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CustomData
This is the extension element to include a name, value pair attached to an element in the custom event XML.
XPath
ODM/ClinicalData/SubjectData/pf:SubjectStatus/pf:CustomData
Example
<pf:SubjectStatus State="Enrolled">
<pf:CustomData Name="CustomDataName" Value="CustomDataValue" />
</pf:SubjectStatus>
XPath
ODM/ClinicalData/SubjectData/pf:StudyEventStatus/pf:CustomData
Example
<pf:StudyEventStatus Complete="No" Frozen="No" Lock="No" SDV="No" StudyEventOID="vstBASE">
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="Yes" FormOID="MEDHISTiSet" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="Yes" FormOID="frmCGI" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="Yes" FormOID="frmDOV" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="No" FormOID="frmPEBase" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="No" FormOID="frmHamD" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="Yes" FormOID="frmDem" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="Yes" FormOID="frmINCEXC" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="No" FormOID="frmRAND" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="No" FormOID="frmVS" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="No" FormOID="frmPI" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="Yes" FormOID="frmECGBase" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="Yes" FormOID="frmPM" />
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="No" FormOID="frmPreg" />
<pf:CustomData Name="CTMSElementName" Value="VisitStatus" />
</pf:StudyEventStatus>
XPath
ODM/ClinicalData/SubjectData/StudyEventData/FormData/pf:CustomData
Example
<FormData FormOID="frmDem">
<ItemGroupData ItemGroupOID="frmDem.sctDemographics">
<ItemData ItemOID="frmDem.sctDemographics.DateofBirth_DEM.DateofBirth_DEM" Value="1975-12-25T-:-:-+00:00" pf:FormattedDateValue="1975-12-25TUNK:UNK:UNK+00:00" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctDemographics.Race.Race" Value="3" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctDemographics.ScreeningDate_DEM.ScreeningDate_DEM" Value="2011-10-26T-:-:-+00:00" pf:FormattedDateValue="2011-10-26TUNK:UNK:UNK+00:00" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctDemographics.Height.Height" Value="153.0" pf:NormalizedValue="153" pf:Alias="vstBase.frmDem">
<MeasurementUnitRef MeasurementUnitOID="cm" />
<Annotation SeqNum="1" pf:DBUID="20401" pf:GUID="{7725F52A-204D-4A07-A4D9-1980F0D41C97}">
<Comment>2nd comment</Comment>
</Annotation>
</ItemData>
<ItemData ItemOID="frmDem.sctDemographics.OnsetAge.OnsetAge" Value="37.0" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctDemographics.Age.Age" Value="46" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctDemographics.Gender.Gender" Value="2" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctDemographics.AgeGroup.AgeGroup" Value="4" pf:Alias="vstBase.frmDem" />
<pf:InFormItemData InFormItemOID="frmDem.sctDemographics.DateofBirth_DEM" Name="DateofBirth_DEM">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
<pf:InFormItemData InFormItemOID="frmDem.sctDemographics.Race" Name="Race">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
<pf:InFormItemData InFormItemOID="frmDem.sctDemographics.ScreeningDate_DEM" Name="ScreeningDate_DEM">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
<pf:InFormItemData InFormItemOID="frmDem.sctDemographics.Height" Name="Height">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
<pf:InFormItemData InFormItemOID="frmDem.sctDemographics.OnsetAge" Name="OnsetAge">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
<pf:InFormItemData InFormItemOID="frmDem.sctDemographics.Age" Name="Age">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
<pf:InFormItemData InFormItemOID="frmDem.sctDemographics.Gender" Name="Gender">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
<pf:InFormItemData InFormItemOID="frmDem.sctDemographics.AgeGroup" Name="AgeGroup">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
</ItemGroupData>
<ItemGroupData ItemGroupOID="frmDem.PatientMedicalHistory">
<ItemData ItemOID="frmDem.PatientMedicalHistory.MedicalHistory.MedicalHistory" Value="A brief summary of the medical history here." pf:Alias="vstBase.frmDem" />
<pf:InFormItemData InFormItemOID="frmDem.PatientMedicalHistory.MedicalHistory" Name="MedicalHistory">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
</ItemGroupData>
<ItemGroupData ItemGroupOID="frmDem.sctFamilyHistoy">
<ItemData ItemOID="frmDem.sctFamilyHistoy.MaritalStatus.MaritalStatus.NeverMarried" IsNull="Yes" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctFamilyHistoy.MaritalStatus.MaritalStatus.Married" Value="Married" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctFamilyHistoy.MaritalStatus.MaritalStatus.Separated" IsNull="Yes" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctFamilyHistoy.MaritalStatus.MaritalStatus.Divorced" IsNull="Yes" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctFamilyHistoy.MaritalStatus.MaritalStatus.Widowed" IsNull="Yes" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctFamilyHistoy.Children.Children" Value="1" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.sctFamilyHistoy.FamilyHistoryofDepression.FamilyHistoryofDepression.1" Value="1" pf:Alias="vstBase.frmDem">
<Annotation SeqNum="1" pf:DBUID="20567" pf:GUID="{06673504-7BD4-4505-A87C-A52406327D2F}">
<Comment>test comment</Comment>
</Annotation>
</ItemData>
<ItemData ItemOID="frmDem.sctFamilyHistoy.FamilyHistoryofDepression.FamilyHistoryofDepression.2" Value="2" pf:Alias="vstBase.frmDem">
<Annotation SeqNum="1" pf:DBUID="20567" pf:GUID="{06673504-7BD4-4505-A87C-A52406327D2F}">
<Comment>test comment</Comment>
</Annotation>
</ItemData>
<ItemData ItemOID="frmDem.sctFamilyHistoy.FamilyHistoryofDepression.FamilyHistoryofDepression.3" Value="3" pf:Alias="vstBase.frmDem">
<Annotation SeqNum="1" pf:DBUID="20567" pf:GUID="{06673504-7BD4-4505-A87C-A52406327D2F}">
<Comment>test comment</Comment>
</Annotation>
</ItemData>
<ItemData ItemOID="frmDem.sctFamilyHistoy.FamilyHistoryofDepression.FamilyHistoryofDepression.1.FamilyHistoryYes.Grandparent" IsNull="Yes" pf:Alias="vstBase.frmDem">
<Annotation SeqNum="1" pf:DBUID="20567" pf:GUID="{06673504-7BD4-4505-A87C-A52406327D2F}">
<Comment>test comment</Comment>
</Annotation>
</ItemData>
<ItemData ItemOID="frmDem.sctFamilyHistoy.FamilyHistoryofDepression.FamilyHistoryofDepression.1.FamilyHistoryYes.Parent" IsNull="Yes" pf:Alias="vstBase.frmDem">
<Annotation SeqNum="1" pf:DBUID="20567" pf:GUID="{06673504-7BD4-4505-A87C-A52406327D2F}">
<Comment>test comment</Comment>
</Annotation>
</ItemData>
<ItemData ItemOID="frmDem.sctFamilyHistoy.FamilyHistoryofDepression.FamilyHistoryofDepression.1.FamilyHistoryYes.Parent_Sibling" Value="Parent_Sibling" pf:Alias="vstBase.frmDem">
<Annotation SeqNum="1" pf:DBUID="20567" pf:GUID="{06673504-7BD4-4505-A87C-A52406327D2F}">
<Comment>test comment</Comment>
</Annotation>
</ItemData>
<ItemData ItemOID="frmDem.sctFamilyHistoy.FamilyHistoryofDepression.FamilyHistoryofDepression.1.FamilyHistoryYes.Sibling" Value="Sibling" pf:Alias="vstBase.frmDem">
<Annotation SeqNum="1" pf:DBUID="20567" pf:GUID="{06673504-7BD4-4505-A87C-A52406327D2F}">
<Comment>test comment</Comment>
</Annotation>
</ItemData>
<ItemData ItemOID="frmDem.sctFamilyHistoy.FamilyHistoryofDepression.FamilyHistoryofDepression.1.FamilyHistoryYes.Other" Value="Other" pf:Alias="vstBase.frmDem">
<Annotation SeqNum="1" pf:DBUID="20567" pf:GUID="{06673504-7BD4-4505-A87C-A52406327D2F}">
<Comment>test comment</Comment>
</Annotation>
</ItemData>
<ItemData ItemOID="frmDem.sctFamilyHistoy.FamilyHistoryofDepression.FamilyHistoryofDepression.1.FamilyHistoryYes.Other.OtherSpecify" Value="What is this" pf:Alias="vstBase.frmDem">
<Annotation SeqNum="1" pf:DBUID="20567" pf:GUID="{06673504-7BD4-4505-A87C-A52406327D2F}">
<Comment>test comment</Comment>
</Annotation>
</ItemData>
<pf:InFormItemData InFormItemOID="frmDem.sctFamilyHistoy.MaritalStatus" Name="MaritalStatus">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
<pf:InFormItemData InFormItemOID="frmDem.sctFamilyHistoy.Children" Name="Children">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
<pf:InFormItemData InFormItemOID="frmDem.sctFamilyHistoy.FamilyHistoryofDepression" Name="FamilyHistoryofDepression">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
</ItemGroupData>
<ItemGroupData ItemGroupOID="frmDem.EmploymentInfo">
<ItemData ItemOID="frmDem.EmploymentInfo.Employed.Employed" Value="1" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.EmploymentInfo.Occupation.Occupation" Value="5" pf:Alias="vstBase.frmDem" />
<ItemData ItemOID="frmDem.EmploymentInfo.AutoFileName" IsNull="Yes" />
<pf:InFormItemData InFormItemOID="frmDem.EmploymentInfo.Employed" Name="Employed">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
<pf:InFormItemData InFormItemOID="frmDem.EmploymentInfo.Occupation" Name="Occupation">
<pf:ItemStatus SourceVerified="No" Critical="StudyDefault" />
</pf:InFormItemData>
</ItemGroupData>
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="Yes" />
<pf:CustomData Name="CTMSElementName" Value="FormDemData" />
</FormData>
XPath
ODM/ClinicalData/SubjectData/StudyEventData/FormData/pf:FormStatus/pf:CustomData
Example
<FormData FormOID="frmDem">
<pf:FormStatus Activated="Yes" Frozen="No" Locked="No" Deleted="No" SVReady="No" SVPartial="No" SVComplete="No" SVSelected="Yes" Signed="No" Completed="Yes">
<pf:CustomData Name="CTMSElementName" Value="DemFormStatus" />
</pf:FormStatus>
</FormData>
XPath
ODM/ClinicalData/SubjectData/StudyEventData/FormData/ItemGroupData/pf:CustomData
Example
<ItemGroupData ItemGroupOID="frmDOSE.sctDosingRecordEntry.sctDosingRecordEntry" ItemGroupRepeatKey="404831346876015">
<pf:ItemGroupStatus SVComplete="Yes" Deleted="No" />
<pf:CustomData Name="CTMSElementName" Value="ItemsetStatus" />
</ItemGroupData>
XPath
ODM/ClinicalData/SubjectData/StudyEventData/FormData/ItemGroupData/ItemData/pf:CustomData\
Example
<ItemData ItemOID="frmDOV2.sctFormstobecompleted.Checkallforms.Checkallforms.ECG" IsNull="Yes" pf:Alias="CheckBoxGroup">
<pf:CustomData Name="CTMSElementName" Value="ItemData" />
</ItemData>
