| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules |
|---|---|---|---|---|
| OID | oid | Required | Unique identifier for the ItemDef element. | The OID attribute value must be unique within the Study/MetaDataVersion. |
| Name | name | Required | Human readable name for the ItemDef. | The Name attribute must be unique within the set of ItemDef elements within a Study/MetadataVersion. |
| DataType | (text | integer | decimal | float | double | date | time | datetime | string | boolean | double | hexBinary | base64Binary | hexFloat | base64Float | partialDate | partialTime | partialDatetime | durationDatetime | intervalDatetime | incompleteDatetime | incompleteDate | incompleteTime | URI ) | Required | Specification of the allowable values and the intended use of the corresponding value elements. | A receiving system is expected to preserve the value and precision of the data. |
| Length | positiveInteger | Optional | Specifies the number of characters allowed for the ItemData/Value when it is represented as a text. its length must be less or equal to N. | Systems that import ClinicalData must be able to process and store all text string with length less than or equal to N. |
| FractionDigits | nonNegativeInteger | Optional | Specifies the number of digits to the right of the decimal point when the DataType is Float. | If DataType=float, Length=N and SignificantDigits=S is a requirement that the receiving system be able to process and store all numeric values of magnitude less than 10N-S that are multiples of 10-S. Larger values may be rejected. Intermediate values may be rounded to the nearest multiple of 10-S. |
| CommentOID | oidref | Optional | Reference to a CommentDef with sponsor provided information related to this ItemDef, | Must match the OID attribute of a CommentDef element within in this Study/MetaDataVersion. |
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