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Tabular Listing of Clinical Studies (TILA-278)

July 12, 2026

๐Ÿ“š Part of the TILA-278 Regulatory Dossier โ€” 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 โ€” the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.

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About this document โ€” a plain-language guide

What it is. Tabular Listing of Clinical Studies (TILA-278)

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 โ€” 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. โ€”


Tabular Listing of Clinical Studies (TILA-278)

Document ID: M52
Version: 1.0
Change History: 1.0 โ€” Initial issue.
Standard(s): ICH M4E(R2)

Tabular Listing of Clinical Studies (M5.2) โ€” TILA-278

StudyPhaseDesignPopulationNStatus
TILA278-2012randomized, double-blind, placebo-controlledUlcerative Colitis (moderate-to-severe)900Completed

Supportive studies, where present, are listed in the programme overview. ICH M4E(R2) ยง5.2.

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