: Public Class
Created: 7/24/2009 1:33:48 PM
Modified: 8/26/2017 2:39:27 AM
DEFINITION:<br/>An activity defined at a global library level that identifies pre-treatment factors by which study subjects are segregated to assure balance of these factors during analysis or before randomization to a study arm or some smaller segment of a study. The decisive factor used to help segregate the study subject into a stratum group for analysis or randomization purposes.<br/><br/>EXAMPLE(S):<br/>- Age Years: 18 to 59 vs. = 60.<br/>- Extra-Cranial Disease Controlled in Months: = 3 vs. #gt; 3.<br/>- Number of Brain Metastases: 1 vs. 2 vs. 3.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Tag Value
Map:C3PRv2.9 StratificationCriterion
Map:CTRv1.0 DefinedStratificationCriterion
Map:NCI CRF Standard CDE 3608v4.0: Study Stratification Text
Constraint Type Status
be participated in by Qualifier Invariant Approved
Associations from Subject are valid only for StudySubject. Associations from ExperimentalUnit are not valid.<br/>
Permissible Result Qualifier Invariant Approved
A DefinedStratificationCriterion must be associated with 2 or more DefinedStratificationCriterionPermissibleResults.<br/>
Object Type Connection Direction Notes
DefinedObservation Class Generalization To DESCRIPTION: Each DefinedStratificationCriterion always specializes one DefinedObservation. Each DefinedObservation might be specialized by one DefinedStratificationCriterion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):