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Element NameTranslatedText
Element Textual Valuetext
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.

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

  • 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.
typeRequired

text/plain, application/xhtml+xml


Contains IANA media type of the TranslatedText element contents. Default value: "text/plain".


  • A TranslatedText element with plain text (either with specified or missing type, given that "text/plain" is a default value) 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 ODM2DEV-59 - Getting issue details... STATUS .

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.


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: <div> <p> <br>
  • Headers: <h1> <h2> <h3> <h4> <h5> <h6>
  • Text styling: <strong> <em> <sup> <sub>
  • Quotes/Unformatted/Code: <blockquote> <code> <pre>
  • Lists: <ul> <ol> <li>
  • Tables: <table> <thead> <tbody> <tr> <th> <td>
  • Lines: <hr>
  • Links: <a>
  • Images: <img>
  • Color: <span style="color:xxx">

Examples

Method description with XHTML formatting.

<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="https://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>


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