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 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 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)
def __len__(self):
return len(self.ItemGroupData)
def __getitem__(self, position):
return self.ItemGroupData[position]
def __iter__(self):
return iter(self.ItemGroupData)
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 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 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)
def __len__(self):
return len(self.StudyEventData)
def __getitem__(self, position):
return self.StudyEventData[position]
def __iter__(self):
return iter(self.StudyEventData)
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
WhereClauseRef = T.ODMListObject(required=True,
element_class=WhereClauseRef,
namespace="def")
class Origin(OE.ODMElement):
namespace = "def"
Type = T.ExtendedValidValues(required=True,
valid_values=[
"Collected", "Derived", "Assigned",
"Protocol", "Predecessor", "Not Available"
])
Source = T.ExtendedValidValues(
valid_values=["Subject", "Investigator", "Vendor", "Sponsor"])
Description = T.ODMObject(element_class=Description)
DocumentRef = T.ODMListObject(element_class=DocumentRef, namespace="def")
class EnumeratedItem(OE.ODMElement):
CodedValue = T.String(required=True)
ExtCodeID = T.String(required=True, namespace="nciodm")
CDISCSynonym = T.ODMListObject(element_class=CDISCSynonym,
namespace="nciodm")
CDISCDefinition = T.ODMObject(required=True,
element_class=CDISCDefinition,
namespace="nciodm")
PreferredTerm = T.ODMObject(required=True,
element_class=PreferredTerm,
namespace="nciodm")
class MetaDataVersion(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
Description = T.String(required=False)
Include = T.ODMObject(element_class=Include)
Protocol = T.ODMObject(element_class=Protocol)
StudyEventDef = T.ODMListObject(element_class=StudyEventDef)
FormDef = T.ODMListObject(element_class=FormDef)
ItemGroupDef = T.ODMListObject(element_class=ItemGroupDef)
ItemDef = T.ODMListObject(element_class=ItemDef)
CodeList = T.ODMListObject(element_class=CodeList)
Presentation = T.ODMListObject(element_class=Presentation)
ConditionDef = T.ODMListObject(element_class=ConditionDef)
MethodDef = T.ODMListObject(element_class=MethodDef)
class ValueListDef(OE.ODMElement):
namespace = "def"
OID = T.OID(required=True)
ItemRef = T.ODMListObject(element_class=ItemRef, required=True)
def __len__(self):
return len(self.ItemRef)
def __getitem__(self, position):
return self.ItemRef[position]
def __iter__(self):
return iter(self.ItemRef)
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 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 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 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 MetaDataVersion(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
Description = T.ODMObject(element_class=Description)
Include = T.ODMObject(element_class=Include)
Protocol = T.ODMObject(element_class=Protocol)
StudyStructure = T.ODMObject(element_class=StudyStructure)
WorkflowDef = T.ODMListObject(element_class=WorkflowDef)
StudyTiming = T.ODMObject(element_class=StudyTiming)
StudyEventGroupDef = T.ODMListObject(element_class=StudyEventGroupDef)
StudyEventDef = T.ODMListObject(element_class=StudyEventDef)
ItemGroupDef = T.ODMListObject(element_class=ItemGroupDef)
ItemDef = T.ODMListObject(element_class=ItemDef)
CodeList = T.ODMListObject(element_class=CodeList)
ConditionDef = T.ODMListObject(element_class=ConditionDef)
MethodDef = T.ODMListObject(element_class=MethodDef)
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.ODMObject(element_class=Origin, namespace="def")
ValueListRef = T.ODMObject(element_class=ValueListRef, namespace="def")
Alias = T.ODMListObject(element_class=Alias)
class Standards(OE.ODMElement):
namespace = "def"
Standard = T.ODMListObject(element_class=Standard,
required=True,
namespace="def")
def __len__(self):
return len(self.Standard)
def __getitem__(self, position):
return self.Standard[position]
def __iter__(self):
return iter(self.Standard)
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 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 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)
class RangeCheck(ODM.RangeCheck):
Comparator = ODM.RangeCheck.Comparator
SoftHard = ODM.RangeCheck.SoftHard
ItemOID = T.OIDRef(required=True, namespace="def")
CheckValue = T.ODMListObject(element_class=CheckValue)
class Description(OE.ODMElement):
TranslatedText = T.ODMListObject(required=True,
element_class=TranslatedText)
class Study(OE.ODMElement):
OID = T.String(required=True)
GlobalVariables = T.ODMObject(required=True, element_class=GlobalVariables)
MetaDataVersion = T.ODMListObject(required=False,
element_class=MetaDataVersion)
class Class(OE.ODMElement):
namespace = "def"
Name = T.Name(required=True)
SubClass = T.ODMListObject(element_class=SubClass, namespace="def")
class CommentDef(OE.ODMElement):
namespace = "def"
OID = T.OID(required=True)
Description = T.ODMObject(element_class=Description)
DocumentRef = T.ODMListObject(element_class=DocumentRef, namespace="def")
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 SupplementalDoc(OE.ODMElement):
namespace = "def"
DocumentRef = T.ODMListObject(required=True,
element_class=DocumentRef,
namespace="def")
class MetaDataVersion(OE.ODMElement):
OID = T.OID(required=True)
Name = T.Name(required=True)
Description = T.String(required=False)
CodeList = T.ODMListObject(element_class=CodeList)
class DocumentRef(OE.ODMElement):
namespace = "def"
leafID = T.String(required=True)
PDFPageRef = T.ODMListObject(element_class=PDFPageRef, namespace="def")
