: Public Class
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/>
- Attributes
- Tagged Values
- Other Links
| Attribute |
Public CD
reasonCode
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 Details:
| Alias: |
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| Initial: |
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| Stereotype: |
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| Ordered: |
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| Range: |
Range:0 to 1 |
| Transient: |
False |
| Derived: |
False |
| IsID: |
False |
Map:Statistics v1.0=SupplementalStatisticalAnalysisPlanVersion.reasonCode
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Notes:
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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/>
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| Tag |
Value |
| Map:Statistics v1.0 |
SupplementalStatisticalAnalysisPlanVersion |
 Details:
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| 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):
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