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Comment: Added parent elements field.


Element NameTranslatedText
Element
XPath(s)

/ODM/Study/Description
/ODM/Study/MetaDataVersion/Description
/ODM/Study/MetaDataVersion/Protocol/Description
/ODM/Study/MetaDataVersion/StudyStructure/Description
/ODM/Study/MetaDataVersion/StudyEventGroupDef/Description
/ODM/Study/MetaDataVersion/StudyEventDef/Description
/ODM/Study/MetaDataVersion/Protocol/StudySummary/Description
/ODM/Study/MetaDataVersion/StudyStructure/Epoch/Description
/ODM/Study/MetaDataVersion/StudyStructure/Arm/Description
/ODM/Study/MetaDataVersion/WorkflowDef/Description
/ODM/Study/MetaDataVersion/ExceptionEvent/Description
/ODM/Study/MetaDataVersion/WorkflowDef/EntryExitCriteria/Description
/ODM/Study/MetaDataVersion/FormDef/Description
/ODM/Study/MetaDataVersion/ItemGroupDef/Description
/ODM/Study/MetaDataVersion/ItemDef/Description
/ODM/Study/MetaDataVersion/ConditionDef/Description
/ODM/Study/MetaDataVersion/MethodDef/Description
//Decode
//ErrorMessage
//Question
//Symbol
//Annotation

Element
Textual ValueText string
Usage
  • Requirement: Required
  • Cardinality: One or more. Multiple TranslatedText child elements can be used to provide description in different languages and types, preferably one for each language and type.
Attributesxml:lang, type
Child ElementsNone
Parent ElementsDescription, Decode, ErrorMessage, Question, Symbol, Annotation


AttributeUsageAllowable ValuesDescriptionBusiness Rule(s)

xml:lang

Optional

See IETF Trust, Tags for Identifying Languages (Section 2.2, References)

Samples:

  • "en" for English
  • "en-GB" for British English

Code representing the language of the enclosed text value. Default value depends on locale.

  • The schema requires xml:lang to  be unique within a parent element for the same type.
  • If only one TranslatedText element is provided, the xml:lang is optional.
  • For submissions to the FDA, text content must be in English.
typeRequired

text/plain, application/xhtml+xml


Contains IANA media type of the TranslatedText element contents.


  • A TranslatedText element with plain text must always be present, despite the fact whether other TranslatedText elements with enhanced presentation of the same text are present or not.
  • When type="application/xhtml+xml", contents of the TranslatedText element must contains a limited number of HTML tags.

Description

Human-readable text that is appropriate for a particular language. TranslatedText elements typically occur in a series, presenting a set of alternative textual renditions for different languages and types.

To find the text appropriate for a target language with tag LT, search for a TranslatedText element whose xml:lang attribute matches LT exactly (ignoring case). If that fails, remove the ending subtag from LT and repeat. If that fails, search for a TranslatedText without an xml:lang attribute and use that. If none is found, there is no suitable text available. E.g.

TranslatedTexts PresentRequestedProcess
<TranslatedText xml:lang="fr-CA">...
<TranslatedText xml:lang="en-GB">...
<TranslatedText>...		fr-FRLook for xml:lang="fr-FR".
This is not found, so look for xml:lang="fr".
This is not found, so look for a TranslatedText with no xml:lang. This is the text that should be used.

To avoid ambiguity, a particular language tag must not occur more than once in a series of TranslatedText elements with the same type. Also, it is not permitted to have more than one TranslatedText element without an xml:lang attribute within the same parent and type.

...