Decision Log (OBX319-301)

Document ID: QA-004
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH E6(R3)

Decision Log — OBX319-301

Chronological record of key programme and study decisions for OBX319-301 (scientific, operational, and regulatory), with rationale, alternatives considered, and the accountable owner, preserving the audit trail behind the dossier.