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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 one or more XML examples (accompanied by explanation of the example(s) as necessary). 

Info

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ODMv2 Element Table Template
ODMv2 Element Table Template

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ODMv2 Attributes Table Template
ODMv2 Attributes Table Template

This specification reflects the elements and attributes that make up the ODM XML schema. The schema for Version 2.0 of the ODM can be found at https://github.com/cdisc-org/DataExchange-ODM. 

Info

The syntax of each XML element is specified as follows:

Element-Name

Body:

content-specification
Attributes:
attribute-name data-format optionality semantic-details
...

The content specification can be "EMPTY", a data format name, or an element group. EMPTY means that this element has no body (nested content). A data format name means that the body can be any text string matching the named format. An element group means that the named elements can be directly nested within this element.

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. An element or element group can be followed by a ? (meaning optional), a * (meaning zero or more occurrences), or a + (meaning one or more occurrences).

Attributes are listed in tabular form, one attribute per row, including the attribute's name, its data format, its optionality, and possibly some semantic details. All attributes are required unless the optionality column contains "(optional)". The ODM foundation schema implements the specification using XML Schema.

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