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• Attributes for components used to itemize and organize the contents of the reporting event, or which may be used in the specification of either analyses or outputs:
  • mainListOfContents:

    Jira
    showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key ARSP-17

    A structured list of the analyses and outputs defined for the reporting event. The list is defined using the ListOfContents class, which allows referenced analyses and outputs to be organized into sections and subsections.
    
  • otherListsOfContents: Additional, optional structured lists of the analyses and outputs defined for the reporting event. Each of these lists is also defined using the ListOfContents class.
    
  • referenceDocuments: The documents referenced within the reporting event, either for documentation or for programming code. Each reference document is defined using the ReferenceDocument class.
    
  • terminologyExtensions: Any sponsor-defined extensions to extensible ARS terminology. One or more additional, sponsor-defined terms may be added to each extensible enumeration using the TerminologyExtension class.
    
  • analysisOutputCategorizations: Any categorizations used to tag analyses or outputs.Each categorization is defined using the AnalysisOutputCategorization class. 
    
• Attributes for components used to define and describe analyses:
  • analysisSets: The analysis sets defined for the reporting event. Each analysis set, or subject population, is defined using the AnalysisSet class as a set of subjects whose data are to be included in the main analyses. This is as defined in the statistical section of the protocol.
    
  • dataSubsets: Any defined data subsets that are used to restrict the records that are included in any given analysis (e.g., inclusion of only treatment-emergent adverse events in an AE summary analysis). Each data subset is defined using the DataSubset class.
    
  • analysisGroupings: Characteristics used to subdivide the subject population (e.g., treatment, sex, age group) or the records in an analysis dataset (e.g., "system organ class" or "preferred term" in an AE analysis dataset, "parameter" or "visit" in a vital signs analysis dataset). Each analysis grouping is defined using the GroupingFactor class.
  • methods:

    Jira
    showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key ARSP-29

    Defined methods used to analyze any analysis variable. Each method, which is defined using the AnalysisMethod class, may contain multiple individual operations. For example, a "summary of categorical variable" method might include separate operations for "count of subject by group" and "percent of subjects by group".
    
  • analyses: The analyses defined for the reporting event. Each analysis is described, using the Analysis class, as a set of operations (i.e., a referenced AnalysisMethod) performed on a specified analysis variable for any specified subset of data records (i.e., any referenced DataSubset) for a given subject population (i.e., a referenced AnalysisSet) which may be subdivided by 1 or more factors (i.e., any referenced GroupingFactor). The results of each analysis are contained within the Analysis class as a property of the analysis and each result is associated with references to all analysis components needed to give the result context—that is, the operation used to calculate the result and a specific value for each grouping factor used for the analysis (e.g., treatment, sex, age group).
    
• Attributes for components used to define and describe outputs:
  • globalDisplaySections: Text values that may be used in a specific display section (e.g., title, footnote) of any display. Each global display section is defined using the GlobalDisplaySection class.
    
  • outputs: The outputs defined for the reporting event. Each output is defined using the Output class and may contain 1 or more defined displays.

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