| Element Name | Standard |
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| Parent Elements | Standards |
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| Element XPath(s) | /ODM/Study/MetaDataVersion/Standards/Standard |
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| Element Textual Value | None |
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| Attributes | OID, Name, Type, PublishingSet, Version, Status, CommentOID |
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| Child Elements | None |
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| Usage/Business Rules |
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| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rule(s) |
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| OID | oid | Required | Unique identifier for the standard. |
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| Name | text | Required | Name of the external standard to which the data conforms. | - The list of values is conditional to each value of the Standard/@Type attribute. The list of allowable values for each Standard/@Type value is provided by an extensible codelist in the CDISC Controlled Terminology.
- Users are encouraged to refer to the most recent version of the CDISC Controlled Terminology (https://www.cdisc.org/standards/terminology/controlled-terminology).
|
| Type | text | Required | The type of standard. | |
| PublishingSet | text | Conditional - Required when Type="CT"
- Not applicable for other standard types
| The name of the publishing set that contains the published standard. | |
| Version | text | Required | Version of the external standard to which the data conforms. | - The version identifier must match the version identifier used in the standard publication.
|
| Status | text | Optional | Publishing status of the standard. | - The list of allowable values is provided by a codelist in the CDISC Controlled Terminology and is not extensible.
- Users are encouraged to refer to the most recent version of the CDISC Controlled Terminology (https://www.cdisc.org/standards/terminology/controlled-terminology).
- If no value is provided, the assumption is that the publishing status is Final.
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| CommentOID | text | Optional | Reference to the unique ID of a CommentDef element that contains the comment for the Standard element - Business Rule: Must match the OID of a CommentDef in the same MetaDataVersion
| - Must match the OID of a CommentDef in the same MetaDataVersion
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