DEFINITION:<br /></p><p>An activity that is intended to occur at some point in the context of a particular study and that is the assignment of an experimental unit to a portion of the study, such as an arm or a portion of an arm (when secondary allocations may occur) based on a randomization book.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>A study has two treatment arms, A and B, to which study subjects will be evenly distributed.  The first study subject to be randomized received treatment Arm A and that was documented as part of the Randomization Book, the next study subject to be randomized will receive the next open treatment, which is Arm B.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>A randomization book is a predefined set of assignments to portions of a study based on criteria, such as stratum group for example, that ensures a desired distribution of experimental units across those portions of the study. For example, the book entries indicate which arm a given experimental unit, Joe, is assigned to based on the fact that he's the 5th person in stratum group #2.<br /></p>