Model Documentation

The ListOfContents class can be used to create structured lists, allowing references to analyses and outputs to be organized into sections and subsections. The class is used to define the mainListOfContents and, if needed, additional otherListsOfContents for the reporting event.

ER Diagram: ListOfContents

An instance of the ListOfContents class is created for each list of contents and, in each instance:

  • The name attribute indicates the name of the list of contents.
  • The description attribute may be used to record a detailed description of the list of contents including, for example, its purpose.
  • The label attribute may be used to record a short description of the list of contents.
  • The contentsList attribute contains the specification of the list of contents, represented as an instance of the NestedList class.

The NestedList class has only 1 attribute, listItems, which is a set of 1 or more list items. Each list item is represented as an instance of the OrderedListItem class and has the following attributes:

  • level: Indicates the level of the list item within the structured list. A value of 1 indicates that the list item is at the first, or top, level; a value of 2 indicates that the list item is at the second level, and so on.
  • order: Indicates the order of the list item with respect to other list items at the same level
  • name: Descriptive text to be displayed for the list item
  • description: May be used to record a detailed description of the list item.
  • label: May be used to record a short alternative description of the list item.

Each list item may also have an association with 1 or more of the following:

  • One of the outputs defined for the reporting event, which is the instance of the Output class identified by the value of the list item's outputId attribute. The value of the outputId attribute must match the value of the id attribute for 1 of the outputs in the reporting event. See the Output section for more information about output definitions.
  • One of the analyses defined for the reporting event, which is the instance of the Analysis class identified by the value of the list item's analysisId attribute. The value of the analysisId attribute must match the value of the id attribute for 1 of the analyses in the reporting event. See the Analysis section for more information about analysis definitions.
  • A sublist of items, represented as another instance of the NestedList class. If a list item has a sublist, the value of the level attribute for items in the sublist should be 1 greater than the list item's level.

Example

Only the mainListOfContents and otherListsOfContents attributes of a reporting event are shown for this example. The example reporting event has the required main list of contents (shown in mainListOfContents) and a single additional list of contents (shown in otherListsOfContents). Each of these 2 lists of contents is represented as an instance of the ListOfContents class. In this example, there are 2 instances of the ListOfContents class containing a total of 6 instances of the NestedList class (each containing a set of list items within the structured list of contents):

Lines 2-47:Show the first instance of the ListOfContents class, which represents the main list of contents for the example reporting event. The sponsor assigned a name of "List of Contents" (line 2) and a label of "LOC" (line 3), but chose not to assign a description.
Lines 5-47, 53-62:Show 2 instances of the NestedList class, each with 2 list items that have level = 1.
Lines 11-42:Show an instance of the NestedList class with 4 list items each with level = 2.
Lines 20-24, 29-33, 38-42:

Show 3 instances of the NestedList class, each with a single list item having level = 3.

Lines 49-62:

Show the second instance of the ListOfContents class, which represents the first (and only) additional list of contents for the example reporting event. The sponsor assigned a name, description and label (lines 49-51) for this list of contents.

YAML Example
mainListOfContents:
  name: List of Contents
  label: LOC
  contentsList:
    listItems:
    - name: Table 2. Baseline Demographic Characteristics, Safety Population, Trial CDISCPILOT01
      level: 1
      order: 1
      outputId: O_T2
      sublist:
        listItems:
        - name: Summary of Subjects by Treatment
          level: 2
          order: 1
          analysisId: A_SAF_SUM_USUBJID_TRT
        - name: Sex
          level: 2
          order: 2
          sublist:
            listItems:
            - name: Summary of Subjects by Treatment
              level: 3
              order: 1
              analysisId: A_SAF_SUM_USUBJID_TRT_SEX
        - name: Age
          level: 2
          order: 3
          sublist:
            listItems:
            - name: Summary of Age by Treatment
              level: 3
              order: 1
              analysisId: A_SAF_SUM_AGE_TRT
        - name: Age groups
          level: 2
          order: 4
          sublist:
            listItems:
            - name: Summary of Subjects by Treatment
              level: 3
              order: 1
              analysisId: A_SAF_SUM_USUBJID_TRT_AGEGRP
    - name: Table 3. Baseline Clinical Characteristic X, Safety Population, Trial CDISCPILOT01
      level: 1
      order: 2
      analysisId: A_SAF_SUM_BLCLCHRX_TRT
      outputId: O_T3
otherListsOfContents:
- name: List of Planned Outputs
  description: List of outputs used for task assignment.
  label: LOPO
  contentsList:
    listItems:
    - name: Table 2. Baseline Demographic Characteristics, Safety Population, Trial CDISCPILOT01
      level: 1
      order: 1
      outputId: O_T2
    - name: Table 3. Baseline Clinical Characteristic X, Safety Population, Trial CDISCPILOT01
      level: 1
      order: 2
      analysisId: A_SAF_SUM_BLCLCHRX_TRT
      outputId: O_T3

If each instance of the ListOfContents class is represented as a row in a table, with each instance of the NestedList class represented as a table of list items, this example could be represented as:

namedescriptionlabelcontentsList
List of Contents
LOC
levelordernameanalysisIdoutputIdsublist
11Table 2. Baseline Demographic Characteristics, Safety Population, Trial CDISCPILOT01
O_T2
levelordernameanalysisIdsublist
21Summary of Subjects by TreatmentA_SAF_SUM_USUBJID_TRT
22Sex
levelordernameanalysisId
31Summary of Subjects by TreatmentA_SAF_SUM_USUBJID_TRT_SEX
23Age
levelordernameanalysisId
31Summary of Age by TreatmentA_SAF_SUM_AGE_TRT
24Age groups
levelordernameanalysisId
31Summary of Subjects by TreatmentA_SAF_SUM_USUBJID_TRT_AGEGRP
12Table 3. Baseline Clinical Characteristic X, Safety Population, Trial CDISCPILOT01A_SAF_SUM_BLCLCHRX_TRTO_T3


List of Planned OutputsList of outputs used for task assignment.LOPO
levelordernameanalysisIdoutputId
11Table 2. Baseline Demographic Characteristics, Safety Population, Trial CDISCPILOT01
O_T2
12Table 3. Baseline Clinical Characteristic X, Safety Population, Trial CDISCPILOT01A_SAF_SUM_BLCLCHRX_TRTO_T3

As the ARS Model does not currently contain any direct link between analyses and the outputs that display the results of the analyses, it is recommended that the mainListOfContents is used to indicate the relationship between outputs and analyses. If an outputId is specified on a list item, it is implied that the output identified by the outputId value contains results of any analysis whose id value is found as an analysisId value on the same list item as the outputId, or on any list item within a sublist that stems from the list item with the outputId.

In the previous example:

  • The output identified as "O_T2" would contain results from the analysis referenced on the first level 2 list item ("A_SAF_SUM_USUBJID_TRT"), as well as results from each of the analyses referenced on the 3 list items with level = 3 ("A_SAF_SUM_USUBJID_TRT_SEX", "A_SAF_SUM_AGE_TRT", and "A_SAF_SUM_USUBJID_TRT_AGEGRP").
  • The output identified as "O_T3" would contain results from the analysis identified as "A_SAF_SUM_BLCLCHRX_TRT".

  • No labels