| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business |
|---|
| Rule(s) | |
|---|---|
| Code | text |
| 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 | 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 readable name for the code system. | |
| SystemVersion | text | Optional | Identifies the version of the 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 |
| oidref | 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. |