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)