class ReferenceData(OE.ODMElement):
StudyOID = T.OIDRef(required=True)
MetaDataVersionOID = T.OIDRef(required=True)
ItemGroupData = T.ODMListObject(element_class=ItemGroupData)
AuditRecords = T.ODMListObject(element_class=AuditRecords)
Signatures = T.ODMListObject(element_class=Signatures)
Annotations = T.ODMListObject(element_class=Annotations)
class Transition(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
SourceOID = T.OIDRef(required=True)
TargetOID = T.OIDRef(required=True)
StartConditionOID = T.OIDRef()
EndConditionOID = T.OIDRef()
class ClinicalData(OE.ODMElement):
StudyOID = T.OIDRef(required=True)
MetaDataVersionOID = T.OIDRef(required=True)
SubjectData = T.ODMListObject(element_class=SubjectData)
AuditRecords = T.ODMListObject(element_class=AuditRecords)
Signatures = T.ODMListObject(element_class=Signatures)
Annotations = T.ODMListObject(element_class=Annotations)
class ItemGroupDef(ODM.ItemGroupDef):
OID = ODM.ItemGroupDef.OID
Name = ODM.ItemGroupDef.Name
Repeating = ODM.ItemGroupDef.Repeating
IsReferenceData = ODM.ItemGroupDef.IsReferenceData
SASDatasetName = ODM.ItemGroupDef.SASDatasetName
Domain = ODM.ItemGroupDef.Domain
Purpose = ODM.ItemGroupDef.Purpose
Structure = T.String(required=True, namespace="def")
ArchiveLocationID = T.String(namespace="def")
CommentOID = T.OIDRef(namespace="def")
IsNonStandard = T.ValueSetString(namespace="def")
StandardOID = T.OIDRef(namespace="def")
HasNoData = T.ValueSetString(namespace="def")
Description = ODM.ItemGroupDef.Description
ItemRef = ODM.ItemGroupDef.ItemRef
Alias = ODM.ItemGroupDef.Alias
Class = T.ODMObject(element_class=Class, namespace="def")
leaf = T.ODMObject(required=True, element_class=leaf, namespace="def")
def __len__(self):
return len(self.ItemRef)
def __getitem__(self, position):
return self.ItemRef[position]
def __iter__(self):
return iter(self.ItemRef)
class TransitionTimingConstraint(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
TransitionOID = T.OIDRef(required=True)
TimepointRelativeTarget = T.DurationDateTimeString(required=True)
MethodOID = T.OIDRef()
TimepointPreWindow = T.DurationDateTimeString(required=True)
TimepointPostWindow = T.DurationDateTimeString(required=True)
Description = T.ODMObject(element_class=Description)
class AbsoluteTimingConstraint(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
StudyEventGroupOID = T.OIDRef()
StudyEventOID = T.OIDRef()
TimepointTarget = T.IncompleteDateTimeString(required=True)
TimepointPreWindow = T.DurationDateTimeString(required=True)
TimepointPostWindow = T.DurationDateTimeString(required=True)
Description = T.ODMObject(element_class=Description)
class KeySet(OE.ODMElement):
StudyOID = T.OIDRef(required=True)
SubjectKey = T.String()
StudyEventOID = T.OIDRef()
StudyEventRepeatKey = T.String()
FormOID = T.OIDRef()
FormRepeatKey = T.String()
ItemGroupOID = T.OIDRef()
ItemGroupRepeatKey = T.String()
ItemOID = T.OIDRef()
class RelativeTimingConstraint(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
PredecessorStudyEventGroupOID = T.OIDRef()
PredecessorStudyEventOID = T.OIDRef()
SuccessorStudyEventGroupOID = T.OIDRef()
SuccessorStudyEventOID = T.OIDRef()
Type = T.ValueSetString()
TimepointRelativeTarget = T.DurationDateTimeString(required=True)
TimepointPreWindow = T.DurationDateTimeString(required=True)
TimepointPostWindow = T.DurationDateTimeString(required=True)
Description = T.ODMObject(element_class=Description)
class ClinicalData(OE.ODMElement):
StudyOID = T.OIDRef(required=True)
MetaDataVersionOID = T.OIDRef(required=True)
SubjectData = T.ODMListObject(element_class=SubjectData)
AuditRecords = T.ODMListObject(element_class=AuditRecords)
Signatures = T.ODMListObject(element_class=Signatures)
Annotations = T.ODMListObject(element_class=Annotations)
def __len__(self):
return len(self.SubjectData)
def __getitem__(self, position):
return self.SubjectData[position]
def __iter__(self):
return iter(self.SubjectData)
class ItemGroupDef(OE.ODMElement):
""" represents ODM v2.0 ItemGroupDef and can serialize as JSON or XML"""
OID = T.OID(required=True)
Name = T.Name(required=True)
Repeating = T.ValueSetString(required=True)
Type = T.ValueSetString()
IsReferenceData = T.ValueSetString(required=False)
DatasetName = T.Name()
Domain = T.String()
Purpose = T.String()
CommentOID = T.OIDRef()
Description = T.ODMObject(element_class=Description)
ItemGroupRef = T.ODMListObject(element_class=ItemGroupRef)
ItemRef = T.ODMListObject(element_class=ItemRef)
WorkflowRef = T.ODMListObject(element_class=WorkflowRef)
Origin = T.ODMListObject(element_class=Origin)
Alias = T.ODMListObject(element_class=Alias)
def __len__(self):
return len(self.ItemRef)
def __getitem__(self, position):
return self.ItemRef[position]
def __iter__(self):
return iter(self.ItemRef)
class SourceItem(OE.ODMElement):
leadID = T.IDRef()
ItemGroupOID = T.OIDRef()
Resource = T.String()
Attribute = T.String()
Path = T.String()
Label = T.String()
class DurationTimingConstraint(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
StructuralElementOID = T.OIDRef(required=True)
DurationTarget = T.DurationDateTimeString(required=True)
DurationPreWindow = T.DurationDateTimeString(required=True)
DurationPostWindow = T.DurationDateTimeString(required=True)
Description = T.ODMObject(element_class=Description)
class ExceptionEvent(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
ConditionOID = T.OIDRef(required=True)
Description = T.ODMObject(element_class=Description)
WorkflowRef = T.ODMObject(element_class=WorkflowRef)
StudyEventGroupRef = T.ODMListObject(element_class=StudyEventGroupRef)
StudyEventRef = T.ODMListObject(element_class=StudyEventRef)
class StudyEventData(OE.ODMElement):
StudyEventOID = T.OIDRef(required=True)
StudyEventRepeatKey = T.String(required=False)
TransactionType = T.ValueSetString(required=False)
AuditRecord = T.ODMObject(required=False, element_class=AuditRecord)
Signature = T.ODMObject(required=False, element_class=Signature)
Annotation = T.ODMListObject(required=False, element_class=Annotation)
FormData = T.ODMListObject(required=False, element_class=FormData)
class FormData(OE.ODMElement):
FormOID = T.OIDRef(required=True)
FormRepeatKey = T.String(required=False)
TransactionType = T.ValueSetString(required=False)
AuditRecord = T.ODMObject(required=False, element_class=AuditRecord)
Signature = T.ODMObject(required=False, element_class=Signature)
ArchiveLayout = T.ODMObject(required=False, element_class=ArchiveLayout)
Annotation = T.ODMListObject(required=False, element_class=Annotation)
ItemGroupData = T.ODMListObject(required=False, element_class=ItemGroupData)
class ItemData(OE.ODMElement):
ItemOID = T.OIDRef(required=True)
TransactionType = T.ValueSetString(required=False)
Value = T.String(required=False)
IsNull = T.ValueSetString(required=False)
AuditRecord = T.ODMObject(required=False, element_class=AuditRecord)
Signature = T.ODMObject(required=False, element_class=Signature)
MeasurementUnitRef = T.ODMObject(required=False, element_class=MeasurementUnitRef)
Annotation = T.ODMListObject(required=False, element_class=Annotation)
class Standard(OE.ODMElement):
namespace = "def"
OID = T.OID(required=True)
Name = T.Name(required=True)
Type = T.String(required=True)
PublishingSet = T.String()
Version = T.String(required=True)
Status = T.String()
CommentOID = T.OIDRef(namespace="def")
class ItemGroupData(OE.ODMElement):
ItemGroupOID = T.OIDRef(required=True)
ItemGroupDataSeq = T.PositiveInteger(required=True, namespace="data")
ItemData = T.ODMListObject(required=False, element_class=ItemData)
def __len__(self):
return len(self.ItemData)
def __getitem__(self, position):
return self.ItemData[position]
def __iter__(self):
return iter(self.ItemData)
class CodeList(ODM.CodeList):
OID = ODM.CodeList.OID
Name = ODM.CodeList.Name
DataType = ODM.CodeList.DataType
IsNonStandard = T.ValueSetString(namespace="def")
StandardOID = T.String(namespace="def")
SASFormatName = ODM.CodeList.SASFormatName
CommentOID = T.OIDRef(namespace="def")
Description = ODM.CodeList.Description
CodeListItem = ODM.CodeList.CodeListItem
EnumeratedItem = ODM.CodeList.EnumeratedItem
ExternalCodeList = ODM.CodeList.ExternalCodeList
Alias = ODM.CodeList.Alias
class ArchiveLayout(OE.ODMElement):
OID = T.OID(required=True)
PdfFileName = T.FileName(required=True)
PresentationOID = T.OIDRef(required=False)
def __len__(self):
return len(self.ItemGroupRef)
def __getitem__(self, position):
return self.ItemGroupRef[position]
def __iter__(self):
return iter(self.ItemGroupRef)
class ItemDef(ODM.ItemDef):
OID = ODM.ItemDef.OID
Name = ODM.ItemDef.Name
DataType = ODM.ItemDef.DataType
Length = ODM.ItemDef.Length
SignificantDigits = ODM.ItemDef.SignificantDigits
SASFieldName = ODM.ItemDef.SASFieldName
DisplayFormat = T.String(namespace="def")
CommentOID = T.OIDRef(namespace="def")
Description = ODM.ItemDef.Description
CodeListRef = ODM.ItemDef.CodeListRef
Origin = T.ODMListObject(element_class=Origin, namespace="def")
ValueListRef = T.ODMObject(element_class=ValueListRef, namespace="def")
Alias = T.ODMListObject(element_class=Alias)
class ODM(OE.ODMElement):
Description = T.String(required=False)
FileType = T.ValueSetString(required=True)
FileOID = T.OID(required=True)
CreationDateTime = T.DateTimeString(required=True)
PriorFileOID = T.OIDRef(required=False)
AsOfDateTime = T.DateTimeString(required=False)
ODMVersion = T.ValueSetString(required=False)
DatasetXMLVersion = T.ExtendedValidValues(required=True, valid_values=["1.0.0", "1.0.1"])
Originator = T.String(required=False)
SourceSystem = T.String(required=False)
SourceSystemVersion = T.String(required=False)
schemaLocation = T.String(required=False, namespace="xs")
ReferenceData = T.ODMListObject(element_class=ReferenceData)
ClinicalData = T.ODMObject(element_class=ClinicalData)
class StudyEventData(OE.ODMElement):
StudyEventOID = T.OIDRef(required=True)
StudyEventRepeatKey = T.String(required=False)
TransactionType = T.ValueSetString(required=False)
AuditRecord = T.ODMObject(required=False, element_class=AuditRecord)
Signature = T.ODMObject(required=False, element_class=Signature)
Annotation = T.ODMListObject(required=False, element_class=Annotation)
FormData = T.ODMListObject(required=False, element_class=FormData)
def __len__(self):
return len(self.FormData)
def __getitem__(self, position):
return self.FormData[position]
def __iter__(self):
return iter(self.FormData)
class ODM(OE.ODMElement):
""" v2.0 """
Description = T.String(required=False)
FileType = T.ValueSetString(required=True)
Granularity = T.ValueSetString(required=False)
Archival = T.ValueSetString(required=False)
FileOID = T.OID(required=True)
CreationDateTime = T.DateTimeString(required=True)
PriorFileOID = T.OIDRef(required=False)
AsOfDateTime = T.DateTimeString(required=False)
ODMVersion = T.ValueSetString(required=False)
Originator = T.String(required=False)
SourceSystem = T.String(required=False)
SourceSystemVersion = T.String(required=False)
ID = T.ID()
Study = T.ODMListObject(element_class=Study)
AdminData = T.ODMListObject(element_class=AdminData)
class ItemGroupData(OE.ODMElement):
ItemGroupOID = T.OIDRef(required=True)
ItemGroupRepeatKey = T.String(required=False)
TransactionType = T.ValueSetString(required=False)
AuditRecord = T.ODMObject(required=False, element_class=AuditRecord)
Signature = T.ODMObject(required=False, element_class=Signature)
ArchiveLayout = T.ODMObject(required=False, element_class=ArchiveLayout)
Annotation = T.ODMListObject(required=False, element_class=Annotation)
ItemData = T.ODMListObject(required=False, element_class=ItemData)
def __len__(self):
return len(self.ItemData)
def __getitem__(self, position):
return self.ItemData[position]
def __iter__(self):
return iter(self.ItemData)
class MetaDataVersion(ODM.MetaDataVersion):
OID = ODM.MetaDataVersion.OID
Name = ODM.MetaDataVersion.Name
Description = ODM.MetaDataVersion.Description
DefineVersion = T.ValueSetString(required=True, namespace="def")
CommentOID = T.OIDRef(namespace="def")
Standards = T.ODMObject(element_class=Standards, namespace="def")
AnnotatedCRF = T.ODMObject(element_class=AnnotatedCRF, namespace="def")
SupplementalDoc = T.ODMObject(element_class=SupplementalDoc,
namespace="def")
ValueListDef = T.ODMListObject(element_class=ValueListDef, namespace="def")
WhereClauseDef = T.ODMListObject(element_class=WhereClauseDef,
namespace="def")
ItemGroupDef = ODM.MetaDataVersion.ItemGroupDef
ItemDef = ODM.MetaDataVersion.ItemDef
CodeList = ODM.MetaDataVersion.CodeList
MethodDef = ODM.MetaDataVersion.MethodDef
CommentDef = T.ODMListObject(element_class=CommentDef, namespace="def")
leaf = T.ODMListObject(element_class=leaf, namespace="def")
class ODM(OE.ODMElement):
Description = T.String(required=False)
FileType = T.ValueSetString(required=True)
Granularity = T.ValueSetString(required=False)
Archival = T.ValueSetString(required=False)
FileOID = T.OID(required=True)
CreationDateTime = T.DateTimeString(required=True)
PriorFileOID = T.OIDRef(required=False)
AsOfDateTime = T.DateTimeString(required=False)
ODMVersion = T.ValueSetString(required=False)
Originator = T.String(required=False)
SourceSystem = T.String(required=False)
SourceSystemVersion = T.String(required=False)
schemaLocation = T.String(required=False, namespace="xs")
ID = T.ID()
Study = T.ODMListObject(element_class=Study)
AdminData = T.ODMListObject(element_class=AdminData)
ReferenceData = T.ODMListObject(element_class=ReferenceData)
ClinicalData = T.ODMListObject(element_class=ClinicalData)
Association = T.ODMListObject(element_class=Association)
class WhereClauseRef(OE.ODMElement):
namespace = "def"
WhereClauseOID = T.OIDRef(required=True)
class WhereClauseDef(OE.ODMElement):
namespace = "def"
OID = T.OID(required=True)
CommentOID = T.OIDRef(namespace="def")
RangeCheck = T.ODMListObject(required=True, element_class=RangeCheck)
class ValueListRef(OE.ODMElement):
namespace = "def"
ValueListOID = T.OIDRef(required=True)
