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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.
  • 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 one or more related analyses (see the note in the NestedList section for information about associating analyses with outputs). Within the output, the results may 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 one or more instances of the OrderedDisplay class. Each instance of the OrderedDisplay class has 2 attributes:

  • order, which contains an integer to order display with respect to other displays in the output (i.e., "1" for the first display in the output, "2" for the second display, etc.)
  • 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 one 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 the name of the output 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 (PDF, RTF, etc.) represented as an instance of the two 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.

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

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

Note that 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 informational document references, including:

  • Specifications for output content (e.g., in a Statistical Analysis Plan),
  • Indications of the location of, or references to, output content within a submission document (e.g., a Clinical Study Report),
  • 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 informational document references.

Example


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