| Attribute | Schema Datatype or Enumeration | Usage | Definition | Business Rules | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| OID | oid | Required | Unique identifier for the ItemGroupDef element. | The OID attribute value must be unique within the Study/MetaDataVersion. | ||||||||||
| Name | name | Required | Human readable name for the ItemGroupDef. | The Name attribute must be unique within set of ItemGroupDef elements within a Study/MetadataVersion. | ||||||||||
| Repeating | (No | Simple | Dynamic | Static) | Required | Characterizes the collection or occurrence of this ItemGroup. Simple - ItemGroupData repeats are expected and may be unbounded. Dynamic - ItemGroupData repeats based on values in a codelist. There may be multiple occurrences for some codelist items. Static - ItemGroupData repeats based on values in a codelist. Only one occurrence may occur for each codelist item. | |||||||||||
| RepeatingLimit | positiveInteger | Optional | Maximum number of repeats. | RepeatingLimit may only be used when Repeating=Simple. | ||||||||||
| IsReferenceData | (Yes | No) | Optional | Specifies whether this ItemGroupDef is used for non-subject data. | Data content for ItemGroupDef elements where the IsReferenceData attribute is "Yes" is under the /ODM/ReferenceData element. | ||||||||||
| Structure | text | Optional | Description of the level of detail represented by individual records in the ItemGroup | |||||||||||
| ArchiveLocationID | oidref | Optional | Reference to the unique ID of a def:leaf that provides the actual location and file name of the data file. |
| ||||||||||
| DatasetName | name | Optional | Name of a file containing the ItemGroupData for this ItemGroupDef. | |||||||||||
| Domain | text | Optional | Identifies the scope or CDISC SDTMIG/SENDIG Domain of the ItemGroup data. | |||||||||||
| Type | (Form | Dataset | Concept) | Optional | Indicates the function of this ItemGroup. Form - data collection. Dataset - tabulation, analysis or operational datasets. Concept - defines a biomedical concept. | |||||||||||
| Purpose | text | Optional | Role of this ItemGroup. | |||||||||||
CommentOID
| oidref | Optional | Reference to a CommentDef with sponsor provided information related to this ItemGroupDef, | Must match the OID attribute of a CommentDef element within this Study/MetaDataVersion. | ||||||||||
| MethodOID | oidref | Optional | Reference to a MethodDef that will proivde one or more data rows as output. | Must match the OID attribute of a MethodDef element within this Study/MetaDataVersion. | ||||||||||
| StandardOID | oidref | Optional | Reference to a Standard element. | Must match the OID attribute of a Standard element within this Study/MetaDataVersion/Standards. |
...