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  • 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.

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xml:lang

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

Samples:

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

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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.

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  • 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.

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text/plain, application/xhtml+xml

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

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  • 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
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyODM2DEV-59
    .

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.

Include Page
TranslatedText Element
TranslatedText Element

Include Page
TranslatedText Attributes
TranslatedText Attributes

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.

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

  • Layout containers: <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>
  • 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>Lists: <ul> <ol> <li>
  • Tables: <table> <caption> <thead> <tfoot> <tbody> <colgroup> <col> <tr> <th> <td>
  • Lines: <hr>
  • Links: <a>
  • Images: <img> <map> <area>
  • Color: <span style="color:xxx">

Examples

Method description with XHTML formatting.

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

Example
titleTranslatedText

Include Page
TranslatedText Example
TranslatedText Example

No Format
<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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