StatisticalAnalysisPlanVersion

: Public Class

Created:	10/28/2009 9:33:49 PM
Modified:	8/7/2012 2:00:08 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{656B1232-B481-4676-B62A-E9E24B1B333B}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SA: Statistical Analysis

DEFINITION: A point-in-time snapshot of a statistical analysis plan. EXAMPLE(S): OTHER NAME(S): NOTE(S): 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.

Attributes
Associations To
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public II
identifier

Details:

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

Map:Statistics v1.0=StatisticalAnalysisPlanVersion.versionIdentifier

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A unique symbol that establishes the identity of a version of the statistical analysis plan.#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;

Public CD
typeCode

Details:

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

Map:Statistics v1.0=StatisticalAnalysisPlanVersion.versionTypeCode

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of statistical analysis plan version.#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;draft, approved#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 ST
description

Details:

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

Map:Statistics v1.0=StatisticalAnalysisPlanVersion.description

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The textual explanation of the statistical analysis plan version. #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
StudyProtocolVersion Class	Name: addressingStatisticalAnalysisPlanVersion	Name: addressedStudyProtocolVersion
Details: DESCRIPTION:<br /></p><p>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 /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the version of the study protocol that is the basis for a statistical analysis plan version.<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>
StatisticalAnalysisPlan Class	Name: versioningStatisticalAnalysisPlanVersion	Name: versionedStatisticalAnalysisPlan
Details: DESCRIPTION:<br /></p><p>Each StatisticalAnalysisPlanVersion always is a version of one StatisticalAnalysisPlan. Each StatisticalAnalysisPlan always has as a version one or more StatisticalAnalysisPlanVersion.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the statistical analysis plan that is the basis for a statistical analysis plan version.<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
StatisticalAnalysisPlanVersionStatus Class	Name: describingStatisticalAnalysisPlanVersionStatus	Name: describedStatisticalAnalysisPlanVersion
Details: DESCRIPTION:<br /></p><p>Each StatisticalAnalysisPlanVersionStatus always describes one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be described by one or more StatisticalAnalysisPlanVersionStatus.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the statuses at different points in time for a particular version of a statistical analysis plan.<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>
StatisticalAnalysisPlanVersionModificationSummary Class	Name: targetStatisticalAnalysisPlanVersionModificationSummary	Name: sourceStatisticalAnalysisPlanVersion
Details: DESCRIPTION:<br /></p><p>Each StatisticalAnalysisPlanVersionModificationSummary always has as source one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be the source for one StatisticalAnalysisPlanVersionModificationSummary.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the changed version of the statistical analysis plan that is used to create a statistical analysis plan version modification summary.<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>
StatisticalAnalysisPlanVersionModificationSummary Class	Name: sourceStatisticalAnalysisPlanVersionModificationSummary	Name: targetStatisticalAnalysisPlanVersion
Details: DESCRIPTION:<br /></p><p>Each StatisticalAnalysisPlanVersionModificationSummary always has as target one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be the target for one StatisticalAnalysisPlanVersionModificationSummary.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the original version of the statistical analysis plan that is used to create a statistical analysis plan version modification summary.<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>
StatisticalAnalysisPlanDocumentVersion Class	Name: createdStatisticalAnalysisPlanDocumentVersion	Name: usedStatisticalAnalysisPlanVersion
Details: DESCRIPTION:<br /></p><p>Each StatisticalAnalysisPlanDocumentVersion always is created from one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be used to create one StatisticalAnalysisPlanDocumentVersion.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the version of a statistical analysis plan that is the basis for a version of a statistical analysis plan document.<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>
SampleSizeConsideration Class	Name: includedSampleSizeConsideration	Name: includingStatisticalAnalysisPlanVersion
Details: DESCRIPTION:<br /></p><p>Each SampleSizeConsideration always is included in one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might include one or more SampleSizeConsideration.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the considerations that inform the calculation of the sample size for a given version of a statistical analysis plan.<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>
GeneralStatisticalConsideration Class	Name: containedGeneralStatisticalConsideration	Name: containingStatisticalAnalysisPlanVersion
Details: DESCRIPTION:<br /></p><p>Each GeneralStatisticalConsideration always is part of one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might have one or more GeneralStatisticalConsideration.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the considerations that inform the detailed design of the analysis plan.<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>
DataMonitoringCommitteeCharterVersion Class	Name: influencingDataMonitoringCommitteeCharterVersion	Name: influencedStatisticalAnalysisPlanVersion
Details: DESCRIPTION:<br /></p><p>Each DataMonitoringCommitteeCharterVersion might influence one or more StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be influenced by one or more DataMonitoringCommitteeCharterVersion.<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: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.

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):