This example shows a selection of documentation document references specified in the documentRefs attribute of 1 analysis method, 1 analysis and 2 outputs:
- The "Summary by group of a categorical variable" analysis method 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".
- The "Summary of Change from Baseline by Treatment, Parameter and Visit" analysis has document references for two reference documents, indicating that:
- 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.
- 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.
- The "Summary of Demographics" output 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".
- The "Overall Summary of Treatment-Emergent Adverse Events" output 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.
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: Sections 7 (General Considerations)
pageNumbers:
- 9
- refType: PhysicalRef
label: 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
...