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An output contains the results from a set of one 1 or more related analyses (see the note 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 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, etc.)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.

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  • name, which contains either the name of the output file or a sponsor-defined 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, etc.) represented as an instance of 1 of the two 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.

Refer to the 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 or , color).
Note

Note that the 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 a Statistical Analysis Plan),an SAP)
  • Indications of the location of, or references to, output content within a submission document (e.g., a Clinical Study ReportCSR),
  • 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.

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