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/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
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- Requirement: Required
- Cardinality: One or more. Multiple TranslatedText child elements can be used to provide description in different languages, 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.
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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.
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text/plain, application/xhtml+xml
Contains IANA media type of the TranslatedText element contents.
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- 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.
| Include Page | ||||
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| Include Page | ||||
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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 Present | Requested | Process |
| <TranslatedText xml:lang="fr-CA">... <TranslatedText xml:lang="en-GB">... <TranslatedText>... | fr-FR | Look 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.
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XHTML
For type="application/xhtml+xml" a limited number of it is possible to use HTML tags is allowed 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/>
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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 
).
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A minimum set of supported HTML tags
The list of allowed HTML tags includes the followingA 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 | ||||||
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| <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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