Protocol Representation Sub-Domain::RandomizationBookEntry

: Public Class

Created:	4/16/2008 10:32:43 AM
Modified:	8/26/2017 2:39:34 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{3937CAAB-B4E7-4952-ADEA-0F1A964B7CBC}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View PR: Protocol Representation, Participant Registration

DEFINITION: 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. EXAMPLE(S): An entry might be mapping the 5th experimental unit in a given Stratum Group to a particular treatment Arm. OTHER NAME(S): NOTE(S): 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.

Attributes
Associations To
Tagged Values
Constraints

Attribute

Public INT.NONNEG
positionNumber

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:1. to 1
Transient:	False
Derived:	False
IsID:	False

Map:C3PR=BookRandomizationEntry.position
Map:C3PRv2.9=BookRandomizationEntry.position

Notes:

DEFINITION: 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. EXAMPLE(S): StratumGroup#: 0; Position: 0; Arm/Portion of Arm: A StratumGroup#: 0; Position: 1; Arm/Portion of Arm: B 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. OTHER NAME(S): NOTE(S):

Public BL
positionFilledIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:C3PR=StratumGroup.currentPosition

Notes:

DEFINITION: Specifies whether the position is filled by an experimental unit assignment. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
StratumGroup Class	Name: randomizingRandomizationBookEntry	Name: randomizedStratumGroup
Details: DESCRIPTION:<br/>Each RandomizationBookEntry might randomize one StratumGroup. Each StratumGroup might be randomized by one or more RandomizationBookEntry.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
PlannedRandomizationBookAllocation Class	Name: definedRandomizationBookEntry	Name: definingPlannedRandomizationBookAllocation
Details: 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: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.<br/>