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The Analysis class is used in the reporting event's analyses attribute to define the analyses for the reporting event. Each analysis is defined as a set of operations (defined in a referenced analysis method) performed on a specified analysis variable for any specified subset of data records (defined in a referenced data subset) for a given subject population (defined in a referenced analysis set) which may be subdivided by one or more factors (defined in any referenced subject or data grouping factor). The results of each analysis are represented as a property of the analysis and each result is associated with references to all analysis components needed to give the result context (i.e., the operation used to calculate the result and a specific value for each of the grouping factors used for the analysis, such as treatment, sex, age group, etc.).
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- One or more references to associated documentation for the analysis may be included in the documentRefs attribute, as described in the DocumentReference section.
- One or more category identifier values may be included in the categoryIds attribute to categorize the analysis, as described in the AnalysisOutputCategorization section.
- The dataset and variable attributes are used to indicate the analysis variable that is the focus of the analysis. In general:
- The USUBJID variable in the ADSL dataset should be used as the analysis variable for analyses that represent summaries of unique subjects numbers.
- The same dataset variable should not be used as both the analysis variable and a grouping variable.
- The analysisSetId attribute contains the identifier value of an instance of the AnalysisSet class to indicate the subject population for the analysis. For analyses performed for an unrestricted subject population, it is recommended that an "All Subjects" population is defined and referenced. Refer to the AnalysisSet section for more information about defining analysis sets.
- The dataSubsetId attribute may contain the identifier value of an instance of the DataSubset class to indicate any restriction of the data records included in the analysis. Refer to the DataSubset section for more information about defining data subsets.
- The orderedGroupings attribute may be used to reference any subject or data grouping factors used for the analysis, as described below.
- The methodId attribute contains the identifier value of an instance of the AnalysisMethod class to indicate the analysis method used to perform the analysis. Each method may contain 1 or more operations, each of which produces a separate result value. Refer to the AnalysisMethod section for more information about analysis methods.
- The referencedAnalysisOperations attribute may be used to identify analyses that produce result values that are used in the calculation results for this analysis. For more information about referenced operation results, including examples, refer to the Operation section.
- The programming code used to generate the results of the analysis may be recorded or referenced in the programmingCode attribute, as described in the AnalysisOutputProgrammingCode section.
- The results attribute contains the results of the analysis, as described in the OperationResult section.
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