DocumentReference

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 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 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 a reference to the document as a whole. In general, there are 2 types of document reference:

• 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)

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

methods:
- id: Mth01_CatVar_Summ_ByGrp
  name: Summary by group of a categorical variable
  documentRefs:
  - referenceDocumentId: CDISCPILOT01_SAP
    pageRefs:
    - refType: PhysicalRef
      label: 7. GENERAL CONSIDERATIONS FOR DATA ANALYSES
      pageNumbers:
      - 9
      - 11
  ...
...
analyses:
- id: An08_02_ChgBl_Summ_ByTrt
  name: Summary of Change from Baseline by Treatment, Parameter and Visit
  documentRefs:
  - referenceDocumentId: CDISCPILOT01_SAP
    pageRefs:
    - refType: PhysicalRef
      label: Section 7 (General Considerations)
      pageNumbers:
      - 9
    - refType: PhysicalRef
      label: Section 11.6 (Other Safety Measures)
      pageNumbers:
      - 17
  - referenceDocumentId: CDISCPILOT01_CSR
    pageRefs:
    - refType: NamedDestination
      pageNames:
      - Table 14-7.02
  ...
...
outputs:
- id: Out14-1-1
  name: Summary of Demographics
  documentRefs:
  - referenceDocumentId: CDISCPILOT01_CSR
    pageRefs:
    - refType: PhysicalRef
      label: Table 14-2.01
      firstPage: 46
      lastPage: 48
  ...
- id: Out14-3-1-1
  name: Overall Summary of Treatment-Emergent Adverse Events
  documentRefs:
  - referenceDocumentId: AE_Summary_Table_Shell
  ...

methods:
- id: Mth04_ContVar_Comp_Anova
  name: Analysis of variance group comparison for a continuous variable
  codeTemplate:
    context: R Version 4.2.3
    documentRef:
      referenceDocumentId: anova_R
  ...
...
analyses:
- id: An03_02_AgeGrp_Comp_ByTrt
  name: Comparison of Age Group by Treatment
  programmingCode:
    context: SAS Version 9.4
    documentRef:
      referenceDocumentId: PROGRAM_CATALOG_SAS
      pageRefs:
      - refType: NamedDestination
        label: Pearson chi-square macro definition
        pageNames:
        - PearsonDef
      - refType: NamedDestination
        label: Pearson macro call for age group
        pageNames:
        - PearsonCall-AgeGrp
   ...
...
outputs: 
- id: Out14-3-2-1
  name: Summary of TEAE by System Organ Class and Preferred Term
  programmingCode:
    context: SAS Version 9.4
    documentRef:
      referenceDocumentId: at14-5-01_sas
  ...
...