: Public Class
DEFINITION:<br /></p><p>Information about all changes made between the current and previous version of the 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>
- Attributes
- Associations To
- Tagged Values
| Attribute |
Public ED
text
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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=StatisticalAnalysisPlanVersionModificationSummary.text
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Textual or media-based summary of the changes.#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;Distribution assumptions for some analyses were not met, so additional analyses were performed to check robustness of results. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Another drug in the class has been approved so additional analyses of a new exploratory endpoint have been added. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Site was non-compliant so additional analyses are needed to handle this site's data. #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;
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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=StatisticalAnalysisPlanVersionModificationSummary.reasonCode
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the motivation, cause, or rationale for the modification.#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;Request by FDA#lt;br /#gt;#lt;/p#gt;#lt;p#gt;New information available#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Change in strategy#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Error correction#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Actual analysis differed from planned#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;
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Public ST
timingDescription
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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=StatisticalAnalysisPlanVersionModificationSummary.timingDescription
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Text description of when the modification occurred relative to the study.#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;Modification made prior to unblinding#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Modification made prior to first subject's first visit#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;
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Public TS.DATETIME
date
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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=StatisticalAnalysisPlanVersionModificationSummary.date
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Notes:
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DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) on which the modification took place.#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;#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;
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| Element |
Source Role |
Target Role |
StatisticalAnalysisPlanVersion
Class
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Name: targetStatisticalAnalysisPlanVersionModificationSummary
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Name: sourceStatisticalAnalysisPlanVersion
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 Details:
DESCRIPTION:<br /></p><p>Each StatisticalAnalysisPlanVersionModificationSummary always has as source one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be the source for one StatisticalAnalysisPlanVersionModificationSummary.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the changed version of the statistical analysis plan that is used to create a statistical analysis plan version modification summary.<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>
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StatisticalAnalysisPlanVersion
Class
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Name: sourceStatisticalAnalysisPlanVersionModificationSummary
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Name: targetStatisticalAnalysisPlanVersion
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Details:
DESCRIPTION:<br /></p><p>Each StatisticalAnalysisPlanVersionModificationSummary always has as target one StatisticalAnalysisPlanVersion. Each StatisticalAnalysisPlanVersion might be the target for one StatisticalAnalysisPlanVersionModificationSummary.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p>Identifies the original version of the statistical analysis plan that is used to create a statistical analysis plan version modification summary.<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>
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| Tag |
Value |
| Map:Statistics v1.0 |
StatisticalAnalysisPlanVersionModificationSummary |
Details:
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