: Public Class
Created: 3/6/2015 2:26:47 PM
Modified: 3/16/2015 3:52:26 PM
Project:
Advanced:
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).<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>randomization, direct assignment based on eligibility criteria, etc.<br /></p><p>"Escalating dose cohort studies" enroll subjects in successive arms, i.e., one arm is completely filled before any subjects are enrolled in the next arm.  In such a study, allocation depends on which arms have been fully enrolled and which are currently open for enrollment.  Note that this example assumes that the experimental unit is the subject (rather than a part of a subject or a group of subjects).<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Element Source Role Target Role
PlannedExperimentalUnitAllocationResult
Class  
Name: assignedExperimentalUnitAllocationResult
 
Name: assigningPlannedExperimentalUnitAllocation
 
Details:
DESCRIPTION: Each PlannedExperimentalUnitAllocationResult always is an option for one PlannedExperimentalUnitAllocation. Each PlannedExperimentalUnitAllocation might assign experimental units to one or more PlannedExperimentalUnitAllocationResult.<br /></p><p><br /></p><p>DEFINITION: This association identifies a relationship between an allocation activity and an option to which experimental units will be assigned.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Tag Value
Map:SDTMIGv3.1.3 TA.TABRANCH
Details:
 
Object Type Connection Direction Notes
PlannedRandomizationBookAllocation Class Generalization From DESCRIPTION: Each PlannedRandomizationBookAllocation always specializes one PlannedExperimentalUnitAllocation. Each PlannedExperimentalUnitAllocation might be specialized by one PlannedRandomizationBookAllocation. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
PlannedActivity Class Generalization To DESCRIPTION: Each PlannedExperimentalUnitAllocation always specializes one PlannedActivity. Each PlannedActivity might be specialized by one PlannedExperimentalUnitAllocation. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):