This roundtable will discuss how statistically valid methods are applied to common misrandomization cases within a clinical trial. These methods are applied within the IVR/IWR while maintaining scientific integrity in order to best define the intent to treat, per protocol, and safety analysis populations.

We will seek to answer the questions:

(1) How can we maintain treatment balance within a randomization schedule when randomization errors threaten the treatment ratio?

(2) How does the communication path between the sponsor and the protocol statistician facilitate the handling of misrandomization cases?

(3) How can we provide a simple yet powerful audit trail that is helpful during study closeout, data analysis, and study audit?