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Attribute	Schema Datatype or Enumeration	Usage	Definition	Business

Rules

Rule(s)
Code	text

RequiredSpecified the Code in the external code source

Optional	A string pattern that identifies a concept as defined by the code system.	When not provided, all codes in the code system are allowed. For example, when referencing the complete set of codes from the MedDRA code system.
System	URI	Required

Unique identifier for the external code source

Identifies the code system that defines the code. If the code is taken from a code system resource then the URL for the code system should be used.
SystemName	text	Optional

Human

Human readable name for the

external

code

source

system.
SystemVersion	text	Optional

Version or edition

Identifies the version of the

external code source

code system
Label	text	Optional	Used to link the value to a named MethodDef parameter.
href	URI	Optional	URI reference to the Code definition.
ref	URI	Optional	Reference to a local instance of the code system.
CommentOID

Optional

Reference to a CommentDef that provides the rationale for the use of the Concept.

Must match the OID attribute of a CommentDef element within in this Study/MetaDataVersion.

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