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).