An Analysis Results Standard model "analysis results standard model" refers to the framework or structure used to store and organize the information related to an analysis result. This includes both the results data generated by the analysis and the metadata that describes the characteristics of that the results data.
The metadata in this model includes information about the source of the results data, the method used for analysis, and any relevant parameters or queries that were used. This metadata is important for helping others understand and reproduce the analysis result, and it can also be used for quality control purposes.
The model defines a set of classes and their attributes, which can be used to represent different aspects of the ARM-TS and ARDthe technical specification of analyses performed and outputs created, and the results of the analyses. The model includes classes such as " ReportingEvent", " Analysis", “AnalysisSet”AnalysisSet, “AnalysisGroup”AnalysisGroup, " Output", and " GroupingFactor", among others. Each class has a set of attributes that define its properties, such as " id", " label", “condition”condition, “whereClauses”whereClauses, " methods", " fileSpecifications", and so on.
The " ReportingEvent " class serves as the root of the model and includes many other classes and attributes that help to organize the data into different categories and groupings. Each reporting event represents a set of analyses and outputs created to meet a specific reporting requirement, such as a CSR or interim analysis.
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As shown in this class diagram, the ReportingEvent class has a set of attributes that can be used to define, itemize, and categorize the analyses and outputs needed for the reporting event:
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- listOfPlannedAnalyses: A structured list of the analyses defined for the reporting event. The list is defined using the NestedList class, which allows referenced analyses (and outputs) to be organized into sections and sub-sections.
- listOfPlannedOutputs: An optional separate structured list of the outputs defined for the reporting event. The list is defined using the NestedList class, which allows referenced outputs (and analyses) to be organized into sections and sub-sections.
- referenceDocuments:
- terminologyExtensions:
- analysisCategorizations: Any categorizations used to tag analyses or outputs. For example, a “Type of analysis” categorization could be created to tag defined analyses or outputs as “Subject Population”, “Safety” or “Efficacy”, and/or an “Estimand Analysis Type” categorization could be created to tag analyses as “Primary Estimator”, “Sensitivity Analysis”, “Supplementary Analysis”. Each categorization is defined using the “AnalysisCategorization” class.
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- 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.
- analysisGroupings: Characteristics used to subdivide the records in an analysis dataset (e.g., "system organ class" or "preferred term" in an adverse events analysis dataset, "parameter" or "visit" in a vital signs analysis dataset). Each data grouping is defined using the “DataGroupingFactor” class and may either contain a set of specified groups (e.g., “Systolic Blood Pressure” and “Temperature” for a vital signs parameter grouping) or be defined as “data-driven”, where the group values are obtained from the data (e.g., system organ class or preferred term for adverse events).
- 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.
- dataGroupings: Characteristics used to subdivide the records in an analysis dataset (e.g., "system organ class" or "preferred term" in an adverse events analysis dataset, "parameter" or "visit" in a vital signs analysis dataset). Each data grouping is defined using the “DataGroupingFactor” class and may either contain a set of specified groups (e.g., “Systolic Blood Pressure” and “Temperature” for a vital signs parameter grouping) or be defined as “data-driven”, where the group values are obtained from the data (e.g., system organ class or preferred term for adverse events).
- methods: 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 one or more factors (i.e., any referenced “SubjectGroupingFactor” or “DataGroupingFactor”). 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 (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.).
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