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 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. |
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 id, name, 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).
object_type | id | name | referenceDocumentId | refType | label | pageNumbers1 | pageNumbers2 | pageNames1 | firstPage | lastPage |
---|---|---|---|---|---|---|---|---|---|---|
methods | Mth01_CatVar_Summ_ByGrp | Summary by group of a categorical variable | CDISCPILOT01_SAP | PhysicalRef | 7. GENERAL CONSIDERATIONS FOR DATA ANALYSES | 9 | 11 | |||
analyses | An08_02_ChgBl_Summ_ByTrt | Summary of Change from Baseline by Treatment, Parameter and Visit | CDISCPILOT01_SAP | PhysicalRef | Sections 7 (General Considerations) | 9 | ||||
analyses | An08_02_ChgBl_Summ_ByTrt | Summary of Change from Baseline by Treatment, Parameter and Visit | CDISCPILOT01_SAP | PhysicalRef | 11.6 (Other Safety Measures) | 17 | ||||
analyses | An08_02_ChgBl_Summ_ByTrt | Summary of Change from Baseline by Treatment, Parameter and Visit | CDISCPILOT01_CSR | NamedDestination | Table 14-7.02 | |||||
outputs | Out14-1-1 | Summary of Demographics | CDISCPILOT01_CSR | PhysicalRef | Table 14-2.01 | 46 | 48 | |||
outputs | Out14-3-1-1 | Overall Summary of Treatment-Emergent Adverse Events | AE_Summary_Table_Shell |