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AttributeSchema Datatype or EnumerationUsage
Allowable ValuesDescription
DefinitionBusiness Rule(s)
OID

oid

Required

Text

Unique identifier for the standard.


NametextRequired
Text

Name of the external standard to which the data conforms.

  • The list of values is conditional to each value of the
def:
  • Standard/@Type attribute. The list of allowable values for each
def:
  • Standard/@Type value is provided by an extensible codelist in the CDISC Controlled Terminology.
  • The name and concept code for this codelist are TBD.
    • TypetextRequired

    The type of standard. 

    TypeRequiredText

    • The list of allowable values is provided by a codelist in the CDISC Controlled Terminology and is extensible.
  • The name and concept code for this codelist are TBD.
    • PublishingSettext

    Conditional

    • Required
    PublishingSetConditionally required
    • when Type="CT"
    • Not applicable for other standard types
    Text

    The name of the publishing set that contains the published standard.

    • The list of allowable values is provided by a codelist in the CDISC Controlled Terminology and is extensible.
  • The name and concept code for this codelist are TBD.
    • VersionRequired

    Text

    • The version identifier should match the version identifier used in the standard publication.
    VersiontextRequired

    Version of the

    Version of an

    external standard to which the data conforms.

    See Section 4.1.1, Standards Considerations. See also Section 1, Introduction, for a list of the versions of CDISC standards supported by Define-XML v2.1.0 at the time of
    • The version identifier must match the version identifier used in the standard publication.
    Status

    text

    Optional

    TextPublishing status of the standard.
    Publishing status of the standard.
    • The list of allowable values is provided by a codelist in the CDISC Controlled Terminology and is not extensible.
  • The name and concept code for this codelist are TBD.
    • If no value is provided, the assumption is that the publishing status is Final.
    def:
    CommentOID textOptional
    Text

    Reference to the unique ID of a

    def:

    CommentDef element that contains the comment for the

    def:

    Standard element

  • See Section 4.8, Comment Definitions.
    • Business Rule: Must match the OID of a
    def:
    • CommentDef in the same MetaDataVersion
    • Must match the OID of a CommentDef in the same MetaDataVersion