| 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 | The Repeating attribute indicates that the ItemGroup may occur repeatedly within the containing element. Simple - the ItemGroup repeats within the containing element and is not bound in any way. Note: It is equivalent to the ODM v1.3.2 case where Repeating="Yes". 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 happen for each codelist item. | For cases where Repeating is set to Dynamic or Static, one ItemRef within the ItemGroup must include the Repeat="Yes" attribute to indicate that that specific ItemRef references the codelist that establishes the Repeating behavior. If IsReferenceData is Yes, the ItemGroup can occur only within a ReferenceData element. If IsReferenceData is No, the ItemGroup can occur only within a ClinicalData element. |
| 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. The name applies to the object itself rather then providing a mapping to a different object. | Could have constraints on individual ODM extensions, such as Define-XML or associated CDISC Metadata Guidelines. For example, DatasetName could be defined as sasName (see Section 2.14, Data Formats) in Define-XML or associated CDISC Metadata Guidelines. |
| Domain | text | Optional | Identifies the scope or CDISC SDTMIG/SENDIG Domain of the ItemGroup data. The domain applies to the object itself rather then providing a mapping to a different object. | Usage requirements are based on the applicable CDISC Standard. Could have constraints on individual ODM extensions, such as Define-XML or associated CDISC Metadata Guidelines. |
| Type | (Form | Section | Dataset | Concept) | Required | identifies the type of data structure the ItemGroup represents. Form - a CRF for data collection. Note, ItemGroupDef Type="Form" replaces the ODM v1.x FormDef element. Section - a section within a CRF. Dataset - tabulation, analysis or operational datasets. Concept - defines a biomedical concept. | Type is an extensible attribute. Type="Section" can only be used when the ItemGroup has a top-level ancestor ItemGroup that has Type="Form". |
| Purpose | text | Optional | Purpose of the ItemGroup. | Usage requirements are based on the applicable CDISC Standard. Could have constraints on individual ODM extensions, such as Define-XML or associated CDISC Metadata Guidelines. |
| StandardOID | oidref | Optional | Reference to a Standard element. | Must match the OID attribute of a Standard element within this Study/MetaDataVersion/Standards. |
| IsNonStandard | Yes | Conditional | Required for ADaM, SDTM, or SEND if StandardOID is not provided. | Should not be provided when StandardOID is provided. |
| HasNoData | Yes | Optional | Used to indicate that an ItemGroupDef has no data. May be used at sponsor's discretion or if required by a regulatory authority | A comment must be included to explain why no data are present for datasets that were planned for use in the study. |
CommentOID | oidref | Optional | Reference to a CommentDef with sponsor provided information related to this ItemGroupDef. It allows annotations to the ItemGroup. | Must match the OID attribute of a CommentDef element within this Study/MetaDataVersion. |
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