Model Documentation

Class: Output

The Output class is used in the reporting event's outputs attribute to define the outputs for the reporting event.

ER Diagram: Output

An instance of the Output class is created for each output and, in each instance,

  • The id attribute contains the identifier value assigned for the output.
  • The version attribute contains the version number of the output.
  • The name attribute indicates the assigned name of the output.
  • The description attribute may be used to record a detailed description of the output.
  • The label attribute may be used to record a short description of the output.
  • One or more category identifier values may be included in the categoryIds attribute to categorize the output, as described in the AnalysisOutputCategorization section.
  • One or more references to associated documentation for the output may be included in the documentRefs attribute, as described in the DocumentReference section.
  • The programming code used to generate the results displayed in the output may be recorded or referenced in the programmingCode attribute, as described in the AnalysisOutputProgrammingCode section.

An output contains the results from a set of 1 or more related analyses (see the Note in the ListOfContents section for information about associating analyses with outputs). Within the output, the results may be represented in a single display or they may be represented in 2 or more separate displays. The display(s) within an output are specified in the displays attribute, which contains 1 or more instances of the OrderedDisplay class. Each instance of the OrderedDisplay class has 2 attributes:

  • order, which contains an integer to order the display with respect to other displays in the output (i.e., "1" for the first display in the output, "2" for the second display, and so on); and
  • display, which contains the specification of the display represented as an instance of the OutputDisplay class. See the OutputDisplay section for more information about output display specifications.

The fileSpecifications attribute of the Output class may be used to specify 1 or more individual files, each of which contains a representation of the output in a specific format. Each file specification is defined as an instance of the OutputFile class, which includes the following attributes:

  • name, which contains either the name of the output file or a sponsor-defined label for the file
  • description, which may be used to record a detailed description of the file
  • label, which may be used to record an alternative label for the file
  • location, which indicates the location of the file relative to the location of the reporting event file
  • fileType, which contains an indication of the file format (e.g., PDF, RTF) represented as an instance of 1 of the 2 specializations of the ExtensibleTerminologyTerm class for the OutputFileTypeEnum enumeration:
    • OutputFileType, in which the controlledTerm attribute contains a file type from the OutputFileTypeEnum enumeration
    • SponsorOutputFileType, in which the sponsorTermId attribute contains the identifier of a sponsor term created in the terminology extension for the OutputFileTypeEnum enumeration

See the TerminologyExtension and ExtensibleTerminologyTerm sections for more information about the definition and use of terminology extensions, including examples.  

  • style, which may be used to record a sponsor-defined, implementation-specific specification of any style properties to be applied to the output file (e.g., font size, color)

The file specifications defined in the fileSpecifications attribute are intended to be used as technical specifications for the creation of individual files containing the results for a specific output. The documentRefs attribute should be used to specify documentation document references, including:

  • Specifications for output content (e.g., in an SAP)
  • Indications of the location of, or references to, output content within a submission document (e.g., a CSR)
  • Any reference to particular pages within a document
  • Any document reference that is described in the ARM for Define-XML specification

Refer to the ReferenceDocument and DocumentReference sections for more information about the definition and use of documentation document references.

Example

This example shows the definitions for 2 outputs. To illustrate the structure of an output specification, all attributes in the Output class are represented for both outputs but, for brevity, some or all of the details have been omitted for the following attributes:
  • display within the displays attribute: refer to the OutputDisplay section for a full example of a display specification.
  • categoryIds: refer to the AnalysisOutputCategorization section for examples of the categorization of outputs.
  • documentRefs: refer to the DocumentReference section for examples of documentation document references specified for an output.
  • programmingCode: refer to the AnalysisOutputProgrammingCode section for examples of the representation of programming code for analyses and outputs.

Lines 2-33:

Show the definition of the "Summary of Demographics" output, in which:

  • Lines 5-10: Show that the results for the output are represented in a single PDF file, which the sponsor named as "Table 14.1.1 Demographics" (line 6) and labeled as "t14-1-1-demog" (line 7). The file (t14-1-1-demog.pdf) is located in the "outputs" sub-folder of the folder that contains the reporting event file.
  • Lines 11-27: Show that the sponsor chose to represent summary statistics for male and female subjects in 2 separate displays within the output.
Lines 34-64:

Show the definition of the "Overall Summary of Treatment-Emergent Adverse Events" output, in which:

  • Lines 34-44: Show that the results for the output are represented in 2 files (1 in RTF format and 1 in PDF format), which the sponsor named as "t14-3-1-1-teae-summ (RTF)" and "t14-3-1-1-teae-summ (PDF)". The sponsor chose to label both files as "t14-3-1-1-teae-summ" (lines 39 and 45). Both files are located in the "outputs" sub-folder of the folder that contains the reporting event file. For both files, the sponsor also used the style attribute to record a formatting element that was meaningful to their implementation system.
  • Lines 51-58: Show that the sponsor chose to represent all results for the output in a single display.

YAML Example
outputs:
- id: Out14-1
  name: Summary of Demographics
  version: 1
  fileSpecifications:
  - name: Table 14.1.1 Demographics
    label: t14-1-1-demog
    fileType:
      controlledTerm: pdf
    location: ./outputs/t14-1-1-demog.pdf
  displays:
  - order: 1
    display:
      id: Disp14-1-1
      name: Demographics - Male
      label: Demog-M
      version: 1
      displayTitle: Summary of Demographics (Male)
      ...
  - order: 2
    display:
      id: Disp14-1-2
      name: Demographics - Female
      label: Demog-F
      version: 1
      displayTitle: Summary of Demographics (Female)
      ...
  categoryIds:
    ...
  documentRefs:
    ...
  programmingCode:
    ...
- id: Out14-3-1-1
  name: Overall Summary of Treatment-Emergent Adverse Events
  version: 1
  fileSpecifications:
  - name: t14-3-1-1-teae-summ (RTF)
    label: t14-3-1-1-teae-summ
    fileType:
      controlledTerm: rtf
    location: ./outputs/t14-3-1-1-teae-summ.rtf
    style: '{fontsize: small}'
  - name: t14-3-1-1-teae-summ (PDF)
    label: t14-3-1-1-teae-summ
    fileType:
      controlledTerm: pdf
    location: ./outputs/t14-3-1-1-teae-summ.pdf
    style: '{fontsize: small}' 
  displays:
  - order: 1
    display:
      id: Disp14-3-1-1
      name: TEAE Summary
      label: TEAE_Summ
      version: 1
      displayTitle: Overall Summary of Treatment-Emergent Adverse Events
      ...
  categoryIds:
    ...
  documentRefs:
    ...
  programmingCode:
    ...
...

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