TerminologyExtension

Model Documentation

The TerminologyExtension class may be used to define sponsor-defined extensions to extensible ARS terminology. In the ARS model, controlled terminology is implemented through the use of enumerations, each of which specifies a static set of valid values. It is not possible for sponsors to modify enumerations to add additional values but there are 4 "extensible" enumerations where a sponsor-defined term may be used instead of one of the terms in the enumeration:

Enumeration Name	Enumeration Description	Used In
AnalysisReasonEnum	The rationale for performing this analysis. It indicates when the analysis was planned.	Analysis
AnalysisPurposeEnum	The purpose of the analysis within the body of evidence (e.g., section in the clinical study report).	Analysis
OperationRoleEnum	The role that the referenced operation's result plays in the calculation of the result of this operation.	Operation
OutputFileTypeEnum	The file format of the file containing output from analyses.	Output

In situations where a sponsor needs to use a sponsor-defined term instead of one of the defined set of controlled terms, a terminology extension is created. A terminology extension is a set of one or more sponsor-defined terms created to be used instead of the controlled terms defined for one of the "extensible" enumerations.

ER Diagram: TerminologyExtension

When needed, a single terminology extension may be created for any of the 4 extensible enumerations, and each terminology extension may contain one or more sponsor terms. The enumeration attribute of the terminology extension indicates the name of the enumeration for which the terminology extension is being created, an identifier value for the terminology extension is specified in the id attribute and one or more sponsor terms are defined in the sponsorTerms attribute, each as an instance of the SponsorTerm class. Each sponsor term has the value to be used for representation in a submission (in the submissionValue attribute), corresponding descriptive text (in the description attribute) and an assigned identifier value (in the id attribute).

The enumerations defined in the ARS model are considered to be CDISC controlled terminology so existing guidance should be followed when assigning sponsor terms for extensible enumerations. This includes, for example, guidance indicating that sponsor terms should not be synonyms for existing controlled terms.

Example

This example shows 2 terminology extensions, with 1 sponsor term defined for the AnalysisReasonEnum enumeration and 2 sponsor terms defined for the OutputFileTypeEnum enumeration:

YAML Example

terminologyExtensions:
- id: SPANREAS
  enumeration: AnalysisReasonEnum
  sponsorTerms:
  - id: SPANREAS1
    submissionValue: DEMONSTRATION
    description: The analysis was included in the set as an additional example to
      demonstrate both a different type of analysis and sponsor terminology for analysis
      reason.
- id: SPFTYPE
  enumeration: OutputFileTypeEnum
  sponsorTerms:
  - id: SPFTYPE_DOCX
    submissionValue: docx
    description: Office Open XML Document Format (DOCX)
  - id: SPFTYPE_ODT
    submissionValue: odt
    description: OpenDocument Text Format (ODT)
...

These terminology extensions could be represented in tabular form as:

id	enumeration	sponsorTerms
id	enumeration	id	submissionValue	description
SPANREAS	AnalysisReasonEnum	SPANREAS1	DEMONSTRATION	The analysis was included in the set as an additional example to demonstrate both a different type of analysis and sponsor terminology for analysis reason.
SPFTYPE	OutputFileTypeEnum	SPFTYPE_DOCX	docx	Office Open XML Document Format (DOCX)
SPFTYPE	OutputFileTypeEnum	SPFTYPE_ODT	odt	OpenDocument Text Format (ODT)

Sponsor terms that have been defined in a terminology extension are referenced through use of an enumeration-specific specialization of the ExtensibleTerminologyTerm class, as described in the ExtensibleTerminologyTerm section.

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TerminologyExtension