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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 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 the displays attribute, which contains one 1 or more instances of the OrderedDisplay class. Each instance of the OrderedDisplay class has 2 attributes:

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The fileSpecifications attribute of the Output class may be used to specify one 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:

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

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 documentation 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 documentation document references.

Example

Include Page
outputs
outputs

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