Element Name | ItemGroupData |
---|---|
Parent Elements | ClinicalData, ReferenceData, StudyEventData |
Element XPath(s) | /ODM/ClinicalData/SubjectData/StudyEventData/ItemGroupData /ODM/ReferenceData/ItemGroupData /ODM/ClinicalData/ItemGroupData |
Element Textual Value | None |
Attributes | ItemGroupOID, ItemGroupRepeatKey, TransactionType, ItemGroupDataSeq |
Child Elements | (ItemGroupData*, ItemData*)+, AuditRecord?, Signature?, Annotation*, Query*) |
Usage/Business Rules |
|
Attribute | Schema Type or Enumeration Values | Usage | Definition | Business Rule(s) |
---|---|---|---|---|
ItemGroupOID | oidref | Required | Reference to an ItemGroupDef for the MetaDataVersion identified in the ClinicalData element. |
|
ItemGroupRepeatKey | repeatKey | Conditional
| A key used to distinguish between repeats of the same type of item group. |
|
TransactionType | Insert | Update | Remove | Upsert | Context | Conditional
| The TransactionType attribute need not be present in a Snapshot document. | |
ItemGroupDataSeq | positiveInteger | Conditional
| Unique sequence # for each ItemGroupData child element (record) in the container element. The ItemGroupDataSeq attribute doesn’t have any other meaning than the sequence in which the items are saved and exchanged for each ItemGroupDef. It is equivalent to the observation # in a dataset. |
|
Clinical data corresponding to an ItemGroupRef defined in the active MetaDataVersion.
The ItemGroupOID and ItemGroupRepeatKey are used together to identify a particular item group. This pair of values uniquely identifies an ItemGroup within the containing StudyEvent. The ItemGroupRepeatKey is present only if the ItemGroupDef is repeating.
The ItemGroupDataSeq doesn’t have any other meaning than the sequence in which the items are saved and exchanged for each ItemGroupDef. It is equivalent to the observation # in a dataset.
PROPOSED BUSINESS RULE (Jozef): ItemGroupDataSeq may only be used when ItemGroupData is a direct child of either ClinicalData or ReferenceData and the ItemGroupData represents a row in a dataset.
ODM-20
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Getting issue details...
STATUS
ItemGroupData can also occur as reference data. In that case, the ItemGroupOID and ItemGroupRepeatKey pair must be unique within the reference data.
The ItemGroupDataSeq and ItemGroupRepeatKey attributes are mutually exclusive.
The model supports nested and repeating item groups.
Example
<?xml version="1.0" encoding="UTF-8"?> <ODM xmlns="http://www.cdisc.org/ns/odm/v2.0" FileOID="MyStudy_1" FileType="Snapshot" CreationDateTime="2019-03-11T17:33:17"> <Study OID="MyStudy" StudyName="My Study"> <MetaDataVersion OID="MDV.MyStudy.001" Name="Study MyStudy 001, Data Definitions V-1"> <ItemGroupDef OID="ODM.IG.DM" Name="Demographics" Repeating="No" Type="Section"> <ItemRef ItemOID="IT.DM.BRTHYR" Mandatory="Yes"/> <ItemRef ItemOID="IT.DM.BRTHMO" Mandatory="Yes"/> <ItemRef ItemOID="IT.DM.BRTHDY" Mandatory="Yes"/> <ItemRef ItemOID="IT.DM.SEX" Mandatory="Yes"/> <ItemRef ItemOID="IT.DM.ETHNIC" Mandatory="Yes"/> <ItemGroupRef ItemGroupOID="ODM.IG.RACE" Mandatory="Yes" /> <ItemGroupRef ItemGroupOID="ODM.IG.RACEOTH" Mandatory="No"/> </ItemGroupDef> <ItemGroupDef OID="ODM.IG.RACE" Name="Race" Repeating="Static" Type="Section"> <ItemRef ItemOID="IT.DM.RACE" Mandatory="Yes" /> </ItemGroupDef> <ItemGroupDef OID="ODM.IG.RACEOTH" Name="Race Other(s)" Repeating="Simple" RepeatingLimit="2" Type="Section"> <ItemRef ItemOID="IT.DM.RACEOTH" Mandatory="No" Repeat="Yes"/> </ItemGroupDef> <ItemDef OID="IT.DM.RACE" Name="RACE" DataType="text" Length="41"> <Description> <TranslatedText xml:lang="en" Type="text/plain">Race</TranslatedText> </Description> <Question> <TranslatedText xml:lang="en" Type="text/plain">Race (Select all that apply)</TranslatedText> </Question> <CodeListRef CodeListOID="CL.RACE"/> </ItemDef> <ItemDef OID="IT.DM.RACEOTH" Name="RACEOTH" DataType="text" Length="41"> <Description> <TranslatedText xml:lang="en" Type="text/plain">Race Other</TranslatedText> </Description> <Question> <TranslatedText xml:lang="en" Type="text/plain">Other Race (Include maximum two other values not listed under RACE)</TranslatedText> </Question> </ItemDef> </MetaDataVersion> </Study> <!-- Clinical Data --> <ClinicalData StudyOID="MyStudy" MetaDataVersionOID="MDV.MyStudy.001"> <!-- Usually, the ItemGroupData is embedded within SubjectData-StudyEventData-(ItemGroupData). This is however omitted here for clarity --> <ItemGroupData ItemGroupOID="IG.DM" ItemGroupDataSeq="2"> <ItemData ItemOID="IT.STUDYID"> <Value>CDISC01</Value> </ItemData> <ItemData ItemOID="IT.DM.DOMAIN"> <Value>DM</Value> </ItemData> <ItemData ItemOID="IT.USUBJID"> <Value>CDISC01.100014</Value> </ItemData> <ItemData ItemOID="IT.DM.SUBJID"> <Value>100014</Value> </ItemData> <ItemData ItemOID="IT.DM.SITEID"> <Value>100</Value> </ItemData> <ItemData ItemOID="IT.DM.BRTHDTC"> <Value>1936-11-01</Value> </ItemData> <ItemData ItemOID="IT.DM.AGE"> <Value>66</Value> </ItemData> <ItemData ItemOID="IT.DM.AGEU"> <Value>YEARS</Value> </ItemData> <ItemData ItemOID="IT.DM.SEX"> <Value>F</Value> </ItemData> <ItemGroupData ItemGroupOID="ODM.IG.RACE" ItemGroupRepeatKey="1"> <ItemData ItemOID="IT.DM.RACE"> <Value>NATIVE HAWAIIAN</Value> </ItemData> </ItemGroupData> <ItemGroupData ItemGroupOID="ODM.IG.RACE" ItemGroupRepeatKey="2"> <ItemData ItemOID="IT.DM.RACE"> <Value>ASIAN</Value> </ItemData> </ItemGroupData> <ItemGroupData ItemGroupOID="ODM.IG.RACE" ItemGroupRepeatKey="3"> <ItemData ItemOID="IT.DM.RACE"> <Value>WHITE</Value> </ItemData> </ItemGroupData> <ItemGroupData ItemGroupOID="ODM.IG.RACEOTH" ItemGroupRepeatKey="1"> <ItemData ItemOID="IT.DM.RACEOTH"> <Value>Other free text Race value"</Value> </ItemData> </ItemGroupData> <ItemGroupData ItemGroupOID="ODM.IG.RACEOTH" ItemGroupRepeatKey="2"> <ItemData ItemOID="IT.DM.RACEOTH"> <Value>Another free text Race value</Value> </ItemData> </ItemGroupData> </ItemGroupData> </ClinicalData> </ODM>
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