Protocol Deviation Log (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. Protocol Deviation Log (OBX319-301)
Why it exists. A quality record showing how the program controls quality and builds the audit trail.
How it is produced here. It is a quality record: a plan or log that shows how the program controls quality and builds the audit trail sitting behind every other document.
Format & governing standard. —
Protocol Deviation Log (OBX319-301)
Document ID: QA-002
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH E6(R3)
Protocol Deviation Log — OBX319-301
Register of protocol deviations for OBX319-301, each classified (major/minor), with root cause, impact on subject safety and data integrity, and CAPA linkage. Reviewed for the clinical study report's deviation summary. ICH E6(R3).
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