DocumentReference

The DocumentReference class is used to create references to any of the reference documents specified in the reporting event's referenceDocuments attribute. Document references may be created for any of the following:

• 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.

The ARS DocumentReference class corresponds with the Define-XML def:DocumentRef element that is referenced in the ARM for Define-XML specification:

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 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 a reference to the document as a whole.  In general, there are two types of document reference:

• Documentation document references, which may be created for analysis methods, analyses or outputs by specifying one or more document references in the documentRefs attribute of the AnalysisMethod, Analysis or Output classes respectively. Only one 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), but the document reference for a specific document may include multiple page references if it's necessary to reference different pages or sections of the document.
• 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 document reference may be created for the programming code associated 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
  • the instance of the AnalysisOutputProgrammingCode class specified in the programmingCode attribute of the analysis or output.

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.

The abstract ARS PageRef class corresponds with the Define-XML def:PDFPageRef element that is referenced in the ARM for Define-XML specification:

All page references must include an indication of the page reference type in the refType attribute, and may also include a description of the page reference in the label attribute. Individual pages or sets of pages may be referenced in different ways using any of the specializations of the abstract PageRef class:

• PageNameRef where:
  • refType is "NamedDestination"
  • pageNames contains one or more named destinations (e.g., bookmarks) in the reference document.
• PageNumberListRef where:
  • refType is "PhysicalRef"
  • pageNumbers contains one or more page numbers.
• PageNumberRangeRef where:
  • refType is "PhysicalRef"
  • firstPage contains the page number of the first page in a range of pages
  • lastPage contains the page number of the last page in the range of pages.

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 range of pages needs to be specified, or if the sponsor prefers to assign different labels for page references of the same type.