: Public Class
Created: 10/28/2009 9:33:49 PM
Modified: 12/1/2018 12:50:05 AM
Project:
Advanced:
DEFINITION:<br/>A point-in-time snapshot of a statistical analysis plan. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The statistical analysis plan evolves during the course of the study and accordingly the snapshot may address a different issue at varying levels of detail relative to the final plan.<br/>
Attribute
Public ID
  identifier
Details:
Map:Statistics v1.0=StatisticalAnalysisPlanVersion.versionIdentifier
Notes: DEFINITION:<br/>A unique symbol that establishes the identity of a version of the statistical analysis plan.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public CD
  typeCode
Details:
Map:Statistics v1.0=StatisticalAnalysisPlanVersion.versionTypeCode
Notes: DEFINITION:<br/>A coded value specifying the kind of statistical analysis plan version.<br/><br/>EXAMPLE(S):<br/>draft, approved<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public ST
  description
Details:
Map:Statistics v1.0=StatisticalAnalysisPlanVersion.description
Notes: DEFINITION:<br/>The textual explanation of the statistical analysis plan version. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
StudyProtocolVersion
Class  
Name: addressingStatisticalAnalysisPlanVersion
 
Name: addressedStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StatisticalAnalysisPlanVersion always addresses the statistical needs of one or more StudyProtocolVersion. Each StudyProtocolVersion might have statistical needs addressed by one or more StatisticalAnalysisPlanVersion.<br/><br/>DEFINITION:<br/>Identifies the version of the study protocol that is the basis for a statistical analysis plan version.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
StatisticalAnalysisPlan
Class  
Name: versioningStatisticalAnalysisPlanVersion
 
Name: versionedStatisticalAnalysisPlan
 
Details:
DESCRIPTION:<br/>Each StatisticalAnalysisPlanVersion always is a version of one StatisticalAnalysisPlan. Each StatisticalAnalysisPlan always has as a version one or more StatisticalAnalysisPlanVersion.<br/><br/>DEFINITION:<br/>Identifies the statistical analysis plan that is the basis for a statistical analysis plan version.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
SampleSizeConsideration
Class  
Name: includedSampleSizeConsideration
 
Name: includingStatisticalAnalysisPlanVersion
 
Details:
DESCRIPTION:<br/>Each SampleSizeConsideration always is included in one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might include one or more SampleSizeConsideration.<br/><br/>DEFINITION:<br/>Identifies the considerations that inform the calculation of the sample size for a given version of a statistical analysis plan.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StatisticalAnalysisPlanDocumentVersion
Class  
Name: createdStatisticalAnalysisPlanDocumentVersion
 
Name: usedStatisticalAnalysisPlanVersion
 
Details:
DESCRIPTION:<br/>Each StatisticalAnalysisPlanDocumentVersion always is created from one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be used to create one StatisticalAnalysisPlanDocumentVersion.<br/><br/>DEFINITION:<br/>Identifies the version of a statistical analysis plan that is the basis for a version of a statistical analysis plan document.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StatisticalAnalysisPlanVersionModificationSummary
Class  
Name: sourceStatisticalAnalysisPlanVersionModificationSummary
 
Name: targetStatisticalAnalysisPlanVersion
 
Details:
DESCRIPTION:<br/>Each StatisticalAnalysisPlanVersionModificationSummary always has as target one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be the target for one StatisticalAnalysisPlanVersionModificationSummary.<br/><br/>DEFINITION:<br/>Identifies the original version of the statistical analysis plan that is used to create a statistical analysis plan version modification summary.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
DataMonitoringCommitteeCharterVersion
Class  
Name: influencingDataMonitoringCommitteeCharterVersion
 
Name: influencedStatisticalAnalysisPlanVersion
 
Details:
DESCRIPTION:<br/>Each DataMonitoringCommitteeCharterVersion might influence one or more StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be influenced by one or more DataMonitoringCommitteeCharterVersion.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
GeneralStatisticalConsideration
Class  
Name: containedGeneralStatisticalConsideration
 
Name: containingStatisticalAnalysisPlanVersion
 
Details:
DESCRIPTION:<br/>Each GeneralStatisticalConsideration always is part of one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might have one or more GeneralStatisticalConsideration.<br/><br/>DEFINITION:<br/>Identifies the considerations that inform the detailed design of the analysis plan.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StatisticalAnalysisPlanVersionStatus
Class  
Name: describingStatisticalAnalysisPlanVersionStatus
 
Name: describedStatisticalAnalysisPlanVersion
 
Details:
DESCRIPTION:<br/>Each StatisticalAnalysisPlanVersionStatus always describes one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be described by one or more StatisticalAnalysisPlanVersionStatus.<br/><br/>DEFINITION:<br/>Identifies the statuses at different points in time for a particular version of a statistical analysis plan.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
StatisticalAnalysisPlanVersionModificationSummary
Class  
Name: targetStatisticalAnalysisPlanVersionModificationSummary
 
Name: sourceStatisticalAnalysisPlanVersion
 
Details:
DESCRIPTION:<br/>Each StatisticalAnalysisPlanVersionModificationSummary always has as source one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be the source for one StatisticalAnalysisPlanVersionModificationSummary.<br/><br/>DEFINITION:<br/>Identifies the changed version of the statistical analysis plan that is used to create a statistical analysis plan version modification summary.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:Statistics v1.0 StatisticalAnalysisPlanVersion
Details:
 
Constraint Type Status
addresses the needs of Qualifier Invariant Approved
Details:
The StatisticalAnalysisPlanVersion must pertain to the same StudyProtocolVersion that the StatisticalAnalysisPlan pertains to.<br/>
Object Type Connection Direction Notes
SupplementalStatisticalAnalysisPlanVersion Class Generalization From DESCRIPTION: Each SupplementalStatisticalAnalysisPlanVersion always specializes one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be specialized by one SupplementalStatisticalAnalysisPlanVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
SampleSizeConsideration Class Weak From DESCRIPTION: Each SampleSizeConsideration always is included in one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might include one or more SampleSizeConsideration. DEFINITION: Identifies the considerations that inform the calculation of the sample size for a given version of a statistical analysis plan. EXAMPLE(S): OTHER NAME(S): NOTE(S):
PrincipalStatisticalAnalysisPlanVersion Class Generalization From DESCRIPTION: Each PrincipalStatisticalAnalysisPlanVersion always specializes one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be specialized by one PrincipalStatisticalAnalysisPlanVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
GeneralStatisticalConsideration Class Strong From DESCRIPTION: Each GeneralStatisticalConsideration always is part of one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might have one or more GeneralStatisticalConsideration. DEFINITION: Identifies the considerations that inform the detailed design of the analysis plan. EXAMPLE(S): OTHER NAME(S): NOTE(S):