|---|---|---|---|
| DM | Special Purpose | 900 | One record per subject |
| SC | Findings | 1,980 | One record per characteristic per subject (EDLEVEL, MARISTAT, EMPLST) |
| VS | Findings | 23,144 | One record per vital sign per visit |
| LB | Findings | 28,930 | One record per lab test per visit |
| AE | Events | 815 | One record per adverse event |
USUBJID = STUDYID-SITEID-SUBJID. SITEID (S001–S017) maps to Korean provinces; COUNTRY=KOR, RACE=ASIAN. Actual = planned arm (no treatment switching modeled).EDLEVEL (Education Level), MARISTAT (Marital Status), EMPLST (Employment Status). Values mapped to English CDISC-aligned controlled terms (source distribution is Korea-grounded).LBSTRESN.AESEV (MILD/MODERATE/SEVERE), AEREL (RELATED/NOT RELATED), AESER (Y for 10 serious events, incl. 3 with fatal outcome). GI disorders are the most frequent SOC.define.xml is Define-XML 2.1 and well-formed (7 datasets incl. ADaM).
Automated subset validation (tools/validate_cdisc.py → DEF-301_validation_report.md) implements a representative subset of CDISC/Pinnacle 21 rules — required variables, controlled terminology (SEX, AESEV, AEREL, AESER, SC test codes), referential integrity (USUBJID across domains ↔ DM ↔ ADSL), and define↔data consistency. Result: 0 Errors, 0 Warnings.
Official Pinnacle 21 Community validation is the formal conformance step. It could not be run in the build environment (the download is registration-gated and the tool is a GUI Java application; programmatic access returns HTTP 403). Manual steps for the reviewer/sponsor:
data/sdtm/ (and data/adam/), Define = regulatory/m5-clinical/define/define.xml, Standard = SDTM-IG 3.x / ADaM-IG 1.x.AESER="Y" for serious events; 3 fatal outcomes).