This example shows a selection of documentation document references specified in the documentRefs attribute of 1 analysis method, 1 analysis, and 2 outputs:

Lines 2-11:

Show the "Summary by group of a categorical variable" analysis method, which has a single documentation document reference indicating that relevant information can be found on pages 9 and 11 of the reference document identified as "CDISCPILOT01_SAP".

Lines 15-32:

Show the "Summary of Change from Baseline by Treatment, Parameter and Visit" analysis, which has document references for 2 reference documents, indicating that:

  • Lines 18-27: In the reference document identified as "CDISCPILOT01_SAP", relevant information can be found on pages 9 and 17. The sponsor created 2 page separate page references in order to assign a specific label to each.
  • Lines 28-32: In the reference document identified as "CDISCPILOT01_CSR", relevant information can be found at the named destination "Table 14-7.02". The sponsor chose not to specify a label for this page reference.
Lines 36-44:

Show the "Summary of Demographics" output, which has a single documentation document reference indicating that relevant information can be found on pages 46 to 48 of the reference document identified as "CDISCPILOT01_CSR".

Lines 45-49:

Show the "Overall Summary of Treatment-Emergent Adverse Events" output, which has a single documentation document reference indicating that relevant information can be found in the reference document identified as "AE_Summary_Table_Shell". No page reference was specified, which indicates that the whole reference document contains relevant information.

YAML Example
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
  ...

These documentation document references could be represented in tabular format as shown in the following table where:

  • The type of object for which the document reference is defined is indicated in the "object_type" column, which contains the name of the object's parent reporting event attribute.
  • Each instance of 1 of the specializations of the PageRef class is shown on a separate row. If there are no page references for a document reference, a single row is shown for the document reference.
  • Values of the idname, and referenceDocumentId attributes is are shown on all rows relating to a document referenced for an object.
  • Values from the pageNumbers and pageNames attributes have been transposed to be shown on a single row, with column names derived from the attribute name with a numeric suffix indicating the value ordinal (e.g., "pageNames1" for the first value of the pageNames attribute, "pageNumbers2" for the second value of the pageNumbers attribute).

$titleHtml
object_typeidnamereferenceDocumentIdrefTypelabelpageNumbers1pageNumbers2pageNames1firstPagelastPage
methodsMth01_CatVar_Summ_ByGrpSummary by group of a categorical variableCDISCPILOT01_SAPPhysicalRef7. GENERAL CONSIDERATIONS FOR DATA ANALYSES911


analysesAn08_02_ChgBl_Summ_ByTrtSummary of Change from Baseline by Treatment, Parameter and VisitCDISCPILOT01_SAPPhysicalRefSections 7 (General Considerations)9



analysesAn08_02_ChgBl_Summ_ByTrtSummary of Change from Baseline by Treatment, Parameter and VisitCDISCPILOT01_SAPPhysicalRef11.6 (Other Safety Measures)17



analysesAn08_02_ChgBl_Summ_ByTrtSummary of Change from Baseline by Treatment, Parameter and VisitCDISCPILOT01_CSRNamedDestination


Table 14-7.02

outputsOut14-1-1Summary of DemographicsCDISCPILOT01_CSRPhysicalRefTable 14-2.01


4648
outputsOut14-3-1-1Overall Summary of Treatment-Emergent Adverse EventsAE_Summary_Table_Shell






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