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Attribute	Schema Datatype or Enumeration	Usage	Definition	Business

Rules

Rule(s)
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

The 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. There may be multiple occurrences for some codelist items.

Static - ItemGroupData repeats based on values in a codelist. Only one occurrence may

occur

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

can 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 element that provides the actual location and file name of the data file.

If provided,

this should

the value must match the leaf

:id

ID attribute of the

def:

leaf child element

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.
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

Indicates

identifies the

function

type of

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".

Purpose

text

Optional

Role

Purpose of

this

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

Must 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

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	ODM2DEV-64

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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