: Public Class
Created: 10/18/2011 11:09:47 AM
Modified: 8/26/2017 2:52:37 AM
Project:
Advanced:
DEFINITION:<br/>A type of statistical analysis plan that is intended to draw conclusions across multiple studies.<br/><br/>EXAMPLE(S):<br/>Plan for integrated analysis of safety data in support of the Integrated Summary of Safety (ISS).<br/>Plan for integrated analysis of efficacy data in support of the Integrated Summary of Effectiveness (ISE).<br/>Plan for multi-study analysis to be presented in a manuscript.<br/>Plan for a meta-analysis of literature studies.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Element Source Role Target Role
StudyProtocol
Class  
Name: integratingIntegratedStatisticalAnalysisPlan
 
Name: integratedStudyProtocol
 
Details:
DESCRIPTION:<br/>Each IntegratedStatisticalAnalysisPlan always integrates data from one or more StudyProtocol. Each StudyProtocol might have data integrated from one or more IntegratedStatisticalAnalysisPlan.<br/><br/>DEFINITION:<br/>Identifies the study protocols whose data is used in the integrated statistical analysis plan. <br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:Statistics v1.0 IntegratedStatisticalAnalysisPlan
Details:
 
Object Type Connection Direction Notes
StatisticalAnalysisPlan Class Generalization To DESCRIPTION: Each IntegratedStatisticalAnalysisPlan always specializes one StatisticalAnalysisPlan. Each StatisticalAnalysisPlan might be specialized by one IntegratedStatisticalAnalysisPlan. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):