Name | Component Type | Xpath | Notes | ArchiveLayout | ArchiveLayoutRef | BasicDefinitions | ||||||||||||||||||||||||||||||||||||||||||
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Archival | Attribute | /ODM/@Archival | Replaced with /ODM/@Context | |||||||||||||||||||||||||||||||||||||||||||||
ID | Attribute | /ODM/ID | Was used by the ds:Signature element to refer back to this element. Signatures are now treated as standardized extensions, and not part of the core ODM. | |||||||||||||||||||||||||||||||||||||||||||||
GlobalVariables | Element | /ODM/Study/GlobalVariables | ||||||||||||||||||||||||||||||||||||||||||||||
Element | /ODM/Study/GlobalVariables/StudyName | Replaced with /ODM/Study/StudyName attribute. | ||||||||||||||||||||||||||||||||||||||||||||||
Element | /ODM/Study/GlobalVariables/StudyDescription | Replaced with /ODM/Study/Description element. | ||||||||||||||||||||||||||||||||||||||||||||||
Element | /ODM/Study/GlobalVariables/ProtocolName | Replaced with /ODM/Study/ProtocolName attribute. | ||||||||||||||||||||||||||||||||||||||||||||||
BasicDefinitions | Element | /ODM/Study/BasicDefinitions | ||||||||||||||||||||||||||||||||||||||||||||||
Description | Attribute | /ODM/Study/MetaDataVersion/@Description | Replaced with the Description child element | |||||||||||||||||||||||||||||||||||||||||||||
EnumeratedItem | Element | /ODM/Study/MetaDataVersion/CodeList/EnumeratedItem | Use Codelist/CodeListItem* without Decode elements. | |||||||||||||||||||||||||||||||||||||||||||||
ExternalCodeList | Element | /ODM/Study/MetaDataVersion/CodeList/ExternalCodeList | Use Codelist/Coding element. | |||||||||||||||||||||||||||||||||||||||||||||
FormRef | Element | /ODM/Study/MetaDataVersion/StudyEventDef/FormRef | Use ItemGroupRef | |||||||||||||||||||||||||||||||||||||||||||||
FormDef | Element | /ODM/Study/MetaDataVersion/FormDef | Use ItemGroupDef | |||||||||||||||||||||||||||||||||||||||||||||
Origin | Attribute | /ODM/Study/MetaDataVersion/ItemGroupDef/@Origin | Replaced with the Origin child element | |||||||||||||||||||||||||||||||||||||||||||||
Role Deprecated 1.3 | Attribute | /ODM/Study/MetaDataVersion/ItemGroupDef/@Role | ||||||||||||||||||||||||||||||||||||||||||||||
SASDatasetName | Attribute | /ODM/Study/MetaDataVersion/ItemGroupDef/@SASDatasetName | Replace with DatasetName attribute | |||||||||||||||||||||||||||||||||||||||||||||
MeasurementUnitRef | Element | /ODM/Study/MetaDataVersion/ItemDef/MeasurementUnitRef | ||||||||||||||||||||||||||||||||||||||||||||||
Role Deprecated 1.3 | Element | /ODM/Study/MetaDataVersion/ItemDef/Role | ||||||||||||||||||||||||||||||||||||||||||||||
Origin | Attribute | /ODM/Study/MetaDataVersion/ItemDef/@Origin | Replaced with Origin child element on ItemRef. | |||||||||||||||||||||||||||||||||||||||||||||
SignificantDigits | Attribute | /ODM/Study/MetaDataVersion/ItemDef/SignificantDigits | ||||||||||||||||||||||||||||||||||||||||||||||
SASFieldname | Attribute | /ODM/Study/MetaDataVersion/ItemDef/@SASFieldname | Use Alias child element | |||||||||||||||||||||||||||||||||||||||||||||
SDSVarName | Attribute | /ODM/Study/MetaDataVersion/ItemDef/@SDSVarname | Use Alias child element | |||||||||||||||||||||||||||||||||||||||||||||
SASFormatName | Attribute | /ODM/Study/MetaDataVersion/CodeList/@SASFormatName | Use Alias child element | |||||||||||||||||||||||||||||||||||||||||||||
ImputationMethod Deprecated 1.3 | Element | /ODM/Study/MetaDataVersion/ImputationMethod | ||||||||||||||||||||||||||||||||||||||||||||||
Presentation | Element | /ODM/Study/MetaDataVersion/Presentation | ||||||||||||||||||||||||||||||||||||||||||||||
Picture | Element | /ODM/Study/AdminData/User/Picture | Replaced with /ODM/AdminData/User/Image | |||||||||||||||||||||||||||||||||||||||||||||
Certificate | Element | /ODM/Study/AdminData/User/Certificate | ||||||||||||||||||||||||||||||||||||||||||||||
FormData | Element | /ODM/ClinicalData/SubjectData/StudyEventData | Use ItemGroupData | |||||||||||||||||||||||||||||||||||||||||||||
ItemData[Type] | Element | /ODM/Study/ClinicalData/FormData/ItemGroupData/ItemDataAny /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataBase64Binary /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataBase64Float /ODM/Study/ClinicalData/FormData/ItemGroupData/ItemDataBoolean /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataDate /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataDateTime /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataDouble /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataDurationDatetime /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataDataFloat /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataHexBinary /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataHexFloat /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataDataIncompleteDate /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataDataIncompleteDatetime /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataDataIncompleteTime /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataInteger /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataIntervalDatetime /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataPartialDate /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataPartialDatetime /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataDatePartialTime /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataString /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataTime /ODM/Study/ClinicalData/FormData/ItemGroupData/temDataURI | ||||||||||||||||||||||||||||||||||||||||||||||
ds:Signature | Element | /ODM/ds:Signature | Signatures are now treated as standardized extensions, and not part of the core ODM. | Certificate (Deprecated) | Comment | GlobalVariables (To delete?) | ImputationMethod Deprecated 1.3 | Include | InvestigatorRef | ItemData | ItemDataAny | ItemDataBase64Binary | ItemDataBase64Float | ItemDataBoolean | ItemDataDate | ItemDataDatetime | ItemDataDouble | ItemDataDurationDatetime | ItemDataFloat | ItemDataHexBinary | ItemDataHexFloat | ItemDataIncompleteDate | ItemDataIncompleteDatetime | ItemDataIncompleteTime | ItemDataInteger | ItemDataIntervalDatetime | ItemDataPartialDate | ItemDataPartialDatetime | ItemDataPartialTime | ItemDataString | ItemDataTime | ItemDataURI | ItemDef | Organization | OtherText | Pager | Phone | Image | Presentation (Deprecated) | ProtocolName | Role Deprecated 1.2 | /ODM/Study/MetaDataVersion/ItemGroupDef | StudyDescription | FormData | StudyName | SubjectData | Symbol | ds:Signature |
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