This example shows a selection of documentation document references specified in the documentRefs attribute of 1 analysis method, 1 analysis, and 2 outputs:
...
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.
|
|
...
...
"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". |
|
...
...
"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. |
|
...
Code Block |
---|
title | YAML Example |
---|
linenumbers | true |
---|
|
Markdown |
---|
```
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: SectionsSection 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).
Dataset2 |
---|
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 |
|
|
|
|
|
|
|
|