: Public Class
Created: 10/18/2011 10:54:26 AM
Modified: 3/16/2015 6:09:56 PM
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DEFINITION:<br /></p><p>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 /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Additional analyses during clinical study report preparation,<br /></p><p>Response to regulatory request, <br /></p><p>Hypothesis generation,<br /></p><p>Pre-specified PK analysis plan, <br /></p><p>Analysis plan for sub-study or study addendum<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Attribute
Public CD
  reasonCode
Details:
Map:Statistics v1.0=SupplementalStatisticalAnalysisPlanVersion.reasonCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the motivation, cause, or rationale for the supplemental 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;Additional analyses during clinical study report preparation,#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Response to regulatory request, #lt;br /#gt;#lt;/p#gt;#lt;p#gt;Hypothesis generation#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;#lt;p#gt;This coded concept is extensible, but the examples above cover a large proportion of possible values.#lt;br /#gt;#lt;/p#gt;
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):