📚 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 Tables, Listings, and Figures (TLF) shells — the empty, pre-specified templates of every output the report will contain.

Why it exists. Before analysis, the exact layout of each table and figure is agreed as a 'shell'. This prevents choosing presentations that flatter the result and lets programming proceed in parallel with data collection.

How it is produced here. The numbers come straight from the study's simulated Phase 3 dataset — they are calculated from the data, not typed in by hand. That is why you see the same figures repeated across the protocol, the analysis plan, the report, and the summaries: they all read from the same source.

Format & governing standard. ICH E3; CSR-aligned shells

Tables, Listings & Figures (TLF) Shells — GLPI103-301

Field	Value
Document ID	TLF-301
Version	1.0
Study No.	GLPI103-301
Standard	ICH E3; CSR-aligned shells
Confidentiality	Confidential

Shell mock-ups for the planned TLFs; each maps to a generated artifact (outputs/). Columns are the three arms (IV / Oral / Semaglutide).

Change History

Version	Date	Author	Summary
1.0	2026-06-29	Biostatistics	Initial shells

Tables

Table	Title	Population	Source
14.1.1	Subject disposition	All randomized	Figure 1 / ADSL
14.1.2	Protocol deviations	FAS	QA-DEV
14.1.3	Demographics & baseline characteristics	FAS	`table1_demographics.xlsx`
14.2.1	Exposure & compliance	Safety	ADSL/EX
14.2.2	Primary efficacy — HbA1c CFB at Week 52 (ANCOVA LS means & contrasts)	FAS	`table2_primary_efficacy.xlsx`, `ancova_results.csv`
14.2.3	Longitudinal HbA1c (MMRM) by visit	FAS	`mmrm_results.csv` / Figure 2
14.2.4	Secondary — weight CFB, FPG CFB	FAS	ADLB/EDC
14.2.5	Responders — HbA1c <7.0%, ≥10% weight loss	FAS	ADLB
14.3.1	TEAE overview & by SOC/PT	Safety	`table3_teae_summary.xlsx`
14.3.2	AESI & hypoglycaemia	Safety	AE
14.3.3	Laboratory shift tables; vital-sign CFB	Safety	ADLB/ADVS

Shell — Table 14.2.2 (Primary, ANCOVA)

Endpoint: Change from baseline in HbA1c (%) at Week 52 — FAS
                         GLPI-103 IV   GLPI-103 Oral   Semaglutide
 N                          xxx            xxx             xxx
 Baseline mean (SD)       x.x (x.x)      x.x (x.x)       x.x (x.x)
 LS mean CFB (95% CI)   -x.xx (..,..)  -x.xx (..,..)   -x.xx (..,..)
 Difference vs Sema       -0.xx          -0.xx             ref
   95% CI / p-value      (..,..) p<.001 (..,..) p<.001     —

Figures

Figure	Title	Source
1	CONSORT disposition flow	`figure1_consort.pdf`
2	Mean HbA1c CFB by visit and arm (MMRM)	`figure2_hba1c_longitudinal.pdf`
3	Subgroup forest plot (HbA1c effect)	`figure3_forest_plot.pdf`

Listings