libname current 'C:\mydata\'; data current.odm; odmversion="1.2"; fileoid="ODM.FileOID"; filetype="Snapshot"; description="Optional descriptive information"; run; data current.study; studyoid="OID.StudyOID"; run; data current.globals; studyname="CDISC Test Study III"; studydescription="This file contains test data for CDISC testing"; protocolname="CDISC-Protocol-00-0000"; run; data current.metadata; metadataversionoid="v1.1.0"; name="Version 1.1.0"; run;
filename xmlout 'C:\XML\aeds.xml'; 1 proc cdisc model=odm write=xmlout; 2 odm data=current.odm; 3 study data=current.study; 4 globalvariables data=current.globals; 5 metadataversion data=current.metadata; 6 clinicaldata data = current.ae 7 domain="AE" name="Adverse Events" comment="All adverse events in this trial"; run; filename xmlout clear;
<?xml version="1.0" encoding="windows-1252" ?> <!-- Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model (ODM) for clinical data interchange You can learn more about CDISC standards efforts at http://www.cdisc.org/standards/index.html --> <ODM xmlns="http://www.cdisc.org/ns/odm/v1.2" xmlns:ds="http://www.w3.org/2000/09/xmldsig#" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xsi:schemaLocation="http://www.cdisc.org/ns/odm/v1.2 ODM1-2-0.xsd" ODMVersion="1.2" FileOID="ODM.FileOID" FileType="Snapshot" Description="Optional descriptive information" AsOfDateTime="2009-03-09T12:45:33" CreationDateTime="2009-03-09T12:45:33" SourceSystem="SAS 9.2 PROC CDISC" SourceSystemVersion="9.02.02M0D01222009 3.00.65"> <Study OID="STUDY.StudyOID"> <!-- GlobalVariables is a REQUIRED section in ODM markup --> <GlobalVariables> <StudyName>CDISC Test Study III</StudyName> <StudyDescription>This file contains test data for CDISC testing</StudyDescription> <ProtocolName>CDISC-Protocol-00-0000</ProtocolName> </GlobalVariables> <BasicDefinitions /> <!-- Internal ODM markup required metadata --> <MetaDataVersion OID="v1.1.0" Name="Version 1.1.0"> <Protocol> <StudyEventRef StudyEventOID="SE.VISIT1" OrderNumber="1" Mandatory="Yes" /> </Protocol> <StudyEventDef OID="SE.VISIT1" Name="Study Event Definition" Repeating="Yes" Type="Common"> <FormRef FormOID="FORM.AE" OrderNumber="1" Mandatory="No" /> </StudyEventDef> <FormDef OID="FORM.AE" Name="Form Definition" Repeating="Yes"> <ItemGroupRef ItemGroupOID="IG.AE" Mandatory="No" /> </FormDef>
<!-- Columns defined in the table --> <ItemGroupDef OID="IG.AE" Repeating="Yes" SASDatasetName="AE" Name="Adverse Events" Domain="AE" Comment="All adverse events in this trial"> <ItemRef ItemOID="ID.TAREA" OrderNumber="1" Mandatory="No" /> <ItemRef ItemOID="ID.PNO" OrderNumber="2" Mandatory="No" /> <ItemRef ItemOID="ID.SCTRY" OrderNumber="3" Mandatory="No" /> <ItemRef ItemOID="ID.F_STATUS" OrderNumber="4" Mandatory="No" /> <ItemRef ItemOID="ID.LINE_NO" OrderNumber="5" Mandatory="No" /> <ItemRef ItemOID="ID.AETERM" OrderNumber="6" Mandatory="No" /> <ItemRef ItemOID="ID.AESTMON" OrderNumber="7" Mandatory="No" /> <ItemRef ItemOID="ID.AESTDAY" OrderNumber="8" Mandatory="No" /> <ItemRef ItemOID="ID.AESTYR" OrderNumber="9" Mandatory="No" /> <ItemRef ItemOID="ID.AESTDT" OrderNumber="10" Mandatory="No" /> <ItemRef ItemOID="ID.AEENMON" OrderNumber="11" Mandatory="No" /> <ItemRef ItemOID="ID.AEENDAY" OrderNumber="12" Mandatory="No" /> <ItemRef ItemOID="ID.AEENYR" OrderNumber="13" Mandatory="No" /> <ItemRef ItemOID="ID.AEENDT" OrderNumber="14" Mandatory="No" /> <ItemRef ItemOID="ID.AESEV" OrderNumber="15" Mandatory="No" /> <ItemRef ItemOID="ID.AEREL" OrderNumber="16" Mandatory="No" /> <ItemRef ItemOID="ID.AEOUT" OrderNumber="17" Mandatory="No" /> <ItemRef ItemOID="ID.AEACTTRT" OrderNumber="18" Mandatory="No" /> <ItemRef ItemOID="ID.AECONTRT" OrderNumber="19" Mandatory="No" /> </ItemGroupDef> <!-- Column attributes as defined in the table --> <ItemDef OID="ID.TAREA" Name="TAREA" SASFieldName="TAREA" DataType="text" Length="4" /> <ItemDef OID="ID.PNO" Name="PNO" SASFieldName="PNO" DataType="text" Length="15" /> <ItemDef OID="ID.SCTRY" Name="SCTRY" SASFieldName="SCTRY" DataType="text" Length="4" /> <ItemDef OID="ID.F_STATUS" Name="F_STATUS" SASFieldName="F_STATUS" DataType="text" Length="1" /> <ItemDef OID="ID.LINE_NO" Name="LINE_NO" SASFieldName="LINE_NO" DataType="integer" Length="2" /> <ItemDef OID="ID.AETERM" Name="AETERM" SASFieldName="AETERM" DataType="text" Length="100" /> <ItemDef OID="ID.AESTMON" Name="AESTMON" SASFieldName="AESTMON" DataType="integer" Length="2" /> <ItemDef OID="ID.AESTDAY" Name="AESTDAY" SASFieldName="AESTDAY" DataType="integer" Length="2" /> <ItemDef OID="ID.AESTYR" Name="AESTYR" SASFieldName="AESTYR" DataType="integer" Length="4" /> <ItemDef OID="ID.AESTDT" Name="AESTDT" SASFieldName="AESTDT" DataType="date" /> <ItemDef OID="ID.AEENMON" Name="AEENMON" SASFieldName="AEENMON" DataType="integer" Length="2" /> <ItemDef OID="ID.AEENDAY" Name="AEENDAY" SASFieldName="AEENDAY" DataType="integer" Length="2" /> <ItemDef OID="ID.AEENYR" Name="AEENYR" SASFieldName="AEENYR" DataType="integer" Length="4" /> <ItemDef OID="ID.AEENDT" Name="AEENDT" SASFieldName="AEENDT" DataType="date" /> <ItemDef OID="ID.AESEV" Name="AESEV" SASFieldName="AESEV" DataType="text" Length="1" /> <ItemDef OID="ID.AEREL" Name="AEREL" SASFieldName="AEREL" DataType="text" Length="1" />
<ItemDef OID="ID.AEOUT" Name="AEOUT" SASFieldName="AEOUT" DataType="text" Length="1" /> <ItemDef OID="ID.AEACTTRT" Name="AEACTTRT" SASFieldName="AEACTTRT" DataType="text" Length="1" /> <ItemDef OID="ID.AECONTRT" Name="AECONTRT" SASFieldName="AECONTRT" DataType="text" Length="1" /> </MetaDataVersion> </Study> <!-- Administrative metadata --> <AdminData /> <!-- Actual data content begins here This section represents each data record in the table --> <ClinicalData StudyOID="STUDY.StudyOID" MetaDataVersionOID="v1.1.0"> <SubjectData SubjectKey="001"> <StudyEventData StudyEventOID="SE.VISIT1" StudyEventRepeatKey="1"> <FormData FormOID="FORM.AE" FormRepeatKey="1"> <ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="1"> <ItemData ItemOID="ID.TAREA" Value="ONC" /> <ItemData ItemOID="ID.PNO" Value="143-02" /> <ItemData ItemOID="ID.SCTRY" Value="USA" /> <ItemData ItemOID="ID.F_STATUS" Value="V" /> <ItemData ItemOID="ID.LINE_NO" Value="1" /> <ItemData ItemOID="ID.AETERM" Value="HEADACHE" /> <ItemData ItemOID="ID.AESTMON" Value="6" /> <ItemData ItemOID="ID.AESTDAY" Value="10" /> <ItemData ItemOID="ID.AESTYR" Value="1999" /> <ItemData ItemOID="ID.AESTDT" Value="1999-06-10" /> <ItemData ItemOID="ID.AEENMON" Value="6" /> <ItemData ItemOID="ID.AEENDAY" Value="14" /> <ItemData ItemOID="ID.AEENYR" Value="1999" /> <ItemData ItemOID="ID.AEENDT" Value="1999-06-14" /> <ItemData ItemOID="ID.AESEV" Value="1" /> <ItemData ItemOID="ID.AEREL" Value="0" /> <ItemData ItemOID="ID.AEOUT" Value="1" /> <ItemData ItemOID="ID.AEACTTRT" Value="0" /> <ItemData ItemOID="ID.AECONTRT" Value="1" /> </ItemGroupData> <ItemGroupData ItemGroupOID="IG.AE" ItemGroupRepeatKey="2"> <ItemData ItemOID="ID.TAREA" Value="ONC" /> <ItemData ItemOID="ID.PNO" Value="143-02" /> <ItemData ItemOID="ID.SCTRY" Value="USA" /> <ItemData ItemOID="ID.F_STATUS" Value="V" /> <ItemData ItemOID="ID.LINE_NO" Value="2" /> <ItemData ItemOID="ID.AETERM" Value="CONGESTION" /> <ItemData ItemOID="ID.AESTMON" Value="6" /> <ItemData ItemOID="ID.AESTDAY" Value="11" /> <ItemData ItemOID="ID.AESTYR" Value="1999" /> <ItemData ItemOID="ID.AESTDT" Value="1999-06-11" /> <ItemData ItemOID="ID.AEENMON" IsNull="Yes" /> <ItemData ItemOID="ID.AEENDAY" IsNull="Yes" /> <ItemData ItemOID="ID.AEENYR" IsNull="Yes" /> <ItemData ItemOID="ID.AEENDT" IsNull="Yes" /> <ItemData ItemOID="ID.AESEV" Value="1" /> <ItemData ItemOID="ID.AEREL" Value="0" /> <ItemData ItemOID="ID.AEOUT" Value="2" /> <ItemData ItemOID="ID.AEACTTRT" Value="0" /> <ItemData ItemOID="ID.AECONTRT" Value="1" /> </ItemGroupData> </FormData> </StudyEventData> </SubjectData> </ClinicalData> </ODM>