Versions Compared

Old Version 3

changes.mady.by.user Sally Cassells

Saved on

compared with

New Version Current

changes.mady.by.user Lex Jansen

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
AttributeSchema Datatype or EnumerationUsageDefinitionBusiness
Rules
Rule(s)
OIDoidRequiredUnique identifier for the ItemGroupDef element.
  • The OID attribute value must be unique within the Study/MetaDataVersion.
NamenameRequiredHuman readable name for the ItemGroupDef.
  • The Name attribute must be unique
within
  • within  set of ItemGroupDef
element
  • elements within a Study/MetadataVersion.
Repeating(No | Simple | Dynamic | Static)Required
Characterises 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.

Only one occurrence may occur for each codelist item

There 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 items

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.
RepeatingLimitpositiveIntegerOptionalMaximum number of repeats.
  • RepeatingLimit can only be used when Repeating="Simple".
IsReferenceData(Yes | No)OptionalSpecifies whether this ItemGroupDef is used for non-subject data.
Datat
  • Data content for ItemGroupDef elements where the IsReferenceData attribute is "Yes" is under the /ODM/ReferenceData element.
StructuretextOptionalDescription of the level of detail represented by individual records in the ItemGroup
ArchiveLocationIDoidrefOptional

Reference to the unique ID of a leaf element that provides the actual location and file name of the data file.

  • If provided, the value must match the leaf ID attribute of the leaf child element.
DatasetNamenameOptionalName 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.
DomaintextOptionalIdentifies 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)
Optional
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".
PurposetextOptional
Role
Purpose of
this
the ItemGroup. 
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.
StandardOIDoidrefOptionalReference to a Standard element.
  • Must match the OID attribute of a Standard element within this Study/MetaDataVersion/Standards.
IsNonStandardYesConditionalRequired for ADaM, SDTM, or SEND if StandardOID is not provided.
  • Must not be provided when StandardOID is provided.
HasNoDataYesOptionalUsed 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

JirashowSummaryfalseserverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyODM2DEV-64

oidrefOptional

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
in
  • this Study/MetaDataVersion.