: Public Class
Created: 10/18/2011 10:54:26 AM
Modified: 8/26/2017 2:52:39 AM
Project:
Advanced:
DEFINITION:<br/>A type of statistical analysis plan version that provides specification for additional analyses not included as part of the principal statistical analysis plan version.  <br/><br/>EXAMPLE(S):<br/>Additional analyses during clinical study report preparation,<br/>Response to regulatory request, <br/>Hypothesis generation,<br/>Pre-specified PK analysis plan, <br/>Analysis plan for sub-study or study addendum<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public CD
  reasonCode
Details:
Map:Statistics v1.0=SupplementalStatisticalAnalysisPlanVersion.reasonCode
Notes: DEFINITION:<br/>A coded value specifying the motivation, cause, or rationale for the supplemental statistical analysis plan.<br/><br/>EXAMPLE(S):<br/>Additional analyses during clinical study report preparation,<br/>Response to regulatory request, <br/>Hypothesis generation<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>This coded concept is extensible, but the examples above cover a large proportion of possible values.<br/>
Tag Value
Map:Statistics v1.0 SupplementalStatisticalAnalysisPlanVersion
Details:
 
Object Type Connection Direction Notes
StatisticalAnalysisPlanVersion Class Generalization To DESCRIPTION: Each SupplementalStatisticalAnalysisPlanVersion always specializes one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be specialized by one SupplementalStatisticalAnalysisPlanVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):