Statistical Analysis Sub-Domain::StatisticalAnalysisPlanVersionModificationSummary

: Public Class

Created:	2/11/2010 3:08:42 PM
Modified:	8/26/2017 2:52:38 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{DD0EC08B-3DCD-46f7-89FC-48B7879D2153}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SA: Statistical Analysis

DEFINITION: Information about all changes made between the current and previous version of the statistical analysis plan. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Attributes
Associations To
Tagged Values

Attribute

Public ED
text

Details:

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

Map:Statistics v1.0=StatisticalAnalysisPlanVersionModificationSummary.text

Notes:

DEFINITION: Textual or media-based summary of the changes. EXAMPLE(S): Distribution assumptions for some analyses were not met, so additional analyses were performed to check robustness of results. Another drug in the class has been approved so additional analyses of a new exploratory endpoint have been added. Site was non-compliant so additional analyses are needed to handle this site's data. OTHER NAME(S): NOTE(S):

Public CD
reasonCode

Details:

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

Map:Statistics v1.0=StatisticalAnalysisPlanVersionModificationSummary.reasonCode

Notes:

DEFINITION: A coded value specifying the motivation, cause, or rationale for the modification. EXAMPLE(S): Request by FDA New information available Change in strategy Error correction Actual analysis differed from planned OTHER NAME(S): NOTE(S):

Public ST
timingDescription

Details:

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

Map:Statistics v1.0=StatisticalAnalysisPlanVersionModificationSummary.timingDescription

Notes:

DEFINITION: Text description of when the modification occurred relative to the study. EXAMPLE(S): Modification made prior to unblinding Modification made prior to first subject's first visit OTHER NAME(S): NOTE(S):

Public TS.DATETIME
date

Details:

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

Map:Statistics v1.0=StatisticalAnalysisPlanVersionModificationSummary.date

Notes:

DEFINITION: The date (and time) on which the modification took place. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
StatisticalAnalysisPlanVersion 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/>
StatisticalAnalysisPlanVersion 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	StatisticalAnalysisPlanVersionModificationSummary
Details: