class RangeCheck(OE.ODMElement):
""" represents ODM v2.0 RangeCheck element that is a child of ItemDef and can serialize as JSON or XML """
Comparator = T.ValueSetString(required=False)
SoftHard = T.ValueSetString()
CheckValue = T.ODMListObject(element_class=CheckValue)
FormalExpression = T.ODMListObject(element_class=FormalExpression)
ErrorMessage = T.ODMObject(element_class=ErrorMessage)
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 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 RangeCheck(OE.ODMElement):
Comparator = T.ValueSetString(required=False)
SoftHard = T.ValueSetString(required=True)
CheckValue = T.ODMListObject(element_class=CheckValue)
FormalExpression = T.ODMListObject(element_class=FormalExpression)
MeasurementUnitRef = T.ODMObject(element_class=MeasurementUnitRef)
ErrorMessage = T.ODMObject(element_class=ErrorMessage)
class AuditRecord(OE.ODMElement):
EditPoint = T.ValueSetString(required=False)
UsedImputationMethod = T.ValueSetString(required=False)
ID = T.ID(required=False)
UserRef = T.ODMObject(required=True, element_class=UserRef)
LocationRef = T.ODMObject(required=True, element_class=LocationRef)
DateTimeStamp = T.ODMObject(required=True, element_class=DateTimeStamp)
ReasonForChange = T.ODMObject(required=False, element_class=ReasonForChange)
SourceID = T.ODMObject(required=False, element_class=SourceID)
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 ItemRef(ODM.ItemRef):
ItemOID = ODM.ItemRef.ItemOID
OrderNumber = ODM.ItemRef.OrderNumber
Mandatory = ODM.ItemRef.Mandatory
KeySequence = ODM.ItemRef.KeySequence
MethodOID = ODM.ItemRef.MethodOID
Role = ODM.ItemRef.Role
RoleCodeListOID = ODM.ItemRef.RoleCodeListOID
IsNonStandard = T.ValueSetString(namespace="def")
HasNoData = T.ValueSetString(namespace="def")
WhereClauseRef = T.ODMListObject(required=True,
element_class=WhereClauseRef,
namespace="def")
class ODM(OE.ODMElement):
Description = T.String(required=False)
FileType = T.ValueSetString(required=True)
Granularity = T.ValueSetString(required=False)
FileOID = T.OID(required=True)
CreationDateTime = T.DateTimeString(required=True)
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")
Study = T.ODMListObject(element_class=Study)
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 Branching(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
Type = T.ValueSetString(required=True)
TargetTransition = T.ODMListObject(element_class=TargetTransition,
required=True)
DefaultTransition = T.ODMListObject(element_class=DefaultTransition)
class CodeListItem(ODM.CodeListItem):
CodedValue = ODM.CodeListItem.CodedValue
Rank = ODM.CodeListItem.Rank
OrderNumber = ODM.CodeListItem.OrderNumber
ExtendedValue = T.ValueSetString(namespace="def")
Decode = ODM.CodeListItem.Decode
Alias = ODM.CodeListItem.Alias
class PDFPageRef(OE.ODMElement):
namespace = "def"
Type = T.ValueSetString(required=True)
PageRefs = T.String()
FirstPage = T.PositiveInteger()
LastPage = T.PositiveInteger()
Title = T.String()
class EnumeratedItem(ODM.EnumeratedItem):
CodedValue = ODM.EnumeratedItem.CodedValue
Rank = ODM.EnumeratedItem.Rank
OrderNumber = ODM.EnumeratedItem.OrderNumber
ExtendedValue = T.ValueSetString(namespace="def")
Description = ODM.CodeList.Description
Alias = ODM.EnumeratedItem.Alias
class MethodDef(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
Type = T.ValueSetString(required=True)
Description = T.ODMObject(required=True, element_class=Description)
FormalExpression = T.ODMListObject(element_class=FormalExpression)
Alias = T.ODMListObject(element_class=Alias)
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 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 CodeList(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
DataType = T.ValueSetString(required=True)
ExtCodeID = T.String(required=True, namespace="nciodm")
CodeListExtensible = T.ValueSetString(required=True, namespace="nciodm")
Description = T.ODMObject(element_class=Description)
EnumeratedItem = T.ODMListObject(element_class=EnumeratedItem)
CDISCSubmissionValue = T.ODMObject(required=True,
element_class=CDISCSubmissionValue,
namespace="nciodm")
CDISCSynonym = T.ODMObject(required=True,
element_class=CDISCSynonym,
namespace="nciodm")
PreferredTerm = T.ODMObject(required=True,
element_class=PreferredTerm,
namespace="nciodm")
class MethodDef(OE.ODMElement):
""" represents ODM v2.0 MethodDef and can serialize as JSON or XML """
OID = T.OID(required=True)
Name = T.Name(required=True)
Type = T.ValueSetString(required=True)
Description = T.ODMObject(required=True, element_class=Description)
MethodSignature = T.ODMObject(element_class=MethodSignature)
FormalExpression = T.ODMListObject(element_class=FormalExpression)
Alias = T.ODMListObject(element_class=Alias)
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 ItemRef(OE.ODMElement):
ItemOID = T.String(required=True)
OrderNumber = T.Integer(required=False)
Mandatory = T.ValueSetString(required=True)
KeySequence = T.Integer(required=False)
MethodOID = T.String(required=False)
Role = T.String()
RoleCodeListOID = T.String()
CollectionExceptionConditionOID = T.String()
class SubjectData(OE.ODMElement):
SubjectKey = T.String(required=True)
TransactionType = T.ValueSetString(required=False)
AuditRecord = T.ODMObject(required=False, element_class=AuditRecord)
Signature = T.ODMObject(required=False, element_class=Signature)
InvestigatorRef = T.ODMObject(required=False, element_class=InvestigatorRef)
SiteRef = T.ODMObject(required=False, element_class=SiteRef)
Annotation = T.ODMListObject(required=False, element_class=Annotation)
StudyEventData = T.ODMListObject(required=False, element_class=StudyEventData)
class CodeList(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
DataType = T.ValueSetString(required=True)
SASFormatName = T.SASFormat()
Description = T.ODMObject(element_class=Description)
CodeListItem = T.ODMListObject(element_class=CodeListItem)
EnumeratedItem = T.ODMListObject(element_class=EnumeratedItem)
ExternalCodeList = T.ODMObject(element_class=ExternalCodeList)
Alias = T.ODMListObject(element_class=Alias)
class CodeList(OE.ODMElement):
""" represents ODM v1.3.2 CodeList element that can serialize as JSON or XML """
OID = T.OID(required=True)
Name = T.Name(required=True)
DataType = T.ValueSetString(required=True)
SASFormatName = T.SASFormat()
Description = T.ODMObject(element_class=Description)
CodeListItem = T.ODMListObject(element_class=CodeListItem)
EnumeratedItem = T.ODMListObject(element_class=EnumeratedItem)
ExternalCodeList = T.ODMObject(element_class=ExternalCodeList)
Alias = T.ODMListObject(element_class=Alias)
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 StudyEventDef(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
Repeating = T.ValueSetString(required=True)
Type = T.ValueSetString(required=True)
Category = T.String(required=False)
Description = T.ODMObject(element_class=Description)
FormRef = T.ODMListObject(element_class=FormRef)
Alias = T.ODMListObject(element_class=Alias)
def __len__(self):
""" returns the number of FormRefs in an StudyEventDef object as the length """
return len(self.FormRef)
def __getitem__(self, position):
""" creates an iterator from an StudyEventDef object that returns the FormRef in position """
return self.FormRef[position]
def __iter__(self):
return iter(self.FormRef)
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 ItemGroupDef(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
Repeating = T.ValueSetString(required=True)
IsReferenceData = T.ValueSetString(required=False)
SASDatasetName = T.SASName()
Domain = T.String()
Origin = T.String()
Purpose = T.String()
Comment = T.String()
Description = T.ODMObject(element_class=Description)
ItemRef = T.ODMListObject(element_class=ItemRef)
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 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 ODM(ODM.ODM):
FileType = ODM.ODM.FileType
FileOID = ODM.ODM.FileOID
CreationDateTime = ODM.ODM.CreationDateTime
AsOfDateTime = ODM.ODM.AsOfDateTime
ODMVersion = ODM.ODM.ODMVersion
Originator = ODM.ODM.Originator
SourceSystem = ODM.ODM.SourceSystem
SourceSystemVersion = ODM.ODM.SourceSystemVersion
schemaLocation = ODM.ODM.schemaLocation
Context = T.ValueSetString(required=True, namespace="def")
ID = ODM.ODM.ID
Study = T.ODMObject(required=True, element_class=Study)
class User(OE.ODMElement):
OID = T.OID(required=True)
UserType = T.ValueSetString()
LoginName = T.ODMObject(element_class=LoginName)
DisplayName = T.ODMObject(element_class=DisplayName)
FullName = T.ODMObject(element_class=FullName)
FirstName = T.ODMObject(element_class=FirstName)
LastName = T.ODMObject(element_class=LastName)
Organization = T.ODMObject(element_class=Organization)
Address = T.ODMListObject(element_class=Address)
Email = T.ODMListObject(element_class=Email)
Pager = T.ODMObject(element_class=Pager)
Fax = T.ODMListObject(element_class=Fax)
Phone = T.ODMListObject(element_class=Phone)
LocationRef = T.ODMListObject(element_class=LocationRef)
Certificate = T.ODMListObject(element_class=Certificate)
