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.

Element Name

TranslatedText

Parent ElementsDescription, Question, Definition, Prompt, CRFCompletionInstructions, ImplementationNotes, CDISCNotes, ErrorMessage, Decode
Element XPath(s)
  • /ODM/Description/TranslatedText
  • /ODM/Study/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/ValueListDefDescription/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudySummary/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Arm/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyStructure/Epoch/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/TrialPhase/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/AbsoluteTimingConstraint/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/RelativeTimingConstraint/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/TransitionTimingConstraint/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyTiming/DurationTimingConstraint/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyIndications/StudyIndication/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyInterventions/StudyIntervention/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyObjectives/StudyObjective/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyEndPoints/StudyEndPoint/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyTargetPopulation/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyEstimand/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyEstimand/InterCurrentEvent/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyEstimands/StudyEstimand/SummaryMeasure/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/InclusionCriteria/Criterion/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/InclusionExclusionCriteria/ExclusionCriteria/Criterion/TranslatedText
  • /ODM/Study/MetaDataVersion/WorkflowDef/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupDef/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventGroupDef/StudyEventGroupRef/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/Protocol/StudyEventDef/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/ItemGroupDef/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/ItemDef/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/ItemDef/Question/TranslatedText
  • /ODM/Study/MetaDataVersion/ItemDef/Definition/TranslatedText
  • /ODM/Study/MetaDataVersion/ItemDef/Prompt/TranslatedText
  • /ODM/Study/MetaDataVersion/ItemDef/CRFCompletionInstructions/TranslatedText
  • /ODM/Study/MetaDataVersion/ItemDef/ImplementationNotes/TranslatedText
  • /ODM/Study/MetaDataVersion/ItemDef/CDISCNotes/TranslatedText
  • /ODM/Study/MetaDataVersion/ItemDef/RangeCheck/ErrorMessage/TranslatedText
  • /ODM/Study/MetaDataVersion/ItemDef/Origin/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/CodeList/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/CodeList/CodeListItem/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/CodeList/CodeListItem/Decode/TranslatedText
  • /ODM/Study/MetaDataVersion/ConditionDef/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/MethodDef/Description/TranslatedText
  • /ODM/Study/MetaDataVersion/CommentDef/Description/TranslatedText
Element Textual Valuetext
Attributesxml:lang, Type
Child ElementsNone
Usage/Business Rules
  • Other Information:
    • Multiple TranslatedText child elements can be used to provide description in different languages and types, preferably one for each language and type.



AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)

xml:lang

xs:language

Optional

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

Note: The xml:lang attribute is part of the XML standard.

See IETF Trust, Tags for Identifying Languages 

  • 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.
  • To avoid ambiguity, a particular language tag must not occur more than once in a series of TranslatedText elements with the same type.
  • Only one TranslatedText element without an xml:lang attribute may occur within the same parent and type.

Examples:

  • "en" for English
  • "en-GB" for British English
Type(text/plain | application/xhtml+xml)Required

Contains IANA media type of the TranslatedText element contents.

  • A TranslatedText element with plain text with specified type "text/plain" 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.
    • Layout containers: <div> <p>
    • Headers: <h1> <h2> <h3> <h4> <h5> <h6>
    • Lists: <ul> <ol> <li>
    • Definitions: <dl> <dt> <dd>
    • Lines: <hr>
    • Block-level quotes/preformatted: <pre> <blockquote>
    • Links: <a>
    • Inline elements: <span> <code> <br> 
    • Text styling: <em> <strong> <b> <i>
    • Tables: <table> <caption> <thead> <tfoot> <tbody> <colgroup> <col> <tr> <th> <td>
    • Images: <img> <map> <area>
    • Color: <span style="color:xxx">



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.

XHTML

For type="application/xhtml+xml" it is possible to use HTML tags for text formatting. Value of the TranslatedText element must be always wrapped in <div> tag with non-whitespace content within it. The <div> must have a proper namespace specified: <div xmlns="https://www.w3.org/1999/xhtml/>

Note that the XHTML is contained in general XML so there is no support for HTML entities like &nbsp; or &copy; etc. Unicode characters shall be used instead. Unicode &#160; substitutes for &nbsp;.

The content should be in the language of the TranslatedText element (xml:lang), but there is no reason to expect that HTML type tooling would understand the TranslatedText element language. For this reason, it is a good practice to use a lang attribute on the <div> (see the note in the HTML 5 specification about use of language ).

A minimum set of supported HTML tags

A base minimum set of HTML tags which needs to be supported for ODM conformance:  

  • Layout containers: <div> <p>
  • Headers: <h1> <h2> <h3> <h4> <h5> <h6>
  • Lists: <ul> <ol> <li>
  • Definitions: <dl> <dt> <dd>
  • Lines: <hr>
  • Block-level quotes/preformatted: <pre> <blockquote>
  • Links: <a>
  • Inline elements: <span> <br> <code> 
  • Text styling: <em> <strong> <b> <i>
  • Tables: <table> <caption> <thead> <tfoot> <tbody> <colgroup> <col> <tr> <th> <td>
  • Images: <img> <map> <area>
  • Color: <span style="color:xxx">

The following example shows a TranslatedText element with both plain text and an enhanced presentation with a limited number of HTML tags.

Example: TranslatedText

TranslatedText
<Description>
    <TranslatedText xml:lang="en" Type="text/plain">Study Day Derivation
Study day (ADY) is derived differently for events occurring:
    Before the first dose date.
    On or after the first dose date.
When the event date (ADT) is before the first dose date (TRTSDT):
ADY = ADT - TRTSTDT.
When the event date (ADT) is on or after the first dose date (TRTSDT):
ADY = ADT - TRTSTDT + 1.
    </TranslatedText>
    <TranslatedText xml:lang="en" Type="application/xhtml+xml">
        <div xmlns="http://www.w3.org/1999/xhtml/">
            <h3>Study Day Derivation</h3>
            <p><strong>Study day</strong> (ADY) is derived differently for events occurring:</p>
            <ol>
                <li>Before the first dose date.</li>
                <li>On or after the first dose date.</li>
            </ol>
            <p>When the event date (<em>ADT</em>) is before the first dose date (<em>TRTSDT</em>):</p>
            <p><code>ADY = ADT - TRTSTDT.</code></p>
            <p>When the event date (<em>ADT</em>) is on or after the first dose date (<em>TRTSDT</em>):</p>
            <p><code>ADY = ADT - TRTSTDT + 1.</code></p>
        </div>
    </TranslatedText>
</Description>







« Description

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