: Public Class
Created: 4/16/2008 10:35:15 AM
Modified: 6/24/2013 4:08:30 PM
Project:
Advanced:
DEFINITION:<br /></p><p>A designation used to segregate study subjects into collections in order to balance the study for analysis. The stratum group is made up of a combination of stratification criterion answers, which ultimately is used to assign study subjects or experimental units to arms on a study.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>A given study may want to require even distribution of gender and age so stratum groups may be defined as:  males under 18, males 18 and over, females under 18, and females 18 and over.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public INT.NONNEG
  groupNumber
Details:
Map:C3PR=StratumGroup.stratumGroupNumber
Map:C3PRv2.9=StratumGroup.stratumGroupNumber
Map:CTRPv1.0=StratumGroup.groupNumberText
Map:CTRPv3.8=StratumGroup.groupNumberText
Map:CTRRr3=StratumGroup.groupNumber
Map:CTRv1.0=StratumGroup.groupNumber
Notes: DEFINITION: #lt;br /#gt;#lt;/p#gt;#lt;p#gt;An integer that identifies the stratum group to study personnel, such as the statistician and registrars. #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;Patient age (years)#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Stratum A#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Gender#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Two-year survival probability#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Disease Type#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Treatment Cohort#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#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;#lt;p#gt;This index is used to cross-reference the stratum group and set of arms during registration. It is provided to perform a lookup in the randomization book or statistical algorithm when performing randomization.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Text is captured using the originalText attribute of the INT.NONNEG data type.#lt;br /#gt;#lt;/p#gt;
Public ST
  description
Details:
Map:CTRPv3.8=StratumGroup.description
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The textual representation of the stratum group.#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;Primary malignancy, Weight loss severity, Concurrent therapy, Patient age (years), Gleason score, Baseline PSA#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
StudyProtocolVersion
Class   		Name: describedStratumGroup
  		Name: describingStudyProtocolVersion
 
Details:
DESCRIPTION:<br /></p><p>Each StratumGroup always is defined by one StudyProtocolVersion. Each StudyProtocolVersion might define one or more StratumGroup.<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>
DefinedStratificationCriterionPermissibleResult
Class   		Name: characterizedStratumGroup
  		Name: characterizingDefinedStratificationCriterionPermissibleResult
 
Details:
DESCRIPTION:<br /></p><p>Each StratumGroup always is characterized by one or more DefinedStratificationCriterionPermissibleResult. Each DefinedStratificationCriterionPermissibleResult always characterizes one or more StratumGroup.<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>
Element Source Role Target Role
RandomizationBookEntry
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>
Tag Value
Map:C3PRv2.9 StratificationCriterionAnswerCombination
Details:
 
Map:C3PRv2.9 StratumGroup
Details:
 
Map:CTRPv1.0 StratumGroup
Details:
 
Map:CTRPv3.8 StratumGroup
Details:
 
Map:CTRRr3 StratumGroup
Details:
 
Map:CTRv1.0 StratumGroup
Details:
 
Constraint Type Status
groupNumber Unique Qualifier Invariant Approved
Details:
A StratumGroup.groupNumber must be unique within the context of the StudyProtocolVersion to which it is associated.