: Public Class
Created: 8/27/2009 4:58:42 PM
Modified: 8/26/2017 2:39:33 AM
DEFINITION:<br/>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/><br/>EXAMPLE(S):<br/>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/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>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/>
Element Source Role Target Role
Name: definedRandomizationBookEntry
Name: definingPlannedRandomizationBookAllocation
DESCRIPTION:<br/>Each RandomizationBookEntry always is defined by one PlannedRandomizationBookAllocation. Each PlannedRandomizationBookAllocation always defines one or more RandomizationBookEntry.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:C3PR BookRandomization
Map:C3PRv2.9 BookRandomization
Map:CTRRr3 PlannedRandomizationBookAllocation
Constraint Type Status
DefinedActivity Qualifier Invariant Approved
A PlannedRandomizationBookAllocation can only reference a StudyActivity that points to DefinedExperimentalUnitAllocation, not any other DefinedActivity subclass.<br/>
Repeat Not Applicable Invariant Approved
The Repeat attributes should not be used for a PlannedRandomizationBookAllocation.<br/>
be participated in by Qualifier Invariant Approved
Associations from ExperimentalUnit are valid. Associations from Subject (including StudySubject) are not valid.<br/>
Object Type Connection Direction Notes
PlannedExperimentalUnitAllocation Class Generalization To DESCRIPTION: Each PlannedRandomizationBookAllocation always specializes one PlannedExperimentalUnitAllocation. Each PlannedExperimentalUnitAllocation might be specialized by one PlannedRandomizationBookAllocation. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):