| 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 | Section | Dataset | Concept) | Required | Indicates the function of this ItemGroup. Form - a CRF for data collection. 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 | Role of this ItemGroup. | |||||||||||
| 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, | Must match the OID attribute of a CommentDef element within this Study/MetaDataVersion. |
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