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The DocumentReference class is used to create references to any of the reference documents specified in the reporting event's referenceDocuments attribute (as described in the ReferenceDocument section). Document references may be created for any of the following:
- documentation Documentation of the analysis as specified in the SAP and/or protocol,
- output Output displays in a clinical study report or integrated summary,
- program Program files containing programming code for specific analysis methods, for analyses, or for outputs.
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A document reference must include the identifier of the reference document (as specified in the referenceDocumentId attribute) to indicate which document is being referenced. If needed, the document reference may also include one 1 or more "page references" (each specified in the pageRefs attribute) to indicate the relevant page or pages within the reference document. A document reference that does not include any page references is areference a reference to the document as a whole. In general, there are two 2 types of document reference:
- Documentation document references, which may be created for analysis methods, analyses or outputs by specifying one 1 or more document references in the documentRefs attribute of the AnalysisMethod, Analysis, or Output classes, respectively. Only one 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, but the document reference for a specific document may include multiple page references if it 's 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 one 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 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 the instance of the 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)
As programming code document references refer to program files , (which usually only contain the set programming code statements for a single analysis method, analysis, or output), programming code document references usually do not include page references.
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ARS PageRef Attributes | Corresponding Define-XML def:PDFPageRef Attribute |
|---|---|
refType | Type |
| label | Title |
| pageNames | PageRefs |
| pageNumbersPageRefs | |
| firstPage | FirstPage |
| lastPage | LastPage |
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Multiple page references may be created for a single document reference if more than one type of page reference is required (e.g., reference to both a set of individual page numbers and a range of page numbers), if more than one 1 range of pages needs to be specified, or if the sponsor prefers to assign different labels for page references of the same type.
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