Analysis

The Analysis class is used in the reporting events 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) 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 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 grouping factors used for the analysis such as treatment, sex, age group, etc.).

An instance of the Analysis class is created for each analysis and, in each instance:

• The id attribute contains the identifier value assigned for the analysis.
• The version attribute contains the version number of the analysis.
• The name attribute indicates the assigned name of the analysis.
• The description attribute may be used record a detailed description of the analysis.
• The reason attribute is used to record the rationale for the analysis, and is equivalent to the arm:AnalysisReason attribute described in the ARM for Define-XML specification. The reason attribute contains an instance of 1 of the two specializations of the ExtensibleTerminologyTerm class for the AnalysisReasonEnum enumeration:
  • AnalysisReason, in which the controlledTerm attribute contains a value from the AnalysisReasonEnum enumeration.
  • SponsorAnalysisReason, in which the sponsorTermId attribute contains the identifier of a sponsor term created in the terminology extension for the AnalysisReasonEnum enumeration. In this case, the submissionValue attribute of the referenced sponsor term is used as the rationale for the analysis. 
• The purpose attribute is used to record the purpose of the analysis, and is equivalent to the arm:AnalysisPurpose attribute described in the ARM for Define-XML specification. The purpose attribute contains an instance of 1 of the two specializations of the ExtensibleTerminologyTerm class for the AnalysisPurposeEnum enumeration:
  • AnalysisPurpose, in which the controlledTerm attribute contains a value from the AnalysisPurposeEnum enumeration.
  • SponsorAnalysisPurpose, in which the sponsorTermId attribute contains the identifier of a sponsor term created in the terminology extension for the AnalysisPurposeEnum enumeration. In this case, the submissionValue attribute of the referenced sponsor term is used as the purpose of the analysis. 

For both reason and purpose, refer to the TerminologyExtension and ExtensibleTerminologyTerm sections for more information about the definition and use of terminology extensions, including examples.  

• 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 analysis sets.
• 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.