Analysis Results Metadata (OBX319-301)
📚 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. Analysis Results Metadata (OBX319-301)
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. —
Analysis Results Metadata (OBX319-301)
Document ID: ARM-301
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): CDISC ARM
Analysis Results Metadata (ARM) — OBX319-301
Results-level metadata for OBX319-301: for each key analysis (primary, key secondary, safety), the analysis parameters, dataset and rows, method, and the traceability to the ADaM datasets and the TFL outputs. CDISC Analysis Results Metadata; Define-XML 2.1.
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