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- Documentation of the analysis as specified in the SAP and/or protocol
- Output displays in a clinical study report or integrated summary
- Program files containing programming code for specific analysis methods, for analyses, or for outputs
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- Documentation document references, which may be created for analysis methods, analyses or outputs by specifying 1 or more document references in the documentRefs attribute of the AnalysisMethod, Analysis, or Output classes, respectively. Only 1 document reference should be created for each document being referenced; referenceDocumentId should be unique within the set of instances of the DocumentReference class included in the documentRefs attribute. However, the document reference for a specific document may include multiple page references if it is necessary to reference different pages or sections of the document. See the AnalysisMethod, Analysis, or Output sections for more information about analysis methods, analyses and outputs.
- Programming code document references, which may be created for the template programming code associated with analysis methods, or for programming code for analyses or outputs. No more than 1 document reference may be created for the programming code associated with any analysis method, analysis, or output and, when included, the document reference is specified in the documentRef attribute of:
- The instance of the AnalysisProgrammingCodeTemplate class specified in the analysis method's codeTemplate attribute (see the AnalysisProgrammingCodeTemplate section for more information about template programming code)
- The instance of the AnalysisOutputProgrammingCode class specified in the programmingCode attribute of the analysis or output (see the AnalysisOutputProgrammingCode section for more information about analysis and output programming code)
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