: Public Class
Created: 4/16/2008 10:32:43 AM
Modified: 6/24/2013 4:09:07 PM
Project:
Advanced:
DEFINITION:<br /></p><p>An item/element of a randomization book that can be used to assign an experimental unit to a planned arm or portion of an arm in a study. <br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>An entry might be mapping the 5th experimental unit in a given Stratum Group to a particular treatment Arm.<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 experimental unit in stratum group #2.<br /></p>
Attribute
Public INT.NONNEG
  positionNumber
Details:
Map:C3PR=BookRandomizationEntry.position
Map:C3PRv2.9=BookRandomizationEntry.position
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An integer specifying the value of a numerical sequence for a stratum group that should be used to assign an experimental unit to an arm or a portion of an arm. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;StratumGroup#: 0;  Position: 0;  Arm/Portion of Arm: A#lt;br /#gt;#lt;/p#gt;#lt;p#gt;StratumGroup#: 0;  Position: 1;  Arm/Portion of Arm: B#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;If 2 experimental units fall in the same Stratum Group i.e. say 0 in the above example, the first will be assigned Arm A because the current position would be 0 and the 2nd  would be assigned Arm B since the current position would be incremented by 1 each time an assignment happens.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public BL
  positionFilledIndicator
Details:
Map:C3PR=StratumGroup.currentPosition
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether the position is filled by an experimental unit assignment. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
StratumGroup
Class   		Name: randomizingRandomizationBookEntry
  		Name: randomizedStratumGroup
 
Details:
DESCRIPTION:<br /></p><p>Each RandomizationBookEntry might randomize one StratumGroup.  Each StratumGroup might be randomized by one or more RandomizationBookEntry.<br /></p><p><br /></p><p>DEFINITION:<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>
PlannedRandomizationBookAllocation
Class   		Name: definedRandomizationBookEntry
  		Name: definingPlannedRandomizationBookAllocation
 
Details:
DESCRIPTION:<br /></p><p>Each RandomizationBookEntry always is defined by one PlannedRandomizationBookAllocation. Each PlannedRandomizationBookAllocation always defines one or more RandomizationBookEntry.<br /></p><p><br /></p><p>DEFINITION:<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:C3PRv2.9 BookRandomizationEntry
Details:
 
Map:CTRRr3 RandomizationBookEntry
Details:
 
Constraint Type Status
positionNumber Unique Qualifier Invariant Approved
Details:
A RandomizationBookEntry.positionNumber must be unique within the context of the StratumGroup to which it's associated if associated to a StratumGroup, otherwise it must be unique within the context of the StudyProtocolVersion to which it is associated.