Study Data Reviewer's Guide (SDRG) — GLPI103-301
| Field | Value |
|---|---|
| Document ID | DEF-301-SDRG |
| 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.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Data Management / Biostatistics | Initial version |
1. Introduction
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).
2. Protocol Summary
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).
3. Standards & Dictionaries
| 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) |
4. Datasets Submitted
| 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 |
5. Domain-Level Notes
- DM —
USUBJID = STUDYID-SITEID-SUBJID.SITEID(S001–S017) maps to Korean provinces;COUNTRY=KOR,RACE=ASIAN. Actual = planned arm (no treatment switching modeled). - SC — Subject characteristics derived from enrollment demographics (Nemotron-Personas-Korea):
EDLEVEL(Education Level),MARISTAT(Marital Status),EMPLST(Employment Status). Values mapped to English CDISC-aligned controlled terms (source distribution is Korea-grounded). - VS — HEIGHT collected at baseline only; WEIGHT/BMI/SYSBP/DIABP per visit.
- LB — HBA1C (primary analyte), FPG, ALT, AST, EGFR. Standardized numeric results in
LBSTRESN. - AE — Treatment-emergent events;
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.
6. Conformance
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:
- Register and download Pinnacle 21 Community from pinnacle21.com (bundles its own JRE).
- New Validation → Source =
data/sdtm/(anddata/adam/), Define =regulatory/m5-clinical/define/define.xml, Standard = SDTM-IG 3.x / ADaM-IG 1.x. - Export the report and append it here with issue dispositions.
7. Known Data Characteristics (simulated dataset)
- 10 serious adverse events and 2 deaths recorded (
AESER="Y" for serious events; 3 fatal outcomes). - 53 major protocol deviations modeled → PPS (847) is a strict subset of FAS (900); see ADRG.
- Screen-failure rate (45.0%) exceeds the planning assumption (≈30%) due to realistic source demographics.