Clinical Trial Agreement & IRB/IEC Approvals (OBX319-301)
Document ID: TMF-013
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH E6(R3)
Clinical Trial Agreement & IRB/IEC Approvals — OBX319-301
The executed clinical trial agreement framework for OBX319-301 and the record of Institutional Review Board / Independent Ethics Committee approvals of the protocol, informed consent, and related documents prior to enrollment. ICH E6(R3).