Attribute | Schema Datatype or Enumeration | Usage | Definition | Business |
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RulesRule(s) |
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OID | oid | Required | Unique identifier for the ItemGroupDef element. | - The OID attribute value must be unique within the Study/MetaDataVersion.
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Name | name | Required | Human readable name for the ItemGroupDef. | - The Name attribute must be unique within set of ItemGroupDef elements within a Study/MetadataVersion.
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Repeating | (No | Simple | Dynamic | Static) | Required |
Characterises the collection or occurrence of this ItemGroupThe Repeating attribute indicates that the ItemGroup may occur repeatedly within the containing element. Simple - |
ItemGroupData repeats are expected and may be unbounded 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. |
Only one occurrence may occur for each codelist itemThere may be multiple occurrences for some codelist items. Static - ItemGroupData repeats based on values in a codelist. |
There may be multiple occurrences for some codelist itemsOnly 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.
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RepeatingLimit | positiveInteger | Optional | Maximum number of repeats. | - RepeatingLimit can only be used when Repeating="Simple".
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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.
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Structure | text | Optional | Description of the level of detail represented by individual records in the ItemGroup |
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ArchiveLocationID | oidref | Optional | Reference to the unique ID of a |
def: leaf element that provides the actual location and file name of the data file. | |
this should - the value must match the leaf
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:id def:If not provided, the root dataset file name is expected to be the same as the Name attribute |
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.
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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.
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Type | (Form | Section | Dataset | Concept) |
OptionalIndicates function this 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".
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Purpose | text | Optional |
Role this CommentOID- 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.
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StandardOID |
Jira |
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showSummary | false |
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server | Issue Tracker (JIRA) |
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serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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key | ODM2DEV-64 CommentDef with sponsor provided information related to this ItemGroupDef,Standard element. | - Must match the OID attribute of a
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CommentDef - Standard element within this Study/MetaDataVersion
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.MethodOID | |
IsNonStandard | Yes | Conditional | Required for ADaM, SDTM, or SEND if StandardOID is not provided. | - Must not be provided when StandardOID is provided.
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HasNoData | Yes |
oidrefReference a MethodDef that will proivde one or more data rows as output.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.
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Must match the OID attribute of a MethodDef element within this Study/MetaDataVersion. | StandardOID Standard element CommentDef with sponsor provided information related to this ItemGroupDef. It allows annotations to the ItemGroup. | - Must match the OID attribute of a
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Standard - CommentDef element within this Study/MetaDataVersion
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/Standards