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The sections that follow describe what an ODM document for this version of ODM can contain.

Each section may begin with a brief description of the element, followed by an element table and an attribute table. An element table describes the different aspects of an element's definition, whereas an attribute table describes the element's attributes. The following templates illustrate the layout of these tables, including headers and descriptions of the content.

In some cases, a section or subsection concludes with an XML example (accompanied by explanation of the example as necessary). 

Element NameName of the element
Parent ElementsA comma-delimited list of the elements that have this element as a child element. A link to each parent element will be provided.
Element XPath(s)List of different XPath values showing where the element belongs in the XML
Element Textual ValueA description of the value of the element. If an element has no text value (e.g., it has child elements instead), then this cell is populated with "None".
AttributesA comma-delimited list of the attributes of this element. If the element has no attributes, this is populated with "None".
Child Elements

An element group enclosed in parentheses.

  • An element group consists of one or more element names, or element groups enclosed in parentheses, and separated with commas or vertical bars.
  • Commas indicate that the elements (or element groups) must occur in the XML sequentially in the order listed in the group. Vertical bars indicate that exactly one of the elements (or element groups) must occur (is required).
  • An element or element group can be followed by one of the following characters:
    • ? (meaning optional, with zero or one occurrence)
    • * (meaning optional, with zero or more occurrences)
    • + (meaning required, with one or more occurrences)
  • When an element or element group is not followed by ?, *, or + it means that the element or element group occurs exactly once.

If the element has no child elements, this is populated with "None".

A link to each child element will be provided.

Usage/Business Rules
  • Business Rule(s): Beyond what is required for schema validation, these represent conformance rules that must be satisfied for a ODM document to be considered compliant with this specification.
  • Other Information: This is populated with any other information about the element, including the conditions under which the element is included, how the schema is applied to support the model, relative position of the element in the model, general information about usage of related element attributes or related child elements, and so on.

AttributeSchema Datatype or EnumerationUsageDefinitionBusiness Rule(s)
Name of the attribute
  • Schema Datatype, linked to the corresponding Datatype definition.
  • Enumeration: a pipe "|" delimited list of allowable value(s), enclosed in parenthesis.
    • Default: This will be populated with a default value if one is provided in the specification.
  • Value Description: A textual description of allowable values
  • This is populated with "Required" when the attribute is required, "Optional" when the attribute is optional, or "Conditional" when the attribute is required under certain conditions.
    • It will include the conditions under which the attribute is Required.
  • A textual description of the attribute beyond what is included in the Allowable Values column.
  • Rules that have to be satisfied in addition to schema validation for an ODM document to be considered compliant with the ODM vx.y,z specification.

This specification reflects the elements and attributes that make up the ODM XML schema. A copy of the XML schema for the ODM is provided as part of the ODM package that may be downloaded from the CDISC website (https://www.cdisc.org/standards/data-exchange/odm).

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