: Public Class
Created: 10/18/2011 11:09:47 AM
Modified: 8/7/2012 1:59:28 PM
Project:
Advanced:
DEFINITION:<br /></p><p>A type of statistical analysis plan that is intended to draw conclusions across multiple studies.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Plan for integrated analysis of safety data in support of the Integrated Summary of Safety (ISS).<br /></p><p>Plan for integrated analysis of efficacy data in support of the Integrated Summary of Effectiveness (ISE).<br /></p><p>Plan for multi-study analysis to be presented in a manuscript.<br /></p><p>Plan for a meta-analysis of literature studies.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Element Source Role Target Role
StudyProtocol
Class  
Name: integratingIntegratedStatisticalAnalysisPlan
 
Name: integratedStudyProtocol
 
Details:
DESCRIPTION:<br /></p><p>Each IntegratedStatisticalAnalysisPlan always integrates data from one or more StudyProtocol. Each StudyProtocol might have data integrated from one or more IntegratedStatisticalAnalysisPlan.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the study protocols whose data is used in the integrated 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>
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):