Randomization & IWRS Plan (OBX319-301)

Document ID: TMF-012
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): ICH E6(R3) / E9

Randomization & IWRS Plan — OBX319-301

The randomization specification for OBX319-301: allocation 1:1:1, stratification factors, block structure, the IWRS/IRT workflow for assignment and drug supply, and emergency unblinding. Generated under access control and held independent of the study team. ICH E6(R3); E9.