Tabular Listing of Clinical Studies (OBX-319)
📚 Part of the OBX-319 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. Tabular Listing of Clinical Studies (OBX-319)
Why it exists. Clinical study documentation supporting the efficacy and safety of the program.
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. —
Tabular Listing of Clinical Studies (OBX-319)
Document ID: M52
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH M4E(R2)
Tabular Listing of Clinical Studies (M5.2) — OBX-319
| Study | Phase | Design | Population | N | Status |
|---|---|---|---|---|---|
| OBX319-301 | 3 | randomized, double-blind, placebo-controlled | Systemic Lupus Erythematosus (moderate-to-severe active) | 480 | Completed |
Supportive studies, where present, are listed in the programme overview. ICH M4E(R2) §5.2.
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