Governance & RACI (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. Governance & RACI (OBX-319)
Why it exists. A program-management document: how the development program is planned and governed.
How it is produced here. It is a program-management document: the planning, budgeting, and governance wrapper around the science — how the whole development program is run as a project.
Format & governing standard. —
Governance & RACI (OBX-319)
Document ID: PM-002
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): Program management
Governance & RACI — OBX-319
Decision rights and accountabilities for the OBX-319 programme: the steering committee, the core team roles, escalation paths, and a RACI matrix across clinical, nonclinical, CMC, regulatory, biostatistics, and operations.
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